# Jurnalul Oficial C 316/2011

| | ISSN 1977-1029
  doi:10.3000/19771029.C_2011.316.ron |
| --- | --- |
| Jurnalul Oficial
  al Uniunii Europene | C 316 |
| | |
| Ediţia în limba română | Comunicări şi informări | Anul 5428 octombrie 2011 |

ISSN 1977-1029

doi:10.3000/19771029.C_2011.316.ron

Jurnalul Oficial

al Uniunii Europene

C 316

Ediţia în limba română

Comunicări şi informări

Anul 5428 octombrie 2011

---

| Informarea nr. | Cuprins | Pagina |
| --- | --- | --- |
| | IV   Informări |
| | INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE |
| | Comisia Europeană |
| 2011/C 316/01 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] | 1 |
| 2011/C 316/02 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE
  sau al articolului 38 din Directiva 2001/82/CE
  ) | 18 |

Informarea nr.

Cuprins

Pagina

IV   Informări

INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

2011/C 316/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

2011/C 316/02

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE
  sau al articolului 38 din Directiva 2001/82/CE
  )

(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE

sau al articolului 38 din Directiva 2001/82/CE

)

18

| RO | |
| --- | --- |

RO

---

IV Informări

INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

| 28.10.2011 | RO | Jurnalul Oficial al Uniunii Europene | C 316/1 |
| --- | --- | --- | --- |

28.10.2011

RO

Jurnalul Oficial al Uniunii Europene

C 316/1

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului
   (1)
  ]

2011/C 316/01

—   Emiterea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.7.2011 | Benlysta | belimumab | Glaxo Group Limited |
| Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

13.7.2011

Benlysta

belimumab

Glaxo Group Limited

Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/11/700/001-002

Pulbere pentru concentrat pentru soluție perfuzabilă

L04AA26

15.7.2011

13.7.2011

Temozolomide Sun

temozolomidă

| Sun Pharmaceuticals Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697/001-012

Capsule

L01AX03

18.7.2011

13.7.2011

Xgeva

denosumab

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703/001-002

Soluție injectabilă

M05BX04

15.7.2011

13.7.2011

Yervoy

ipilimumab

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/698/001-002

Concentrat pentru soluție perfuzabilă

L01XC11

15.7.2011

18.7.2011

Victrelis

boceprevir

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/11/704/001

Capsule

J05AE

20.7.2011

20.7.2011

Fampyra

fampridină

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/11/699/001-002

Comprimat cu eliberare prelungită

N07XX07

25.7.2011

20.7.2011

TOBI Podhaler

Tobramicină

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/10/652/001-003

Capsulă cu pulbere de inhalat

J01GB01

25.7.2011

26.7.2011

Ibandronic acid Sandoz

acid ibandronic

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/11/685/001-005

Comprimat filmat

M05BA06

28.7.2011

27.7.2011

Zoely

nomegestrol/estradiol

| Merck Serono Europe Limited |
| --- |
| 56 Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Limited

56 Marsh Wall, London E14 9TP, United Kingdom

EU/1/11/690/001-002

Comprimat filmat

G03AA14

1.8.2011

18.8.2011

Entacapone Orion

entacaponă

| Orion Corporation |
| --- |
| Orionintie 1, FI-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708/001-004

Comprimat filmat

N04BX02

22.8.2011

24.8.2011

Levodopa/Carbidopa/Entacapone Orion

levodopa/carbidopa/entacapona

| Orion Corporation |
| --- |
| Orionintie 1, FI-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706/001-033

Comprimat filmat

N04BA03

29.8.2011

24.8.2011

Trajenta

linagliptin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707/001-011

Comprimat filmat

A10BH05

30.8.2011

26.8.2011

Levetiracetam ratiopharm

Levetiracetam

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/11/702/001-031

Comprimat filmat

Soluție orală

N03AX14

31.8.2011

26.8.2011

Levetiracetam Teva

Levetiracetam

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/11/701/001-028

Comprimat filmat

N03AX14

31.8.2011

—   Modificarea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 5.7.2011 | Irbesartan Winthrop | Sanofi-Aventis |
| 174, avenue de France, F-75013 Paris, France |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

5.7.2011

Irbesartan Winthrop

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/376/001-033

7.7.2011

5.7.2011

Relistor

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/08/463/001-011

7.7.2011

7.7.2011

Adrovance

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/364/005

EU/1/06/364/009

11.7.2011

7.7.2011

Ammonaps

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/99/120/001-004

12.7.2011

7.7.2011

Hirobriz Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/594/001-010

11.7.2011

7.7.2011

Modigraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

11.7.2011

7.7.2011

Removab

| Fresenius Biotech GmbH |
| --- |
| Am Haag 6-7, D-82166 Graefelfing, Deutschland |

Fresenius Biotech GmbH

Am Haag 6-7, D-82166 Graefelfing, Deutschland

EU/1/09/512/001-002

11.7.2011

11.7.2011

NovoRapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

EU/1/99/119/017-023

13.7.2011

11.7.2011

Onbrez Breezhaler

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593/001-010

13.7.2011

11.7.2011

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/07/394/001-009

13.7.2011

13.7.2011

Sildenafil ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603/001-015

18.7.2011

13.7.2011

Stocrin

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/99/111/001-005

EU/1/99/111/008-011

18.7.2011

13.7.2011

Sustiva

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

18.7.2011

13.7.2011

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/132/001-050

18.7.2011

13.7.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

18.7.2011

18.7.2011

Crixivan

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/96/024/001-005

EU/1/96/024/010

20.7.2011

18.7.2011

Intrinsa

| Warner Chilcott UK Ltd |
| --- |
| Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom |

Warner Chilcott UK Ltd

Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom

EU/1/06/352/001-003

20.7.2011

18.7.2011

Livensa

| Warner Chilcott Deutschland Gmbh |
| --- |
| Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland |

Warner Chilcott Deutschland Gmbh

Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland

EU/1/06/351/001-003

20.7.2011

18.7.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

20.7.2011

18.7.2011

ReFacto AF

| Wyeth Europa Ltd. |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-008

20.7.2011

18.7.2011

Savene

| SpePharm Holding BV |
| --- |
| Kingsfordweg 151, GR Amsterdam 1043, Nederland |

SpePharm Holding BV

Kingsfordweg 151, GR Amsterdam 1043, Nederland

EU/1/06/350/001

20.7.2011

20.7.2011

Atriance

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/403/001

25.7.2011

20.7.2011

Betaferon

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, D - 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

Müllerstrasse 170-178, D - 13342 Berlin, Deutschland

EU/1/95/003/003-012

25.7.2011

20.7.2011

Esbriet

| InterMune UK Ltd |
| --- |
| 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom |

InterMune UK Ltd

4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom

EU/1/11/667/001-003

26.7.2011

20.7.2011

Intelence

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

25.7.2011

20.7.2011

Ratiograstim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/08/444/001-012

25.7.2011

20.7.2011

Rivastigmine 1 A Pharma

| 1 A Pharma GmbH |
| --- |
| Keltenring 1+3, Oberhaching 82041, Deutschland |

1 A Pharma GmbH

Keltenring 1+3, Oberhaching 82041, Deutschland

EU/1/09/585/001-018

25.7.2011

20.7.2011

Rivastigmine Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/09/599/001-018

25.7.2011

20.7.2011

Silgard

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-008

EU/1/06/358/018-021

25.7.2011

20.7.2011

Zalasta

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415/001-056

25.7.2011

26.7.2011

Avaglim

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/06/349/001-010

28.7.2011

26.7.2011

Bondronat

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/012/004

EU/1/96/012/009-013

28.7.2011

26.7.2011

Busilvex

| Pierre Fabre Médicament |
| --- |
| 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France |

Pierre Fabre Médicament

45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France

EU/1/03/254/002

28.7.2011

26.7.2011

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/296/001-009

28.7.2011

26.7.2011

Forsteo

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/03/247/001-002

28.7.2011

26.7.2011

Infanrix hexa

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-008

EU/1/00/152/019-020

28.7.2011

26.7.2011

Kuvan

| Merck Serono Europe Limited |
| --- |
| 56 Marsh Wall, London E14 9TP, United Kingdom |

Merck Serono Europe Limited

56 Marsh Wall, London E14 9TP, United Kingdom

EU/1/08/481/001-003

28.7.2011

26.7.2011

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614/001-003

28.7.2011

26.7.2011

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

28.7.2011

26.7.2011

Retacrit

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/07/431/001-025

28.7.2011

26.7.2011

Stelara

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

28.7.2011

26.7.2011

Xeristar

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/297/001-008

28.7.2011

27.7.2011

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

2.8.2011

27.7.2011

Beromun

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/99/097/001

1.8.2011

27.7.2011

Bondenza

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/266/003-006

29.7.2011

27.7.2011

Bonviva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/265/003-006

29.7.2011

27.7.2011

Copalia

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372/001-039

1.8.2011

27.7.2011

Dafiro

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371/001-039

1.8.2011

27.7.2011

Ecalta

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/416/001-002

29.7.2011

27.7.2011

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

3.8.2011

27.7.2011

Eporatio

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/573/001-028

29.7.2011

27.7.2011

Exforge

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370/001-039

29.7.2011

27.7.2011

Exjade

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/356/001-009

1.8.2011

27.7.2011

Faslodex

| AstraZeneca UK Limited |
| --- |
| Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom |

AstraZeneca UK Limited

Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom

EU/1/03/269/001-002

1.8.2011

27.7.2011

Fosavance

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/310/005

EU/1/05/310/009

29.7.2011

27.7.2011

Gardasil

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-008

EU/1/06/357/018-021

29.7.2011

27.7.2011

Imprida

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373/001-039

29.7.2011

27.7.2011

Integrilin

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex, UB6 ONN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/99/109/001-002

1.8.2011

27.7.2011

Kiovig

| Baxter AG |
| --- |
| Industriestraße 67, A - 1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A - 1221 Wien, Österreich

EU/1/05/329/001-006

29.7.2011

27.7.2011

Leflunomide Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604/001-010

2.8.2011

27.7.2011

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/07/433/001

29.7.2011

27.7.2011

PhotoBarr

| Axcan Pharma International BV |
| --- |
| Engelenkampstraat 72, 6131 JJ Sittard, Nederland |

Axcan Pharma International BV

Engelenkampstraat 72, 6131 JJ Sittard, Nederland

EU/1/04/272/001-002

2.8.2011

27.7.2011

PREZISTA

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

2.8.2011

27.7.2011

Rapamune

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

1.8.2011

27.7.2011

Relistor

| TMC Pharma Services Ltd. |
| --- |
| Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom |

TMC Pharma Services Ltd.

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom

EU/1/08/463/001-011

1.8.2011

27.7.2011

Silgard

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-021

2.8.2011

27.7.2011

Sycrest

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/10/640/001-006

2.8.2011

27.7.2011

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

29.7.2011

27.7.2011

Truvada

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

3.8.2011

27.7.2011

Valdoxan

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France |

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

1.8.2011

27.7.2011

Vantavo

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/572/005

EU/1/09/572/009

1.8.2011

27.7.2011

Yentreve

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-008

29.7.2011

1.8.2011

alli

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/401/007-016

3.8.2011

1.8.2011

Doribax

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

3.8.2011

1.8.2011

Gardasil

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-021

3.8.2011

1.8.2011

Iressa

| AstraZeneca AB |
| --- |
| Sodertalje S 151 85, Sverige |

AstraZeneca AB

Sodertalje S 151 85, Sverige

EU/1/09/526/001-002

3.8.2011

1.8.2011

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

2.8.2011

1.8.2011

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-014

3.8.2011

1.8.2011

Rivastigmine Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/513/001-020

3.8.2011

1.8.2011

RoActemra

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

3.8.2011

5.8.2011

ATryn

| GTC Biotherapeutics UK Limited |
| --- |
| 10 Norwich Street, London EC4A 1BD, United Kingdom |

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355/001-003

10.8.2011

5.8.2011

Biograstim

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a, D-13407 Berlin, Deutschland |

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/08/450/001-010

10.8.2011

5.8.2011

Biopoin

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a, D-13407 Berlin, Deutschland |

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

10.8.2011

5.8.2011

Enbrel

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-022

10.8.2011

5.8.2011

Focetria

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

10.8.2011

5.8.2011

Hepsera

| Gilead Sciences International Limited |
| --- |
| Cambridge, CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/03/251/001-002

10.8.2011

5.8.2011

Hycamtin

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/96/027/001

EU/1/96/027/003-007

10.8.2011

5.8.2011

InductOs

| Wyeth Europa Ltd. |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

10.8.2011

5.8.2011

Silapo

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432/001-022

10.8.2011

5.8.2011

Synflorix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-010

10.8.2011

5.8.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

10.8.2011

10.8.2011

Arava

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

12.8.2011

10.8.2011

Cholestagel

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/268/001-004

12.8.2011

10.8.2011

Filgrastim Hexal

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496/001-016

12.8.2011

10.8.2011

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

12.8.2011

10.8.2011

Optisulin

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

12.8.2011

10.8.2011

Oslif Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/586/001-010

12.8.2011

10.8.2011

Vidaza

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom |

Celgene Europe Ltd

1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom

EU/1/08/488/001

12.8.2011

10.8.2011

Zarzio

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, A-6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495/001-016

12.8.2011

18.8.2011

Ariclaim

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/283/008-012

22.8.2011

18.8.2011

Karvezide

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

22.8.2011

18.8.2011

Osseor

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France |

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

22.8.2011

18.8.2011

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

22.8.2011

18.8.2011

Protelos

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France |

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

22.8.2011

18.8.2011

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

22.8.2011

18.8.2011

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

22.8.2011

19.8.2011

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430/001-002

23.8.2011

24.8.2011

Afinitor

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

30.8.2011

24.8.2011

Efficib

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457/001-016

30.8.2011

24.8.2011

Enbrel

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/99/126/001-022

9.9.2011

24.8.2011

Intelence

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 - 2340 Beerse - België |

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

30.8.2011

24.8.2011

IntronA

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/127/011-039

EU/1/99/127/041-044

30.8.2011

24.8.2011

Janumet

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455/001-016

30.8.2011

24.8.2011

Januvia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383/001-018

30.8.2011

24.8.2011

Kentera

| Nicobrand Limited |
| --- |
| 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP |

Nicobrand Limited

189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP

EU/1/03/270/001-005

30.8.2011

24.8.2011

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

30.8.2011

24.8.2011

Mepact

| IDM PHARMA SAS |
| --- |
| 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France |

IDM PHARMA SAS

11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France

EU/1/08/502/001

30.8.2011

24.8.2011

Micardis

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/98/090/017-022

29.8.2011

24.8.2011

Modigraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

29.8.2011

24.8.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

26.8.2011

24.8.2011

Mycamine

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/08/448/001-002

26.8.2011

24.8.2011

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon, Industrial Estate, Co.Clare, Ireland |

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/05/331/001-055

26.8.2011

24.8.2011

Nplate

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497/001-008

30.8.2011

24.8.2011

Optisulin

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

29.8.2011

24.8.2011

Osigraft

| Howmedica International S. de R.L. |
| --- |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

30.8.2011

24.8.2011

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/131/001-050

26.8.2011

24.8.2011

Pelzont

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/460/001-014

26.8.2011

24.8.2011

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/107/001-005

29.8.2011

24.8.2011

Reyataz

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267/001-010

30.8.2011

24.8.2011

Ristaben

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621/001-018

30.8.2011

24.8.2011

Ristfor

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620/001-016

30.8.2011

24.8.2011

Stalevo

| Orion Corporation |
| --- |
| Orionintie 1, FIN-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-038

30.8.2011

24.8.2011

Starlix

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/174/001-021

30.8.2011

24.8.2011

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

26.8.2011

24.8.2011

Tesavel

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435/001-018

30.8.2011

24.8.2011

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/122/001-002

30.8.2011

24.8.2011

Tredaptive

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/459/001-014

30.8.2011

24.8.2011

Trevaclyn

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/458/001-014

30.8.2011

24.8.2011

Tygacil

| Wyeth Europa Ltd. |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

30.8.2011

24.8.2011

VELCADE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

30.8.2011

24.8.2011

Velmetia

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456/001-016

30.8.2011

24.8.2011

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/212/001-026

30.8.2011

24.8.2011

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/132/001-050

30.8.2011

24.8.2011

Yttriga

| Eckert & Ziegler Nuclitec GmbH |
| --- |
| Gieselweg 1, Braunschweig 38110, Deutschland |

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1, Braunschweig 38110, Deutschland

EU/1/05/322/001-002

29.8.2011

24.8.2011

Zevalin

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/264/001

30.8.2011

24.8.2011

Zometa

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-009

30.8.2011

26.8.2011

Alisade

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex, UB6 ONN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/08/474/001-003

31.8.2011

26.8.2011

Avamys

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/434/001-003

31.8.2011

26.8.2011

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

31.8.2011

26.8.2011

Corlentor

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France |

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/317/001-014

31.8.2011

26.8.2011

Fertavid

| SP Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |

SP Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/09/510/001-019

31.8.2011

26.8.2011

HBVAXPRO

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, 69007 Lyon, France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

31.8.2011

26.8.2011

Insulin Human Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

31.8.2011

26.8.2011

Procoralan

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France |

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/316/001-014

31.8.2011

26.8.2011

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, NL-4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

31.8.2011

26.8.2011

Sebivo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/388/001-003

31.8.2011

26.8.2011

Tepadina

| ADIENNE S.r.l. |
| --- |
| via Broseta, 64/B, 24128 Bergamo, Italia |

ADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo, Italia

EU/1/10/622/001-002

31.8.2011

26.8.2011

Topotecan Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, DR Utrecht 3542, Nederland |

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/09/552/001-004

31.8.2011

—   Emiterea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului
   (2)
  ): Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.8.2011 | Proteq West Nile | Canarypox virus recombinat West Nile (vCP2017) | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

5.8.2011

Proteq West Nile

Canarypox virus recombinat West Nile (vCP2017)

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/129/001-004

Suspension pentru injecție

QI05AX

10.8.2011

5.8.2011

Zulvac 1 Bovis

Virus Inactivat al Bolii Limbii Albastre, serotip 1, tulpina BTV-1/ALG2006/01 E1 RP ≥ 1

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/11/130/001-003

Suspension pentru injecție

QI02AA08

10.8.2011

5.8.2011

Zulvac 1 Ovis

Virus Inactivat al Bolii Limbii Albastre, serotip 1, tulpina BTV-1/ALG2006/01 E1 RP ≥ 1

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/11/131/001-006

Suspension pentru injecție

QI04AA02

10.8.2011

18.8.2011

Emdocam

Meloxicam

| Emdoka bvba |
| --- |
| J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe |

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe

EU/2/11/128/001-003

Soluție injectabilă

QM01AC06

22.8.2011

—   Modificarea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 7.7.2011 | Leucofeligen FeLV/RCP | VIRBAC S.A. |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

7.7.2011

Leucofeligen FeLV/RCP

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France

EU/2/09/097/001-002

11.7.2011

7.7.2011

Palladia

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/09/100/001-003

12.7.2011

7.7.2011

ProMeris Duo

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/2/06/065/001-010

11.7.2011

11.7.2011

Trocoxil

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/08/084/001-005

13.7.2011

13.7.2011

Loxicom

| Norbrook Laboratories Limited |
| --- |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |

Norbrook Laboratories Limited

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090/001-018

18.7.2011

20.7.2011

Posatex

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/08/081/001-003

25.7.2011

27.7.2011

Poulvac FluFend H5N3 RG

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/060/001-002

1.8.2011

27.7.2011

ProMeris

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/064/001-004

1.8.2011

27.7.2011

Slentrol

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/07/071/001-003

2.8.2011

5.8.2011

Cerenia

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/06/062/001-005

10.8.2011

5.8.2011

Virbagen Omega

| VIRBAC S.A. |
| --- |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros - France |

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/01/030/001-004

10.8.2011

19.8.2011

Nobilis Influenza H5N2

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/06/061/001-004

23.8.2011

19.8.2011

Zolvix

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172, DK-2100 Copenhagen, Danmark |

Novartis Healthcare A/S

Lyngbyvej 172, DK-2100 Copenhagen, Danmark

EU/2/09/101/001-010

23.8.2011

24.8.2011

Suvaxyn Aujeszky 783 +O/W

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland

EU/2/98/009/001-006

30.8.2011

—   Retragerea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului)

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 10.8.2011 | Yarvitan | Janssen Pharmaceutica N.V. |
| Turnhoutseweg 30, B-2340 Beerse, België |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

10.8.2011

Yarvitan

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, B-2340 Beerse, België

EU/2/06/063/001-003

12.8.2011

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

(1)  JO L 136, 30.4.2004, p. 1.

(2)  JO L 136, 30.4.2004, p. 1.

---

| 28.10.2011 | RO | Jurnalul Oficial al Uniunii Europene | C 316/18 |
| --- | --- | --- | --- |

28.10.2011

RO

Jurnalul Oficial al Uniunii Europene

C 316/18

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 iulie 2011 până la 31 august 2011

(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE
   (1)
  sau al articolului 38 din Directiva 2001/82/CE
   (2)
  )

2011/C 316/02

—   Emiterea, prelungirea sau modificarea unei autorizații naționale de introducere pe piață

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 24.8.2011 | Clavudale | A se vedea anexa I | A se vedea anexa I | 25.8.2011 |
| 20.7.2011 | Kytril | A se vedea anexa II | A se vedea anexa II | 22.7.2011 |
| 13.7.2011 | Doxycycline 50 % WSP and associated names | A se vedea anexa III | A se vedea anexa III | 14.7.2011 |
| 13.7.2011 | Doxyfar 50 % and associated names | A se vedea anexa IV | A se vedea anexa IV | 14.7.2011 |
| 13.7.2011 | alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid | A se vedea anexa V | A se vedea anexa V | 15.7.2011 |
| 13.7.2011 | Dianeal PD4 and Extraneal and associated names | A se vedea anexa VI | A se vedea anexa VI | 15.7.2011 |
| 7.7.2011 | Docetaxel Teva Generics and associated names | A se vedea anexa VII | A se vedea anexa VII | 8.7.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

24.8.2011

Clavudale

A se vedea anexa I

A se vedea anexa I

25.8.2011

20.7.2011

Kytril

A se vedea anexa II

A se vedea anexa II

22.7.2011

13.7.2011

Doxycycline 50 % WSP and associated names

A se vedea anexa III

A se vedea anexa III

14.7.2011

13.7.2011

Doxyfar 50 % and associated names

A se vedea anexa IV

A se vedea anexa IV

14.7.2011

13.7.2011

alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid

A se vedea anexa V

A se vedea anexa V

15.7.2011

13.7.2011

Dianeal PD4 and Extraneal and associated names

A se vedea anexa VI

A se vedea anexa VI

15.7.2011

7.7.2011

Docetaxel Teva Generics and associated names

A se vedea anexa VII

A se vedea anexa VII

8.7.2011

—   Eliberarea unei autorizații de introducere pe piață - lista cererilor refuzate

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 5.8.2011 | Combimox Lactating Cow Intramammary Suspension and associated names | A se vedea anexa VIII | A se vedea anexa VIII | 9.8.2011 |
| 5.8.2011 | Combisyn Lactating Cow Intramammary suspension | A se vedea anexa IX | A se vedea anexa IX | 9.8.2011 |
| 5.8.2011 | Nisamox Lactating Cow Intramammary Suspension | A se vedea anexa X | A se vedea anexa X | 8.8.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

A se vedea anexa VIII

A se vedea anexa VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

A se vedea anexa IX

A se vedea anexa IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

A se vedea anexa X

A se vedea anexa X

8.8.2011

—   Suspendarea unei autorizații naționale de introducere pe piață

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 5.8.2011 | Combimox Lactating Cow Intramammary Suspension and associated names | A se vedea anexa VIII | A se vedea anexa VIII | 9.8.2011 |
| 5.8.2011 | Combisyn Lactating Cow Intramammary suspension | A se vedea anexa IX | A se vedea anexa IX | 9.8.2011 |
| 5.8.2011 | Nisamox Lactating Cow Intramammary Suspension | A se vedea anexa X | A se vedea anexa X | 8.8.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

A se vedea anexa VIII

A se vedea anexa VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

A se vedea anexa IX

A se vedea anexa IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

A se vedea anexa X

A se vedea anexa X

8.8.2011

---

(1)  JO L 311, 28.11.2001, p. 67.

(2)  JO L 311, 28.11.2001, p. 1.

---

ANEXA I

LISTA CU DENUMIRILE COMERCIALE, FORMA FARMACEUTICĂ, CONCENTRAȚIA PRODUSULUI MEDICAMENTOS DE UZ VETERINAR, SPECIILE DE ANIMALE, CALEA DE ADMINISTRARE, SOLICITANTUL/DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ DIN STATELE MEMBRE

| Statul membru UE/SEE | Solicitantul/deținătorul autorizației de punere pe piață | Denumirea comercială | Forma farmaceutică | Concentrații | Specii de animale | Frecvența și calea de administrare | Doza recomandată |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Belgia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Republica Cehă | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Danemarca | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Standard dose rate of 10 mg amoxicillin/2.5 mg clavulanic acid/kg bodyweight |
| Finlanda | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Franța | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Germania | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Grecia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Ungaria | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Islanda | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Irlanda | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Luxemburg | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Țările de Jos | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Norvegia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Polonia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Portugalia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Republica Slovacă | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Spania | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Suedia | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |
| Regatul Unit | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Comprimate | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Pisici și câini | Administrare orală, de două ori pe zi timp de 5-7 zile | Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală |

Statul membru UE/SEE

Solicitantul/deținătorul autorizației de punere pe piață

Denumirea comercială

Forma farmaceutică

Concentrații

Specii de animale

Frecvența și calea de administrare

Doza recomandată

Austria

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Belgia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Republica Cehă

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Danemarca

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Standard dose rate of 10 mg amoxicillin/2.5 mg clavulanic acid/kg bodyweight

Finlanda

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Franța

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Germania

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Grecia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Ungaria

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Islanda

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Irlanda

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Luxemburg

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Țările de Jos

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Norvegia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Polonia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Portugalia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Republica Slovacă

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Spania

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Suedia

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 40 mg/10 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

Regatul Unit

Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom

Clavudale 50 mg tablet for cats and dogs

Comprimate

Amoxicillin 40 mg

Clavulanic acid 10 mg

Pisici și câini

Administrare orală, de două ori pe zi timp de 5-7 zile

Rată de doză standard de 10 mg amoxicilină/2,5 mg acid clavulanic/kg de greutate corporală

---

ANEXA II

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIILE, CĂILE DE ADMINISTRARE ALE MEDICAMENTELOR, DEȚINĂTORII AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat Numele | Concentrația | Forma farmaceutică | Calea de administrare | Conținutul (concentrația) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Roche Austria GmbH, Engelhorngasse 3, 1211 Wien |
| Austria |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat Numele

Concentrația

Forma farmaceutică

Calea de administrare

Conținutul (concentrația)

Austria

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 3 mg - Injektionslösung

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 ml

Austria

| Roche Austria GmbH, Engelhorngasse 3, 1211 Wien |
| --- |
| Austria |

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 2 mg - Filmtabletten

2 mg

Comprimat filmat

Orală

Belgia

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg/1 ml solution injectable

1 mg

Soluție ținjectabilă

Intravenoasă

1 mg/1 ml

Belgia

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 3 mg/3 ml solution injectable

3 mg

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Belgia

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg comprimés pelliculés

1 mg

Comprimat filmat

Orală

Bulgaria

| Roche Bulgaria EOOD, |
| --- |
| 16 Bialo Pole Str. |
| 1618 Sofia |
| Bulgaria |

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

1 mg/ml

Soluție ținjectabilă/ perfuzabilă

Intravenoasă

1 ml (1 mg/ml)

3 ml (1 mg/ml)

Bulgaria

| Roche Bulgaria EOOD, |
| --- |
| 16 Bialo Pole Str. |
| 1618 Sofia |
| Bulgaria |

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

2 mg

Comprimat filmat

Orală

Republica Cehă

| Roche s.r.o., |
| --- |
| Dukelských hrdinů 52 |
| 170 00 Praha 7 |
| Czech Republic |

Roche s.r.o.,

Dukelských hrdinů 52

170 00 Praha 7

Czech Republic

Kytril 2 mg

2 mg

Comprimat filmat

Orală

Republica Cehă

| Roche s.r.o., |
| --- |
| Dukelských hrdinů 52 |
| 170 00 Praha 7 |
| Czech Republic |

Roche s.r.o.,

Dukelských hrdinů 52

170 00 Praha 7

Czech Republic

Kytril inj./inf

1 mg/ml

Soluție ținjectabilă/ perfuzabilă

Intravenoasă

1 mg/1 ml

Estonia

| Roche Eesti OÜ |
| --- |
| Lõõtsa 2, 11415 |
| Tallinn |
| Estonia |

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg/ml

Concentrat pentru soluție ținjectabilă/ perfuzabilă

Intravenoasă

1 mg/ml (1 ml and 3 ml)

Estonia

| Roche Eesti OÜ |
| --- |
| Lõõtsa 2, 11415 |
| Tallinn |
| Estonia |

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg

Comprimat filmat

Orală

Finlanda

| Roche Oy |
| --- |
| PL 12 |
| 02181 Espoo |
| Finland |

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg

Comprimat filmat

Orală

Finlanda

| Roche Oy |
| --- |
| PL 12 |
| 02181 Espoo |
| Finland |

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

2 mg

Comprimat filmat

Orală

Finlanda

| Roche Oy |
| --- |
| PL 12 |
| 02181 Espoo |
| Finland |

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg/ml

Soluție ținjectabilă

Intravenoasă

5 × 1 ml and 5 × 3 ml

Franța

| ROCHE |
| --- |
| 52 Boulevard du Parc |
| 92521 NEUILLY SUR SEINE cedex |
| France |

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 3 mg/3 ml solution injectable pour voie intraveineuse

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Franța

| ROCHE |
| --- |
| 52 Boulevard du Parc |
| 92521 NEUILLY SUR SEINE cedex |
| France |

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 1 mg/ comprimé pelliculé

1 mg

Comprimat filmat

Orală

Franța

| ROCHE |
| --- |
| 52 Boulevard du Parc |
| 92521 NEUILLY SUR SEINE cedex |
| France |

ROCHE

52 Boulevard du Parc

92521 NEUILLY SUR SEINE cedex

France

Kytril 2 mg comprimé pelliculé

2 mg

Comprimat filmat

Orală

Germania

| Roche Pharma AG |
| --- |
| Emil-Barell-Straße 1 |
| 79639 Grenzach-Wyhlen |
| Germany |

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

1 mg/1 ml Injektionslösung

1 mg

Soluție ținjectabilă

Intravenoasă

1 ml

Germania

| Roche Pharma AG |
| --- |
| Emil-Barell-Straße 1 |
| 79639 Grenzach-Wyhlen |
| Germany |

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

Filmtabletten 2 mg

2 mg

Comprimat filmat

Orală

Germania

| Roche Pharma AG |
| --- |
| Emil-Barell-Straße 1 |
| 79639 Grenzach-Wyhlen |
| Germany |

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Kevatril

3 mg/3 ml Injektionslösung

3 mg

Soluție ținjectabilă

Intravenoasă

3 ml

Grecia

| Roche (Hellas ) |
| --- |
| A.E. |
| Alamanas 4 & Delfon, 15125 Maroussi |
| Greece |

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

1 mg

Comprimat filmat

Orală

Grecia

| Roche (Hellas ) |
| --- |
| A.E. |
| Alamanas 4 & Delfon, 15125 Maroussi |
| Greece |

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

2 mg

Comprimat filmat

Orală

Grecia

| Roche (Hellas ) |
| --- |
| A.E. |
| Alamanas 4 & Delfon, 15125 Maroussi |
| Greece |

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

1 mg/1 ml

Soluție ținjectabilă

Intravenoasă

1 mg/1 ml

Grecia

| Roche (Hellas ) |
| --- |
| A.E. |
| Alamanas 4 & Delfon, 15125 Maroussi |
| Greece |

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Ungaria

| Roche (Hungary) Ltd |
| --- |
| H-2040 Budaörs |
| Edison u. 1. |
| Hungary |

Roche (Hungary) Ltd

H-2040 Budaörs

Edison u. 1.

Hungary

Kytril

1 mg

Comprimat filmat

Orală

Ungaria

| Roche (Hungary) Ltd |
| --- |
| H-2040 Budaörs |
| Edison u. 1. |
| Hungary |

Roche (Hungary) Ltd

H-2040 Budaörs

Edison u. 1.

Hungary

Kytril

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Irlanda

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 1 mg

1 mg

Comprimat filmat

Orală

Irlanda

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 2 mg

2 mg

Comprimat filmat

Orală

Irlanda

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Ampoules 1 mg/1 ml concentrate for solution for infusion or injection

1 mg/1 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

1 ml contains 1 mg granisetron (hydrochloride)

1 mg contains 9 mg sodium chloride = 3.54 mg sodium

Irlanda

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Infusion 3 mg/3 ml concentrate for solution for infusion or injection

3 mg/3 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

3 ml contains 3 mg granisetron (hydrochloride)

3 ml contains 27 mg sodium chloride = 10.62 mg sodium

Italia

| Roche S.p.A. |
| --- |
| Piazza Durante 11 |
| 20131 Milano |
| Italy |

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Italia

| Roche S.p.A. |
| --- |
| Piazza Durante 11 |
| 20131 Milano |
| Italy |

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

1 mg/1 ml

Soluție ținjectabilă

Intravenoasă

1 mg/1 ml

Italia

| Roche S.p.A. |
| --- |
| Piazza Durante 11 |
| 20131 Milano |
| Italy |

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

3 mg/5 ml

Soluție ținjectabilă

Intravenoasă

3 mg/5 ml

Italia

| Roche S.p.A. |
| --- |
| Piazza Durante 11 |
| 20131 Milano |
| Italy |

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

1 mg

Comprimat filmat

Orală

Italia

| Roche S.p.A. |
| --- |
| Piazza Durante 11 |
| 20131 Milano |
| Italy |

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

2 mg

Comprimat filmat

Orală

Letonia

| Roche Latvija SIA |
| --- |
| G. Astras 8b |
| Riga, LV-1082 |
| Latvia |

Roche Latvija SIA

G. Astras 8b

Riga, LV-1082

Latvia

Kytril 1 mg/ml solution for injection

1 mg/ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Letonia

| Roche Latvija SIA |
| --- |
| G. Astras 8b |
| Riga, LV-1082 |
| Latvia |

Roche Latvija SIA

G. Astras 8b

Riga, LV-1082

Latvia

Kytril 1 mg film-coated tablets

1 mg

Comprimat filmat

Orală

Lituania

| UAB „Roche Lietuva” |
| --- |
| J. Jasinskio 16b, LT-01112 Vilnius |
| Lithuania |

UAB „Roche Lietuva”

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg

Comprimat filmat

Orală

Lituania

| UAB „Roche Lietuva” |
| --- |
| J. Jasinskio 16b, LT-01112 Vilnius |
| Lithuania |

UAB „Roche Lietuva”

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg/ml

Soluție ținjectabilă/ perfuzabilă

Intravenoasă

1 mg/1 ml

Lituania

| UAB „Roche Lietuva” |
| --- |
| J. Jasinskio 16b, LT-01112 Vilnius |
| Lithuania |

UAB „Roche Lietuva”

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

3 mg/3 ml

Soluție ținjectabilă/ perfuzabilă

Intravenoasă

3 mg/3 ml

Luxemburg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg/1 ml solution injectable

1 mg

Soluție ținjectabilă

Intravenoasă

1 mg/1 ml

Luxemburg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 3 mg/3 ml solution injectable

3 mg

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml

Luxemburg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Kytril 1 mg comprimés pelliculés

1 mg

Comprimat filmat

Orală

Malta

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Tablets 1 mg

1 mg

Comprimat filmat

Orală

Malta

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW, United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW, United Kingdom

Kytril Injection 3 mg/3 ml

3 mg/3 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

1 ml contains 1 mg granisetron (hydrochloride)

Olanda

| Roche Nederland B.V., Postbus 44, 3440 AA Woerden |
| --- |
| Netherlands |

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril i.v. 3 mg = 3 ml, oplossing voor injectie 1 mg/ml

1 mg/ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Olanda

| Roche Nederland B.V., Postbus 44, 3440 AA Woerden |
| --- |
| Netherlands |

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril i.v. 1 mg = 1 ml, oplossing voor injectie 1 mg/ml

1 mg/ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Olanda

| Roche Nederland B.V., Postbus 44, 3440 AA Woerden |
| --- |
| Netherlands |

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril 1 mg tabletten, omhulde tabletten

1 mg

Comprimat filmat

Orală

Olanda

| Roche Nederland B.V., Postbus 44, 3440 AA Woerden |
| --- |
| Netherlands |

Roche Nederland B.V., Postbus 44, 3440 AA Woerden

Netherlands

Kytril 2 mg tabletten, omhulde tabletten

2 mg

Comprimat filmat

Orală

Portugalia

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada nacional 249-1, 2720-413, Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

1 mg

Comprimat filmat

Orală

Portugalia

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada nacional 249-1, 2720-413, Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

2 mg

Comprimat filmat

Orală

Portugalia

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada nacional 249-1, 2720-413, Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

1 mg/1 ml

Soluție ținjectabilă

Intravenoasă

1 ml (1 mg/1 ml)

Portugalia

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada nacional 249-1, 2720-413, Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada nacional 249-1, 2720-413, Amadora

Portugal

Kytril

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 ml (3 mg/3 ml)

România

| Roche Romania SRL |
| --- |
| 9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest |
| Romania |

Roche Romania SRL

9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest

Romania

Kytril 1 mg

1 mg

Comprimat filmat

Orală

România

| Roche Romania SRL |
| --- |
| 9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest |
| Romania |

Roche Romania SRL

9-9A Dimitrie Pompei Street, Building 19, Entrance B, 3rd Floor, Sector (District) 2, Bucharest

Romania

Kytril

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

3 mg/3 ml (1 mg/ml)

Republica Slovacia

| Roche Slovensko s.r.o. |
| --- |
| Cintorínska 3/A |
| Bratislava |
| Slovak Republic |

Roche Slovensko s.r.o.

Cintorínska 3/A

Bratislava

Slovak Republic

Kytril 1 mg

1 mg

Comprimat filmat

Orală

Republica Slovacia

| Roche Slovensko s.r.o. |
| --- |
| Cintorínska 3/A |
| Bratislava |
| Slovak Republic |

Roche Slovensko s.r.o.

Cintorínska 3/A

Bratislava

Slovak Republic

Kytril 2 mg

2 mg

Comprimat filmat

Orală

Republica Slovacia

| F.Hoffmann-La Roche Ltd. |
| --- |
| Basel, Switzerland |

F.Hoffmann-La Roche Ltd.

Basel, Switzerland

Kytril INJ/INF

1 mg/1 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

1 mg/1 ml

Slovenia

| Roche farmacevtska družba d.o.o. |
| --- |
| Vodovodna cesta 109 |
| 1000 Ljubljana |
| Slovenia |

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 2 mg filmsko obložene tablete

2 mg

Comprimat filmat

Orală

Slovenia

| Roche farmacevtska družba d.o.o. |
| --- |
| Vodovodna cesta 109 |
| 1000 Ljubljana |
| Slovenia |

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 1 mg/1 ml raztopina za injiciranje

1 mg/1 ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Slovenia

| Roche farmacevtska družba d.o.o. |
| --- |
| Vodovodna cesta 109 |
| 1000 Ljubljana |
| Slovenia |

Roche farmacevtska družba d.o.o.

Vodovodna cesta 109

1000 Ljubljana

Slovenia

Kytril 3 mg/3 ml raztopina za injiciranje

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Spania

| Roche Farma S.A. |
| --- |
| C/ Eucalipto 33 |
| 28016 Madrid |
| Spain |

Roche Farma S.A.

C/ Eucalipto 33

28016 Madrid

Spain

Kytril 1 mg comprimidos recubiertos con película

1 mg

Comprimat filmat

Orală

Spania

| Roche Farma S.A. |
| --- |
| C/ Eucalipto 33 |
| 28016 Madrid |
| Spain |

Roche Farma S.A.

C/ Eucalipto 33

28016 Madrid

Spain

Kytril 1 mg/1 ml solución inyectable

1 mg/1 ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Spania

| Roche Farma S.A. |
| --- |
| C/ Eucalipto 33 |
| 28016 Madrid |
| Spain |

Roche Farma S.A.

C/ Eucalipto 33

28016 Madrid

Spain

Kytril 3 mg/3 ml solución inyectable

3 mg/3 ml

Soluție ținjectabilă

Intravenoasă

1 mg/ml

Suedia

| Roche AB |
| --- |
| Box 47327 |
| 100 74 Stockholm |
| Sweden |

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg

Comprimat filmat

Orală

Suedia

| Roche AB |
| --- |
| Box 47327 |
| 100 74 Stockholm |
| Sweden |

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

2 mg

Comprimat filmat

Orală

Suedia

| Roche AB |
| --- |
| Box 47327 |
| 100 74 Stockholm |
| Sweden |

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg/ml

Soluție ținjectabilă

Intravenoasă

5 × 1 ml

5 × 3 ml

Marea Britanie

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Tablets 1 mg

1 mg

Comprimat filmat

Orală

Marea Britanie

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Tablets 2 mg

2 mg

Comprimat filmat

Orală

Marea Britanie

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Ampoule 1 mg/1 ml

1 mg/1 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

1 ml contains 1 mg granisetron (hydrochloride)

Marea Britanie

| Roche Products Limited, |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| United Kingdom |

Roche Products Limited,

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

Kytril Infusion 3 mg/ml

3 mg/3 ml

Concentrat pentru soluție țperfuzabilă/ injectabilă

Intravenoasă

1 mg of granisetron per 1 ml solution

---

ANEXA III

DENUMIRE, FORMĂ FARMACEUTICĂ, CONCENTRAȚIA PRODUSULUI MEDICAMENTOS, SPECII DE ANIMALE, CĂI DE ADMINISTRARE ȘI TITULARUL/SOLICITANTUL AUTORIZAȚIEI DE INTRODUCERE PE PIAȚĂ

| Statul membru | Titularul autorizației de introducere pe piață Numele și adresa | Denumirea inventată | INN Concentrație | Forma farmaceutică | Specii de animale |
| --- | --- | --- | --- | --- | --- |
| Belgia | Dopharma Research BV |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Statul membru

Titularul autorizației de introducere pe piață Numele și adresa

Denumirea inventată

INN Concentrație

Forma farmaceutică

Specii de animale

Belgia

Dopharma Research BV

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Viței alăptați, porcine, găini neouătoare

Bulgaria

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 %

WSP

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Viței, porcine, păsări

Danemarca

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxylin Vet.

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Porcine

Grecia

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Pui (pui de carne), viței, porcine

Ungaria

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Pulbere pentru soluție orală

Viței, porcine, pui

Lituania

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 %

Doxycycline hyclate

500 mg/g

Pulbere pentru soluție orală

Viței, porcine, păsări

Olanda

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Pulbere pentru administrare în apa de băut

Găini neouătoare

Polonia

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxymed 50

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Viței, pui, porcine

Portugalia

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Vetadoxi 50

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Bovine (viței), porcine, păsări

România

| Dopharma B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| OLANDA |

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

OLANDA

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Pulbere hidrosolubilă

Păsări (nu se permite utilizarea la păsări care produc ouă pentru consumul uman), viței, porcine

---

ANEXA IV

LISTA DENUMIRILOR, FORMELOR FARMACEUTICE, CONCENTRAȚIILOR PRODUSELOR MEDICINALE VETERINARE, SPECIILOR DE ANIMALE, CĂII DE ADMINISTRARE, TITULARILOR AUTORIZAȚIEI DE INTRODUCERE PE PIAȚĂ DIN STATELE MEMBRE

| Statul membru | Deținătorul autorizației de comercializare | Denumirea atribuită | INN & Concentrația | Forma farmaceutică | Speciile de animale |
| --- | --- | --- | --- | --- | --- |
| Austria | Eurovet Animal Health B.V., |
| Handelsweg 25, 5531 AE Bladel, |
| The Netherlands |

Statul membru

Deținătorul autorizației de comercializare

Denumirea atribuită

INN & Concentrația

Forma farmaceutică

Speciile de animale

Austria

Eurovet Animal Health B.V.,

Handelsweg 25, 5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Austria

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Belgia

| Eurovet N.V. |
| --- |
| Poorthoevestraat 4, 3 |
| 550 Heusen-Zolder |
| Belgium |

Eurovet N.V.

Poorthoevestraat 4, 3

550 Heusen-Zolder

Belgium

Soludox 50 %

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini

Republica Cehă

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Danemarca

| Eurovet Animal Health B.V., |
| --- |
| P.O. 179, |
| Handelsweg 25, |
| NL-5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

P.O. 179,

Handelsweg 25,

NL-5531 AE Bladel,

The Netherlands

Soludox Vet.

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Estonia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, suukaudse lahuse pulber sigadele

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Estonia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, suukaudse lahuse pulber kanadele

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Finlanda

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Finlanda

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi kanoille

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Franța

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour poulets

Doxycycline (as hyclate)

433 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Franța

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson pour porcs.

Doxycycline (as hyclate)

433 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Germania

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Hühner

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Germania

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Grecia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g κόνις για χρήση στο πόσιμο νερό για όρνιθες

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Ungaria

| Eurovet Animal Health B.V., |
| --- |
| P.O. 179, |
| Handelsweg 25, |
| NL-5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

P.O. 179,

Handelsweg 25,

NL-5531 AE Bladel,

The Netherlands

Soludox 50 % pulvis A.U.V.

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Italia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvere per uso in acqua di bevanda per suini

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Italia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvere per uso in acqua di bevanda per polli.

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Letonia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Letonia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni vistām

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Lituania

| Eurovet Animal Health B.V. |
| --- |
| Handelsveg 25 - PO Box 179, |
| 5530 AD Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

SOLUDOX 500 mg/g, geriamieji milteliai,

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini

Olanda

| Eurovet Animal Health B.V. |
| --- |
| Handelsveg 25 - PO Box 179, |
| 5530 AD Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

DOXY ORT 50 %

Poeder voor toediening aan het drinkwater van varkens en kippen

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini.

Olanda

| Eurovet Animal Health B.V. |
| --- |
| Handelsveg 25 - PO Box 179, |
| 5530 AD Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179,

5530 AD Bladel

The Netherlands

DOXYFAR 50 %

Poeder voor toediening aan het drinkwater van varkens en kippen

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini.

Olanda

| Eurovet Animal Health B.V. |
| --- |
| Handelsveg 25 - PO Box 179 |
| 5530 AD Bladel |
| The Netherlands |

Eurovet Animal Health B.V.

Handelsveg 25 - PO Box 179

5530 AD Bladel

The Netherlands

SOLUDOX 50 %, poeder voor toediening via het drinkwater aan varkens en kippen

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini.

Olanda

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg per gram voor gebruik in drinkwater voor kippen

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Polonia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 50 %; 500 mg/g proszek do podawania w wodzie do picia dla swiń i kur

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Găini

Slovacia

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g prášok pre užívanie s pitnou vodou pre ošípané

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Spania

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para porcino

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Spania

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para pollos.

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Regatul Unit al Marii Britanii

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox, 500 mg/g, Water Soluble Powder for Pigs

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

Regatul Unit al Marii Britanii

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g powder for use in drinking water for chickens

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Găini

Regatul Unit al Marii Britanii

| Eurovet Animal Health B.V., |
| --- |
| Handelsweg 25, |
| 5531 AE Bladel, |
| The Netherlands |

Eurovet Animal Health B.V.,

Handelsweg 25,

5531 AE Bladel,

The Netherlands

Soludox 500 mg/g powder for use in drinking water for pigs

Doxycycline hyclate

500 mg/g

Pulbere pentru utilizare în apa de băut

Porci

---

ANEXA V

LISTA CU NUMELE, FORMA FARMACEUTICA SI DOZAJUL PRODUSULUI MEDICAMENTOS, CALEA DE ADMINISTRARE, DETINATORUL DE AUTORIZATIE DE PUNERE PE PIATA IN STATELE MEMBRE

Produse medicamentoase care contin acid alendronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 |
| Wien, Austria |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

AT - Austria

AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120

Wien, Austria

Alemol 70 mg - einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

| Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 |
| --- |
| Wien, Austria |

Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020

Wien, Austria

Alendrohexal 70 mg - einmal wöchentlich Filmtabletten

70 mg

Comprimate filmate

orala

AT - Austria

| Genericon Pharma GmbH, Hafnerstraße 211, A-8054 |
| --- |
| Graz, Austria |

Genericon Pharma GmbH, Hafnerstraße 211, A-8054

Graz, Austria

Alendronorm 70 mg - einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK

Alendronsäure Accord

70 mg einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK

Alendronsäure Accord

10 mg Tabletten

10 mg

Comprimate

orala

AT - Austria

| Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 |
| --- |
| Wien, Austria |

Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020

Wien, Austria

Alendrohexal 70 mg - einmal wöchentlich Filmtabletten

70 mg

Comprimate filmate

orala

AT - Austria

| Actavis Group PTC ehf, Reykjavikurvegur 76-78, |
| --- |
| 220 Hafnarfjördur, Iceland |

Actavis Group PTC ehf, Reykjavikurvegur 76-78,

220 Hafnarfjördur, Iceland

Alendronsäure Actavis

70 mg einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

| Arcana Arzneimittel GmbH, Hütteldorfer Straße 299, |
| --- |
| A-1140 Wien, Austria |

Arcana Arzneimittel GmbH, Hütteldorfer Straße 299,

A-1140 Wien, Austria

Alendronsäure ‧Arcana‧

70 mg - einmal wöchentlich - Tabletten

70 mg

Comprimate

orala

AT - Austria

| Bluefish Pharmaceuticals |
| --- |
| AB, Torsgatan 11, 111 23 |
| Stockholm, Sweden |

Bluefish Pharmaceuticals

AB, Torsgatan 11, 111 23

Stockholm, Sweden

Alendronsäure Bluefish

70 mg einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

| Interpharm Produktions |
| --- |
| GmbH, Effingergasse 21, A-1160 Wien, Austria |

Interpharm Produktions

GmbH, Effingergasse 21, A-1160 Wien, Austria

Alendronsäure

„Interpharm” 70 mg einmal wöchentlich - Tabletten

70 mg

Comprimate

orala

AT - Austria

| Interpharm Produktions |
| --- |
| GmbH, Effingergasse 21, A-1160 Wien, Austria |

Interpharm Produktions

GmbH, Effingergasse 21, A-1160 Wien, Austria

Alendronsäure

„Interpharm” 10 mg - Tabletten

10 mg

Comprimate

orala

AT - Austria

| 1A Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 |
| --- |
| Wien, Austria |

1A Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020

Wien, Austria

Alendronsäure 1A Pharma 70 mg - einmal wöchentlich Filmtabletten

70 mg

Comprimate filmate

orala

AT - Austria

| Ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |
| Austria |

Ratiopharm Arzneimittel

Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Austria

Alendronsäure

„ratiopharm” 70 mg - einmal wöchentlich

Tabletten

70 mg

Comprimate

orala

AT - Austria

| Sandoz GmbH, Biochemiestraße 10 |
| --- |
| A-6250 Kundl, Austria |

Sandoz GmbH, Biochemiestraße 10

A-6250 Kundl, Austria

Alendronsäure Sandoz

70 mg - einmal wöchentlich Filmtabletten

70 mg

Comprimate filmate

orala

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| A-1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

A-1190 Wien

Austria

Alendronstad 70 mg einmal wöchentlich Tabletten

70 mg

Comprimate

orala

AT - Austria

Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria

Fosamax einmal wöchentlich 70 mg Tabletten

70 mg

Comprimate

orala

AT - Austria

Merck Sharp & Dohme GmbH, EURO PLAZA Gebäude G, 5.Stock, Am Euro Platz 2, A-1120 Wien, Austria

Fosamax 10 mg - Tabletten

10 mg

Comprimate

orala

BE - Belgia

| Arrow Generics Limited |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom |

Arrow Generics Limited

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom

Alendronate Arrow

Generics

10 mg

Comprimate

Uz oral

BE - Belgia

| Arrow Generics Limited |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, |
| United Kingdom |

Arrow Generics Limited

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ,

United Kingdom

Alendronate Arrow

Generics

70 mg

Comprimate

Uz oral

BE - Belgia

| Eurogenerics N.V. Heizel Esplanade b22 |
| --- |
| 1020 Brussels |
| Belgium |

Eurogenerics N.V. Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

10 mg

Comprimate

Uz oral

BE - Belgia

| Eurogenerics N.V. Heizel Esplanade b22 |
| --- |
| 1020 Brussels |
| Belgium |

Eurogenerics N.V. Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

70 mg

Comprimate

Uz oral

BE - Belgia

| Mylan BVBA/SPRL Terhulpsesteenweg 6A |
| --- |
| 1560 Hoeilaart |
| Belgium |

Mylan BVBA/SPRL Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

10 mg

Comprimate

Uz oral

BE - Belgia

| Mylan BVBA/SPRL Terhulpsesteenweg 6A |
| --- |
| 1560 Hoeilaart |
| Belgium |

Mylan BVBA/SPRL Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

70 mg

Comprimate

Uz oral

BE - Belgia

| Teva Pharma Belgium N.V. Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V. Laarstraat 16

2610 Wilrijk

Belgium

Alendronate teva

70 mg

Comprimate

Uz oral

BE - Belgia

| Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200 |
| --- |
| Brussels, Belgium |

Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200

Brussels, Belgium

Fosamax hebdomadaire

70 mg

Comprimate

Uz oral

BE - Belgia

| Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200 |
| --- |
| Brussels, Belgium |

Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200

Brussels, Belgium

Fosamax

10 mg

Comprimate

Uz oral

BG - Bulgaria

| Tchaikapharma |
| --- |
| 1172 Sofia |
| 1 G. M. Dimitrov Blvd |
| Sofia |
| Bulgaria |

Tchaikapharma

1172 Sofia

1 G. M. Dimitrov Blvd

Sofia

Bulgaria

Fosanate

70 mg

Comprimate filmate

orala

BG - Bulgaria

| Betapharm Arzneimittel |
| --- |
| GmbH, Kobelweg 95, 86156 |
| Augsburg , Germany |

Betapharm Arzneimittel

GmbH, Kobelweg 95, 86156

Augsburg , Germany

Instrel

70 mg

Comprimate

orala

BG - Bulgaria

| Smarjeska cesta 6, 8501 |
| --- |
| Novo mesto – Slovenia |

Smarjeska cesta 6, 8501

Novo mesto – Slovenia

Lindron

10 mg

Comprimate

orala

BG - Bulgaria

| Teva Pharmaceuticals |
| --- |
| N.V.Gogol 15 |
| ЕООД |
| Sofia |
| Bulgaria |

Teva Pharmaceuticals

N.V.Gogol 15

ЕООД

Sofia

Bulgaria

Tevanate

70 mg

Comprimate

orala

BG - Bulgaria

| Actavis Group PTC ehf, Iceland Reykjavikurvegur |
| --- |
| 76-78, IS-220, |
| Hafnarfjordur |

Actavis Group PTC ehf, Iceland Reykjavikurvegur

76-78, IS-220,

Hafnarfjordur

Alendronat Actavis

70 mg

Comprimate

orala

BG - Bulgaria

| Sandoz GmbH, 10 |
| --- |
| Biochemie strasse, A-6250 |
| Kundl, Austria |

Sandoz GmbH, 10

Biochemie strasse, A-6250

Kundl, Austria

Forosa

70 mg

Comprimate filmate

orala

BG - Bulgaria

| Merck Sharp & Dohme |
| --- |
| Bulgaria |
| 55, Nicola Vaptzarov blvd. EXPO 2000 1st floor-east |
| wing, sections B1&B2 |
| Sofia 1407 Bulgaria. |

Merck Sharp & Dohme

Bulgaria

55, Nicola Vaptzarov blvd. EXPO 2000 1st floor-east

wing, sections B1&B2

Sofia 1407 Bulgaria.

Fosamax OW

70 mg

Comprimate

orala

CY - Cipru

Merck Sharp & Dohme BV, Waarderweg 39, 2031 bn Haarlem, The Netherlands

Fosamax tablet 70 mg

70 mg

Comprimate

orala

CY - Cipru

Pharmanel Pharmaceuticals SA, 106 Marathons Avenue, Athens, Greece

Difonate tablet 70 mg

70 mg

Comprimate

orala

CY - Cipru

| Farmanic-Chemipharma SA, |
| --- |
| 137 Filis Avenue, 13451 |
| Kamatero, Attikis, Greece |

Farmanic-Chemipharma SA,

137 Filis Avenue, 13451

Kamatero, Attikis, Greece

Ledronin tablet 70 mg

70 mg

Comprimate

orala

CY - Cipru

| Arrow Generics Limited, Unit |
| --- |
| 2 Eastman |
| Way,Hertfordshire, SG1 |
| 4SZ,Stevenage,UK |

Arrow Generics Limited, Unit

2 Eastman

Way,Hertfordshire, SG1

4SZ,Stevenage,UK

Alendronic -Acid Arrow tablet 10 mg

10 mg

Comprimate

orala

CY - Cipru

| Arrow Generics Limited, Unit |
| --- |
| 2 Eastman |
| Way,Hertfordshire, SG1 |
| 4SZ,Stevenage,UK |

Arrow Generics Limited, Unit

2 Eastman

Way,Hertfordshire, SG1

4SZ,Stevenage,UK

Alendronic -Acid Arrow tablet 70 mg

70 mg

Comprimate

orala

CY - Cipru

Aurobindo Pharma (Malta) Limited, 46/2 South street, Valetta, Malta

Alendronic Acid

Aurobindo tablet 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Orion Corporation, Orionintie 1A, FI-02200 |
| --- |
| Espoo, Finland |

Orion Corporation, Orionintie 1A, FI-02200

Espoo, Finland

Aldrion 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Generics Ltd., Mylan Albany Gate, Darkes Lane, Potters Bar |
| --- |
| Hertfordshire |
| EN6 1AG |
| United Kingdom |

Generics Ltd., Mylan Albany Gate, Darkes Lane, Potters Bar

Hertfordshire

EN6 1AG

United Kingdom

Alendrogen 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Actavis Group hf. Reykavikurvegi 76-78 |
| --- |
| 220 Hafnarfirdi |
| Iceland |

Actavis Group hf. Reykavikurvegi 76-78

220 Hafnarfirdi

Iceland

Alendronat Actavis

70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Accord Healthcare Ltd |
| --- |
| Sage House |
| Pinner Road |
| Harrow Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcare Ltd

Sage House

Pinner Road

Harrow Middlesex HA1 4HF

United Kingdom

Alendronát Natrium

Accord 10 mg

10 mg

Comprimate

orala

CZ - Republica Ceha

| Accord Healthcare Ltd |
| --- |
| Sage House |
| Pinner Road |
| Harrow Middlesex HA1 4HF |
| United Kingdom |

Accord Healthcare Ltd

Sage House

Pinner Road

Harrow Middlesex HA1 4HF

United Kingdom

Alendronát Natrium

Accord 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Sandoz GmbH, Biochemiestraße 10 |
| --- |
| 6250 Kundl, Austria |

Sandoz GmbH, Biochemiestraße 10

6250 Kundl, Austria

Alendronat Sandoz 70

70 mg

Comprimate

orala

CZ - Republica Ceha

| Ratiopharm GmbH, Graf- Arco-Straße 3 |
| --- |
| 89079 Ulm, Germany |

Ratiopharm GmbH, Graf- Arco-Straße 3

89079 Ulm, Germany

Alendronat- Ratiopharm 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c |
| --- |
| 150 00 Praha 5 |
| Cezch Republic |

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Alendronate_Teva

70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Arrow Generics Ltd |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, |
| United Kingdom |

Arrow Generics Ltd

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ,

United Kingdom

Alenwin 70

70 mg

Comprimate

orala

CZ - Republica Ceha

| Apotex Nederland BV Bio Science Park Archimedesweg 2 |
| --- |
| 2333 CN Leiden, Netherlands |

Apotex Nederland BV Bio Science Park Archimedesweg 2

2333 CN Leiden, Netherlands

Apo-Alendronat 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

Merck Sharp & Dohme BV Waarderweg 39, 2031 BN Haarlem, Netherlands

Fosamax 70 mg

1xtýdně

70 mg

Comprimate

orala

CZ - Republica Ceha

| Arrow Generics Ltd |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom |

Arrow Generics Ltd

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom

Fosteofos 70

70 mg

Comprimate

orala

CZ - Republica Ceha

Bentley Pharmaceuticals Ireland Ltd, 25/28 North Wall Quay, Dublin 1, Ireland

Gendron 70 mg

70 mg

Comprimate

orala

CZ - Republica Ceha

| Richter Gedeon Nyrt. Gyömrői út 19-21. |
| --- |
| H-1103 Budapest |
| Hungary |

Richter Gedeon Nyrt. Gyömrői út 19-21.

H-1103 Budapest

Hungary

Siranin 70 mg potahované tablety

70 mg

Comprimate

orala

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevanate 10 mg

Tabletten

11,6 mg

Comprimate

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevanate 70 mg

Tabletten

81,2 mg

Comprimate

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevabone-4 70 mg

Tabletten und 1

Mikrogramm

Weichkapseln

81,2 mg

1 μ

Comprimate si capsule moi

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevabone-5 70 mg

Tabletten und 1

Mikrogramm

Weichkapseln

81,2 mg

1 μ

Comprimate si capsule moi

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevabone-3 70 mg

Tabletten und 1

Mikrogramm

Weichkapseln

81,2 mg

1 μ

Comprimate si capsule moi

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevabone-2 70 mg

Tabletten und 1

Mikrogramm

Weichkapseln

81,2 mg

1 μ

Comprimate si capsule moi

Uz oral

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Tevabone 70 mg

Tabletten und 1

Mikrogramm

Weichkapseln

81,2 mg

1 μ

Comprimate si capsule moi

Uz oral

DE - Germania

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Alendronsäure - 1 A Pharma 70 mg Filmtabletten

91,35 mg

Comprimate filmate

Uz oral

DE - Germania

| AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 |
| --- |
| D-89143 Blaubeuren |

AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Alendronsäure AbZ 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Accord Healthcare Limited Sage House, 319, Pinner Road |
| --- |
| GB-HA1 4HF NORTH HARROW, MIDDLESEX |

Accord Healthcare Limited Sage House, 319, Pinner Road

GB-HA1 4HF NORTH HARROW, MIDDLESEX

Alendronsäure Accord

70 mg Tabletten

91,371 mg

Comprimate

Uz oral

DE - Germania

| Accord Healthcare Limited Sage House, 319, Pinner Road |
| --- |
| GB-HA1 4HF NORTH HARROW, MIDDLESEX |

Accord Healthcare Limited Sage House, 319, Pinner Road

GB-HA1 4HF NORTH HARROW, MIDDLESEX

Alendronsäure Accord

10 mg Tabletten

13,053 mg

Comprimate

Uz oral

DE - Germania

| acis Arzneimittel GmbH Lil-Dagover-Ring 7 |
| --- |
| D-82031 Grünwald |

acis Arzneimittel GmbH Lil-Dagover-Ring 7

D-82031 Grünwald

Alendronat acis 70 mg

Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76 - 78 |
| IS-220 Hafnarfjördur |

Actavis Group PTC ehf

Reykjavikurvegur 76 - 78

IS-220 Hafnarfjördur

Alendronsäure-Actavis

70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 |
| --- |
| D-89150 Laichingen |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Alendronsäure AL 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Alendronsäure AWD 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| AWD.pharma GmbH & Co.KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |

AWD.pharma GmbH & Co.KG

Wasastr. 50

D-01445 Radebeul

Alendronsäure AWD 10 mg Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| axcount Generika AG Max-Planck-Str. 36b |
| --- |
| D-61381 Friedrichsdorf |

axcount Generika AG Max-Planck-Str. 36b

D-61381 Friedrichsdorf

Alendronsäure axcount

70 mg

91,37 mg

Comprimate

Uz oral

DE - Germania

| Basics GmbH Hemmelrather Weg 201 |
| --- |
| D-51377 Leverkusen |

Basics GmbH Hemmelrather Weg 201

D-51377 Leverkusen

ALENDRONSÄURE BASICS einmal wöchentlich 70 mg Tabletten

76,188 mg

Comprimate

Uz oral

DE - Germania

| betapharm Arzneimittel |
| --- |
| GmbH Kobelweg 95 |
| D-86156 Augsburg |

betapharm Arzneimittel

GmbH Kobelweg 95

D-86156 Augsburg

Alendron beta einmal wöchentlich 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| betapharm Arzneimittel |
| --- |
| GmbH Kobelweg 95 |
| D-86156 Augsburg |

betapharm Arzneimittel

GmbH Kobelweg 95

D-86156 Augsburg

Alendron 10 mg

Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| biomo pharma GmbH Josef-Diezgen-Str 3 |
| --- |
| D-53773 Hennef |

biomo pharma GmbH Josef-Diezgen-Str 3

D-53773 Hennef

Alendronsäure-biomo

70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Bluefish Pharmaceuticals AB Torsgatan 11 |
| --- |
| S-111 23 Stockholm |

Bluefish Pharmaceuticals AB Torsgatan 11

S-111 23 Stockholm

Alendronsäure Bluefish

70 mg Tabletten

91,37 mg

Comprimate

Uz oral

DE - Germania

| CT Arzneimittel GmbH Lengeder Str. 42a |
| --- |
| D-13407 Berlin |

CT Arzneimittel GmbH Lengeder Str. 42a

D-13407 Berlin

Alendronsäure-CT 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| esparma GmbH Seepark 7 |
| --- |
| D-39116 Magdeburg |

esparma GmbH Seepark 7

D-39116 Magdeburg

Alendron esparma 70 mg einmal wöchentlich Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Gedeon Richter Plc. Gyömröi ut 19 - 21 |
| --- |
| H-1103 Budapest |

Gedeon Richter Plc. Gyömröi ut 19 - 21

H-1103 Budapest

Alendronate Richter 70 mg Filmtabletten

91,35 mg

Comprimate filmate

Uz oral

DE - Germania

| Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 |
| --- |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50

D-90449 Nürnberg

Alendronsäure Heumann 10 mg Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 |
| --- |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50

D-90449 Nürnberg

Alendronsäure Heumann 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Alendron-Hexal 10 mg

Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Alendron-Hexal 10 einmal wöchentlich 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Juta Pharma GmbH Gutenbergstr. 13 |
| --- |
| D-24941 Flensburg |

Juta Pharma GmbH Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 70 mg

Tablette

91,36 mg

Comprimate

Uz oral

DE - Germania

| Juta Pharma GmbH Gutenbergstr. 13 |
| --- |
| D-24941 Flensburg |

Juta Pharma GmbH Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 10 mg

Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| KSK-Pharma Vertriebs AG Finkenstr. 1 |
| --- |
| D-76327 Pfinztal- Berghausen |

KSK-Pharma Vertriebs AG Finkenstr. 1

D-76327 Pfinztal- Berghausen

Alendro-KSK 70 mg

91,37 mg

Comprimate

Uz oral

DE - Germania

| mibe GmbH Arznzemittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Alendromed 70 mg

91,36 mg

Comprimate

Uz oral

DE - Germania

| MSD Sharp & Dohme GmbH Lindenplatz 1 |
| --- |
| D-85540 Haar |

MSD Sharp & Dohme GmbH Lindenplatz 1

D-85540 Haar

FOSAMAX 10 mg

Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| MSD Sharp & Dohme GmbH Lindenplatz 1 |
| --- |
| D-85540 Haar |

MSD Sharp & Dohme GmbH Lindenplatz 1

D-85540 Haar

FOSAMAX einmal wöchentlich 70 mg Tabletten

91,37 mg

Comprimate

Uz oral

DE - Germania

| Mylan dura GmbH Wittichstr. 6 |
| --- |
| D-64295 Darmstadt |

Mylan dura GmbH Wittichstr. 6

D-64295 Darmstadt

Alendronsäure Mylan

70 mg Tabletten

91,37 mg

Comprimate

Uz oral

DE - Germania

| Mylan dura GmbH Wittichstr. 6 |
| --- |
| D-64295 Darmstadt |

Mylan dura GmbH Wittichstr. 6

D-64295 Darmstadt

Alendrosäure dura 70 mg Tabletten

91,37 mg

Comprimate

Uz oral

DE - Germania

| Mylan dura GmbH Wittichstr. 6 |
| --- |
| D-64295 Darmstadt |

Mylan dura GmbH Wittichstr. 6

D-64295 Darmstadt

Alendrossa 10 mg

13,05 mg

Comprimate

Uz oral

DE - Germania

| Orion Corporation |
| --- |
| Orionintie 1 |
| FIN-=2200 ESPOO |

Orion Corporation

Orionintie 1

FIN-=2200 ESPOO

Alendronsäure Orion

70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Ovamex Limited |
| --- |
| 118 larch crescent GB-UB4 9EB HAYES, MIDDLESEX |

Ovamex Limited

118 larch crescent GB-UB4 9EB HAYES, MIDDLESEX

Alendronsäure Ovamex 70 mg Tabletten

91,363 mg

Comprimate

Uz oral

DE - Germania

| Ovamex Limited |
| --- |
| 118 larch crescent |
| GB-UB4 9EB HAYES, MIDDLESEX |

Ovamex Limited

118 larch crescent

GB-UB4 9EB HAYES, MIDDLESEX

Alendronsäure Ovamex 10 mg Tabletten

13,052 mg

Comprimate

Uz oral

DE - Germania

| ratiopharm GmbH Graf-Arco-STr. 3 |
| --- |
| D-89079 Ulm |

ratiopharm GmbH Graf-Arco-STr. 3

D-89079 Ulm

Alendronsäure- ratiopharm 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Sandoz Pharmaceuticals |
| --- |
| GmbH Raiffeisenstr. 11 |
| D-83607 Holzkirchen |

Sandoz Pharmaceuticals

GmbH Raiffeisenstr. 11

D-83607 Holzkirchen

Alendron-Sandoz einmal wöchentlich 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Stadapharm GmbH Stadastr. 2 - 18 |
| --- |
| D-61118 Bad Vilbel |

Stadapharm GmbH Stadastr. 2 - 18

D-61118 Bad Vilbel

Alendronsäure STADA 10 mg Tabletten

13,05 mg

Comprimate

Uz oral

DE - Germania

| Stadapharm GmbH Stadastr. 2 - 18 |
| --- |
| D-61118 Bad Vilbel |

Stadapharm GmbH Stadastr. 2 - 18

D-61118 Bad Vilbel

Alendronsäure STADA 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Winthrop Arzneimittel GmbH Urmitzer Str. 5 |
| --- |
| D-56218 Mülheim-Kärlich |

Winthrop Arzneimittel GmbH Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Alendron Winthrop einmal wöchentlich 70 mg Tabletten

91,36 mg

Comprimate

Uz oral

DE - Germania

| Mylan dura GmbH Wittichstr. 6 |
| --- |
| D-64295 Darmstadt |

Mylan dura GmbH Wittichstr. 6

D-64295 Darmstadt

Alendrokit dura

91,36 mg

1 495,5 mg

4 mg

Comprimate si comprimate filmate

Uz oral

DE - Germania

| TECNIMEDE - Sociedade |
| --- |
| Técnico-Medicinal, S.A. (BS2) |
| Rua da Tapada Grande, n2 |
| P-2710-089 ABRUNHEIRA, SINTRA |

TECNIMEDE - Sociedade

Técnico-Medicinal, S.A. (BS2)

Rua da Tapada Grande, n2

P-2710-089 ABRUNHEIRA, SINTRA

Alendronsäure Tecnimede 70 mg Filmtabletten

91,35 mg

Comprimate filmate

Uz oral

DE - Germania

| Volkspharma GmbH August-Wessels-Str. 5 |
| --- |
| D-86154 Augsburg |

Volkspharma GmbH August-Wessels-Str. 5

D-86154 Augsburg

Alendronsäure 70 mg

Volkspharma Tabletten

91,37 mg

Comprimate

Uz oral

DK - Danemarca

| 1A Farma, Herstedøstervej |
| --- |
| 27-29, DK-2620 |
| Albertslund, Denmark |

1A Farma, Herstedøstervej

27-29, DK-2620

Albertslund, Denmark

Alendronat "1A Farma"

70 mg

Comprimate filmate

orala

DK - Danemarca

| Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O. |
| --- |
| 425, IS-220 Hafnarfjördur, |
| Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 76-78, P.O.

425, IS-220 Hafnarfjördur,

Iceland

Alendronat "Actavis"

70 mg

Comprimate

orala

DK - Danemarca

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, |
| England |

Arrow Generics Limited, Unit

2, Eastman Way Stevenage, SG1 4SZ Hertfordshire,

England

Alendronat "Arrow"

10 mg

Comprimate

orala

DK - Danemarca

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England |

Arrow Generics Limited, Unit

2, Eastman Way Stevenage, SG1 4SZ Hertfordshire, England

Alendronat "Arrow"

70 mg

Comprimate

orala

DK - Danemarca

| BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 |
| --- |
| Stockholm, Sweden |

BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23

Stockholm, Sweden

Alendronat "Bluefish"

70 mg

Comprimate

orala

DK - Danemarca

| Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 |
| --- |
| 35 Stockholm; Sweden |

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104

35 Stockholm; Sweden

Alendronat "Mylan"

10 mg

Comprimate

orala

DK - Danemarca

| Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104 |
| --- |
| 35 Stockholm; Sweden |

Mylan AB, P.O.box 23033, Ynglingagatan 14, SE-104

35 Stockholm; Sweden

Alendronat "Mylan"

70 mg

Comprimate

orala

DK - Danemarca

| Orifarm Generics A/S, Energivej 15, DK-5260 |
| --- |
| Odense S., Denmark |

Orifarm Generics A/S, Energivej 15, DK-5260

Odense S., Denmark

Alendronat "Orifarm"

70 mg

Comprimate

orala

DK - Danemarca

| Orion Corporation Orion |
| --- |
| Pharma, Orionintie 1, FI- |
| 02200 Espoo, Finland |

Orion Corporation Orion

Pharma, Orionintie 1, FI-

02200 Espoo, Finland

Alendronat "Orion"

70 mg

Comprimate

orala

DK - Danemarca

| Pharmachemie B.V., PO Box |
| --- |
| 552, Swensweg 5, NL-2031 |
| GA Haarlem, Nederlands |

Pharmachemie B.V., PO Box

552, Swensweg 5, NL-2031

GA Haarlem, Nederlands

Alendronat "PCH"

10 mg

Comprimate

orala

DK - Danemarca

| Ranbaxy (UK) Ltd., 20 |
| --- |
| Balderton Street, W1K 6TL London, UK |

Ranbaxy (UK) Ltd., 20

Balderton Street, W1K 6TL London, UK

Alendronat "Ranbaxy"

70 mg

Comprimate

orala

DK - Danemarca

| Sandoz A/S, C.F. Tietgens |
| --- |
| Boulevard 40, DK-5220 |
| Odense SØ, Denmark |

Sandoz A/S, C.F. Tietgens

Boulevard 40, DK-5220

Odense SØ, Denmark

Alendronat "Sandoz"

70 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Alendronat "Stada"

70 mg

Comprimate

orala

DK - Danemarca

| Teva Denmark A/S, Parallelvej 10-12, DK-2800 |
| --- |
| Kongens Lyngby, Denmark |

Teva Denmark A/S, Parallelvej 10-12, DK-2800

Kongens Lyngby, Denmark

Alendronat "Teva"

70 mg

Comprimate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Alendronat

"ratiopharm"

70 mg

Comprimate

orala

DK - Danemarca

| Merck Sharp & Dohme B.V., PO Box 581, Waarderweg |
| --- |
| 39, NL-2031 BN Haarlem, |
| Nederlands |

Merck Sharp & Dohme B.V., PO Box 581, Waarderweg

39, NL-2031 BN Haarlem,

Nederlands

Fasamax Ugetablet

70 mg

Comprimate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Alendronat "Stada"

10 mg

Comprimate

orala

DK - Danemarca

| Teva Denmark A/S, Parallelvej 10-12, DK-2800 |
| --- |
| Kongens Lyngby, Denmark |

Teva Denmark A/S, Parallelvej 10-12, DK-2800

Kongens Lyngby, Denmark

Alendronat "Teva"

10 mg

Comprimate

orala

EL - Grecia

VIANEX S.A. TATIOIOU STREET Nea Erythrea 14671

FOSAMAX

10 MG/TAB

Comprimate

orala

EL - Grecia

VIANEX S.A. TATIOIOU STREET Nea Erythrea 14671

FOSAMAX

5 MG/TAB

Comprimate

orala

EL - Grecia

VIANEX S.A. TATIOIOU STREET Nea Erythrea 14671

FOSAMAX ONCE WEEKLY

70 MG/TAB

Comprimate

orala

EL - Grecia

FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS ACHAIAS AND TROIZINIAS, KIFISSIA 14564

OSASTON

70 MG/TAB

Comprimate

orala

EL - Grecia

| BIOMEDICA-CHEMICA S.A. G. LYRA 25 |
| --- |
| KATW KIFISSIA |

BIOMEDICA-CHEMICA S.A. G. LYRA 25

KATW KIFISSIA

AMPINE

70 MG/TAB

Comprimate

orala

EL - Grecia

| KLEVA AFBEE |
| --- |
| PARNITHOS AVENUE 189 |
| ACHARNES ATTIKIS 13675 |

KLEVA AFBEE

PARNITHOS AVENUE 189

ACHARNES ATTIKIS 13675

DARGOL

70 MG/TAB

Comprimate

orala

EL - Grecia

MED-ONE AFBEE AGIOU PETROU 30 & EPAMEINONDA ACHARNES 13675

DEBENAL

70 MG/TAB

Comprimate

orala

EL - Grecia

| GENERICS PHARMA HELLAS |
| --- |
| ΕΠΕ |
| VOULIAGMENIS AVENUE |
| 577A |
| 16451 ARGYROUPOLI P.O. BOX 72571 |

GENERICS PHARMA HELLAS

ΕΠΕ

VOULIAGMENIS AVENUE

577A

16451 ARGYROUPOLI P.O. BOX 72571

ALENDRONATE / GENERICS

70 MG/TAB

Comprimate

orala

EL - Grecia

| GENERICS PHARMA HELLAS |
| --- |
| ΕΠΕ |
| VOULIAGMENIS AVENUE |
| 577A |
| 16451 ARGYROUPOLI P.O. BOX 72572 |

GENERICS PHARMA HELLAS

ΕΠΕ

VOULIAGMENIS AVENUE

577A

16451 ARGYROUPOLI P.O. BOX 72572

ALENDRONATE / GENERICS

10 MG/TAB

Comprimate

orala

EL - Grecia

| ALAPIS ABEE AUTOKRATOROS NIKOLAOU |
| --- |
| 2 |
| ATHENS 17671 |

ALAPIS ABEE AUTOKRATOROS NIKOLAOU

2

ATHENS 17671

MELDOZ

70 MG/TAB

Comprimate

orala

EL - Grecia

| VELKA HELLAS AEBE KAPODISTRIOU AND KORINTHOU 12 |
| --- |
| NEO PSYCHIKO 15451 |

VELKA HELLAS AEBE KAPODISTRIOU AND KORINTHOU 12

NEO PSYCHIKO 15451

OSTAVEN

70 MG/TAB

Comprimate

orala

EL - Grecia

| ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage, |
| --- |
| Herts |
| United Kingdom |

ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage,

Herts

United Kingdom

ALENDRONIC ACID/ARROW

10 MG/TAB

Comprimate

orala

EL - Grecia

| ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage, |
| --- |
| Herts |
| United Kingdom |

ARROW GENERICS LIMITED, HERTS, UNITED KINGDOM Unit 2, Eastman Way, Stevenage,

Herts

United Kingdom

ALENDRONIC ACID/ARROW

70 MG/TAB

Comprimate

orala

EL - Grecia

PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS 15344

OSTEONAT

70 MG/TAB

Comprimate

orala

EL - Grecia

| MEDARTE PHARMACEUTICALS ΑΒΕΕ SPYROU VRETTOU 10 |
| --- |
| METAMORFOSI 14452 |

MEDARTE PHARMACEUTICALS ΑΒΕΕ SPYROU VRETTOU 10

METAMORFOSI 14452

OSTALERT

70 MG/TAB

Comprimate

orala

EL - Grecia

| VOCATE PHARMACEUTICALS S.A. |
| --- |
| GOUNARI 150, GLYFADA 16674 |

VOCATE PHARMACEUTICALS S.A.

GOUNARI 150, GLYFADA 16674

FOSAZOM

70 MG/TAB

Comprimate

orala

EL - Grecia

| GENEPHARM S.A. |
| --- |
| 18km MARATHONOS AVENUE |
| PALLINI ATTIKIS 15351 |

GENEPHARM S.A.

18km MARATHONOS AVENUE

PALLINI ATTIKIS 15351

FOSALEN

70 MG/TAB

Comprimate

orala

EL - Grecia

| SANTA PHARMA S.A. ASKLIPIOU 4 |
| --- |
| KRYONERI ATTIKIS 14568 |

SANTA PHARMA S.A. ASKLIPIOU 4

KRYONERI ATTIKIS 14568

ALEFOS

70 MG/TAB

Comprimate

orala

EL - Grecia

| IASIS PHARMAC.HELLAS |
| --- |
| 137 FYLIS AVENUE KAMATERO 13451 |

IASIS PHARMAC.HELLAS

137 FYLIS AVENUE KAMATERO 13451

LEDRONIN

70 MG/TAB

Comprimate

orala

EL - Grecia

PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS 15344

DIFONATE

70 MG/TAB

Comprimate

orala

EL - Grecia

| ANFARM HELLAS S.A. PERIKLEOUS 53-57 |
| --- |
| GERAKAS ATTIKIS 15344 |

ANFARM HELLAS S.A. PERIKLEOUS 53-57

GERAKAS ATTIKIS 15344

RIDON

70 MG/TAB

Comprimate

orala

EL - Grecia

| AURORA PHARMACEUTICALS S.A. EVROU 4 & MESSINIAS 2 |
| --- |
| GERAKAS 15344 |

AURORA PHARMACEUTICALS S.A. EVROU 4 & MESSINIAS 2

GERAKAS 15344

AURODREN

70 MG/TAB

Comprimate

orala

EL - Grecia

| VIOFAR LTD |
| --- |
| ETHNIKIS ANTISTASEWS & TRIZINIAS |
| ACHARNES 13671 |

VIOFAR LTD

ETHNIKIS ANTISTASEWS & TRIZINIAS

ACHARNES 13671

DEPAREX

70 MG/TAB

Comprimate

orala

EL - Grecia

| BIOSPRAY ABEE |
| --- |
| 18KM MARATHONOS AVENUE |
| PALLINI 15344 |

BIOSPRAY ABEE

18KM MARATHONOS AVENUE

PALLINI 15344

ALENDRAL

70 MG/TAB

Comprimate

orala

EL - Grecia

| FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144 |
| --- |
| PALLINI 15351 |

FARMATHEN HELLAS ABEE MARATHONOS AVENUE 144

PALLINI 15351

POROCALM

70 MG/TAB

Comprimate

orala

EL - Grecia

| SANDOZ GMBH, KUNDL, AUSTRIA Biochemiestrasse 10, |
| --- |
| A-6250, Kundl |
| Tirol, Austria |

SANDOZ GMBH, KUNDL, AUSTRIA Biochemiestrasse 10,

A-6250, Kundl

Tirol, Austria

FOROSA

70 MG/TAB

Comprimate

orala

EL - Grecia

| RAFARM AEBE KORINTHOU 12 |
| --- |
| NEO PSYCHIKO 15451 |

RAFARM AEBE KORINTHOU 12

NEO PSYCHIKO 15451

MOSMASS

70 MG/TAB

Comprimate

orala

EL - Grecia

ROTTAPHARM HELLAS S.A. PRDUCTION AND COMMERCE OF PHARMACEUTICALS ACHAIAS AND TRIZINIAS NEA KIFISSIA 14564

LOZOSTUN

70 MG/TAB

Comprimate

orala

EL - Grecia

| DELEGANT HOLDINGS LTD, CYPRUS |
| --- |
| AGIAS ELENIS 36 |
| COMMERCIAL CENTRE GALAXY 401 |
| NICOSIA 1061 |
| CYPRUS |

DELEGANT HOLDINGS LTD, CYPRUS

AGIAS ELENIS 36

COMMERCIAL CENTRE GALAXY 401

NICOSIA 1061

CYPRUS

DELFOZA

70 MG/TAB

Comprimate

orala

EL - Grecia

| SPECIFAR ABEE |
| --- |
| 28TH OCTOBER 1 |
| AGIA VARVARA 123 51 |

SPECIFAR ABEE

28TH OCTOBER 1

AGIA VARVARA 123 51

DROFAZ

70 MG/TAB

Comprimate

orala

EL - Grecia

| EVANGELOS KALOFOLIAS & CO IAPHARM |
| --- |
| MENANDROU 54 |
| ATHENS 10431 |

EVANGELOS KALOFOLIAS & CO IAPHARM

MENANDROU 54

ATHENS 10431

FOSANDRON

70 MG/TAB

Comprimate

orala

EL - Grecia

| TARGET PHARMA LTD MENANDROU 54 |
| --- |
| ATHENS 10431 |

TARGET PHARMA LTD MENANDROU 54

ATHENS 10431

ARTHROPLUS

70 MG/TAB

Comprimate

orala

EL - Grecia

| VIVAX PHARMACEUTICALS LTD, |
| --- |
| DERVENAKION 38 |
| GERAKAS ATTIKIS 15344 |

VIVAX PHARMACEUTICALS LTD,

DERVENAKION 38

GERAKAS ATTIKIS 15344

EN-POR

70 MG/TAB

Comprimate

orala

EL - Grecia

PHARMANEL PHARMACEUTICALS S.A. MARATHONOS 106, GERAKAS 15344

MORALEN

70 MG/TAB

Comprimate

orala

EL - Grecia

| FARMEX S.A. |
| --- |
| KIFISSOU AVENUE 132 |
| ATHENS 12131 |

FARMEX S.A.

KIFISSOU AVENUE 132

ATHENS 12131

ENIMON

70 MG/TAB

Comprimate

orala

EL - Grecia

| ALET PHARMACEUTICALS ABEE |
| --- |
| AIDINIOU 26, CHALANDRI 12461 |

ALET PHARMACEUTICALS ABEE

AIDINIOU 26, CHALANDRI 12461

ALEDROLET

70 MG/TAB

Comprimate

orala

EL - Grecia

| PHARMA LINE S.A. TH. PETALA 41 |
| --- |
| NEA CHALKIDONA 14343 |

PHARMA LINE S.A. TH. PETALA 41

NEA CHALKIDONA 14343

ZULGAR

70 MG/TAB

Comprimate

orala

EL - Grecia

| VERISFIELD (UK) LTD, U.K. |
| --- |
| 41 Chalton street, London, NW1 1JD, United Kingdom |

VERISFIELD (UK) LTD, U.K.

41 Chalton street, London, NW1 1JD, United Kingdom

ZEMAROS

70 MG/TAB

Comprimate

orala

EL - Grecia

| HELP ΑΒΕΕ |
| --- |
| VALAORITOU 10 |
| METAMORFOSI ATTIKIS |
| 14452 |

HELP ΑΒΕΕ

VALAORITOU 10

METAMORFOSI ATTIKIS

14452

OSTEOS

70 MG/TAB

Comprimate

orala

EL - Grecia

| FARMEDIA AE |
| --- |
| ATHINAS 22 & APOLLONOS GERAKAS ATTIKIS 15344 |

FARMEDIA AE

ATHINAS 22 & APOLLONOS GERAKAS ATTIKIS 15344

FARMEMAX

70 MG/TAB

Comprimate

orala

EL - Grecia

| FARMAZAK S.A. NAOUSSIS 31 |
| --- |
| VOTANIKOS 10447 |

FARMAZAK S.A. NAOUSSIS 31

VOTANIKOS 10447

ZAKODRONATE

70 MG/TAB

Comprimate

orala

EL - Grecia

| TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS Computerweg 10, |
| --- |
| 3542 DR, Utrecht, The Netherlands |

TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS Computerweg 10,

3542 DR, Utrecht, The Netherlands

TEVANATE

70 MG/TAB

Comprimate

orala

ES - Spania

| MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 |
| --- |
| MADRID |

MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027

MADRID

FOSAMAX Semanal 70 mg comprimidos

70 mg

Comprimate filmate

orala

ES - Spania

| MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027 |
| --- |
| MADRID |

MERCK SHARP AND DOHME DE ESPAÑA, S.A.Josefa Valcarcel, 38 28027

MADRID

FOSAMAX 10 mg

Comprimidos

10 mg

Comprimate

orala

ES - Spania

| MYLAN PHARMACEUTICALS, S.L.Plom 2-4, 5o Planta |
| --- |
| 08038 Barcelona |

MYLAN PHARMACEUTICALS, S.L.Plom 2-4, 5o Planta

08038 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL MYLAN 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036 |
| --- |
| Madrid |

LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036

Madrid

ÁCIDO ALENDRÓNICO SEMANAL ALTER 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| MERCK S.L.María de Molina, |
| --- |
| 40 28006 Madrid |

MERCK S.L.María de Molina,

40 28006 Madrid

CALBION SEMANAL 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036 |
| --- |
| Madrid |

LABORATORIOS ALTER, S.A.Mateo Inurria, 30 28036

Madrid

BIFOAL SEMANAL 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIO STADA, S.L.Frederic Mompou, 5 |
| --- |
| 08960 Sant Just Desvern |
| Barcelona |

LABORATORIO STADA, S.L.Frederic Mompou, 5

08960 Sant Just Desvern

Barcelona

ÁCIDO ALENDRÓNICO SEMANAL STADA 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

RATIOPHARM ESPAÑA, S.A.Avda. de Burgos, 16 D - 5a Planta 28036 Madrid

ACIDO ALENDRONICO SEMANAL RATIOPHARM 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina |
| --- |
| 203.Edificio Euromadrid |
| 28290 Las Matas |
| Madrid |

LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina

203.Edificio Euromadrid

28290 Las Matas

Madrid

ÁCIDO ALENDRÓNICO EDIGEN 10 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina |
| --- |
| 203.Edificio Euromadrid |
| 28290 Las Matas |
| Madrid |

LABORATORIOS EDIGEN, S.A Chile 8, 2o Oficina

203.Edificio Euromadrid

28290 Las Matas

Madrid

ÁCIDO ALENDRÓNICO EDIGEN 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| TEVA GENERICOS ESPAÑOLA, S.L.Guzmán el Bueno 133, Edificio Britania |
| --- |
| 4oIzq.28003 Madrid |

TEVA GENERICOS ESPAÑOLA, S.L.Guzmán el Bueno 133, Edificio Britania

4oIzq.28003 Madrid

ACIDO ALENDRONICO TEVA 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| MABO FARMA, S.ACarretera |
| --- |
| M-300 Km 30,500. 28802 |
| Alcalá de Henares |

MABO FARMA, S.ACarretera

M-300 Km 30,500. 28802

Alcalá de Henares

ÁCIDO ALENDRÓNICO SEMANAL MABO 70

mg COMPRIMIDOS

70 mg

Comprimate

orala

ES - Spania

| CANTABRIA PHARMA, S.L.c/ Ribera del Loira, 46 edificio |
| --- |
| 2 28042 Madrid |
| Spain |

CANTABRIA PHARMA, S.L.c/ Ribera del Loira, 46 edificio

2 28042 Madrid

Spain

ALENDROCARE SEMANAL 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| SANDOZ FARMACEUTICA, S.A.Avda. Osa Mayor, |
| --- |
| 4Aravaca 28023 (Madrid) |

SANDOZ FARMACEUTICA, S.A.Avda. Osa Mayor,

4Aravaca 28023 (Madrid)

ÁCIDO ALENDRÓNICO SEMANAL SANDOZ 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo, |
| --- |
| 6 28760 Tres Cantos |

LABORATORIOS NORMON, S.A.Ronda de Valdecarrizo,

6 28760 Tres Cantos

ACIDO ALENDRONICO SEMANAL NORMON 70 mg Comprimidos

70 mg

Comprimate

orala

ES - Spania

| TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda. Pio XII, 92, Edificio Ural A, Planta 16-4 |
| --- |
| 28036 Madrid |

TECNIMEDE ESPAÑA, INDUSTRIA FARMACEUTICA, S.A. Avda. Pio XII, 92, Edificio Ural A, Planta 16-4

28036 Madrid

ACIDO ALENDRONICO SEMANAL TECNIGEN

70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| PHARMAGENUS, S.A. Avda. Camí Real, 51-57 08184 |
| --- |
| Palau-solita i Plegamans |
| Barcelona |

PHARMAGENUS, S.A. Avda. Camí Real, 51-57 08184

Palau-solita i Plegamans

Barcelona

ACIDO ALENDRONICO SEMANAL PHARMAGENUS 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 |
| --- |
| 08007 Barcelona |

LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9

08007 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| TEVA PHARMA S.L.U. C/ Anabel Segura, 11, Edificio Albatros B, 1a planta 28108 |
| --- |
| Alcobendas |

TEVA PHARMA S.L.U. C/ Anabel Segura, 11, Edificio Albatros B, 1a planta 28108

Alcobendas

SEMANDROL SEMANAL

70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

QUALIGEN, S.L.Avda. Barcelona, 69 08970 Sant Joan Despi

ACIDO ALENDRÓNICO SEMANAL QUALIGEN

70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

LABORATORIOS DAVUR, S.L.Teide, 4-planta baja. Poligono Empresarial La Marina 28703 San Sebastian de los Reyes

ÁCIDO ALENDRÓNICO SEMANAL DAVUR 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| RIMAFAR, S.L.Pol. Ind. Malpica Calle C, No 4 50016 |
| --- |
| Zaragoza |

RIMAFAR, S.L.Pol. Ind. Malpica Calle C, No 4 50016

Zaragoza

ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR

70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| KERN PHARMA, S.L.Venus, |
| --- |
| 72. Poligono Industrial |
| Colon II.08228 Tarrasa |

KERN PHARMA, S.L.Venus,

72. Poligono Industrial

Colon II.08228 Tarrasa

ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos

70 mg

Comprimate

orala

ES - Spania

| KORHISPANA S.L.Carretera de Castellvell, 24 43206 |
| --- |
| Reus |

KORHISPANA S.L.Carretera de Castellvell, 24 43206

Reus

ACIDO ALENDRONICO SEMANAL KORHISPANA 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| GERVASI FARMACIA, S.L.Juan XXIII, 15-19 |
| --- |
| 08950 Esplugues de |
| Llobregat |

GERVASI FARMACIA, S.L.Juan XXIII, 15-19

08950 Esplugues de

Llobregat

LEFOSAN SEMANAL 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS ALACAN INDUSTRIAS QUIMICO FARMACEUTICAS, S.A.Sagitario, 14 03006 |
| --- |
| Alicante |

LABORATORIOS ALACAN INDUSTRIAS QUIMICO FARMACEUTICAS, S.A.Sagitario, 14 03006

Alicante

ADELAN SEMANAL 70 mg Comprimidos

70 mg

Comprimate

orala

ES - Spania

| FARMALIDER, S.A.Aragoneses, 15 28108 |
| --- |
| Alcobendas |

FARMALIDER, S.A.Aragoneses, 15 28108

Alcobendas

ACIDO ALENDRONICO SEMANAL

FARMALIDER 70 mg comprimidos recubiertos con

película

70 mg

Comprimate filmate

orala

ES - Spania

SINTEXLINE S.A.Polígono Industrial La Red, Calle 11 no 2 41500 Alcalá de Guadaira

ALENDROGYN 70 mg comprimidos recubiertos con película

70 mg

Comprimate filmate

orala

ES - Spania

| FARMALIDER, S.A.Aragoneses, 15 28108 |
| --- |
| Alcobendas |

FARMALIDER, S.A.Aragoneses, 15 28108

Alcobendas

ALENDROFARM 70 mg comprimidos recubiertos con pelicula

70 mg

Comprimate filmate

orala

ES - Spania

| LABORATORIOS COMBIX, S.L.San Rafael, 3. Pol. Industrial Alcobendas 28108 |
| --- |
| Alcobendas |

LABORATORIOS COMBIX, S.L.San Rafael, 3. Pol. Industrial Alcobendas 28108

Alcobendas

ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película

70 mg

Comprimate filmate

orala

ES - Spania

ALMUS FARMACEUTICA, S.A.Avda. Verge de Montserrat, 6 08820 El Prat de Llobregat

ACIDO ALENDRONICO SEMANAL ALMUS 70 mg comprimidos recubiertos con película

70 mg

Comprimate filmate

orala

ES - Spania

| PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015 |
| --- |
| Valencia |

PENSA PHARMA, S.A.U Jorge Comín (médico pediatra), 3 - bajos 46015

Valencia

ÁCIDO ALENDRÓNICO SEMANAL PENSA 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 |
| --- |
| 08007 Barcelona |

LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9

08007 Barcelona

ACIDO ALENDRONICO SEMANAL RANBAXYGEN 70 mg Comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9 |
| --- |
| 08007 Barcelona |

LABORATORIOS RANBAXY, S.L.Passeig de Gracia, 9

08007 Barcelona

ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LAREQ PHARMA S.L Laguna, |
| --- |
| 66-68-70. Poligono |
| Industrial Urtinsa II 28923 |
| Alcorcón |

LAREQ PHARMA S.L Laguna,

66-68-70. Poligono

Industrial Urtinsa II 28923

Alcorcón

ACIDO ALENDRONICO SEMANAL LAREQ 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| LABORATORIOS PEREZ GIMENEZ, S.A.Pol. Ind. Los Mochos. Polígono 8 - Parcela |
| --- |
| 20. Crta. A-431, Km 19 |
| 14720 Almodovar del Río |

LABORATORIOS PEREZ GIMENEZ, S.A.Pol. Ind. Los Mochos. Polígono 8 - Parcela

20. Crta. A-431, Km 19

14720 Almodovar del Río

ÁCIDO ALENDRÓNICO SEMANAL CUVE 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón

ACIDO ALENDRONICO SEMANAL VIR 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 |
| --- |
| - Area B Aravaca (Madrid) |

BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4

- Area B Aravaca (Madrid)

ACIDO ALENDRONICO SEMANAL BEXAL 70 mg comprimidos recubiertos con película

70 mg

Comprimate

orala

ES - Spania

ACOST COMERCIAL GENERIC-PHARMA, S.L.Centro Empresarial Osa Mayor. Osa Mayor, 4 Area B Aravaca (Madrid)

ACIDO ALENDRONICO SEMANAL ACOST 70 mg comprimidos recubiertos con película

70 mg

Comprimate

orala

ES - Spania

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.Laguna, 66-68-70. Poligono Industrial Urtinsa II 28923 Alcorcón

ALENVIR SEMANAL 70 mg comprimidos

70 mg

Comprimate

orala

ES - Spania

| Apotex Europe BV Darwinweg 20 |
| --- |
| 2333 CR Leiden |
| Netherlands |

Apotex Europe BV Darwinweg 20

2333 CR Leiden

Netherlands

ÁCIDO ALENDRÓNICO APOTEX 70 mg comprimidos

70 mg

Comprimate

orala

ET - Estonia

| Merck Sharp & Dohme OÜ Peterburi tee 46 |
| --- |
| 11415 Tallinn |
| ESTONIA |

Merck Sharp & Dohme OÜ Peterburi tee 46

11415 Tallinn

ESTONIA

FOSAMAX 70 MG

70 mg

Comprimate

Uz oral

ET - Estonia

| Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 |
| --- |
| 4HF, Middlesex |
| UNITED KINGDOM |

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1

4HF, Middlesex

UNITED KINGDOM

ALENDRONIC ACID ACCORD 70 MG

70 mg

Comprimate

Uz oral

ET - Estonia

| Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1 |
| --- |
| 4HF, Middlesex |
| UNITED KINGDOM |

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow HA1

4HF, Middlesex

UNITED KINGDOM

ALENDRONIC ACID ACCORD 10 MG

10 mg

Comprimate

Uz oral

ET - Estonia

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| ICELAND |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

ICELAND

LENDRATE

70 mg

Comprimate

Uz oral

ET - Estonia

| Gedeon Richter Plc. Gyömrõi ut 19-21 |
| --- |
| 1103 Budapest |
| HUNGARY |

Gedeon Richter Plc. Gyömrõi ut 19-21

1103 Budapest

HUNGARY

SEDRON

70 mg

Comprimate filmate

Uz oral

ET - Estonia

| KRKA d.d., Novo Mesto |
| --- |
| Shmarjeshka cesta 6, |
| 8501 Novo Mesto |
| SLOVENIA |

KRKA d.d., Novo Mesto

Shmarjeshka cesta 6,

8501 Novo Mesto

SLOVENIA

LINDRON

10 mg

Comprimate

Uz oral

ET - Estonia

| MEPHA Lda. |
| --- |
| Lagoas Park Edifico 5-A, Piso 2, 2740-298 Porto |
| Salvo |
| PORTUGAL |

MEPHA Lda.

Lagoas Park Edifico 5-A, Piso 2, 2740-298 Porto

Salvo

PORTUGAL

DENSIDRON

70 mg

Comprimate filmate

Uz oral

ET - Estonia

| Orion Corporation |
| --- |
| Orionintie 1 |
| FIN-02200 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FIN-02200 Espoo

FINLAND

ALENDROONHAPE ORION

70 mg

Comprimate

Uz oral

ET - Estonia

| Ranbaxy (UK) Limited |
| --- |
| 20 Balderton Street, London |
| W1K 6TL |
| UNITED KINGDOM |

Ranbaxy (UK) Limited

20 Balderton Street, London

W1K 6TL

UNITED KINGDOM

RALENOST 70 MG

70 mg

Comprimate

Uz oral

ET - Estonia

| Teva Pharma B.V. Computerweg 10 |
| --- |
| 3542 DR Utrecht |
| THE NETHERLANDS |

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

THE NETHERLANDS

ALENOTOP

70 mg

Comprimate

Uz oral

ET - Estonia

| Teva Pharma B.V. Computerweg 10 |
| --- |
| 3542 DR Utrecht |
| THE NETHERLANDS |

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

THE NETHERLANDS

TEVANATE 70 MG

70 mg

Comprimate

Uz oral

FI - Finlanda

| Ranbaxy UK Ltd, 20 |
| --- |
| Balderton Street, LONDON W1K 6TL, United Kingdom |

Ranbaxy UK Ltd, 20

Balderton Street, LONDON W1K 6TL, United Kingdom

Alendronat Ranbaxy

70 mg

Comprimate

orala

FI - Finlanda

| Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 |
| --- |
| HAFNARFJORDUR, Iceland |

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220

HAFNARFJORDUR, Iceland

Alendronat Actavis

70 mg

Comprimate

orala

FI - Finlanda

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way Stevenage, HERTS SG14SZ, United |
| Kingdom |

Arrow Generics Limited, Unit

2, Eastman Way Stevenage, HERTS SG14SZ, United

Kingdom

Alendronat Arrow

10 mg

Comprimate

orala

FI - Finlanda

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom |

Arrow Generics Limited, Unit

2, Eastman Way Stevenage, HERTS SG14SZ, United Kingdom

Alendronat Arrow

70 mg

Comprimate

orala

FI - Finlanda

| Bluefish Pharmaceuticals |
| --- |
| AB, Torsgatan 11, 11123 |
| STOCKHOLM, Sweden |

Bluefish Pharmaceuticals

AB, Torsgatan 11, 11123

STOCKHOLM, Sweden

Alendronat Bluefish

70 mg

Comprimate

orala

FI - Finlanda

| Hexal A/S, Kanalholmen 8- |
| --- |
| 12, 2650 HVIDOVRE, Denmark |

Hexal A/S, Kanalholmen 8-

12, 2650 HVIDOVRE, Denmark

Alendronat Hexal

70 mg

Comprimate filmate

orala

FI - Finlanda

| Mylan AB, BOX 23033, |
| --- |
| 10435 STOCKHOLM, Sweden |

Mylan AB, BOX 23033,

10435 STOCKHOLM, Sweden

Alendronat Mylan

70 mg

Comprimate

orala

FI - Finlanda

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Alendronat Orifarm

70 mg

Comprimate

orala

FI - Finlanda

| Orion Corporation, Orion |
| --- |
| Pharma, Orionintie 1, 02200 |
| Espoo, Finland |

Orion Corporation, Orion

Pharma, Orionintie 1, 02200

Espoo, Finland

Alendronat Orion

70 mg

Comprimate

orala

FI - Finlanda

ratiopharm GmbH, Graf- Arco-Strasse 3, 89079 Ulm, Germany

Alendronat ratiopharm

70 mg

Comprimate filmate

orala

FI - Finlanda

| Sandoz A/S, C. F. Tietgens |
| --- |
| Boulevard 40, 5220 |
| ODENSE SØ, Denmark |

Sandoz A/S, C. F. Tietgens

Boulevard 40, 5220

ODENSE SØ, Denmark

Alendronat Sandoz

70 mg

Comprimate filmate

orala

FI - Finlanda

| Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX |
| --- |
| 581, 2031 BN HAARLEM, Netherlands |

Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX

581, 2031 BN HAARLEM, Netherlands

Fosamax

10 mg

Comprimate

orala

FI - Finlanda

| Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX |
| --- |
| 581, 2031 BN HAARLEM, Netherlands |

Merck Sharp & Dohme B.V., Waarderweg 39, P.O.BOX

581, 2031 BN HAARLEM, Netherlands

Fosamax

70 mg

Comprimate

orala

FR - Franta

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ALMUS 10 mg, comprimé

10 mg

Comprimate

orala

FR - Franta

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ALMUS 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| ALTER |
| --- |
| 3, avenue de la Baltique |
| ZI de Courtaboeuf |
| 91140 Villebon Sur Yvette |
| FRANCE |

ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

FRANCE

ACIDE ALENDRONIQUE ALTER 70 mg, comprimé pelliculé

70 mg

Comprimate

orala

FR - Franta

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ARROW 10 mg, comprimé

10 mg

Comprimate

orala

FR - Franta

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

ACIDE ALENDRONIQUE ARROW 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| BIOGARAN |
| --- |
| 15, boulevard Charles de |
| Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de

Gaulle

92700 Colombes

FRANCE

ACIDE ALENDRONIQUE BIOGARAN 10 mg, comprimé

10 mg

Comprimate

orala

FR - Franta

| BIOGARAN |
| --- |
| 15, boulevard Charles de |
| Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de

Gaulle

92700 Colombes

FRANCE

ACIDE ALENDRONIQUE BIOGARAN 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt |
| Cedex |
| FRANCE |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt

Cedex

FRANCE

ACIDE

ALENDRONIQUE EG 10 mg, comprimé

10 mg

Comprimate

orala

FR - Franta

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt |
| Cedex |
| FRANCE |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt

Cedex

FRANCE

ACIDE

ALENDRONIQUE EG 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE ALENDRONIQUE MYLAN, 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| TEVA SANTE Le Palatin 1 |
| --- |
| 1 cours du Triangle |
| 92936 Paris la Défense |
| Cedex |
| FRANCE |

TEVA SANTE Le Palatin 1

1 cours du Triangle

92936 Paris la Défense

Cedex

FRANCE

ACIDE ALENDRONIQUE PHR LAB 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| KROMME RIJN APOTHEEK Langstraat 4C |
| --- |
| 3981 EV BUNNIK PAYS-BAS |

KROMME RIJN APOTHEEK Langstraat 4C

3981 EV BUNNIK PAYS-BAS

ACIDE ALENDRONIQUE QUALIHEALTH 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE ALENDRONIQUE QUALIMED 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 |
| --- |
| 89079 Ulm |
| ALLEMAGNE |

RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3

89079 Ulm

ALLEMAGNE

ACIDE ALENDRONIQUE RATIOPHARM 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| SANDOZ |
| --- |
| 49, avenue Georges |
| Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges

Pompidou

92300 Levallois-Perret

FRANCE

ACIDE ALENDRONIQUE SANDOZ 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain |
| Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain

Rolland

75014 Paris

FRANCE

ACIDE ALENDRONIQUE WINTHROP 10 mg, comprimé

10 mg

Comprimate

orala

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain |
| Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain

Rolland

75014 Paris

FRANCE

ACIDE ALENDRONIQUE WINTHROP 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| ZYDUS FRANCE |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des |
| Peupliers |
| 92000 Nanterre |
| FRANCE |

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des

Peupliers

92000 Nanterre

FRANCE

ACIDE ALENDRONIQUE ZYDUS 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| PHARMEMMA |
| --- |
| Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE |

PHARMEMMA

Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE

ARONADE 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| THERAMEX |
| --- |
| 6, avenue Albert II Zone F - Bloc B |
| 98000 Monaco |
| MONACO |

THERAMEX

6, avenue Albert II Zone F - Bloc B

98000 Monaco

MONACO

AURENA 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| PHARMEMMA |
| --- |
| Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE |

PHARMEMMA

Unit 2, Ashbourne Manufacturing Park Ashbourne County Meath IRLANDE

DRONACID 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| MERCK SHARP & DOHME CHIBRET |
| --- |
| 3, avenue Hoche |
| 75114 Paris Cedex 08 |
| FRANCE |

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSAMAX 10 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| MERCK SHARP & DOHME CHIBRET |
| --- |
| 3, avenue Hoche |
| 75114 Paris Cedex 08 |
| FRANCE |

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSAMAX 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| MERCK SHARP & DOHME CHIBRET |
| --- |
| 3, avenue Hoche |
| 75114 Paris Cedex 08 |
| FRANCE |

MERCK SHARP & DOHME CHIBRET

3, avenue Hoche

75114 Paris Cedex 08

FRANCE

FOSATROL 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

ACIDE ALENDRONIQUE BIOGALENIQUE 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES |
| --- |
| 4, place Louis Armand |
| 75012 Paris |
| FRANCE |

LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES

4, place Louis Armand

75012 Paris

FRANCE

ACIDE ALENDRONIQUE RANBAXY 70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

ACIDE ALENDRONIQUE RPG

70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| TEVA SANTE Le Palatin 1 |
| --- |
| 1 cours du Triangle |
| 92936 Paris la Défense |
| Cedex |
| FRANCE |

TEVA SANTE Le Palatin 1

1 cours du Triangle

92936 Paris la Défense

Cedex

FRANCE

ACIDE ALENDRONIQUE TEVA

70 mg, comprimé

70 mg

Comprimate

orala

FR - Franta

| TEVA SANTE Le Palatin 1 |
| --- |
| 1 cours du Triangle |
| 92936 Paris la Défense |
| Cedex |
| FRANCE |

TEVA SANTE Le Palatin 1

1 cours du Triangle

92936 Paris la Défense

Cedex

FRANCE

ALENDRONATE TEVA

10 mg, comprimé

10 mg

Comprimate

orala

HU - Ungaria

| Generics (UK) Ltd. |
| --- |
| Albany Gate, Darkes Lane, Potters bar |
| EN61AG Hertfordshire |
| UK |

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

ALENDIS 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37

mg sodium alendronate]

Comprimate

orala

HU - Ungaria

| Arrow Generics Ltd. Stevenage |
| --- |
| SG14SZ Hertfordshire |
| UK |

Arrow Generics Ltd. Stevenage

SG14SZ Hertfordshire

UK

ALENDROMAX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium alendronate

trihydrate]

Comprimate

orala

HU - Ungaria

| Sandoz Hungária Kft., |
| --- |
| 1114 Budapest, Bartók Béla út 43-47. |
| Hungary |

Sandoz Hungária Kft.,

1114 Budapest, Bartók Béla út 43-47.

Hungary

ALENDRON HEXAL 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36

mg sodium alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Bluefish Pharmaceuticals |
| --- |
| ABTorsgatan 11 |
| 111 23 Stockholm |
| Sweden |

Bluefish Pharmaceuticals

ABTorsgatan 11

111 23 Stockholm

Sweden

ALENDRONAT BLUEFISH 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37

mg sodium alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Orion Corporation |
| --- |
| Orionintie 1. |
| 2200 Espoo |
| Finland |

Orion Corporation

Orionintie 1.

2200 Espoo

Finland

ALENDRONAT ORION

70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium

alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Pliva Hungária Kft. Galagonya u. 5. |
| --- |
| 1036 Budapest |
| Hungary (The company is the member of TEVA Group Teva Magyarország zRt,1134budapest, Róbert Károly krt.59)) |

Pliva Hungária Kft. Galagonya u. 5.

1036 Budapest

Hungary (The company is the member of TEVA Group Teva Magyarország zRt,1134budapest, Róbert Károly krt.59))

ALENDRONAT PLIVA

70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36

mg alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Ratiopharm Hungária Kft. Uzsoki u. 36/A |
| --- |
| 1145 Budapest |
| Hungary |

Ratiopharm Hungária Kft. Uzsoki u. 36/A

1145 Budapest

Hungary

ALENDRONAT- RATIOPHARM 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,36 mg sodium

alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

ALENDRONAT- RICHTER 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35

mg sodium alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Sandoz Hungária Kft., |
| --- |
| 1114 Budapest, Bartók Béla út 43-47. |
| Hungary |

Sandoz Hungária Kft.,

1114 Budapest, Bartók Béla út 43-47.

Hungary

ALENDRONAT- SANDOZ 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate]

Comprimate filmate

orala

HU - Ungaria

| Apotex Europe B.V. Darwinweg 20. |
| --- |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V. Darwinweg 20.

2333 CR Leiden

Holland

ALENDRONSAV APOTEX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,35

mg sodium alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

Calcisedron-D

filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

Calcisedron-D Trio filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35

mg sodium alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Aramis Pharma Kft. Mester u. 28. III/5. |
| --- |
| 1095 Budapest |
| Hungary |

Aramis Pharma Kft. Mester u. 28. III/5.

1095 Budapest

Hungary

DRONAVIC 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium

alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Apotex Europe B.V. Darwinweg 20. |
| --- |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V. Darwinweg 20.

2333 CR Leiden

Holland

EPOLAR 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,35

mg sodium alendronate]

Comprimate

orala

HU - Ungaria

| Apotex Europe B.V. Darwinweg 20. |
| --- |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V. Darwinweg 20.

2333 CR Leiden

Holland

EPOLAR Trio 70 mg tabletta és rágótabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate]

Comprimate si comprimate masticabile

orala

HU - Ungaria

| Actavis Group PTC ehf. Reykjavikurvegur 76-78. |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf. Reykjavikurvegur 76-78.

220 Hafnarfjordur

Iceland

FLADOR 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37

mg sodium alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Medico Uno Pharma Kft. Viadukt u. 12. |
| --- |
| 2051 Biatorbágy |
| Hungary |

Medico Uno Pharma Kft. Viadukt u. 12.

2051 Biatorbágy

Hungary

FORTIMAX tabletta

70,0 mg Alendronic acid

[in the form of 91,37 mg sodium

alendronate trihydrate]

Comprimate

orala

HU - Ungaria

| Merck Sharp & Dohme Magyarország Kft. Alkotás u. 48-50. |
| --- |
| 1123 Budapest |
| Hungary |

Merck Sharp & Dohme Magyarország Kft. Alkotás u. 48-50.

1123 Budapest

Hungary

FOSAMAX 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 91,37

mg sodium alendronate]

Comprimate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

HANTRUX 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Vera Pharma Kft. Rákos köz 22. |
| --- |
| 1028 Budapest |
| Hungary |

Vera Pharma Kft. Rákos köz 22.

1028 Budapest

Hungary

MASSIDRON 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 81,2

mg mg sodium alendronate monohydrate]

Comprimate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

MATEKIT 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

SEDRON 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35

mg sodium alendronate trihydrate]

Comprimate filmate

orala

HU - Ungaria

| Teva Magyarország Zrt. |
| --- |
| 2100 Gödöllő, Repülőtéri út 5. |

Teva Magyarország Zrt.

2100 Gödöllő, Repülőtéri út 5.

TRABECAN-TEVA 70 mg tabletta

70,0 mg Alendronic acid

[in the form of 81,2 mg mg sodium

alendronate monohydrate]

Comprimate

orala

HU - Ungaria

| Teva Magyarország Zrt. |
| --- |
| 2100 Gödöllő, Repülőtéri út 5. |

Teva Magyarország Zrt.

2100 Gödöllő, Repülőtéri út 5.

TRABECAN Duo TEVA tabletta és lágy kapszula

70,0 mg Alendronic acid

[in the form of 81,2

mg mg sodium alendronate monohydrate]

Comprimate si capsule moi

orala

HU - Ungaria

| Richter Gedeon nyrt. Gyömrői út 19-21. |
| --- |
| 1103 Budapest |
| Hungary |

Richter Gedeon nyrt. Gyömrői út 19-21.

1103 Budapest

Hungary

UTERITRIN 70 mg filmtabletta

70,0 mg Alendronic acid

[in the form of 91,35 mg sodium

alendronate trihydrate]

Comprimate filmate

orala

IE - Irlanda

| Merck Sharp & Dohme |
| --- |
| Limited |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU United Kingdom |

Merck Sharp & Dohme

Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU United Kingdom

Fosamax

10 mg

Comprimate

orala

IE - Irlanda

| Merck Sharp & Dohme |
| --- |
| Limited |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU United Kingdom |

Merck Sharp & Dohme

Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU United Kingdom

Fosamax

70 mg

Comprimate

orala

IE - Irlanda

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Co. Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Co. Tipperary

Ireland

Osteomel Once weekly

70 mg

Comprimate

orala

IE - Irlanda

| PLIVA Pharma Ltd. Vision House Bedford Road Petersfield |
| --- |
| Hants, GU32 3QB United Kingdom |

PLIVA Pharma Ltd. Vision House Bedford Road Petersfield

Hants, GU32 3QB United Kingdom

Fosalen Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |

Rowex Ltd

Bantry

Co. Cork

Romax Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

| Laboratorios Davur S.L.U. C/Anabel Segura 11 |
| --- |
| Edificio Albatros B |
| 1a planta |
| Alcobendas |
| 28108 Madrid |
| Spain |

Laboratorios Davur S.L.U. C/Anabel Segura 11

Edificio Albatros B

1a planta

Alcobendas

28108 Madrid

Spain

Alendronic Acid Once

Weekly 70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

| McDermott Laboratories Ltd. t/a Gerard Laboratories |
| --- |
| 35/36 Baldoyle Industrial |
| Estate, Grange Road, Dublin 13 |
| McDermott Laboratories Ltd. t/a Gerard Laboratories |
| 35/36 Baldoyle Industrial |
| Estate, Grange Road, Dublin 13 |

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial

Estate, Grange Road, Dublin 13

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial

Estate, Grange Road, Dublin 13

Fostepor 10 mg Tablets

10 mg

Comprimate

orala

IE - Irlanda

| McDermott Laboratories Ltd. t/a Gerard Laboratories |
| --- |
| 35/36 Baldoyle Industrial |
| Estate, Grange Road, Dublin 13 |
| McDermott Laboratories Ltd. t/a Gerard Laboratories |
| 35/36 Baldoyle Industrial |
| Estate, Grange Road, Dublin 14 |

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial

Estate, Grange Road, Dublin 13

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial

Estate, Grange Road, Dublin 14

Fostepor Once Weekly

70 mg Tablets

10 mg

Comprimate

orala

IE - Irlanda

| PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 |
| --- |
| 3QB, United Kingdom |

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32

3QB, United Kingdom

Fosalen 10 mg Tablets

10 mg

Comprimate

orala

IE - Irlanda

| PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 |
| --- |
| 3QB, United Kingdom |

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32

3QB, United Kingdom

Fosalen Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Tevanate Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Fosalen Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

| Bluefish Pharmaceuticals |
| --- |
| AB, Torsgatan 11, 111 23 |
| Stockholm, Sweden. |

Bluefish Pharmaceuticals

AB, Torsgatan 11, 111 23

Stockholm, Sweden.

Alendronic Acid

Bluefish Once weekly

70 mg Tablets

70 mg

Comprimate

orala

IE - Irlanda

| Actavis Group PTC ehf; Reykjavikurvegi 76-78, |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Fostolin Once Weekly

70 mg Tablets

70 mg

Comprimate

orala

IS - Islanda

| Arrow Generics Ltd., Unit 2 |
| --- |
| Eastman Way Stevenage, Hertz SG1 4SZ U.K |

Arrow Generics Ltd., Unit 2

Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow

10 mg

Comprimate

orala

IS - Islanda

| Arrow Generics Ltd., Unit 2 |
| --- |
| Eastman Way Stevenage, Hertz SG1 4SZ U.K |

Arrow Generics Ltd., Unit 2

Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow week tablet

70 mg

Comprimate

orala

IS - Islanda

| Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220

Hafnarfjordur, Iceland

Alendronat Actavis

70 mg

Comprimate

orala

IS - Islanda

Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K

Alendronat Ranbaxy

70 mg

Comprimate

orala

IS - Islanda

Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Netherlands

Fosamax week tablet

70 mg

Comprimate

orala

IS - Islanda

| Williams & Halls ehf, Hverfisgata 105 101 |
| --- |
| Reykjavík, Iceland |

Williams & Halls ehf, Hverfisgata 105 101

Reykjavík, Iceland

Ostacid

70 mg

Comprimate filmate

orala

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

10 mg

Comprimate

Uz oral

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

70 mg

Comprimate

Uz oral

IT - Italia

| ACCORD HEALTHCARE LIMITED |
| --- |
| Sage House,319 |
| Pinner Road |
| North Harrow Middlesex |

ACCORD HEALTHCARE LIMITED

Sage House,319

Pinner Road

North Harrow Middlesex

ALENDRONATO AHCL

10 mg

Comprimate

Uz oral

IT - Italia

ACTAVIS GROUP PTC EHF Reykjavikurvegi 76-78

ALENDRONATO ACTAVIS

70 mg

Comprimate

Uz oral

IT - Italia

| AGIPS FARMACEUTICI Srl |
| --- |
| Via Amendola 4 - 16035 |
| Rapallo (GE) |

AGIPS FARMACEUTICI Srl

Via Amendola 4 - 16035

Rapallo (GE)

GLAMOR

70 mg

Comprimate filmate

Uz oral

IT - Italia

| ALMUS Srl |
| --- |
| Via Cesarea, 11/10 - 16121 |
| Genova |

ALMUS Srl

Via Cesarea, 11/10 - 16121

Genova

ALENDRONATO ALMUS

70 mg

Comprimate filmate

Uz oral

IT - Italia

ARROW GENERICS LTD Unit 2, Eastman way Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

10 MG

Comprimate

Uz oral

IT - Italia

ARROW GENERICS LTD Unit 2, Eastman way Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

70 mg

Comprimate

Uz oral

IT - Italia

| BENTLEY PHARMACEUTICALS IRELAND LTD |
| --- |
| 25-28 North Wall Uay |
| Dublin 1 - Ireland |

BENTLEY PHARMACEUTICALS IRELAND LTD

25-28 North Wall Uay

Dublin 1 - Ireland

ALENDRONATO BENTLEY PHARMACEUTICALS IRELAND

70 mg

Comprimate

Uz oral

IT - Italia

| BIOHEALTH PHARMACEUTICALS Srl Via Bolognese, 250 |
| --- |
| Pistoia - Italy |

BIOHEALTH PHARMACEUTICALS Srl Via Bolognese, 250

Pistoia - Italy

ASTON

70 mg

Comprimate filmate

Uz oral

IT - Italia

| BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA |
| --- |
| Via Morolense, 87 - 03013 |
| Ferentino (FR) |

BIOMEDICA FOSCAMA INDUSTRIA CHIMICA FARMACEUTICA SpA

Via Morolense, 87 - 03013

Ferentino (FR)

ALOST

70 mg

Comprimate

Uz oral

IT - Italia

| LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl

Via Pavia, 6 - 20136

Milano - Italy

DORYX

70 mg

Comprimate

Uz oral

IT - Italia

| DOC GENERICI Srl |
| --- |
| Via Manuzio, 7 - 20124 |
| Milano |

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC GENERICI

70 mg

Comprimate

Uz oral

IT - Italia

| DOC GENERICI Srl |
| --- |
| Via Manuzio, 7 - 20124 |
| Milano |

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC

70 mg

Comprimate

Uz oral

IT - Italia

| DR REDDY'S Srl |
| --- |
| Via Fernanada Wittgens, 6 - 20123 |
| Milano |

DR REDDY'S Srl

Via Fernanada Wittgens, 6 - 20123

Milano

ALENDRONATO DR REDDY'S

70 mg

Comprimate

Uz oral

IT - Italia

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

10 mg

Comprimate

Uz oral

IT - Italia

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

70 mg

Comprimate

Uz oral

IT - Italia

| EPIFARMA Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ALENIC

70 mg

Comprimate

Uz oral

IT - Italia

| EPIFARMA Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO EPIFARMA

70 mg

Comprimate

Uz oral

IT - Italia

| FG Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

FG Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO FG

70 mg

Comprimate

Uz oral

IT - Italia

| FIDIA FARMACEUTICI SpA Via Ponte D/Fabbrica, 3/A - |
| --- |
| 25031 |
| Abano Terme (PD) |

FIDIA FARMACEUTICI SpA Via Ponte D/Fabbrica, 3/A -

25031

Abano Terme (PD)

ACIDO ALENDRONICO FIDIA

70 mg

Comprimate

Uz oral

IT - Italia

| GERMED PHARMA SpA Via Cesare Cantù, 11 - 20092 |
| --- |
| Cinisello Balsamo (MI) |

GERMED PHARMA SpA Via Cesare Cantù, 11 - 20092

Cinisello Balsamo (MI)

ALENDRONATO GERMED

10 mg

Comprimate

Uz oral

IT - Italia

| GERMED PHARMA SpA Via Cesare Cantù, 11 - 20092 |
| --- |
| Cinisello Balsamo (MI) |

GERMED PHARMA SpA Via Cesare Cantù, 11 - 20092

Cinisello Balsamo (MI)

ALENDRONATO GERMED

70 mg

Comprimate

Uz oral

IT - Italia

| HEXAL SpA |
| --- |
| Via Paracelso, 16 - 20041 |
| Agrate Brianza (MI) |

HEXAL SpA

Via Paracelso, 16 - 20041

Agrate Brianza (MI)

ALENDRONATO HEXAL

70 mg

Comprimate

Uz oral

IT - Italia

| ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE Srl |
| --- |
| Via Salaria, 1240 - 00138 |
| Roma |

ISTITUTO CHIMICO INTERNAZIONALE DR. GIUSEPPE RENDE Srl

Via Salaria, 1240 - 00138

Roma

REALEN

70 mg

Comprimate

Uz oral

IT - Italia

| ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, 15 - 20143 |
| --- |
| Milano |

ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

10 mg

Comprimate

Uz oral

IT - Italia

| ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, 15 - 20143 |
| --- |
| Milano |

ISTITUTO GENTILI SpA Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

70 mg

Comprimate

Uz oral

IT - Italia

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

ALENDRONATO ALTER

70 mg

Comprimate

Uz oral

IT - Italia

| MERCK SHARP & DOHME Ltd |
| --- |
| Hertford Road, Hoddesdon |
| Hertfordshire EN119BU |

MERCK SHARP & DOHME Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

10 mg

Comprimate

Uz oral

IT - Italia

| MERCK SHARP & DOHME Ltd |
| --- |
| Hertford Road, Hoddesdon |
| Hertfordshire EN119BU |

MERCK SHARP & DOHME Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

70 mg

Comprimate

Uz oral

IT - Italia

| MYLAN SpA |
| --- |
| Via Vittor Pisani, 20 - 20124 |
| Milano |

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ALENDRONATO MYLAN GENERICS

70 mg

Comprimate

Uz oral

IT - Italia

| NEOPHARMED Srl Via San Giuseppe Cottolengo, 15 - 20143 |
| --- |
| Milano |

NEOPHARMED Srl Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

10 mg

Comprimate

Uz oral

IT - Italia

| NEOPHARMED Srl Via San Giuseppe Cottolengo, 15 - 20143 |
| --- |
| Milano |

NEOPHARMED Srl Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

70 mg

Comprimate

Uz oral

IT - Italia

| PENSA PHARMA SpA |
| --- |
| Via Rossellini Ippolito, 12 |
| 20124 - Milano |

PENSA PHARMA SpA

Via Rossellini Ippolito, 12

20124 - Milano

ALENDRONATO PENSA

70 mg

Comprimate

Uz oral

IT - Italia

| PHARMEG Srl |
| --- |
| Via dei Giardini, 24 - 85033 |
| Episcopia (PZ) |

PHARMEG Srl

Via dei Giardini, 24 - 85033

Episcopia (PZ)

PORODRON

70 mg

Comprimate

Uz oral

IT - Italia

| RANBAXY ITALIA SpA |
| --- |
| p.zza Filippo Meda, 3 - |
| 20121 Milano |

RANBAXY ITALIA SpA

p.zza Filippo Meda, 3 -

20121 Milano

ALENDRONATO RANBAXY ITALIA

70 mg

Comprimate

Uz oral

IT - Italia

| RATIOPHARM GMBH Graf Arco-strasse, 3 |
| --- |
| Ulm D-89070 |

RATIOPHARM GMBH Graf Arco-strasse, 3

Ulm D-89070

ALENDRONATO RATIOPHARM

70 mg

Comprimate

Uz oral

IT - Italia

| S.F.GROUP Srl |
| --- |
| Via Beniamino Segre, 59 |
| 00134 Roma Italy |

S.F.GROUP Srl

Via Beniamino Segre, 59

00134 Roma Italy

NOFRATTIL

70 mg

Comprimate filmate

Uz oral

IT - Italia

| SANDOZ SpA |
| --- |
| L.go U. Boccioni, 1 - 21040 |
| Origgio (VA) |

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ALENDRONATO SANDOZ

70 mg

Comprimate

Uz oral

IT - Italia

| SEGIX ITALIA Srl |
| --- |
| Via Del Mare, 36 - 00040 |
| Pomezia (RM) |

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

10 mg

Comprimate

Uz oral

IT - Italia

| SEGIX ITALIA Srl |
| --- |
| Via Del Mare, 36 - 00040 |
| Pomezia (RM) |

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

70 mg

Comprimate

Uz oral

IT - Italia

| SIGMATAU GENERICS SpA Via Pontina Km30, 400 |
| --- |
| 00040 Pomezia (RM) |

SIGMATAU GENERICS SpA Via Pontina Km30, 400

00040 Pomezia (RM)

ACIDO ALENDRONICO SIGMA TAU GENERICS

70 mg

Comprimate

Uz oral

IT - Italia

| SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA

Viale Shakespeare, 47

00144 Roma

DRONAL

10 mg

Comprimate

Uz oral

IT - Italia

| SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA

Viale Shakespeare, 47

00144 Roma

DRONAL

70 mg

Comprimate

Uz oral

IT - Italia

| SO.SE.PHARM Srl |
| --- |
| Via dei Castelli Romani, 22 |
| 00040 Pomezia (RM) |

SO.SE.PHARM Srl

Via dei Castelli Romani, 22

00040 Pomezia (RM)

LOSS

70 mg

Comprimate filmate

Uz oral

IT - Italia

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano - Italy |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano - Italy

ALENDRONATO TEVA

70 mg

Comprimate

Uz oral

IT - Italia

| ACCORD HEALTHCARE LIMITED |
| --- |
| Sage House,319 |
| Pinner Road |
| North Harrow Middlesex |

ACCORD HEALTHCARE LIMITED

Sage House,319

Pinner Road

North Harrow Middlesex

ALENDRONATO AHCL

70 mg

Comprimate

Uz oral

LT - Lituania

| KRKA d.d., Šmarješka Cesta |
| --- |
| 6 8501 Novo mesto, Slovenia |

KRKA d.d., Šmarješka Cesta

6 8501 Novo mesto, Slovenia

Lindron

10 mg

Comprimate

Uz oral

LT - Lituania

| Sandoz d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana Slovenia |

Sandoz d.d., Verovškova 57

SI-1000 Ljubljana Slovenia

Alendon

70 mg

Comprimate

Uz oral

LT - Lituania

| Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220

Hafnarfjordur, Iceland

Lendrate

70 mg

Comprimate

Uz oral

LT - Lituania

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

70 mg

Comprimate

Uz oral

LT - Lituania

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

10 mg

Comprimate

Uz oral

LT - Lituania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Alenotop

70 mg

Comprimate

Uz oral

LT - Lituania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Tevanate

70 mg

Comprimate

Uz oral

LT - Lituania

Mepha Lda., Lagoas Park, Edificio 5-A, Piso 2, 2740-298 Porto Salvo, Portugal

Densidron

70 mg

Comprimate

Uz oral

LT - Lituania

| Ranbaxy UK Ltd., 20 |
| --- |
| Balderton Street London |
| W1K 6TL, United Kingdom |

Ranbaxy UK Ltd., 20

Balderton Street London

W1K 6TL, United Kingdom

Ralenost

70 mg

Comprimate

Uz oral

LT - Lituania

| Gedeon Richter Plc., 1103 |
| --- |
| Budapest Gyömrői út 19-21, Hungary |

Gedeon Richter Plc., 1103

Budapest Gyömrői út 19-21, Hungary

Sedron

70 mg

Comprimate filmate

Uz oral

LT - Lituania

| Pharmaceutical Works |
| --- |
| POLPHARMA SA, 19 |
| Pelplińska Street 83-200 |
| Starogard Gdański, Poland |

Pharmaceutical Works

POLPHARMA SA, 19

Pelplińska Street 83-200

Starogard Gdański, Poland

Ostemax

70 mg

Comprimate

Uz oral

LT - Lituania

| UAB „Merck Sharp & Dohme”, Kęstučio 59/27, |
| --- |
| LT-08124 Vilnius, Lithuania |

UAB „Merck Sharp & Dohme”, Kęstučio 59/27,

LT-08124 Vilnius, Lithuania

Fosamax

70 mg

Comprimate

Uz oral

LT - Lituania

| Orion Corporation, Orionintie 1, FI-02200 |
| --- |
| Espoo, Finland |

Orion Corporation, Orionintie 1, FI-02200

Espoo, Finland

Alendorion

70 mg

Comprimate

Uz oral

LU - Luxemburg

| Merck Sharp & Dohme |
| --- |
| 5, Clos du Linx |
| B-1200 Bruxelles |

Merck Sharp & Dohme

5, Clos du Linx

B-1200 Bruxelles

Fosamax-70

Hebdomadaire

70 mg

Comprimate

orala

LV - Latvia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium

Accord

10 mg

Comprimate

Uz oral

LV - Latvia

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium

Accord

70 mg

Comprimate

Uz oral

LV - Latvia

| Orion Corporation, Orionintie 1, FI-02200 |
| --- |
| Espoo Finland |

Orion Corporation, Orionintie 1, FI-02200

Espoo Finland

Alendorion

70 mg

Comprimate

Uz oral

LV - Latvia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Alenotop

70 mg

Comprimate

Uz oral

LV - Latvia

| Mepha Lda., Lagoas Park, |
| --- |
| 2740-298 Porto Salvo, Portugal |

Mepha Lda., Lagoas Park,

2740-298 Porto Salvo, Portugal

Densidron

70 mg

Comprimate filmate

Uz oral

LV - Latvia

| Gedeon Richter Plc., 1103 |
| --- |
| Budapest, Gyomroi ut 19- |
| 21, Hungary |

Gedeon Richter Plc., 1103

Budapest, Gyomroi ut 19-

21, Hungary

Sedron

70 mg

Comprimate filmate

Uz oral

LV - Latvia

| Pharmaceutical Works |
| --- |
| Polpharma SA., 19 |
| Pelplinska Str., 83-200 |
| Starogard Gdanski, Poland |

Pharmaceutical Works

Polpharma SA., 19

Pelplinska Str., 83-200

Starogard Gdanski, Poland

Ostemax

70 mg

Comprimate

Uz oral

LV - Latvia

| Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220

Hafnarfjordur, Iceland

Lendrate

70 mg

Comprimate

Uz oral

LV - Latvia

SIA"Merck Sharp & Dohme Latvija", Skanstes iela 13, Riga LV-1013, Latvia

Fosamax

70 mg

Comprimate

Uz oral

MT - Malta

Mepha - Investigação, Desenvolvimento e Fabricação Farmaceutica, Lda.

Densidron

70 mg

Comprimate filmate

orala

MT - Malta

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Fosamax

70 mg

Comprimate

orala

MT - Malta

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way, Stevenage, Hertfordshire |
| SG1 4SZ, United kingdom. |

Arrow Generics Limited, Unit

2, Eastman Way, Stevenage, Hertfordshire

SG1 4SZ, United kingdom.

Alendronic Acid 10 mg tablets

10 mg

Comprimate

orala

MT - Malta

| Arrow Generics Limited, Unit |
| --- |
| 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom. |

Arrow Generics Limited, Unit

2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.

Alendronic Acid 70 mg tablets

70 mg

Comprimate

orala

MT - Malta

Aurobindo Pharma (Malta) Ltd, 46/2 South Street, Valletta VLT11, Malta

Alendronic Acid 70 mg tablet

70 mg

Comprimate

orala

MT - Malta

| Accord Healthcare Limited |
| --- |
| Sage House |
| 319, Pinner Road |
| North Harrow |
| Middlesex HA1 4 HF United Kingdom |

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4 HF United Kingdom

Alendronate Sodium

Accord 10 mg Tablets

10 mg

Comprimate

orala

MT - Malta

| Accord Healthcare Limited |
| --- |
| Sage House |
| 319, Pinner Road |
| North Harrow Middlesex HA1 4 HF United Kingdom |

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow Middlesex HA1 4 HF United Kingdom

Alendronate Sodium

Accord 70 mg Tablets

70 mg

Comprimate

orala

MT - Malta

| Actavis Group PTC ehf; Reykjavikurvegi 76-78, |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Lendrate

70 mg

Comprimate

orala

NL - Olanda

| acis Arzneimittel GmbH Lil-Dagover-Ring 7 |
| --- |
| 82031 Grünwald, Germany |

acis Arzneimittel GmbH Lil-Dagover-Ring 7

82031 Grünwald, Germany

Osteonorm 70 mg

70 mg

Comprimate

orala

NL - Olanda

| ratiopharm Nederland bv |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| Netherlands |

ratiopharm Nederland bv

Florapark 4

2012 HK Haarlem

Netherlands

Alendroninezuur ratiopharm 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Sandoz B.V., Veluwezoom 22 |
| --- |
| 1327 AH Almere |
| Netherlands |

Sandoz B.V., Veluwezoom 22

1327 AH Almere

Netherlands

Alendroninezuur

Sandoz 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Iono Limited |
| --- |
| 65 Delamere Road, Hayes |
| Middlesex UB4 ONN United Kingdom |

Iono Limited

65 Delamere Road, Hayes

Middlesex UB4 ONN United Kingdom

Alendroninezuur Iono

70 mg

70 mg

Comprimate

orala

NL - Olanda

| Iono Limited |
| --- |
| 65 Delamere Road, Hayes |
| Middlesex UB4 ONN United Kingdom |

Iono Limited

65 Delamere Road, Hayes

Middlesex UB4 ONN United Kingdom

Alendroninezuur Iono

10 mg

10 mg

Comprimate

orala

NL - Olanda

| Pharmachemie B.V. Swensweg 5 |
| --- |
| 2031 GA Haarlem |
| Netherlands |

Pharmachemie B.V. Swensweg 5

2031 GA Haarlem

Netherlands

Alendroninezuur 10

PCH

10 mg

Comprimate

orala

NL - Olanda

| Pharmachemie B.V. Swensweg 5 |
| --- |
| 2031 GA Haarlem |
| Netherlands |

Pharmachemie B.V. Swensweg 5

2031 GA Haarlem

Netherlands

Alendroninezuur 70

PCH

70 mg

Comprimate

orala

NL - Olanda

| Centrafarm Services B.V. Nieuwe Donk 9 |
| --- |
| 47879 AC Etten-Leur |
| Netherlands |

Centrafarm Services B.V. Nieuwe Donk 9

47879 AC Etten-Leur

Netherlands

Alendroninezuur CF 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211 |
| --- |
| 8054 Graz Austria |

Genericon Pharma Gesellschaft m.b.H. Hafnerstraße 211

8054 Graz Austria

Alendronorm 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Bentley Pharmaceuticals |
| --- |
| Limited, |
| 25/28 North Wall Quay |
| Dublin 1 |
| Ireland |

Bentley Pharmaceuticals

Limited,

25/28 North Wall Quay

Dublin 1

Ireland

Alendroninezuur

Bentley 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Biomedica Foscama Industria Chimico- Farmaceutica S.p.A. |
| --- |
| Via Morolense, 87 – 03010 |
| Ferentino |

Biomedica Foscama Industria Chimico- Farmaceutica S.p.A.

Via Morolense, 87 – 03010

Ferentino

Dronatex 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ |
| --- |
| United Kingdom |

Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ

United Kingdom

Alendroninezuur Arrow

70 mg

70 mg

Comprimate

orala

NL - Olanda

| Apotex Europe BV Darwinweg 20 |
| --- |
| 2333 CR Leiden |
| Netherlands |

Apotex Europe BV Darwinweg 20

2333 CR Leiden

Netherlands

Alendroninezuur

Apotex 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Ranbaxy Belgium NV Leuvensestraat 28b |
| --- |
| 1800 Vilvoorde |
| Belgium |

Ranbaxy Belgium NV Leuvensestraat 28b

1800 Vilvoorde

Belgium

Alendratol 10 mg

10 mg

Comprimate

orala

NL - Olanda

| Ranbaxy Belgium NV Leuvensestraat 28b |
| --- |
| 1800 Vilvoorde |
| Belgium |

Ranbaxy Belgium NV Leuvensestraat 28b

1800 Vilvoorde

Belgium

Alendratol 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Ranbaxy Belgium NV Leuvensestraat 28b |
| --- |
| 1800 Vilvoorde |
| Belgium |

Ranbaxy Belgium NV Leuvensestraat 28b

1800 Vilvoorde

Belgium

Randronate 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Sandoz B.V., Veluwezoom 22 |
| --- |
| 1327 AH Almere |
| Netherlands |

Sandoz B.V., Veluwezoom 22

1327 AH Almere

Netherlands

Alendroninezuur

Sandoz 10 mg

10 mg

Comprimate

orala

NL - Olanda

| Sandoz B.V., Veluwezoom 22 |
| --- |
| 1327 AH Almere |
| Netherlands |

Sandoz B.V., Veluwezoom 22

1327 AH Almere

Netherlands

Alendroninezuur

Sandoz 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Mylan BV Dieselweg 25 |
| --- |
| 3752 LB Bunschoten |
| Netherlands |

Mylan BV Dieselweg 25

3752 LB Bunschoten

Netherlands

Alendroninezuur Mylan

10 mg

10 mg

Comprimate

orala

NL - Olanda

| Mylan BV Dieselweg 25 |
| --- |
| 3752 LB Bunschoten |
| Netherlands |

Mylan BV Dieselweg 25

3752 LB Bunschoten

Netherlands

Alendroninezuur Mylan

70 mg

70 mg

Comprimate

orala

NL - Olanda

| Apothecon B.V. Nijverheidsweg 3, 3771 ME Barneveld |
| --- |
| Netherlands |

Apothecon B.V. Nijverheidsweg 3, 3771 ME Barneveld

Netherlands

Alendroninezuur 70A

70 mg

Comprimate

orala

NL - Olanda

| mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| 06796 Brehna |
| Germany |

mibe GmbH Arzneimittel

Münchener Str. 15

06796 Brehna

Germany

Ostadil 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78,220 |
| Hafnarfjordur |

Actavis Group PTC ehf

Reykjavikurvegur 76-78,220

Hafnarfjordur

Alendroninezuur

Actavis 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Centrafarm Services B.V. Nieuwe Donk 9 |
| --- |
| 47879 AC Etten-Leur |
| Netherlands |

Centrafarm Services B.V. Nieuwe Donk 9

47879 AC Etten-Leur

Netherlands

Alendroninezuur CF 10 mg

10 mg

Comprimate

orala

NL - Olanda

| Bluefish Pharmaceuticals |
| --- |
| AB, Torsgatan 11 |
| 111 23 Stockholm |
| Sweden |

Bluefish Pharmaceuticals

AB, Torsgatan 11

111 23 Stockholm

Sweden

Akendroninezuur

Bluefish 70 mg

70 mg

Comprimate

orala

NL - Olanda

| WILL-PHARMA Wilgenlaan 5 |
| --- |
| 1161 JK Zwanenburg |
| Netherlands |

WILL-PHARMA Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Bonendro

70 mg / 1 000 mg /

880 IU

Comprimate si granule

orala

NL - Olanda

| Merck Sharp & Dohme BV Waarderweg 39 |
| --- |
| 2031 BN Haarlem |
| Netherlands |

Merck Sharp & Dohme BV Waarderweg 39

2031 BN Haarlem

Netherlands

Fosamax 10 mg

10 mg

Comprimate

orala

NL - Olanda

| Merck Sharp & Dohme BV Waarderweg 39 |
| --- |
| 2031 BN Haarlem |
| Netherlands |

Merck Sharp & Dohme BV Waarderweg 39

2031 BN Haarlem

Netherlands

Fosamax 70 mg

70 mg

Comprimate

orala

NL - Olanda

| WILL-PHARMA Wilgenlaan 5 |
| --- |
| 1161 JK Zwanenburg |
| Netherlands |

WILL-PHARMA Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Alendronax 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF |
| --- |
| United Kingdom |

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF

United Kingdom

Alendroninezuur

Accord 10 mg

10 mg

Comprimate

orala

NL - Olanda

| Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF |
| --- |
| United Kingdom |

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF

United Kingdom

Alendroninezuur

Accord 70 mg

70 mg

Comprimate

orala

NL - Olanda

| Ranbaxy Belgium NV Leuvensestraat 28b |
| --- |
| 1800 Vilvoorde |
| Belgium |

Ranbaxy Belgium NV Leuvensestraat 28b

1800 Vilvoorde

Belgium

Alendroninezuur 70

Ranbaxy

70 mg

Comprimate

orala

NO - Norvegia

| Arrow Generics Ltd, 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, |
| united Kingdom |

Arrow Generics Ltd, 2

Eastman Way, Stevenage, Hertfordshire, SG1 4SZ,

united Kingdom

Alendronat Arrrow

10 mg

Comprimate

orala

NO - Norvegia

| Arrow Generics Ltd, 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom |

Arrow Generics Ltd, 2

Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom

Alendronat Arrrow

70 mg

Comprimate

orala

NO - Norvegia

| ratiopharm GmbH, Graf- Arco-Strasse 3, D-89070 |
| --- |
| Ulm Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, D-89070

Ulm Germany

Alendronate ratiopharm

70 mg

Comprimate

orala

NO - Norvegia

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

10 mg

Comprimate

orala

NO - Norvegia

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

70 mg

Comprimate

orala

NO - Norvegia

| Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123 |
| --- |
| Stockholm, Sweden |

Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123

Stockholm, Sweden

Alendronat Bluefish

70 mg

Comprimate

orala

NO - Norvegia

| Mylan AB, Box 23033, |
| --- |
| 10435 Stockholm, Sweden |

Mylan AB, Box 23033,

10435 Stockholm, Sweden

Alendronat Mylan

70 mg

Comprimate

orala

NO - Norvegia

| Mylan AB, Box 23033, |
| --- |
| 10435 Stockholm, Sweden |

Mylan AB, Box 23033,

10435 Stockholm, Sweden

Alendronat Mylan

70 mg

Comprimate

orala

NO - Norvegia

| Sandoz A/S, Edvard |
| --- |
| Thomsens Vej 14, DK-2300 |
| København S, Danmark |

Sandoz A/S, Edvard

Thomsens Vej 14, DK-2300

København S, Danmark

Alendronat Sandoz

70 mg

Comprimate

orala

NO - Norvegia

| Teva Sweden AB, Box 1070, |
| --- |
| 25110 Helsingborg, Sweden |

Teva Sweden AB, Box 1070,

25110 Helsingborg, Sweden

Alendronat Teva

10 mg

Comprimate

orala

NO - Norvegia

| Teva Sweden AB, Box 1070, |
| --- |
| 25110 Helsingborg, Sweden |

Teva Sweden AB, Box 1070,

25110 Helsingborg, Sweden

Alendronat Teva

70 mg

Comprimate

orala

PL - Polonia

| Polfarmex S.A. Józefów st. 9 |
| --- |
| 99-300 Kutno, Poland |

Polfarmex S.A. Józefów st. 9

99-300 Kutno, Poland

Akost

70 mg + 91,37 mg

Comprimate

orala

PL - Polonia

| Sandoz GmbH Biochemiestrasse 10, A- |
| --- |
| 6250 Kundl, Austria |

Sandoz GmbH Biochemiestrasse 10, A-

6250 Kundl, Austria

Aldron 70

70 mg

Comprimate filmate

orala

PL - Polonia

| ICN Polfa Rezszów S.A. Przemysłowa 2 |
| --- |
| 35-959 Rzeszów, Poland |

ICN Polfa Rezszów S.A. Przemysłowa 2

35-959 Rzeszów, Poland

Alenato

10 mg

Comprimate

orala

PL - Polonia

| Ranbaxy (Poland) Sp. z o.o. Kubickiego st. 11, |
| --- |
| 02-954 Warsaw, Poland |

Ranbaxy (Poland) Sp. z o.o. Kubickiego st. 11,

02-954 Warsaw, Poland

Alendran 70

70 mg

Comprimate

Uz oral

PL - Polonia

| Orion Corporation |
| --- |
| Orionintie 1A, FI-02200 |
| Espoo, Finland |

Orion Corporation

Orionintie 1A, FI-02200

Espoo, Finland

Alendrion

70 mg

Comprimate

Uz oral

PL - Polonia

| Generics [UK] Ltd. |
| --- |
| Station Close, Potters Bar, Hertfordshire, |
| EN61TL, United Kingdom |

Generics [UK] Ltd.

Station Close, Potters Bar, Hertfordshire,

EN61TL, United Kingdom

Alendrogen

70 mg

Comprimate

Uz oral

PL - Polonia

| Sandoz GmbH Biochemiestrasse 10, A- |
| --- |
| 6250 Kundl, Austria |

Sandoz GmbH Biochemiestrasse 10, A-

6250 Kundl, Austria

AlendroLek 70

70 mg

Comprimate

Uz oral

PL - Polonia

| Arrow Generics Ltd |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, |
| United Kingdom |

Arrow Generics Ltd

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ,

United Kingdom

Alendromax 10 mg tabletki

10 mg

Comprimate

Uz oral

PL - Polonia

| Arrow Generics Ltd |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom |

Arrow Generics Ltd

2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom

Alendromax 70 mg tabletki

70 mg

Comprimate

Uz oral

PL - Polonia

| Bluefish Pharmaceuticals AB Torsgatan 11 |
| --- |
| SE-111 23 Stockholm |
| Sweden |

Bluefish Pharmaceuticals AB Torsgatan 11

SE-111 23 Stockholm

Sweden

Alendronat Bluefish

70 mg/ tabl.

Comprimate

Uz oral

PL - Polonia

| PHARMABILL |
| --- |
| Jægersborg Alle 213 2 th DK-2820 Gentofte Denmark |

PHARMABILL

Jægersborg Alle 213 2 th DK-2820 Gentofte Denmark

Alendronat Pharmabill

70 mg

Comprimate filmate

Uz oral

PL - Polonia

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, |
| 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm,

89073, Germany

Alendronat-ratiopharm

70

70 mg

Comprimate

Uz oral

PL - Polonia

| Arrow Poland S.A. Al. Jana Pawła II 23 |
| --- |
| 00-854 Warsaw, Poalnd |

Arrow Poland S.A. Al. Jana Pawła II 23

00-854 Warsaw, Poalnd

Alendronate Arrow

10 mg

Comprimate

Uz oral

PL - Polonia

| Arrow Poland S.A. Al. Jana Pawła II 23 |
| --- |
| 00-854 Warsaw, Poalnd |

Arrow Poland S.A. Al. Jana Pawła II 23

00-854 Warsaw, Poalnd

Alendronate Arrow

70 mg

Comprimate

Uz oral

PL - Polonia

| Medana Pharma S.A. |
| --- |
| 10 Władysława Łokietka st., |
| 98-200 Sieradz, Poland |

Medana Pharma S.A.

10 Władysława Łokietka st.,

98-200 Sieradz, Poland

Alendronate Medana

70 mg

Comprimate

Uz oral

PL - Polonia

| ACCORD HEALTHCARE LTD. Reg. Off.: Suite No. 10 & 11 |
| --- |
| Sage House |
| 319 Pinner Road, |
| North Harrow, Middlesex |
| HA14HF, UK |

ACCORD HEALTHCARE LTD. Reg. Off.: Suite No. 10 & 11

Sage House

319 Pinner Road,

North Harrow, Middlesex

HA14HF, UK

Alendronate Sodium

Accord

10 mg

Comprimate

Uz oral

PL - Polonia

| ACCORD HEALTHCARE LTD. Reg. Off.: Suite No. 10 & 11 |
| --- |
| Sage House |
| 319 Pinner Road, |
| North Harrow, Middlesex |
| HA14HF, UK |

ACCORD HEALTHCARE LTD. Reg. Off.: Suite No. 10 & 11

Sage House

319 Pinner Road,

North Harrow, Middlesex

HA14HF, UK

Alendronate Sodium

Accord

70 mg

Comprimate

Uz oral

PL - Polonia

| Teva Pharmaceuticals Polska |
| --- |
| Sp. z o.o. |
| 53 Emilii Plater St., |
| 00-113, Warsaw, Poland |

Teva Pharmaceuticals Polska

Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Alendronate Teva

70 mg

Comprimate

Uz oral

PL - Polonia

| Farmacom Sp. z o.o. Mogilska 80 st. |
| --- |
| 31-546, Cracow, Poland |

Farmacom Sp. z o.o. Mogilska 80 st.

31-546, Cracow, Poland

Alendronatum

Farmacom

70 mg

Comprimate

Uz oral

PL - Polonia

| PLIVA Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80 |
| --- |
| 31-546 Cracow, Poland |

PLIVA Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80

31-546 Cracow, Poland

Alenotop

10 mg

Comprimate

Uz oral

PL - Polonia

| Mepha Lda. Lagoas Park Edificio 5-A, Piso 2 |
| --- |
| 2740-298 Porto Salvo |
| Portugal |

Mepha Lda. Lagoas Park Edificio 5-A, Piso 2

2740-298 Porto Salvo

Portugal

Densidron

70 mg

Comprimate filmate

Uz oral

PL - Polonia

| MSD Polska Sp. z o.o. Chlodna st., 51 |
| --- |
| 00-867, Warsaw, Poland |

MSD Polska Sp. z o.o. Chlodna st., 51

00-867, Warsaw, Poland

Fosamax 70

70 mg

Comprimate

Uz oral

PL - Polonia

| Phargem Sp. z o.o. Foksal St. 18/210/02 |
| --- |
| 00-372 Warsaw, Poland |

Phargem Sp. z o.o. Foksal St. 18/210/02

00-372 Warsaw, Poland

Kwas alendronowy 70 mg Tabletka

70 mg

Comprimate

Uz oral

PL - Polonia

| Actavis Group PTC ehf. Reykjavikurvegi 76-78 |
| --- |
| 220 Hafnarfirdi, Iceland |

Actavis Group PTC ehf. Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Lendrate

70 mg

Comprimate

Uz oral

PL - Polonia

| Zakłady Farmaceutyczne |
| --- |
| Polpharma SA Pelplińska st. 19 |
| 83-200 Starogard Gdański, |
| Poland |

Zakłady Farmaceutyczne

Polpharma SA Pelplińska st. 19

83-200 Starogard Gdański,

Poland

Ostemax 70 comfort

70 mg

Comprimate

Uz oral

PL - Polonia

| Teva Pharmaceuticals Polska |
| --- |
| Sp. z o.o. |
| 53 Emilii Plater St., |
| 00-113, Warsaw, Poland |

Teva Pharmaceuticals Polska

Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Ostenil

10 mg

Comprimate

Uz oral

PL - Polonia

| Teva Pharmaceuticals Polska |
| --- |
| Sp. z o.o. |
| 53 Emilii Plater St., |
| 00-113, Warsaw, Poland |

Teva Pharmaceuticals Polska

Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Ostenil 70

70 mg

Comprimate

Uz oral

PL - Polonia

| Apotex Europe Ltd. Rowan House, 41 London Street, Reading |
| --- |
| Berkshire, RG1 4PS, United |
| Kingdom |

Apotex Europe Ltd. Rowan House, 41 London Street, Reading

Berkshire, RG1 4PS, United

Kingdom

Ostodronic

70 mg

Comprimate

Uz oral

PL - Polonia

| Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. |
| --- |
| Al. Jana Pawła II 80 |
| 00-175 Warsaw, Poland |

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.

Al. Jana Pawła II 80

00-175 Warsaw, Poland

Ostolek

10 mg

Comprimate filmate

Uz oral

PL - Polonia

| Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. |
| --- |
| Al. Jana Pawła II 80 |
| 00-175 Warsaw, Poland |

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.

Al. Jana Pawła II 80

00-175 Warsaw, Poland

Ostolek

70 mg

Comprimate filmate

Uz oral

PL - Polonia

Biofarm Sp. z o.o. Wałbrzyska 13, 60-198, Poznan, Poalnd

Rekostin 70 mg

70 mg

Comprimate

Uz oral

PL - Polonia

| Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o |
| --- |
| Ks. J. Poniatowskiego st. 5 |
| 05-825 Grodzisk |
| Mazowiecki, Poland |

Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o

Ks. J. Poniatowskiego st. 5

05-825 Grodzisk

Mazowiecki, Poland

Sedron 70 mg tabletki powlekane

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875 |
| --- |
| Lisboa Portugal |

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875

Lisboa Portugal

Ácido Alendrónico

Lendral

70 mg

Comprimate

Uz oral

PT - Portugalia

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque |
| 1, R/C Esqo |
| 1499-016 Algés, Portugal |

Mylan, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque

1, R/C Esqo

1499-016 Algés, Portugal

Ácido Alendrónico

Mylan

70 mg

Comprimate

Uz oral

PT - Portugalia

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque |
| 1, R/C Esqo |
| 1499-016 Algés, Portugal |

Mylan, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque

1, R/C Esqo

1499-016 Algés, Portugal

Ácido Alendrónico

Mylan

10 mg

Comprimate

Uz oral

PT - Portugalia

| Premium Pharma - Sociedade Técnico Medicinal, Lda. |
| --- |
| Rua da Tapada Grande, n.o |
| 2, Abrunheira, São Pedro de |
| Penaferrim |
| 2714-530 Sintra, Portugal |

Premium Pharma - Sociedade Técnico Medicinal, Lda.

Rua da Tapada Grande, n.o

2, Abrunheira, São Pedro de

Penaferrim

2714-530 Sintra, Portugal

Ácido Alendrónico

Flamisul

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Teva Pharma - Produtos |
| --- |
| Farmacêuticos, Lda. |
| Edifício Cyprium, Av. 25 de |
| Abril, 15, 2o F |
| 2795-195 Linda-a-Velha |
| Portugal |

Teva Pharma - Produtos

Farmacêuticos, Lda.

Edifício Cyprium, Av. 25 de

Abril, 15, 2o F

2795-195 Linda-a-Velha

Portugal

Ácido Alendrónico

Teva

70 mg

Comprimate

Uz oral

PT - Portugalia

| Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour, |
| Islândia |

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour,

Islândia

Ácido Alendrónico

Actavis

70 mg

Comprimate

Uz oral

PT - Portugalia

| Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour, Islândia |

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour, Islândia

Caldronate

70 mg

Comprimate

Uz oral

PT - Portugalia

| Almus, Lda. |
| --- |
| Rua Engenheiro Ferreira |
| Dias, 772 |
| 4149-014 Porto |

Almus, Lda.

Rua Engenheiro Ferreira

Dias, 772

4149-014 Porto

Ácido Alendrónico

Almus

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina, Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina, Portugal

Ácido Alendrónico Alter

70 mg

Comprimate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina, Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina, Portugal

Ácido Alendrónico Alter

10 mg

Comprimate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina, Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina, Portugal

Ácido Alendrónico Bifosal 10 mg Comprimidos

10 mg

Comprimate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830 Coina, Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830 Coina, Portugal

Ácido Alendrónico Bifosal 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

APceuticals - Farmacêutica, Lda.

Ácido Alendrónico

Apceuticals

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Apotex Europe, B.V. Darwinweg 20 |
| --- |
| 2333 CR Leiden |
| Netherland |

Apotex Europe, B.V. Darwinweg 20

2333 CR Leiden

Netherland

Ácido Alendrónico

Apotex

70 mg

Comprimate

Uz oral

PT - Portugalia

| Arrowblue Produtos |
| --- |
| Farmacêuticos S.A. |
| Av. D. João II, 10 Esqo - Torre Fernão de Magalhães |
| 1998-025 Lisboa, Portugal |

Arrowblue Produtos

Farmacêuticos S.A.

Av. D. João II, 10 Esqo - Torre Fernão de Magalhães

1998-025 Lisboa, Portugal

Ácido Alendrónico Arrowblue 10 mg Comprimidos

10 mg

Comprimate

Uz oral

PT - Portugalia

| Arrowblue Produtos |
| --- |
| Farmacêuticos S.A. |
| Av. D. João II, 10 Esqo - Torre Fernão de Magalhães |
| 1998-025 Lisboa, Portugal |

Arrowblue Produtos

Farmacêuticos S.A.

Av. D. João II, 10 Esqo - Torre Fernão de Magalhães

1998-025 Lisboa, Portugal

Ácido Alendrónico Arrowblue 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Arrowblue Produtos |
| --- |
| Farmacêuticos S.A. |
| Av. D. João II, 10 Esqo - Torre Fernão de Magalhães |
| 1998-025 Lisboa, Portugal |

Arrowblue Produtos

Farmacêuticos S.A.

Av. D. João II, 10 Esqo - Torre Fernão de Magalhães

1998-025 Lisboa, Portugal

Ácido Alendrónico Winthrop 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Atlantic Pharma - Produções |
| --- |
| Farmacêuticas, S.A. Zona Industrial da Abrunheira, Rua da Tapada Grande, 2 |
| 2710-089 Sintra |
| Portugal |

Atlantic Pharma - Produções

Farmacêuticas, S.A. Zona Industrial da Abrunheira, Rua da Tapada Grande, 2

2710-089 Sintra

Portugal

Ácido Alendrónico

Blocan

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o |
| --- |
| 2794-038 Carnaxide, Portugal |

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

70 mg

Comprimate

Uz oral

PT - Portugalia

| Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o |
| --- |
| 2794-038 Carnaxide, Portugal |

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o

2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

10 mg

Comprimate

Uz oral

PT - Portugalia

| Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, |
| --- |
| 84-B 1549-005 Lisboa, Portugal |

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo,

84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico

Nozat

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, |
| --- |
| 84-B 1549-005 Lisboa, Portugal |

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo,

84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico

Baldacci

70 mg

Comprimate

Uz oral

PT - Portugalia

| Biara - Produtos |
| --- |
| Farmacêuticos, Lda. |
| Av. José Malhoa - Edifício |
| Malhoa Plaza no 2, piso- escritório 2.2 |
| 1070-325 Lisboa, Portugal |

Biara - Produtos

Farmacêuticos, Lda.

Av. José Malhoa - Edifício

Malhoa Plaza no 2, piso- escritório 2.2

1070-325 Lisboa, Portugal

Ácido Alendrónico

Prella

70 mg

Comprimate

Uz oral

PT - Portugalia

| Bluepharma - Indústria |
| --- |
| Farmacêutica, S.A. |
| São Martinho do Bispo |
| Apartado 7003 |
| 3045-016 Coimbra, Portugal |

Bluepharma - Indústria

Farmacêutica, S.A.

São Martinho do Bispo

Apartado 7003

3045-016 Coimbra, Portugal

Ácido Alendrónico

Bluepharma

70 mg

Comprimate

Uz oral

PT - Portugalia

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor |
| Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos, |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor

Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos,

Portugal

Ácido Alendrónico Ciclum 10 mg Comprimidos

10 mg

Comprimate

Uz oral

PT - Portugalia

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor |
| Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos, Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor

Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos, Portugal

Ácido Alendrónico Ciclum 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Cinfa Portugal, Lda. |
| --- |
| Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark |
| 2790-221 Carnaxide, Portugal |

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark

2790-221 Carnaxide, Portugal

Ácido alendrónico

Cinfa

70 mg

Comprimate

Uz oral

PT - Portugalia

| Daquimed - Comércio de Produtos Farmacêuticos, S.A. |
| --- |
| Av. Associação Comercial e Industrial de Gondomar, |
| 330 - Zona Industrial da Portelinha |
| 4510-688 Fânzeres, Portugal |

Daquimed - Comércio de Produtos Farmacêuticos, S.A.

Av. Associação Comercial e Industrial de Gondomar,

330 - Zona Industrial da Portelinha

4510-688 Fânzeres, Portugal

Ácido Alendrónico

Daquimed

70 mg

Comprimate

Uz oral

PT - Portugalia

| Dr. Reddy's Laboratories (UK) Ltd. |
| --- |
| 6 Riverview Road, Beverley |
| HU17 OLD East Yorkshire, UK |

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley

HU17 OLD East Yorkshire, UK

Ácido Alendrónico Dr. Reddy's

70 mg

Comprimate

Uz oral

PT - Portugalia

| Faribérica - Produtos Farmacêuticos, S.A. |
| --- |
| Estrada de Luz, 90 - 9o D/E |
| 1600-160 Lisboa, Portugal |

Faribérica - Produtos Farmacêuticos, S.A.

Estrada de Luz, 90 - 9o D/E

1600-160 Lisboa, Portugal

Ácido Alendrónico

Faribérica

70 mg

Comprimate

Uz oral

PT - Portugalia

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2, Abrunheira |
| 2710-089 Sintra, Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra, Portugal

Ácido Alendrónico

Rinicas

70 mg

Comprimate

Uz oral

PT - Portugalia

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2, Abrunheira |
| 2710-089 Sintra, Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra, Portugal

Ácido Alendrónico

Farmoz

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Frosst Portuguesa - Produtos Farmacêuticos, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 |
| --- |
| - Porto Salvo Apartado 214 |
| 2780-730 Paço D' Arcos, Portugal |

Frosst Portuguesa - Produtos Farmacêuticos, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19

- Porto Salvo Apartado 214

2780-730 Paço D' Arcos, Portugal

Ácido Alendrónico

Frosst 70 mg

70 mg

Comprimate

Uz oral

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escritório 8 |
| --- |
| 2710-444 Sintra, Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escritório 8

2710-444 Sintra, Portugal

Ácido Alendrónico Generis 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto |
| --- |
| 2790-012 Portela de |
| Carnaxide, Portugal |

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto

2790-012 Portela de

Carnaxide, Portugal

Ácido Alendrónico

Germed

70 mg

Comprimate

Uz oral

PT - Portugalia

| Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto |
| --- |
| 2790-012 Portela de Carnaxide, Portugal |

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto

2790-012 Portela de Carnaxide, Portugal

Ácido Alendrónico

Normon

70 mg

Comprimate

Uz oral

PT - Portugalia

| Helm Portugal, Lda. |
| --- |
| Estrada Nacional n.o 10, Km 140, 260 |
| 2695-066 Bobadela - Loures Portugal |

Helm Portugal, Lda.

Estrada Nacional n.o 10, Km 140, 260

2695-066 Bobadela - Loures Portugal

Alehelm

70 mg

Comprimate

Uz oral

PT - Portugalia

| Helm Portugal, Lda. |
| --- |
| Estrada Nacional n.o 10, Km 140, 260 |
| 2695-066 Bobadela - Loures Portugal |

Helm Portugal, Lda.

Estrada Nacional n.o 10, Km 140, 260

2695-066 Bobadela - Loures Portugal

Aleostito

70 mg

Comprimate

Uz oral

PT - Portugalia

| ITF Farma - Produtos Farmacêuticos, Lda. |
| --- |
| Rua Consiglieri Pedroso, 123 - Queluz de Baixo |
| 2730-056 Barcarena, Portugal |

ITF Farma - Produtos Farmacêuticos, Lda.

Rua Consiglieri Pedroso, 123 - Queluz de Baixo

2730-056 Barcarena, Portugal

Ácido Alendrónico ITF

70 mg

Comprimate

Uz oral

PT - Portugalia

| Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 |
| --- |
| 2740-298 Porto Salvo, Portugal |

Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3

2740-298 Porto Salvo, Portugal

Ácido Alendrónico Jaba

70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros, Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico

Labesfal

10 mg

Comprimate

Uz oral

PT - Portugalia

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros, Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico

Labesfal

70 mg

Comprimate

Uz oral

PT - Portugalia

| Laboratórios Anova - Produtos Farmacêuticos, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés, Portugal |

Laboratórios Anova - Produtos Farmacêuticos, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés, Portugal

Ácido Alendrónico

Anova

70 mg

Comprimate

Uz oral

PT - Portugalia

| Laboratórios Anova - Produtos Farmacêuticos, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés, Portugal |

Laboratórios Anova - Produtos Farmacêuticos, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés, Portugal

Ácido Alendrónico

Laquifa

70 mg

Comprimate

Uz oral

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 |
| --- |
| A, Manique de Baixo 2645-436 Alcabideche, Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148

A, Manique de Baixo 2645-436 Alcabideche, Portugal

Ácido Alendrónico

Azevedos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Laboratórios Basi - Indústria |
| --- |
| Farmacêutica, S.A. Rua do Padrão, 98 |
| 3000-312 Coimbra, Portugal |

Laboratórios Basi - Indústria

Farmacêutica, S.A. Rua do Padrão, 98

3000-312 Coimbra, Portugal

Ácido Alendrónico Basi

70 mg

Comprimate

Uz oral

PT - Portugalia

| Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park, Edifício 5 A - Piso 2 |
| 2740-298 Porto Salvo, Portugal |

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park, Edifício 5 A - Piso 2

2740-298 Porto Salvo, Portugal

Ácido Alendrónico Mepha 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park, Edifício 5 A - Piso 2 |
| 2740-298 Porto Salvo, Portugal |

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park, Edifício 5 A - Piso 2

2740-298 Porto Salvo, Portugal

Ácido Alendrónico

Stroban

70 mg

Comprimate

Uz oral

PT - Portugalia

Mer Medicamentos, Lda. Office Park da Beloura, Edifício 4 - Piso 1 - Escritório 8, Quinta da Beloura 2710-444 Sintra, Portugal

Ácido Alendrónico Mer

70 mg

Comprimate

Uz oral

PT - Portugalia

| Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo |
| --- |
| Apartado 214 |
| 2770-192 Paço d' Arcos, Portugal |

Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo

Apartado 214

2770-192 Paço d' Arcos, Portugal

Fosamax

10 mg

Comprimate

Uz oral

PT - Portugalia

| Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo |
| --- |
| Apartado 214 |
| 2770-192 Paço d' Arcos, Portugal |

Merck Sharp & Dohme, Lda. Quinta da Fonte - Edifício Vasco da Gama, 19 - Porto Salvo

Apartado 214

2770-192 Paço d' Arcos, Portugal

Fosamax 70 mg

70 mg

Comprimate

Uz oral

PT - Portugalia

| Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10 |
| --- |
| 2740-271 Porto Salvo, Portugal |

Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10

2740-271 Porto Salvo, Portugal

Ácido Alendrónico

Parke-Davis

70 mg

Comprimate

Uz oral

PT - Portugalia

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 |
| --- |
| 1495-139 Miraflores - Algés, Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31

1495-139 Miraflores - Algés, Portugal

Ácido Alendrónico

Pharmakern

70 mg

Comprimate

Uz oral

PT - Portugalia

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 |
| --- |
| 1495-139 Miraflores - Algés, Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31

1495-139 Miraflores - Algés, Portugal

Ácido Alendrónico

GIDE

70 mg

Comprimate

Uz oral

PT - Portugalia

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Rua do Campo Alegre, |
| 1306, 3o - Sala 301/302 - Edifício Botânico |
| 4150-174 Porto, Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Rua do Campo Alegre,

1306, 3o - Sala 301/302 - Edifício Botânico

4150-174 Porto, Portugal

Ácido Alendrónico

Ranbaxy

70 mg

Comprimate

Uz oral

PT - Portugalia

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Rua do Campo Alegre, |
| 1306, 3o - Sala 301/302 - Edifício Botânico |
| 4150-174 Porto, Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Rua do Campo Alegre,

1306, 3o - Sala 301/302 - Edifício Botânico

4150-174 Porto, Portugal

Ácido Alendrónico

Alendrol

70 mg

Comprimate

Uz oral

PT - Portugalia

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide, |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso

2790-143 Carnaxide,

Portugal

Ácido Alendrónico ratiopharm 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício |
| --- |
| 1, 2o - Escritório 15 |
| 2710-693 Sintra Portugal |

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício

1, 2o - Escritório 15

2710-693 Sintra Portugal

Ácido Alendrónico Sandoz 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício |
| --- |
| 1, 2o - Escritório 15 |
| 2710-693 Sintra Portugal |

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício

1, 2o - Escritório 15

2710-693 Sintra Portugal

Ácido Alendrónico

1Apharma

70 mg

Comprimate

Uz oral

PT - Portugalia

| Sociedade J. Neves, Lda. Parque Industrial do Seixal |
| --- |
| 2840-068 Paio Pires, Portugal |

Sociedade J. Neves, Lda. Parque Industrial do Seixal

2840-068 Paio Pires, Portugal

Ácido Alendrónico J. Neves 70 mg Comprimidos

70 mg

Comprimate

Uz oral

PT - Portugalia

| Tecnifar - Indústria Técnica |
| --- |
| Farmacêutica, S.A. Rua Tierno Galvan - |
| Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa, Portugal |

Tecnifar - Indústria Técnica

Farmacêutica, S.A. Rua Tierno Galvan -

Amoreiras - Torre 3 - 12o

1099-036 Lisboa, Portugal

Adronat

10 mg

Comprimate

Uz oral

PT - Portugalia

| Tecnifar - Indústria Técnica |
| --- |
| Farmacêutica, S.A. Rua Tierno Galvan - |
| Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa, Portugal |

Tecnifar - Indústria Técnica

Farmacêutica, S.A. Rua Tierno Galvan -

Amoreiras - Torre 3 - 12o

1099-036 Lisboa, Portugal

Adronat 70 mg

70 mg

Comprimate

Uz oral

PT - Portugalia

| Tecnimede - Sociedade |
| --- |
| Técnico-Medicinal, S.A. |
| Rua da Tapada Grande, 2 - Abrunheira |
| 2710-089 Sintra Portugal |

Tecnimede - Sociedade

Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 - Abrunheira

2710-089 Sintra Portugal

Ácido Alendrónico Ecosis 70 mg Comprimidos

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Tetrafarma - Produtos |
| --- |
| Farmacêuticos, Lda. |
| Rua Helena Aragão, 20 R/C Frente - Massamá |
| 2745-879 Queluz, Portugal |

Tetrafarma - Produtos

Farmacêuticos, Lda.

Rua Helena Aragão, 20 R/C Frente - Massamá

2745-879 Queluz, Portugal

Ácido Alendrónico

Tetrafarma

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 |
| --- |
| 2794-093 Carnaxide, Portugal |

ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1

2794-093 Carnaxide, Portugal

Ácido Alendrónico ToLife 70 mg Comprimidos

70 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do- chão esq, São Sebastião da Pedreira |
| --- |
| 1000 Lisboa, Portugal |

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.o 24, rés-do- chão esq, São Sebastião da Pedreira

1000 Lisboa, Portugal

Ácido Alendrónico

Flazium

70 mg

Comprimate filmate

Uz oral

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 5 mg

5 mg

Comprimate

orala

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 10 mg

10 mg

Comprimate

orala

RO - Romania

MERCK SHARP & DOHME ROMÂNIA S.R.L.Bucharest Business ParkȘos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 70 mg

70 mg

Comprimate

orala

RO - Romania

S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 10 mg

10 mg

Comprimate

orala

RO - Romania

S.C. TEVA PHARMACEUTICALS S.R.L.,Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 70 mg

70 mg

Comprimate

orala

RO - Romania

SANDOZ S.R.L. , Str. Livezeni nr. 7A, Târgu Mureș, România

ALENDRONAT SANDOZ

70 mg

Comprimate filmate

orala

RO - Romania

GEDEON RICHTER ROMÂNIA S.A. , România

SEDRON

70 mg

Comprimate filmate

orala

RO - Romania

| ACCORD HEALTHCARE LIMITED, Sage house, 319 |
| --- |
| Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie |

ACCORD HEALTHCARE LIMITED, Sage house, 319

Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD10 mg

10 mg

Comprimate

orala

RO - Romania

| ACCORD HEALTHCARE LIMITED, Sage house, 319 |
| --- |
| Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie |

ACCORD HEALTHCARE LIMITED, Sage house, 319

Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD 70 mg

70 mg

Comprimate

orala

RO - Romania

TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 10 mg

10 mg

Comprimate

orala

RO - Romania

TERAPIA SA,Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 70 mg

70 mg

Comprimate

orala

RO - Romania

LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr.29, Bucuresti sector 2, Romania

ANDRONIK

70 mg

Comprimate filmate

orala

RO - Romania

BLUEFISH PHARMACEUTICALS AB, Torsgatan 11, 111 23 Stockholm, Sweden

ACID ALENDRONIC BLUEFISH

70 mg

Comprimate

orala

RO - Romania

| PHARMACEUTICAL WORKS POLPHARMA SA,19 |
| --- |
| Pelplińska Street, |
| 83-200 Starogard Gdański, Polonia |

PHARMACEUTICAL WORKS POLPHARMA SA,19

Pelplińska Street,

83-200 Starogard Gdański, Polonia

OSTEMAX

70 mg

Comprimate

orala

RO - Romania

Dr. REDDY’S LABORATORIES , Str. Av. Petre Crețu nr. 74, et. 1, ap. 2, sect. 1, București, România

INSTREL

70 mg

Comprimate

orala

RO - Romania

| Teva Pharmaceuticals S.R.L, Str Domnita Ruxandra |
| --- |
| nr. 12, parter, sector 2, |
| 020562, Bucuresti |
| Romania |

Teva Pharmaceuticals S.R.L, Str Domnita Ruxandra

nr. 12, parter, sector 2,

020562, Bucuresti

Romania

Teva nat, 70 mg comprimate

70 mg

Comprimate

orala

SE - Suedia

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax

10 mg

Comprimate

orala

SE - Suedia

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and |
| Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and

Northern Ireland (GBR)

Alendronate Arrow

10 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and |
| Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and

Northern Ireland (GBR)

Alendronate Arrow veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alenat

10 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and |
| Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and

Northern Ireland (GBR)

Alenat veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Medarin

10 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and |
| Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and

Northern Ireland (GBR)

Medarin veckotablett

70 mg

Comprimate

orala

SE - Suedia

| ratiopharm GmbH, Graf- Arco-Strasse 3, |
| --- |
| DE-89079 Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3,

DE-89079 Ulm, Germany

Dedarin veckotablett

70 mg

Comprimate

orala

SE - Suedia

CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE-13407 Berlin, Germany

Gendarin veckotablett

70 mg

Comprimate

orala

SE - Suedia

| PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, |
| --- |
| GU32 3QB, United Kingdom and Northern Ireland |

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire,

GU32 3QB, United Kingdom and Northern Ireland

Kendarin

10 mg

Comprimate

orala

SE - Suedia

| PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, |
| --- |
| GU32 3QB, United Kingdom and Northern Ireland |

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire,

GU32 3QB, United Kingdom and Northern Ireland

Kendarin veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and |
| Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and

Northern Ireland (GBR)

Alendroarrow

10 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendroarrow veckotablett

70 mg

Comprimate

orala

SE - Suedia

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Alendronat ratiopharm veckotablett

70 mg

Comprimate

orala

SE - Suedia

| STADA Arzneimittel AG, Stadastrasse 2-18, |
| --- |
| DE-61118 Bad Vilbel, Germany |
| (DEU) |

STADA Arzneimittel AG, Stadastrasse 2-18,

DE-61118 Bad Vilbel, Germany

(DEU)

Alendrostad

10 mg

Comprimate

orala

SE - Suedia

| STADA Arzneimittel AG, Stadastrasse 2-18, |
| --- |
| DE-61118 Bad Vilbel, Germany |
| (DEU) |

STADA Arzneimittel AG, Stadastrasse 2-18,

DE-61118 Bad Vilbel, Germany

(DEU)

Alendrostad veckotablett

70 mg

Comprimate

orala

SE - Suedia

| STADA Arzneimittel AG, Stadastrasse 2-18, |
| --- |
| DE-61118 Bad Vilbel, Germany |
| (DEU) |

STADA Arzneimittel AG, Stadastrasse 2-18,

DE-61118 Bad Vilbel, Germany

(DEU)

Alendronat STADA

10 mg

Comprimate

orala

SE - Suedia

| STADA Arzneimittel AG, Stadastrasse 2-18, |
| --- |
| DE-61118 Bad Vilbel, Germany |
| (DEU) |

STADA Arzneimittel AG, Stadastrasse 2-18,

DE-61118 Bad Vilbel, Germany

(DEU)

Alendronat STADA

veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 |
| --- |
| Wien, Austria (AUT) |

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160

Wien, Austria (AUT)

Alendronat Interpharm

10 mg

Comprimate

orala

SE - Suedia

| Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 |
| --- |
| Wien, Austria (AUT) |

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160

Wien, Austria (AUT)

Alendronat Interpharm veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Hexal A/S Kanalholmen 8-12 |
| --- |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Alendronat Hexal

10 mg

Comprimate

orala

SE - Suedia

| Hexal A/S Kanalholmen 8-12 |
| --- |
| DK-2650 Hvidovre |
| Denmark |

Hexal A/S Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Alendronat Hexal

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

AlendroLich

10 mg

Comprimate

orala

SE - Suedia

| Arrow Generics Ltd, Unit 2 |
| --- |
| Eastman Way, Stevenage, Hertfordshire SGI 4SZ, |
| United Kingdom and Northern Ireland (GBR) |

Arrow Generics Ltd, Unit 2

Eastman Way, Stevenage, Hertfordshire SGI 4SZ,

United Kingdom and Northern Ireland (GBR)

AlendroLich

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Orifarm Generics A/S Energivej 15 |
| --- |
| POB 69 DK-5260 Odense S Denmark |

Orifarm Generics A/S Energivej 15

POB 69 DK-5260 Odense S Denmark

Alendronat Orifarm

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

Mylan AB Box 23033 104 35 Stockholm Sweden

Alendronat Mylan

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Pharmaceutical Works |
| --- |
| Polpharma S.A. 19 Pelplinska Str. |
| PL-83-200 Starogard Gdanski Poland |

Pharmaceutical Works

Polpharma S.A. 19 Pelplinska Str.

PL-83-200 Starogard Gdanski Poland

Alendropol

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Pharmaceutical Works Polpharma S.A. 19 |
| --- |
| Pelplinska Str. PL-83-200 Starogard Gdanski Poland |

Pharmaceutical Works Polpharma S.A. 19

Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendrixen

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Pharmaceutical Works Polpharma S.A. 19 |
| --- |
| Pelplinska Str. PL-83-200 Starogard Gdanski Poland |

Pharmaceutical Works Polpharma S.A. 19

Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Polerixen Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| HELP S.A. Pharmaceuticals |
| --- |
| 10, Valaoritou Str. Metamorphosis 144 52 Athen Greece |

HELP S.A. Pharmaceuticals

10, Valaoritou Str. Metamorphosis 144 52 Athen Greece

Terixen Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Pharmaceutical Works Polpharma S.A. 19 |
| --- |
| Pelplinska Str. PL-83-200 Starogard Gdanski Poland |

Pharmaceutical Works Polpharma S.A. 19

Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alenpol Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Pharmaceutical Works Polpharma S.A. 19 |
| --- |
| Pelplinska Str. PL-83-200 Starogard Gdanski Poland |

Pharmaceutical Works Polpharma S.A. 19

Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendronat Polpharma

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Ranbaxy (UK) Ltd |
| --- |
| 20 Baldertoon Street |
| London W1K 6TL United Kingdom |

Ranbaxy (UK) Ltd

20 Baldertoon Street

London W1K 6TL United Kingdom

Alendronat Ranbaxy

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Mylan AB Box 23033 |
| --- |
| 104 35 Stockholm Sweden |

Mylan AB Box 23033

104 35 Stockholm Sweden

Alendronat Mylan

10 mg

Comprimate

orala

SE - Suedia

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ Denmark |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ Denmark

Alendronat Sandoz

Veckotablett

70 mg

Comprimate filmate

orala

SE - Suedia

| Hexal A/S Kanalholmen 8-12 |
| --- |
| DK-2650 Hvidovre Denmark |

Hexal A/S Kanalholmen 8-12

DK-2650 Hvidovre Denmark

Alendronat Hexal

Veckotablett

70 mg

Comprimate filmate

orala

SE - Suedia

| 1A Farma A/S Herstedøstervej 27-29 |
| --- |
| DK-2620 Albertslund |
| Denmark |

1A Farma A/S Herstedøstervej 27-29

DK-2620 Albertslund

Denmark

Alendronat 1A Farma

Veckotablett

70 mg

Comprimate filmate

orala

SE - Suedia

| Accord Healthcare Limited |
| --- |
| Sage House |
| 319 Pinner Road |
| North Harrow, Middlesex |
| HA1 4HF |
| United Kingdom |

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow, Middlesex

HA1 4HF

United Kingdom

Alendronat Accord

10 mg

Comprimate

orala

SE - Suedia

| Accord Healthcare Limited |
| --- |
| Sage House |
| 319 Pinner Road |
| North Harrow, Middlesex |
| HA1 4HF |
| United Kingdom |

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow, Middlesex

HA1 4HF

United Kingdom

Alendronat Accord

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Bluefish Pharmaceuticals AB Torsgatan 11 |
| --- |
| 111 23 Stockholm |
| Sweden |

Bluefish Pharmaceuticals AB Torsgatan 11

111 23 Stockholm

Sweden

Alendronat Bluefish

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Actavis Group PTC ehf. Reykjavikurvegur 76-78 |
| --- |
| IS-220 Hafnarfjördur |
| Island |

Actavis Group PTC ehf. Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Island

Alendronat Actavis

Veckotablett

70 mg

Comprimate

orala

SE - Suedia

| Orion Corporation, Orion Pharma |
| --- |
| PO Box 65 |
| FI-02101 Espoo |
| Finland |

Orion Corporation, Orion Pharma

PO Box 65

FI-02101 Espoo

Finland

Alendronat Orion

Veckotablett

70 mg

Comprimate

orala

SI - Slovenia

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Alenax 70 mg tablete

70 mg

Comprimate

Uz oral

SI - Slovenia

| Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231 |
| --- |
| Ljubljana- Črnuče, Slovenia |

Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231

Ljubljana- Črnuče, Slovenia

Alendor 70 mg tablete

70 mg

Comprimate

Uz oral

SI - Slovenia

| Arrow Generics Limited, |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, UK |

Arrow Generics Limited,

2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 10 mg

10 mg

Comprimate

Uz oral

SI - Slovenia

| Arrow Generics Limited, |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire, UK |

Arrow Generics Limited,

2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 70 mg

70 mg

Comprimate

Uz oral

SI - Slovenia

Lek farmacevtska družba, d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia

Alendronat Lek 70 mg filmsko obložene tablete

70 mg

Comprimate filmate

Uz oral

SI - Slovenia

| Kemofarmacija d.d., cesta na Brdo 100, SI-1000 |
| --- |
| Ljubljana Slovenia |

Kemofarmacija d.d., cesta na Brdo 100, SI-1000

Ljubljana Slovenia

Forosa 70 mg filmsko obložene tablete

70 mg

Comprimate filmate

Uz oral

SI - Slovenia

Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI-1000 Ljubljana

Fosamax enkrat tedensko 70 mg tablete

70 mg

Comprimate

Uz oral

SI - Slovenia

| Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501 |
| --- |
| Novo mesto, Slovenia |

Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501

Novo mesto, Slovenia

Lindron 10 mg tablete

10 mg

Comprimate

Uz oral

SI - Slovenia

| Actavis Group PTC ehf., Reykjavikurvegi 78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 78, 220

Hafnarfjordur, Iceland

Natrijev alendronat

Actavis 70 mg tablete

70 mg

Comprimate

Uz oral

SI - Slovenia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, NL

Tevanate 70 mg tablete

70 mg

Comprimate

Uz oral

SK - Slovacia

| Merck Sharp & Dohme B.V. Waarderweg 39 |
| --- |
| P.O. Box 581, Haarlem, |
| 2031 BN Netherlands |

Merck Sharp & Dohme B.V. Waarderweg 39

P.O. Box 581, Haarlem,

2031 BN Netherlands

FOSAMAX 70 mg 1 x týždenne

70 mg

Comprimate

Uz oral

SK - Slovacia

| Bentley Pharmaceuticals |
| --- |
| Ireland Limited |
| North Wall Quay 25 - 28 |
| Dublin 1 |
| Ireland |

Bentley Pharmaceuticals

Ireland Limited

North Wall Quay 25 - 28

Dublin 1

Ireland

Gendron 70 Tablety

70 mg

Comprimate

Uz oral

SK - Slovacia

| Teva Pharmaceuticals CR , s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Praha 5 |
| Czech Republic |

Teva Pharmaceuticals CR , s.r.o.

Radlická 3185/1c

150 00 Praha 5

Czech Republic

Tevalen 70 mg

70 mg

Comprimate

Uz oral

SK - Slovacia

| Gedeon Richter Plc. Gyômrôi út 19-21 |
| --- |
| 1103, Budapest |
| Hungary |

Gedeon Richter Plc. Gyômrôi út 19-21

1103, Budapest

Hungary

Siranin 70 mg filmom obalené tablety

70 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Generics (UK) Ltd. |
| --- |
| Station Close, Hertfordshire |
| Potters Bar, EN6 1TL United Kingdom |

Generics (UK) Ltd.

Station Close, Hertfordshire

Potters Bar, EN6 1TL United Kingdom

Alendrogen 70 mg

70 mg

Comprimate

Uz oral

SK - Slovacia

| Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ |
| --- |
| United Kingdom |

Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG14SZ

United Kingdom

Alendromax 70 mg tablety

70 mg

Comprimate

Uz oral

SK - Slovacia

| ratiopharm GmbH Graf-Arco-Strasse 3 |
| --- |
| Ulm, 89079 |
| Germany |

ratiopharm GmbH Graf-Arco-Strasse 3

Ulm, 89079

Germany

Alendronat-ratiopharm

70 mg

70 mg

Comprimate

Uz oral

SK - Slovacia

| Sandoz Pharmaceuticals d.d. |
| --- |
| Verovškova 57, Ľubľana |
| 1000 |
| Slovenia |

Sandoz Pharmaceuticals d.d.

Verovškova 57, Ľubľana

1000

Slovenia

Alendronát Sandoz 70 mg 1 x týždenne tablety

70 mg

Comprimate

Uz oral

SK - Slovacia

| Xeolas Pharmaceuticals |
| --- |
| Limited |
| 97 Furry Park Road |
| Killester, Dublin 5 |
| Ireland |

Xeolas Pharmaceuticals

Limited

97 Furry Park Road

Killester, Dublin 5

Ireland

Bonasol 70 mg perorálny roztok

70 mg

Solutie orala

Uz oral

SK - Slovacia

| Actavis Group PTC ehf; Reykjavikurvegi 76-78, |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Alendronat Actavis

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax

10 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax Once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Adronat Once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alegen Once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alendros Once Weekly

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosatrol Once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

| Sandoz Limited, 37 |
| --- |
| Woolmer Way, Bordon, Hampshire GU35 9QE |

Sandoz Limited, 37

Woolmer Way, Bordon, Hampshire GU35 9QE

alendronic acid

70 mg

Comprimate filmate

orala

UK - Marea Britanie

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

| Gideon Richter Plc, Gyomrui |
| --- |
| Utca 19-21, Budapest H-1103, Hungary |

Gideon Richter Plc, Gyomrui

Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

Comprimate filmate

orala

UK - Marea Britanie

| Gideon Richter Plc, Gyomrui |
| --- |
| Utca 19-21, Budapest H-1103, Hungary |

Gideon Richter Plc, Gyomrui

Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

Comprimate filmate

orala

UK - Marea Britanie

Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire HU17 0LD, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

| Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire |
| --- |
| GU23 3QB, United Kingdom |

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire

GU23 3QB, United Kingdom

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

| Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire |
| --- |
| GU23 3QB, United Kingdom |

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire

GU23 3QB, United Kingdom

alendronic acid once- weekly

70 mg

Comprimate

orala

UK - Marea Britanie

Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Prostrakan Limited, 3 Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom

Ostalis

70 mg

Comprimate filmate

orala

UK - Marea Britanie

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

10 mg

Comprimate

orala

UK - Marea Britanie

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid once weekly

70 mg

Comprimate

orala

UK - Marea Britanie

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

| Laboratorios Davur S.L., Calle Teide 4. Parque Empresarial La Marina, |
| --- |
| 28700 San Sebastian De |
| Los Reyes, Madrid E-28700 |
| Spain |

Laboratorios Davur S.L., Calle Teide 4. Parque Empresarial La Marina,

28700 San Sebastian De

Los Reyes, Madrid E-28700

Spain

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

| Apotex Europe BV, Darwinweg 20, Leiden, NL |
| --- |
| 2333 CR, Netherlands |

Apotex Europe BV, Darwinweg 20, Leiden, NL

2333 CR, Netherlands

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Wockhardt UK Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK

alendronic acid

70 mg

Comprimate

orala

UK - Marea Britanie

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

alendronic acid

70 mg

Comprimate

orala

Produse medicamentoase care contin acid clodronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Bayer Austria Ges.m.b.H. Herbststraße 6 – 10 |
| A-1160 Wien, Austria |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

AT - Austria

Bayer Austria Ges.m.b.H. Herbststraße 6 – 10

A-1160 Wien, Austria

Bonefos 800 mg - Filmtabletten

800 mg (Clodronate Disodium)

Comprimate filmate

orala

AT - Austria

| Bayer Austria Ges.m.b.H. Herbststraße 6 – 10 |
| --- |
| A-1160 Wien, Austria |

Bayer Austria Ges.m.b.H. Herbststraße 6 – 10

A-1160 Wien, Austria

Bonefos 300 mg - Konzentrat zur Infusionsbereitung

300 mg/5 ml (Clodronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Roche Austria GmbH, Engelhorngasse 3, A-1211 |
| --- |
| Wien, Austria |

Roche Austria GmbH, Engelhorngasse 3, A-1211

Wien, Austria

Lodronat 520 mg - Filmtabletten

520 mg (Clodronate Disodium)

Comprimate filmate

orala

BE - Belgia

| Bayer SA.NV. |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem-Machelen |
| Belgium |

Bayer SA.NV.

J.E. Mommaertslaan 14

1831 Diegem-Machelen

Belgium

Bonefos

300 mg/5 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Bayer SA.NV. |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem-Machelen |
| Belgium |

Bayer SA.NV.

J.E. Mommaertslaan 14

1831 Diegem-Machelen

Belgium

Bonefos

800 mg

Comprimate filmate

Uz oral

BG - Bulgaria

Актавис ЕАД, ул. "Атанас Дуков" No 29, София 1407, България

Sindronat

400 mg

Capsule tari

orala

CZ - Republica Ceha

| Bayer Schering Pharma Oy |
| --- |
| PO Box 415, FI-20101 |
| Turku, Finland |

Bayer Schering Pharma Oy

PO Box 415, FI-20101

Turku, Finland

Bonefos

60 mg/1 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Bayer Schering Pharma Oy |
| --- |
| PO Box 415, FI-20101 |
| Turku, Finland |

Bayer Schering Pharma Oy

PO Box 415, FI-20101

Turku, Finland

Bonefos 400 mg

400 mg

Capsule tari

orala

CZ - Republica Ceha

| Bayer Schering Pharma Oy |
| --- |
| PO Box 415, FI-20101 |
| Turku, Finland |

Bayer Schering Pharma Oy

PO Box 415, FI-20101

Turku, Finland

Bonefos 800 mg

800 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Roche s.r.o., Dukelských hrdinů 567/52, 170 00 |
| --- |
| Praha-Holešovice, Czech |
| Republic |

Roche s.r.o., Dukelských hrdinů 567/52, 170 00

Praha-Holešovice, Czech

Republic

Lodronat 520

520 mg

Comprimate filmate

orala

DE - Germania

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Clodron 800-1 A Pharma

1 000 mg

Comprimate filmate

Uz oral

DE - Germania

| 1 A Pharma GmbH Keltenring 1 + 3 |
| --- |
| D-82041 Oberhaching |

1 A Pharma GmbH Keltenring 1 + 3

D-82041 Oberhaching

Clodron 400-1 A Pharma

500 mg

Comprimate filmate

Uz oral

DE - Germania

Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen

Bonefos pro infusione

75 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen

Bonefos

500 mg

Capsule tari

Uz oral

DE - Germania

Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen

BONEFOS FILMTABLETTEN

800 mg

1 000 mg

Comprimate filmate

Uz oral

DE - Germania

| betapharm Arzneimittel |
| --- |
| GmbH Kobelweg 95 |
| D-86156 Augsburg |

betapharm Arzneimittel

GmbH Kobelweg 95

D-86156 Augsburg

Clodron beta 800 mg

1 000 mg

Comprimate filmate

Uz oral

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Clodron HEXAL PI

374,9 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg

HEXAL Filmtabletten

1 000 mg

Comprimate filmate

Uz oral

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg

HEXAL Filmtabletten

500 mg

Comprimate filmate

Uz oral

DE - Germania

| Roche Pharma AG Emil-Barell-Str. 1 |
| --- |
| D-79639 Grenzach-Wyhlen |

Roche Pharma AG Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Ostac

649,73 mg

Comprimate filmate

Uz oral

DE - Germania

| Sandoz Pharmaceuticals |
| --- |
| GmbH Raiffeisenstr. 11 |
| D-83607 Holzkirchen |

Sandoz Pharmaceuticals

GmbH Raiffeisenstr. 11

D-83607 Holzkirchen

Clodron Sandoz 300 mg Konzentrat zur Herstellung einer Infusionslösung

374,9 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna

Bonefos

800 mg

Comprimate filmate

orala

ES - Spania

QUIMICA FARMACEUTICA BAYER, S.L.Av. Baix Llobregat, 3-5 08970 Sant Joan Despi

BONEFOS 400 mg cápsulas

400 mg

Capsule

orala

ET - Estonia

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku |
| FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku

FINLAND

BONEFOS

800 mg

Comprimate filmate

Uz oral

ET - Estonia

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku |
| FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku

FINLAND

BONEFOS

400 mg

Capsule tari

Uz oral

ET - Estonia

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku |
| FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku

FINLAND

BONEFOS

60 mg 1 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FI - Finlanda

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

400 mg

Capsule tari

orala

FI - Finlanda

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

800 mg

Comprimate filmate

orala

FI - Finlanda

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Clodrobon

400 mg

Capsule tari

orala

FI - Finlanda

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Clodrobon

800 mg

Comprimate filmate

orala

FR - Franta

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| FRANCE |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 300 mg/5 ml, solution injectable pour perfusion en ampoule

300 mg/5 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| FRANCE |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 400 mg, gélule

400 mg

Capsule

Uz oral

FR - Franta

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| FRANCE |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

FRANCE

CLASTOBAN 800 mg, gélule

800 mg

Comprimate

Uz oral

FR - Franta

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

CLODRONATE DE SODIUM G GAM 400 mg, comprimé enrobé

400 mg

Comprimate

Uz oral

FR - Franta

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

CLODRONATE DE SODIUM G GAM 800 mg, comprimé pelliculé

800 mg

Comprimate

Uz oral

FR - Franta

| ROCHE |
| --- |
| 52, boulevard du Parc |
| 92521 Neuilly-sur-Seine |
| Cedex |
| FRANCE |

ROCHE

52, boulevard du Parc

92521 Neuilly-sur-Seine

Cedex

FRANCE

LYTOS 520 mg, comprimé pelliculé

520 mg

Comprimate

Uz oral

HU - Ungaria

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47. |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 800 mg tabletta

800 mg Disodium clodronate anhydrous

(in the form of 1 000 mg

Disodium clodronate

tetrahydrate

Comprimate

orala

HU - Ungaria

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47. |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 400 mg kemény kapszula

400 mg Disodium clodronate anhydrous

(in the form of 500 mg

Disodium

clodronate tetrahydrate

Capsule tari

orala

HU - Ungaria

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47. |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47.

20210 Turku

Finland

BONEFOS 60 mg/ml koncentrátum oldatos infúzióhoz

60 mg/ml Disodium clodronate anhydrous

(in the form

Disodium clodronate tetrahydrate

Concentrat pentru solutie perfuzabila

Intravenoasa

IE - Irlanda

Bayer Limited The Atrium Blackthorn Road Dublin 18

Bonefos 800 mg film- coated tablets.

800 mg

Comprimate filmate

orala

IS - Islanda

Bayer Ab, Box 606, Solna, Sweden

Bonefos

800 mg

Comprimate

orala

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031 |
| --- |
| Abano Terme (PD) |

FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| PROMEDICA Srl |
| --- |
| Via Palermo, 26/A - 43100 |
| Parma |

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA |
| --- |
| Via Biella, 8 |
| 20143 Milano |

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL Via E. Bazzano, 14 |
| --- |
| 16019 Ronco Scrivia - Genova (Italy) |

ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL Via E. Bazzano, 14

16019 Ronco Scrivia - Genova (Italy)

NIKLOD

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| ABC FARMACEUTICI SpA |
| --- |
| Corso Vittorio Emanuele II, 72 10121 Torino |

ABC FARMACEUTICI SpA

Corso Vittorio Emanuele II, 72 10121 Torino

CLODRONATO ABC

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| ABC FARMACEUTICI SpA |
| --- |
| Corso Vittorio Emanuele II, 72 10121 Torino |

ABC FARMACEUTICI SpA

Corso Vittorio Emanuele II, 72 10121 Torino

CLODRONATO ABC

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

300 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

400 mg

Capsule tari

Uz oral

IT - Italia

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ACIDO CLODRONICO EG

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| FARMACEUTICI CABER SpA |
| --- |
| Viale Città d' Europa, 681 |
| 00144 Roma |

FARMACEUTICI CABER SpA

Viale Città d' Europa, 681

00144 Roma

OSTEONORM

100 mg

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031 |
| --- |
| Abano Terme (PD) |

FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

300 mg/10 ml

Solutie injectabila

Intravenoasa

IT - Italia

| FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031 |
| --- |
| Abano Terme (PD) |

FIDIA FARMACEUTICI SpA Via Ponte Della Fabbrica, 3/A - 35031

Abano Terme (PD)

CLODRON

400 mg

Capsule

Uz oral

IT - Italia

| ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL Via E. Bazzano, 14 |
| --- |
| 16019 Ronco Scrivia - Genova (Italy) |

ISTITUTO BIOCHIMICO NAZIONALE SAVIO SRL Via E. Bazzano, 14

16019 Ronco Scrivia - Genova (Italy)

NIKLOD

300 mg/10 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| LISAPHARMA SpA Via Licinio, 11 |
| --- |
| 22036 Erba (CO) |

LISAPHARMA SpA Via Licinio, 11

22036 Erba (CO)

MOTICLOD

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| LISAPHARMA SpA Via Licinio, 11 |
| --- |
| 22036 Erba (CO) |

LISAPHARMA SpA Via Licinio, 11

22036 Erba (CO)

MOTICLOD

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| MASTELLI Srl |
| --- |
| Via Bussana Vecchia, 32 |
| 18032 San Remo (IM) |

MASTELLI Srl

Via Bussana Vecchia, 32

18032 San Remo (IM)

CLIMACLOD

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| MASTELLI Srl |
| --- |
| Via Bussana Vecchia, 32 |
| 18032 San Remo (IM) |

MASTELLI Srl

Via Bussana Vecchia, 32

18032 San Remo (IM)

CLIMACLOD

100 mg/3,3 ml

Solutie injectabila

Intramusculara

IT - Italia

| MYLAN SpA |
| --- |
| Via Aquileia, 35 - 20092 |
| Cinisello Balsamo |
| Milano |

MYLAN SpA

Via Aquileia, 35 - 20092

Cinisello Balsamo

Milano

ACIDO CLODRONICO MYLAN GENERICS

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| MYLAN SpA |
| --- |
| Via Vittor Pisani, 20 - 20124 |
| Milano |

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ACIDO CLODRONICO MYLAN GENERICS

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| PROMEDICA Srl |
| --- |
| Via Palermo, 26/A - 43100 |
| Parma |

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

300 mg/10 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| ROTTAPHARM SpA Via Galleria Unione,5 |
| --- |
| 20122 Milano (MI) |

ROTTAPHARM SpA Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| ROTTAPHARM SpA Via Galleria Unione,5 |
| --- |
| 20122 Milano (MI) |

ROTTAPHARM SpA Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| SANDOZ SpA |
| --- |
| L.go U. Boccioni, 1 - 21040 |
| Origgio (VA) |

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ACIDO CLODRONICO

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| SANDOZ SpA |
| --- |
| L.go U. Boccioni, 1 - 21040 |
| Origgio (VA) |

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ACIDO CLODRONICO

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA |
| --- |
| Via Biella, 8 |
| 20143 Milano |

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

300 mg/10 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA |
| --- |
| Via Biella, 8 |
| 20143 Milano |

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

400 mg

Capsule

Uz oral

IT - Italia

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano - Italy |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano - Italy

CLODRONATO TEVA

100 mg/3,3 ml

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

CLODRONATO TEVA

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

LABORATORIO PRODOTTI FARMACEUTICI BONISCONTRO & GAZZONE Srl

Via Pavia, 6 - 20136

Milano - Italy

CLODEOSTEN

100 mg/3,3 ml

Solutie injectabila

IT - Italia

| ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, |
| --- |
| 681 00144 Roma |

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa,

681 00144 Roma

TRAXOVICAL

100 mg/3,3 ml

Solutie injectabila

IT - Italia

| ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, |
| --- |
| 681 00144 Roma |

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa,

681 00144 Roma

TRAXOVICAL

300 mg/10 ml

Solutie perfuzabila

Intravenoasa

LU - Luxemburg

| Bayer s.a. |
| --- |
| 14, J.E. Mommaertslaan |
| B-1831 Diegem |

Bayer s.a.

14, J.E. Mommaertslaan

B-1831 Diegem

Bonefos

300 mg/5 ml

Solutie perfuzabila

Uz intravenos

LV - Latvia

| Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 |
| --- |
| Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210

Turku, Finland

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LV - Latvia

| Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 |
| --- |
| Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210

Turku, Finland

Bonefos

400 mg

Capsule

Uz oral

MT - Malta

| Bayer plc |
| --- |
| Consumer Care Division |
| Bayer House |
| Strawberry Hill Newbury Berkshire |
| RG14 1JA |
| United Kingdom |

Bayer plc

Consumer Care Division

Bayer House

Strawberry Hill Newbury Berkshire

RG14 1JA

United Kingdom

Bonefos

400 mg

Capsule

orala

NL - Olanda

| Roche Nederland B.V. Beneluxlaan 2a |
| --- |
| 3446 GR Woerden |
| Netherlands |

Roche Nederland B.V. Beneluxlaan 2a

3446 GR Woerden

Netherlands

Ostac, concentration for solution for infusion 30 mg/ml

30 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Roche Nederland B.V. Beneluxlaan 2a |
| --- |
| 3446 GR Woerden |
| Netherlands |

Roche Nederland B.V. Beneluxlaan 2a

3446 GR Woerden

Netherlands

Ostac® 520, filmcaoted tablets 520 mg

520 mg

Comprimate filmate

orala

NL - Olanda

| Bayer B.V. Energieweg 1 |
| --- |
| 3641 RT Mijdrecht |

Bayer B.V. Energieweg 1

3641 RT Mijdrecht

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Bayer B.V. Energieweg 1 |
| --- |
| 3641 RT Mijdrecht |

Bayer B.V. Energieweg 1

3641 RT Mijdrecht

Bonefos capsules 400 mg

400 mg

Capsule tari

orala

NL - Olanda

| Bayer B.V. Energieweg 1 |
| --- |
| 3641 RT Mijdrecht |

Bayer B.V. Energieweg 1

3641 RT Mijdrecht

Bonefos tablets 800 mg

800 mg

Comprimate filmate

orala

NO - Norvegia

| Bayer AB Box 606 |
| --- |
| 169 26 Solna |
| Sweden |

Bayer AB Box 606

169 26 Solna

Sweden

Bonefos

800 mg

Comprimate filmate

orala

PL - Polonia

Bayer Schering Pharma AG Berlin, D-13342, Germany

Bonefos

400 mg

Capsule tari

orala

PL - Polonia

Bayer Schering Pharma AG Berlin, D-13342, Germany

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

Bayer Schering Pharma AG Berlin, D-13342, Germany

Bonefos

800 mg

Comprimate filmate

orala

PL - Polonia

| Actavis Group PTC ehf. Reykjavikurvegi 76-78 |
| --- |
| 220 Hafnarfirdi, Iceland |

Actavis Group PTC ehf. Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Sindronat

400 mg

Capsule tari

orala

PT - Portugalia

| Roche Farmacêutica |
| --- |
| Química, Lda. |
| Estrada Nacional 249, 1, |
| 2720-413 Amadora |
| Portugal |

Roche Farmacêutica

Química, Lda.

Estrada Nacional 249, 1,

2720-413 Amadora

Portugal

Ostac

520 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Lusalfarma - Especialidades |
| --- |
| Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, |
| Outurela |
| 2794-003 Carnaxide |
| Portugal |

Lusalfarma - Especialidades

Farmacêuticas, Lda. Rua Quinta Pinheiro, 5,

Outurela

2794-003 Carnaxide

Portugal

Bonefos

800 mg

Comprimate filmate

Uz oral

RO - Romania

| BAYER SCHERING PHARMA OY, |
| --- |
| Pansiontie 47, 20210 Turku, Finland |

BAYER SCHERING PHARMA OY,

Pansiontie 47, 20210 Turku, Finland

BONEFOS 400 mg, capsules

400 mg

Capsule

orala

RO - Romania

| BAYER SCHERING PHARMA OY, |
| --- |
| Pansiontie 47, 20210 Turku, |
| Finland |

BAYER SCHERING PHARMA OY,

Pansiontie 47, 20210 Turku,

Finland

BONEFOS 800 mg, capsules

800 mg

Capsule

orala

RO - Romania

| BAYER SCHERING PHARMA OY, |
| --- |
| Pansiontie 47, 20210 Turku, Finland |

BAYER SCHERING PHARMA OY,

Pansiontie 47, 20210 Turku, Finland

BONEFOS 60 mg/ml concentrate for solution for infusion

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

RO - Romania

| ACTAVIS S.R.L. |
| --- |
| B-dul Ion Mihalache, nr. 11 |
| Sector 1, Cod 011171, Sector 1, Cod 011171, |
| București, Romania |

ACTAVIS S.R.L.

B-dul Ion Mihalache, nr. 11

Sector 1, Cod 011171, Sector 1, Cod 011171,

București, Romania

SINDRONAT 300 mg/5 ml concentrate for solution for infusion

300 mg/5 ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| Bayer AB Box 606 |
| --- |
| 169 26 Solna |
| Sweden |

Bayer AB Box 606

169 26 Solna

Sweden

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| Bayer AB Box 606 |
| --- |
| 169 26 Solna |
| Sweden |

Bayer AB Box 606

169 26 Solna

Sweden

Bonefos

800 mg

Comprimate filmate

orala

SI - Slovenia

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 60 mg/ml koncentrat za raztopine za infundiranje

60 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

SI - Slovenia

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 800 mg filmsko obložene tablete

800 mg

Comprimate filmate

Uz oral

SK - Republica Slovaca

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

60 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SK - Republica Slovaca

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

400 mg

Capsule tari

orala

SK - Republica Slovaca

| Bayer Schering Pharma Oy, Pansiontie 47, PL 415, |
| --- |
| 20210 Turku, Finland |

Bayer Schering Pharma Oy, Pansiontie 47, PL 415,

20210 Turku, Finland

Bonefos

800 mg

Comprimate filmate

orala

UK - Marea Britanie

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

400 mg

Capsule

orala

UK - Marea Britanie

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

800 mg

Comprimate filmate

orala

UK - Marea Britanie

| Roche Products Limited, 6 |
| --- |
| Falcon Way, Shire Park, Welwyn Garden City, AL7 |
| 1TW, UK |

Roche Products Limited, 6

Falcon Way, Shire Park, Welwyn Garden City, AL7

1TW, UK

Loron 540

Comprimate filmate

orala

UK - Marea Britanie

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Clasteon

400 mg

Capsule

orala

UK - Marea Britanie

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Sodium clodronate

400 mg

Capsule

orala

UK - Marea Britanie

| Caduceus Pharma Limited, |
| --- |
| 6th floor, 94 Wigmore |
| Street, London W1U 3RF, UK |

Caduceus Pharma Limited,

6th floor, 94 Wigmore

Street, London W1U 3RF, UK

Disodium Clodronate

60 mg/ml

Solutie injectabila

Intravenoasa

Produse medicamentoase care contin acid etidronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| BE - Belgia | Procter & Gamble Pharmaceuticals SA.NV. Temselaan 100 | Didronel | 200 mg | Comprimate | Uz oral |
| BE - Belgia | Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| 1831 Diegem, Belgium |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

BE - Belgia

Procter & Gamble Pharmaceuticals SA.NV. Temselaan 100

Didronel

200 mg

Comprimate

Uz oral

BE - Belgia

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Osteodidronel

400 mg

Comprimate

Uz oral

DE - Germania

| mibe GmbH Arznzemittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Etidronat 200 mg

Jenapharm

200 mg

Comprimate

Uz oral

DE - Germania

| C.H.R. Heim Arzneimittel |
| --- |
| GmbH Elisabethenstr. 34 |
| D-64283 Darmstadt |

C.H.R. Heim Arzneimittel

GmbH Elisabethenstr. 34

D-64283 Darmstadt

Etical

400 mg

1 250 mg

Comprimate

Uz oral

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Etidron HEXAL Kombi

400 mg

1 250 mg

Comprimate si comprimate efervescente

Uz oral

DE - Germania

| Warner Chilcott Deutschland |
| --- |
| GmbH |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland

GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Didronel-Kit

400 mg

1 250 mg

Comprimate

Uz oral

DK - Danemarca

Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB- TW20 9 NW Egham, Surrey, England

Didronate

200 mg

Comprimate

orala

DK - Danemarca

Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB- TW20 9 NW Egham, Surrey, England

Didronate/Calcium

"Procter & Gamble"

400 mg + 500 mg calcium

Comprimate

orala

EL - Grecia

| UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES |
| --- |
| 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA |
| KIFISSIA 14564 |

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14564

OSTOPOR

200 MG/CAP

Capsule tari

orala

EL - Grecia

| UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES |
| --- |
| 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14565 |

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14565

OSTOPOR

300 MG/CAP

Capsule tari

orala

EL - Grecia

| UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES |
| --- |
| 14KM OF NATIONAL HIGHWAY ATHENS-LAMIA |
| KIFISSIA 14566 |

UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES

14KM OF NATIONAL HIGHWAY ATHENS-LAMIA

KIFISSIA 14566

OSTOPOR

400 MG/CAP

Capsule tari

orala

EL - Grecia

PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS G. KORONIS S.A.

ANFOZAN

400 MG/CAP

Capsule tari

orala

ES - Spania

| LABORATORIOS VIÑAS, S.A. Provenza, 386 08025 |
| --- |
| Barcelona |

LABORATORIOS VIÑAS, S.A. Provenza, 386 08025

Barcelona

OSTEUM

200 mg

Comprimate

orala

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

DIDRONEL 200 mg, comprimé

200 mg

Comprimate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

DIDRONEL 400 mg, comprimé

400 mg

Comprimate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

DIPOROS 400 mg, comprimé

400 mg

Comprimate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ETIDRONATE DISODIQUE PROCTER

& GAMBLE

PHARMACEUTICALS

200 mg, comprimé

200 mg

Comprimate

Uz oral

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ETIDRONATE MYLAN

200 mg, comprimé

200 mg

Comprimate

Uz oral

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ETIDRONATE MYLAN

400 mg, comprimé

400 mg

Comprimate

Uz oral

FR - Franta

| SANDOZ |
| --- |
| 49, avenue Georges |
| Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges

Pompidou

92300 Levallois-Perret

FRANCE

ETIDRONATE SANDOZ

400 mg, comprimé

400 mg

Comprimate

Uz oral

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

ETIDRON

300 mg

Capsule

Uz oral

NL - Olanda

| Procter & Gamble Pharmaceuticals Nederland B.V. |
| --- |
| Postbus 2507 |
| 3000 CM Rotterdam |
| Netherlands |

Procter & Gamble Pharmaceuticals Nederland B.V.

Postbus 2507

3000 CM Rotterdam

Netherlands

Didronel 400

400 mg

Comprimate

orala

NL - Olanda

| Warner Chilcott Nederland |
| --- |
| B.V. |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland

B.V.

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Didrokit, combinatieverpakking

400 mg +

1 250 mg

Comprimate si comprimate efervescente

orala

NO - Norvegia

Warner Chilcott UK Ltd.; Old Belfast Rd, Larne BT40 2SH, UK

Didronate + Calsium

Kombinasjonspakning

400 mg/500 mg

Comprimate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Didronate

200 mg

Comprimate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Didronate 400 mg + Calcium 500 mg

Didronate 400 mg + Calcium

500 mg

Comprimate

orala

UK - Marea Britanie

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

ETIDRONATE DISODIUM

200 mg

Comprimate

orala

UK - Marea Britanie

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL

200 mg

Comprimate

orala

UK - Marea Britanie

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL PMO

400 mg

Comprimate

orala

UK - Marea Britanie

Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK

TILOETCA COMBI

400 mg

Comprimate

orala

UK - Marea Britanie

Arrow Generics Limited, Unit 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United Kingdom

DISODIUM ETIDRONATE

200 mg

Comprimate

orala

UK - Marea Britanie

| Arrow Generics Limited, Unit |
| --- |
| 2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ, |
| United Kingdom |

Arrow Generics Limited, Unit

2 Eastman Way, Stevenage, Hertfordshire SG1 4SZ,

United Kingdom

DISODIUM ETIDRONATE

400 mg

Comprimate

orala

Produse medicamentoase care contin acid neridronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| IT - Italia | ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

IT - Italia

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

25 mg

Solutie injectabila

Intramusculara, intravenoasa

IT - Italia

| ABIOGEN PHARMA SpA Via Meucci, 36 - 56014 |
| --- |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

100 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

Produse medicamentoase care contin acid pamidronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria | Aredia 15 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel | 15 mg/5 ml (Pamidronate Disodium) | Pulbere si solvent pentru solutie perfuzabila | Intravenoasa |
| AT - Austria | Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria | Aredia 30 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel | 30 mg/10 ml (Pamidronate Disodium) | Pulbere si solvent pentru solutie perfuzabila | Intravenoasa |
| AT - Austria | Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria | Aredia 90 mg - Trockensubstanz zur Infusionsbereitung mit Lösungmittel | 90 mg/10 ml (Pamidronate Disodium) | Pulbere si solvent pentru solutie perfuzabila | Intravenoasa |
| AT - Austria | medac |
| Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3 |
| D-20354 Hamburg, Germany |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

AT - Austria

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 15 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

15 mg/5 ml (Pamidronate Disodium)

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

AT - Austria

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 30 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel

30 mg/10 ml (Pamidronate Disodium)

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

AT - Austria

Novartis Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria

Aredia 90 mg - Trockensubstanz zur Infusionsbereitung mit Lösungmittel

90 mg/10 ml (Pamidronate Disodium)

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

AT - Austria

medac

Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3

D-20354 Hamburg, Germany

Ebedronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Hospira Deutschland GmbH Rablstraße 24 |
| --- |
| 81669 München, Germany |

Hospira Deutschland GmbH Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 3 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Hospira Deutschland GmbH Rablstraße 24 |
| --- |
| 81669 München, Germany |

Hospira Deutschland GmbH Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 6 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

6 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Hospira Deutschland GmbH Rablstraße 24 |
| --- |
| 81669 München, Germany |

Hospira Deutschland GmbH Rablstraße 24

81669 München, Germany

Pamidronat Dinatrium Hospira 9 mg/ml, Konzentrat zur Herstellung einer Infusionslösung

9 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Stada Arzneimittel GmbH, Muthgasse 36, A-1190 |
| --- |
| Wien, Austria |

Stada Arzneimittel GmbH, Muthgasse 36, A-1190

Wien, Austria

Pamidronat STADA 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

AT - Austria

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16, |
| A-1010 Wien, Austria |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16,

A-1010 Wien, Austria

Pamitor 15 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

15 mg/ml (Pamidronate Disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Novartis Pharma N.V. Medialaan 40 |
| --- |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma N.V. Medialaan 40

1800 Vilvoorde

Belgium

Aredia

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Novartis Pharma N.V. Medialaan 40 |
| --- |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma N.V. Medialaan 40

1800 Vilvoorde

Belgium

Aredia

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Teva Pharma Belgium N.V. Laarstraat 16 |
| --- |
| 2610 Wilrijk |
| Belgium |

Teva Pharma Belgium N.V. Laarstraat 16

2610 Wilrijk

Belgium

Pamidrin

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Actavis Group PTC EHF Reykjavikuregur 76-78 |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC EHF Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Actavis Group PTC EHF Reykjavikuregur 76-78 |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC EHF Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Actavis Group PTC EHF Reykjavikuregur 76-78 |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC EHF Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

Pamidronaat Actavis

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Hospira Benelux BVBA Stallestraat 63 |
| --- |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium

Hospira

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Hospira Benelux BVBA Stallestraat 63 |
| --- |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium

Hospira

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Hospira Benelux BVBA Stallestraat 63 |
| --- |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium

Hospira

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Eurogenerics N.V. Heizel Esplanade b22 |
| --- |
| 1020 Brussels |
| Belgium |

Eurogenerics N.V. Heizel Esplanade b22

1020 Brussels

Belgium

Pamidronate EG

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BE - Belgia

| Mylan BVBA/SPRL Terhulpsesteenweg 6A |
| --- |
| 1560 Hoeilaart |
| Belgium |

Mylan BVBA/SPRL Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Pamidronate Mylan

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BG - Bulgaria

Tchaikapharma High Quality Medicines, 1, G.M. Dimitorv Blvd, 1172 Sofia, Bulgaria

Pamitor

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

BG - Bulgaria

| Novartis Pharma GmbH, Roonstrasse 25, D-90429 |
| --- |
| Nuernberg, Germany |

Novartis Pharma GmbH, Roonstrasse 25, D-90429

Nuernberg, Germany

Aredia

30 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

BG - Bulgaria

Actavis Group PTC ehf, Iceland Reykjavikurvegur 76-78, IS-220, Hafnarfjordur

Clastodron

3 mg/ml,

Concentrat pentru solutie perfuzabila, 5 ml

Uz intravenos

BG - Bulgaria

| Actavis Group PTC ehf, Iceland Reykjavikurvegur |
| --- |
| 76-78, IS-220, Hafnarfjordur |

Actavis Group PTC ehf, Iceland Reykjavikurvegur

76-78, IS-220, Hafnarfjordur

Clastodron

6 mg/ml

Concentrat pentru solutie perfuzabila - 10 ml

Uz intravenos

BG - Bulgaria

| Actavis Group PTC ehf, Iceland Reykjavikurvegur |
| --- |
| 76-78, IS-220, Hafnarfjordur |

Actavis Group PTC ehf, Iceland Reykjavikurvegur

76-78, IS-220, Hafnarfjordur

Clastodron

9 mg/ml

Concentrat pentru solutie perfuzabila - 10 ml

Uz intravenos

CY - Cipru

| PHARMACEUTICAL TRADING CO LTD, 18 |
| --- |
| THOUKIDIDOU STR, P O BOX 40628, 6306 |
| LARNACA, CYPRUS |

PHARMACEUTICAL TRADING CO LTD, 18

THOUKIDIDOU STR, P O BOX 40628, 6306

LARNACA, CYPRUS

PAMIDRONATE DISODIUM CONCENTRATE FOR SOLUTION FOR INFUSION 9 mg/ml

9 mg/ml, 10 ml

Solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Novartis s.r.o., U nákladového nádraží |
| --- |
| 3265/10, 130 00 Praha- Strašnice |
| (Nagano III.), Czech |
| Republic |

Novartis s.r.o., U nákladového nádraží

3265/10, 130 00 Praha- Strašnice

(Nagano III.), Czech

Republic

Aredia 15 mg

1,5 mg/ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Novartis s.r.o., U nákladového nádraží |
| --- |
| 3265/10, 130 00 Praha- Strašnice |
| (Nagano III.), Czech |
| Republic |

Novartis s.r.o., U nákladového nádraží

3265/10, 130 00 Praha- Strašnice

(Nagano III.), Czech

Republic

Aredia 30 mg

3 mg/ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D- |
| --- |
| 20354 Hamburg, Germany |

Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D-

20354 Hamburg, Germany

Pamidronate Medac

3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c |
| --- |
| 150 00 Praha 5 |
| Cezch Republic |

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Pamidronate-Teva

3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

CZ - Republica Ceha

| Torrex Chiesi CZ, s.r.o. , |
| --- |
| Na květnici 878/33, 140 00 |
| Praha-Nusle, Czech |
| Republic |

Torrex Chiesi CZ, s.r.o. ,

Na květnici 878/33, 140 00

Praha-Nusle, Czech

Republic

Pamitor 15 mg/ml

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| axios Pharma GmbH Hauptstr. 198 |
| --- |
| D-33647 Bielefeld |

axios Pharma GmbH Hauptstr. 198

D-33647 Bielefeld

axidronat 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Cancernova GmbH onkologische Arzneimittel |
| --- |
| Lil-Dagover-Ring 7 |
| D-82031 Grünwald |

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 15 mg Pulver zur Herstellung einer Infusionslösung

15,36 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Cancernova GmbH onkologische Arzneimittel |
| --- |
| Lil-Dagover-Ring 7 |
| D-82031 Grünwald |

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 30 mg Pulver zur Herstellung einer Infusionslösung

30,9 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Cancernova GmbH onkologische Arzneimittel |
| --- |
| Lil-Dagover-Ring 7 |
| D-82031 Grünwald |

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung

61,74 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Cancernova GmbH onkologische Arzneimittel |
| --- |
| Lil-Dagover-Ring 7 |
| D-82031 Grünwald |

Cancernova GmbH onkologische Arzneimittel

Lil-Dagover-Ring 7

D-82031 Grünwald

NOVAPAM 60 mg Pulver zur Herstellung einer Infusionslösung

92,75 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

DE - Germania

| cell Pharm GmbH Theodor-Heuss-Str. 52 |
| --- |
| D-61118 Bad Vilbel |

cell Pharm GmbH Theodor-Heuss-Str. 52

D-61118 Bad Vilbel

PAMIDRO-cell 3

mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| TEVA Deutschland GmbH Wasastr. 50 |
| --- |
| D-01445 Radebeul |

TEVA Deutschland GmbH Wasastr. 50

D-01445 Radebeul

Pamidronat-GRY 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| HEXAL AG Industriestr. 25 |
| --- |
| D-83607 Holzkirchen |

HEXAL AG Industriestr. 25

D-83607 Holzkirchen

Pamidron HEXAL 15 mg/ml Konzentrat zur Herstellung einer Infsionslösung

15 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| HIKMA Farmaceutica (Portugal) S.A. |
| --- |
| Estrada do Rio da Mo, 8,8 A e 8 B - Fervenca |
| P-2705-906 TERRUGem SNT |

HIKMA Farmaceutica (Portugal) S.A.

Estrada do Rio da Mo, 8,8 A e 8 B - Fervenca

P-2705-906 TERRUGem SNT

Ribodronat 3 mg/ ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Hospira Deutschland GmbH Rablstr. 24 |
| --- |
| D-81669 München |

Hospira Deutschland GmbH Rablstr. 24

D-81669 München

Pamidronat Hospira 3 mg/ml Konzentrat zur Herstellung einer Infsionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Hospira Deutschland GmbH Rablstr. 24 |
| --- |
| D-81669 München |

Hospira Deutschland GmbH Rablstr. 24

D-81669 München

Pamidronat Hospira 6 mg/ml Konzentrat zur Herstellung einer Infsionslösung

6 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Hospira Deutschland GmbH Rablstr. 24 |
| --- |
| D-81669 München |

Hospira Deutschland GmbH Rablstr. 24

D-81669 München

Pamidronat Hospira 9 mg/ml Konzentrat zur Herstellung einer Infsionslösung

9 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstr. 3 |
| D-20354 Hamburg |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstr. 3

D-20354 Hamburg

Pamifos 3 mg/ml Konzentrat zur Herstellung eriner Infusionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DE - Germania

| Novartis Pharma GmbH Roonstr. 25 |
| --- |
| D-90429 Nürnberg |

Novartis Pharma GmbH Roonstr. 25

D-90429 Nürnberg

Aredia 15 mg

15 mg

Pulbere si solvent pentru solutie injectabila

Intravenoasa

DE - Germania

| Novartis Pharma GmbH Roonstr. 25 |
| --- |
| D-90429 Nürnberg |

Novartis Pharma GmbH Roonstr. 25

D-90429 Nürnberg

Aredia 30 mg

30 mg

Pulbere si solvent pentru solutie injectabila

Intravenoasa

DE - Germania

| Novartis Pharma GmbH Roonstr. 25 |
| --- |
| D-90429 Nürnberg |

Novartis Pharma GmbH Roonstr. 25

D-90429 Nürnberg

Aredia 90 mg

90 mg

Pulbere si solvent pentru solutie injectabila

Intravenoasa

DE - Germania

| Novartis Pharma GmbH Roonstr. 25 |
| --- |
| D-90429 Nürnberg |

Novartis Pharma GmbH Roonstr. 25

D-90429 Nürnberg

Aredia 60 mg

60 mg

Pulbere si solvent pentru solutie injectabila

Intravenoasa

DE - Germania

| Onkovis GmbH Grube 45 |
| --- |
| D-82377 Penzberg |

Onkovis GmbH Grube 45

D-82377 Penzberg

Pamidronat Onkovis

3 mg/ml Konzentrat zur Herstellung

einer Infusionslösung

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Helm AG, Nordkanalstrasse |
| --- |
| 28D, DE-20097 Hamburg, Germany |

Helm AG, Nordkanalstrasse

28D, DE-20097 Hamburg, Germany

Epsilonat

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, |
| --- |
| DE-61118 Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8,

DE-61118 Bad Vilbel, Germany

Pamidrocell

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Hexal AG, Industriestrasse |
| --- |
| 25, DE-83607 Holzkirchen, Germany |

Hexal AG, Industriestrasse

25, DE-83607 Holzkirchen, Germany

Pamidronat "Hexal"

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Meda AS, Solvang 8, |
| --- |
| DK-3450 Allerød, Denmark |

Meda AS, Solvang 8,

DK-3450 Allerød, Denmark

Pamidronat "Meda"

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| SE-11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

SE-11148 Stockholm, Sweden

Pamidronatdinatrium

"BMM Pharma"

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| SE-11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

SE-11148 Stockholm, Sweden

Pamidronatdinatrium

"BMM Pharma"

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| SE-11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

SE-11148 Stockholm, Sweden

Pamidronatdinatrium

"BMM Pharma"

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 |
| --- |
| 3RW Warwickshire, England |

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31

3RW Warwickshire, England

Pamidronatdinatrium

"Hospira"

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 |
| --- |
| 3RW Warwickshire, England |

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31

3RW Warwickshire, England

Pamidronatdinatrium

"Hospira"

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 |
| --- |
| 3RW Warwickshire, England |

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31

3RW Warwickshire, England

Pamidronatdinatrium

"Hospira"

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| Teva Denmark A/S, Parallelvej 10-12, DK-2800 |
| --- |
| Kongens Lyngby, Denmark |

Teva Denmark A/S, Parallelvej 10-12, DK-2800

Kongens Lyngby, Denmark

Pamidronatdinatrium

"Teva"

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

DK - Danemarca

| medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, |
| --- |
| DE-20354 Hamburg, Germany |

medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3,

DE-20354 Hamburg, Germany

Pamifos

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire |
| --- |
| CV31 3RW United Kingdom |

HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire

CV31 3RW United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

6 MG/1 ML

Concentrat pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| MEDICUS S.A. VALAORITOU 10 |
| --- |
| METAMORFOSI ATTIKIS 14452 |

MEDICUS S.A. VALAORITOU 10

METAMORFOSI ATTIKIS 14452

PAMIDRONE

60 MG/VIAL

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| MEDICUS S.A. VALAORITOU 10 |
| --- |
| METAMORFOSI ATTIKIS 14453 |

MEDICUS S.A. VALAORITOU 10

METAMORFOSI ATTIKIS 14453

PAMIDRONE

90 MG/VIAL

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire |
| --- |
| CV31 3RW United Kingdom |

HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire

CV31 3RW United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

3 MG/1 ML

Concentrat pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire |
| --- |
| CV31 3RW United Kingdom |

HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire

CV31 3RW United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

6 MG/1 ML

Concentrat pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire |
| --- |
| CV31 3RW United Kingdom |

HOSPIRA UK LIMITED, U.K. Queensway, Royal Leamington Spa Warwickshire

CV31 3RW United Kingdom

PAMIDRONATE DISODIUM / HOSPIRA

9 MG/1 ML

Concentrat pentru solutie perfuzabila

Intravenoasa

EL - Grecia

| ALAPIS ABEE AUTOKRATOROS NIKOLAOU 2 |
| --- |
| ATHENS 17671 |

ALAPIS ABEE AUTOKRATOROS NIKOLAOU 2

ATHENS 17671

PAMERIT

15 MG/1 ML

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 3 mg/ml concentrado para solución para perfusión

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 6 mg/ml concentrado para solución para perfusión

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

HOSPIRA UK LIMITED Queensway. Royal Leadmington Spa Warwickshire CV31 3RW Reino Unido

PAMIDRONATO HOSPIRA 9 mg/ml concentrado para solución para perfusión

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

| NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 |
| --- |
| Barcelona |

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013

Barcelona

AREDIA 15 mg polvo y disolvente para solución para perfusión

15 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 |
| --- |
| Barcelona |

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013

Barcelona

AREDIA 30 mg polvo y disolvente para solución para perfusión

30 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013 |
| --- |
| Barcelona |

NOVARTIS FARMACEUTICA, S.A.Gran Via de les Corts Catalanes, 764 08013

Barcelona

AREDIA 90 mg polvo y disolvente para solución para perfusión

90 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2o 08006 |
| --- |
| BARCELONA |

GENERIS FARMACÉUTICA, S.A.MOIÁ, 1, 2o 08006

BARCELONA

PAMIDRONATO GENERIS 15 mg/ml concentrado para solución para perfusión

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

| LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 |
| --- |
| Sant Just Desvern |

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960

Sant Just Desvern

PAMIDRONATO STADA 3 mg/ml concentrado para solución para perfusión

3 mg /ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

| MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Fehlandtstrasse 3 |
| --- |
| Hamburgo D-20354 |

MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Fehlandtstrasse 3

Hamburgo D-20354

PAMIFOS 3 mg/ml concentrado para solución para perfusión

3 mg /ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

| LABORATORIO STADA, S.L. Frederic Mompou, 5 08960 |
| --- |
| Sant Just Desvern |

LABORATORIO STADA, S.L. Frederic Mompou, 5 08960

Sant Just Desvern

PAMIDRONATO TEVA

3 mg/ml, concentrado para solución para

perfusión

3 mg /ml

Concentrat pentru solutie perfuzabila

Intravenoasa

ES - Spania

| COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 |
| --- |
| 08970 Sant Joan Despi |

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8

08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión

15 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 |
| --- |
| 08970 Sant Joan Despi |

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8

08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión

30 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 |
| --- |
| 08970 Sant Joan Despi |

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8

08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión

60 mg

Solutie perfuzabila

Intravenoasa

ES - Spania

| COMBINO PHARM, S.L.Fructuos Gelabert, 6-8 |
| --- |
| 08970 Sant Joan Despi |

COMBINO PHARM, S.L.Fructuos Gelabert, 6-8

08970 Sant Joan Despi

PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión

90 mg

Solutie perfuzabila

Intravenoasa

ET - Estonia

| Novartis Finland OY Metsänneidonkuja 10 |
| --- |
| FIN-02130 Espoo |
| FINLAND |

Novartis Finland OY Metsänneidonkuja 10

FIN-02130 Espoo

FINLAND

AREDIA

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

ET - Estonia

| Torrex Chiesi Pharma |
| --- |
| GmbH Gonzagagasse |
| 16/16, 1010 Vienna |
| AUSTRIA |

Torrex Chiesi Pharma

GmbH Gonzagagasse

16/16, 1010 Vienna

AUSTRIA

PAMITOR 15 MG/ML

15 mg 1 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FI - Finlanda

| medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, |
| --- |
| 20354 Hamburg, Germany |

medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3,

20354 Hamburg, Germany

Pamifos

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| Stada Arzneimittel AG, Stadastrasse 2 - 18, |
| --- |
| 61118 BAD VILBEL, Germany |

Stada Arzneimittel AG, Stadastrasse 2 - 18,

61118 BAD VILBEL, Germany

Paminject

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| Meda Oy, Vaisalantie 4, |
| --- |
| 02130 Espoo, Finland |

Meda Oy, Vaisalantie 4,

02130 Espoo, Finland

Pamidronat Meda

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium

Hospira

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium

Hospira

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium

Hospira

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| 11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

11148 Stockholm, Sweden

Pamidronate BMM Pharma

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| 11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

11148 Stockholm, Sweden

Pamidronate BMM Pharma

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FI - Finlanda

| BMM Pharma AB, Blasieholmsgatan 2, |
| --- |
| 11148 Stockholm, Sweden |

BMM Pharma AB, Blasieholmsgatan 2,

11148 Stockholm, Sweden

Pamidronate BMM Pharma

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 15 mg/5 ml, poudre et solvant pour solution pour perfusion

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 60 mg/10 ml, poudre et solvant

pour solution pour

perfusion

60 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

AREDIA 90 mg/10 ml, poudre et solvant

pour solution pour perfusion

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NORDIC PHARMA |
| --- |
| 216, boulevard Saint Germain |
| 75007 Paris |
| FRANCE |

NORDIC PHARMA

216, boulevard Saint Germain

75007 Paris

FRANCE

OSTEPAM 15 mg/ml, solution à diluer pour perfusion

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| AGUETTANT |
| --- |
| 1, rue Alexander Fleming |
| 69007 Lyon |
| FRANCE |

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT

15 mg/5 ml, poudre

et solvant pour solution pour perfusion

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| AGUETTANT |
| --- |
| 1, rue Alexander Fleming |
| 69007 Lyon |
| FRANCE |

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT

60 mg/10 ml, poudre et solvant pour solution pour

perfusion

60 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| AGUETTANT |
| --- |
| 1, rue Alexander Fleming |
| 69007 Lyon |
| FRANCE |

AGUETTANT

1, rue Alexander Fleming

69007 Lyon

FRANCE

PAMIDRONATE DE SODIUM AGUETTANT

90 mg/10 ml, poudre et solvant pour

solution pour perfusion

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| HOSPIRA FRANCE |
| --- |
| 17-19, rue Jeanne Braconnier |
| Immeuble Volta |
| 92360 Meudon La Forêt |
| FRANCE |

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier

Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| HOSPIRA FRANCE |
| --- |
| 17-19, rue Jeanne Braconnier |
| Immeuble Volta |
| 92360 Meudon La Forêt |
| FRANCE |

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier

Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 6 mg/ml, solution à diluer pour perfusion

6 mg/ml,

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| HOSPIRA FRANCE |
| --- |
| 17-19, rue Jeanne Braconnier Immeuble Volta |
| 92360 Meudon La Forêt |
| FRANCE |

HOSPIRA FRANCE

17-19, rue Jeanne Braconnier Immeuble Volta

92360 Meudon La Forêt

FRANCE

PAMIDRONATE DE SODIUM HOSPIRA 9 mg/ml, solution à diluer pour perfusion

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

PAMIDRONATE DE SODIUM MYLAN 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 15 mg/5 ml, poudre et solvant pour solution pour perfusion

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 60 mg/10 ml, poudre et solvant pour solution pour perfusion

60 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| NOVARTIS PHARMA |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

PAMIDRONATE DE SODIUM NOVARTIS PHARMA 90 mg/10 ml, poudre et solvant pour solution pour perfusion

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

FR - Franta

| RATIOPHARM (ALLEMAGNE) |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| ALLEMAGNE |

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

ALLEMAGNE

PAMIDRONATE DE SODIUM RATIOPHARM 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| TEVA SANTE Le Palatin 1 |
| --- |
| 1 cours du Triangle |
| 92936 Paris la Défense |
| Cedex |
| FRANCE |

TEVA SANTE Le Palatin 1

1 cours du Triangle

92936 Paris la Défense

Cedex

FRANCE

PAMIDRONATE DE SODIUM TEVA 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| PHARMAKI GENERICS (ROYAUME-UNI) |
| --- |
| 5 Bourlet Close |
| W1W 7BL London |
| ROYAUME-UNI |

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS

3 mg/ml, solution à

diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| PHARMAKI GENERICS (ROYAUME-UNI) |
| --- |
| 5 Bourlet Close |
| W1W 7BL London |
| ROYAUME-UNI |

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS

6 mg/ml, solution à diluer pour perfusion

6 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| PHARMAKI GENERICS (ROYAUME-UNI) |
| --- |
| 5 Bourlet Close |
| W1W 7BL London |
| ROYAUME-UNI |

PHARMAKI GENERICS (ROYAUME-UNI)

5 Bourlet Close

W1W 7BL London

ROYAUME-UNI

PAMIDRONATE PHARMAKI GENERICS

9 mg/ml, solution à

diluer pour perfusion

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

FR - Franta

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt |
| Cedex |
| FRANCE |

EG LABO - LABORATOIRES EUROGENERICS

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt

Cedex

FRANCE

PAMINJECT 3 mg/ml, solution à diluer pour perfusion

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

HU - Ungaria

| Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47. Bartók-Ház, V. em. |
| --- |
| 1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47. Bartók-Ház, V. em.

1114 Budapest

Hungary

AREDIA 30 mg por és oldószer oldatos infúzióhoz

30.0 mg Disodium pamidronate, anhydrous

[from Disodium pamidronate pentahydrate

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Hospira UK Limited Queensway, Royal Leamington Spa, |
| --- |
| Warwickshire CV31 3RW, UK |

Hospira UK Limited Queensway, Royal Leamington Spa,

Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 5 ml

3 mg/ml Pamidronic acid (equal to pamidronate disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Hospira UK Limited Queensway, Royal Leamington |
| --- |
| Spa,Warwickshire CV31 3RW, UK |

Hospira UK Limited Queensway, Royal Leamington

Spa,Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 3 mg/ml koncentrátum oldatos infúzióhoz, 10 ml

3 mg/ml Pamidronic acid (equal to pamidronate disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Hospira UK Limited Queensway, Royal Leamington |
| --- |
| Spa,Warwickshire CV31 3RW, UK |

Hospira UK Limited Queensway, Royal Leamington

Spa,Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 6 mg/ml koncentrátum oldatos infúzióhoz

6 mg/ml Pamidronic acid (equal to pamidronate disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Hospira UK Limited Queensway, Royal Leamington |
| --- |
| Spa,Warwickshire CV31 3RW, UK |

Hospira UK Limited Queensway, Royal Leamington

Spa,Warwickshire CV31 3RW, UK

PAMIDRONATE HOSPIRA 9 mg/ml koncentrátum oldatos infúzióhoz

9 mg/ml Pamidronic acid (equal to pamidronate disodium)

Concentrat pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Medac GmbH Fehlandstrasse 3. |
| --- |
| 20354 Hamburg |
| Germany |

Medac GmbH Fehlandstrasse 3.

20354 Hamburg

Germany

PAMIFOS 3 mg/ml koncentrátum oldatos infúzióhoz

3 mg/ml Disodium pamidronate (equal to Pamidronic acid)

Concentrat pentru solutie perfuzabila

Intravenoasa

HU - Ungaria

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16. |
| 1010 Vienna |
| Austria |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16.

1010 Vienna

Austria

PAMITOR 15 mg/ml koncentrátum oldatos infúzióhoz

15 mg/ ml Disodium pamidronate

(equal to 12,6 mg pamidronic

acid)

Concentrat pentru solutie perfuzabila

Intravenoasa

IE - Irlanda

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

30 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IE - Irlanda

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

90 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IS - Islanda

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira 3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IS - Islanda

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira 6 mg/ml

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IS - Islanda

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira 9 mg/ml

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2 |
| --- |
| 15067 Novi Ligure (AL) |

BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2 |
| --- |
| 15067 Novi Ligure (AL) |

BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

30 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2 |
| --- |
| 15067 Novi Ligure (AL) |

BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

60 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2 |
| --- |
| 15067 Novi Ligure (AL) |

BIOINDUSTRIA L.I.M. SpA Via de Ambrosiis, 2

15067 Novi Ligure (AL)

PAMIDRONATO BIOINDUSTRIA LIM

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| HIKMA ITALIA SpA Viale Certosa, 10 |
| --- |
| 27100 Pavia |

HIKMA ITALIA SpA Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

15 mg/5 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| HIKMA ITALIA SpA Viale Certosa, 10 |
| --- |
| 27100 Pavia |

HIKMA ITALIA SpA Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

30 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| HIKMA ITALIA SpA Viale Certosa, 10 |
| --- |
| 27100 Pavia |

HIKMA ITALIA SpA Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

60 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| HIKMA ITALIA SpA Viale Certosa, 10 |
| --- |
| 27100 Pavia |

HIKMA ITALIA SpA Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

90 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HIKMA Attenzione: E' Hospira

15 mg

Solutie injectabila

Intravenoasa

IT - Italia

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

IT - Italia

| NOVARTIS FARMA SpA Largo Umberto Boccioni, 2 |
| --- |
| 21040 Origgio (VA) |

NOVARTIS FARMA SpA Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

15 mg/5 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| NOVARTIS FARMA SpA Largo Umberto Boccioni, 2 |
| --- |
| 21040 Origgio (VA) |

NOVARTIS FARMA SpA Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

30 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| NOVARTIS FARMA SpA Largo Umberto Boccioni, 2 |
| --- |
| 21040 Origgio (VA) |

NOVARTIS FARMA SpA Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

60 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| NOVARTIS FARMA SpA Largo Umberto Boccioni, 2 |
| --- |
| 21040 Origgio (VA) |

NOVARTIS FARMA SpA Largo Umberto Boccioni, 2

21040 Origgio (VA)

AREDIA

90 mg/10 ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

IT - Italia

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

15 mg/5 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

30 mg/10 ml

Solutie perfuzabila

Intravenoasa

IT - Italia

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

60 mg/10 ml

Solutie perfuzabila

Uz intravenos

IT - Italia

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

90 mg/10 ml

Solutie perfuzabila

Uz intravenos

IT - Italia

| RATIOPHARM GMBH Graf Arco-strasse, 3 |
| --- |
| Ulm D-89070 |

RATIOPHARM GMBH Graf Arco-strasse, 3

Ulm D-89070

PAMIDRONATO RATIOPHARM

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

IT - Italia

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

PAMIDRONATO TEVA

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

IT - Italia

| CRINOS SpA Via Pavia, 6 |
| --- |
| 20136 Milano |

CRINOS SpA Via Pavia, 6

20136 Milano

AMIDROX

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

IT - Italia

| Actavis Itlay S.p.A. Via Luigi Pasteur, 10 |
| --- |
| 20014 Nerviano (MI) Italy |

Actavis Itlay S.p.A. Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

IT - Italia

| Actavis Itlay S.p.A. Via Luigi Pasteur, 10 |
| --- |
| 20014 Nerviano (MI) Italy |

Actavis Itlay S.p.A. Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

6 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

IT - Italia

| Actavis Itlay S.p.A. Via Luigi Pasteur, 10 |
| --- |
| 20014 Nerviano (MI) Italy |

Actavis Itlay S.p.A. Via Luigi Pasteur, 10

20014 Nerviano (MI) Italy

PAMIDRONATO ACTAVIS

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

| Torrex Chiesi -Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Viena, Austria |

Torrex Chiesi -Pharma

GmbH, Gonzagagasse

16/16, 1010 Viena, Austria

Pamitor

60 mg/4 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

| Torrex Chiesi -Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Viena, Austria |

Torrex Chiesi -Pharma

GmbH, Gonzagagasse

16/16, 1010 Viena, Austria

Pamitor

90 mg/6 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

| Torrex Chiesi -Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Viena, Austria |

Torrex Chiesi -Pharma

GmbH, Gonzagagasse

16/16, 1010 Viena, Austria

Pamitor

30 mg/2 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

| Torrex Chiesi -Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Viena, Austria |

Torrex Chiesi -Pharma

GmbH, Gonzagagasse

16/16, 1010 Viena, Austria

Pamitor

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium

Hospira

9 mg/ ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium

Hospira

6 mg/ ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LT - Lituania

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium

Hospira

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LU - Luxemburg

| NOVARTIS PHARMA GMBH |
| --- |
| 25, ROONSTRASSE |
| D 90429 NUERNBERG |

NOVARTIS PHARMA GMBH

25, ROONSTRASSE

D 90429 NUERNBERG

Aredia

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

LU - Luxemburg

| EUROGENERICS S.A ESPLANADE HEYSEL, B.22 |
| --- |
| B 1020 BRUXELLES |

EUROGENERICS S.A ESPLANADE HEYSEL, B.22

B 1020 BRUXELLES

Paminject

3 mg/ml

Solutie perfuzabila

Uz intravenos

LU - Luxemburg

| HOSPIRA BENELUX SPRL |
| --- |
| 63, RUE DE STALLE |
| B 1180 BRUXELLES |

HOSPIRA BENELUX SPRL

63, RUE DE STALLE

B 1180 BRUXELLES

Pamidronate

Disodique Hospira

3 mg/ml

Solutie perfuzabila

Uz intravenos

LU - Luxemburg

| HOSPIRA BENELUX SPRL |
| --- |
| 63, RUE DE STALLE |
| B 1180 BRUXELLES |

HOSPIRA BENELUX SPRL

63, RUE DE STALLE

B 1180 BRUXELLES

Pamidronate

Disodique Hospira

6 mg/ml

Solutie perfuzabila

Uz intravenos

LU - Luxemburg

| TEVA PHARMA BELGIUM S.A. |
| --- |
| 16, LAARSTRAAT |
| B 2610 WILRIJK |

TEVA PHARMA BELGIUM S.A.

16, LAARSTRAAT

B 2610 WILRIJK

Pamidrin

3 mg/ml

Solutie perfuzabila

Uz intravenos

LV - Latvia

| Torrex Chiesi Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Vienna, Austria |

Torrex Chiesi Pharma

GmbH, Gonzagagasse

16/16, 1010 Vienna, Austria

PAMITOR

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LV - Latvia

| Torrex Chiesi Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Vienna, Austria |

Torrex Chiesi Pharma

GmbH, Gonzagagasse

16/16, 1010 Vienna, Austria

PAMITOR

30 mg/2 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LV - Latvia

| Torrex Chiesi Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Vienna, Austria |

Torrex Chiesi Pharma

GmbH, Gonzagagasse

16/16, 1010 Vienna, Austria

PAMITOR

60 mg/4 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

LV - Latvia

| Torrex Chiesi Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Vienna, Austria |

Torrex Chiesi Pharma

GmbH, Gonzagagasse

16/16, 1010 Vienna, Austria

PAMITOR

90 mg/6 ml

Concentrat pentru solutie perfuzabila

Uz intravenos

MT - Malta

| Novartis Pharmaceuticals |
| --- |
| UK Limited |
| Frimley Business Park, Frimley, |
| Camberley, Surrey GU16 |
| 7SR England |

Novartis Pharmaceuticals

UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16

7SR England

Aredia

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

MT - Malta

| Novartis Pharmaceuticals |
| --- |
| UK Limited |
| Frimley Business Park, Frimley, |
| Camberley, Surrey GU16 |
| 7SR England |

Novartis Pharmaceuticals

UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16

7SR England

Aredia

30 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

MT - Malta

| Novartis Pharmaceuticals |
| --- |
| UK Limited |
| Frimley Business Park, Frimley, |
| Camberley, Surrey GU16 |
| 7SR England |

Novartis Pharmaceuticals

UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16

7SR England

Aredia

60 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

MT - Malta

| Novartis Pharmaceuticals |
| --- |
| UK Limited |
| Frimley Business Park, Frimley, |
| Camberley, Surrey GU16 |
| 7SR England |

Novartis Pharmaceuticals

UK Limited

Frimley Business Park, Frimley,

Camberley, Surrey GU16

7SR England

Aredia

90 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

NL - Olanda

| Nordic Pharma B.V. Tolweg 15 |
| --- |
| 3741 LM Baarn |
| Netherlands |

Nordic Pharma B.V. Tolweg 15

3741 LM Baarn

Netherlands

Pamidronaat dinatrium 15 mg

15 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Nordic Pharma B.V. Tolweg 15 |
| --- |
| 3741 LM Baarn |
| Netherlands |

Nordic Pharma B.V. Tolweg 15

3741 LM Baarn

Netherlands

Pamidronaat dinatrium 30 mg

30 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Nordic Pharma B.V. Tolweg 15 |
| --- |
| 3741 LM Baarn |
| Netherlands |

Nordic Pharma B.V. Tolweg 15

3741 LM Baarn

Netherlands

Pamidronaat dinatrium 60 mg

60 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Nordic Pharma B.V. Tolweg 15 |
| --- |
| 3741 LM Baarn |
| Netherlands |

Nordic Pharma B.V. Tolweg 15

3741 LM Baarn

Netherlands

Pamidronaat dinatrium 90 mg

90 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Pharmachemie B.V. Swensweg 5 |
| --- |
| 2031 GA Haarlem |
| Netherlands |

Pharmachemie B.V. Swensweg 5

2031 GA Haarlem

Netherlands

Pamidronaatdinatrium

3 mg/ml PCH

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| All-gen Pharmaceuticals & Generics B.V. |
| --- |
| Rouboslaan 32 |
| 2252 TR Voorschoten |
| Netherlands |

All-gen Pharmaceuticals & Generics B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pamidronaatdinatrium

Allgen 3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| All-gen Pharmaceuticals & Generics B.V. |
| --- |
| Rouboslaan 32 |
| 2252 TR Voorschoten |
| Netherlands |

All-gen Pharmaceuticals & Generics B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pamidronaatdinatrium

Allgen 6 mg/ml

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| All-gen Pharmaceuticals & Generics B.V. |
| --- |
| Rouboslaan 32 |
| 2252 TR Voorschoten |
| Netherlands |

All-gen Pharmaceuticals & Generics B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pamidronaatdinatrium

Allgen 9 mg/ml

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Hospira Benelux BVBA, Stallestraat 63 |
| --- |
| 1180 Brussel |
| Belgium |

Hospira Benelux BVBA, Stallestraat 63

1180 Brussel

Belgium

Pamidronaatdinatrium

Hospira 3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Hospira Benelux BVBA, Stallestraat 63 |
| --- |
| 1180 Brussel |
| Belgium |

Hospira Benelux BVBA, Stallestraat 63

1180 Brussel

Belgium

Pamidronaatdinatrium

Hospira 6 mg/ml

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Hospira Benelux BVBA, Stallestraat 63 |
| --- |
| 1180 Brussel |
| Belgium |

Hospira Benelux BVBA, Stallestraat 63

1180 Brussel

Belgium

Pamidronaatdinatrium

Hospira 9 mg/ml

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NL - Olanda

| Medac Gesellschaft für klinische Spezialpreparate mbH |
| --- |
| Fehlandtstr. 3 |
| 20354 Hamburg Germany |

Medac Gesellschaft für klinische Spezialpreparate mbH

Fehlandtstr. 3

20354 Hamburg Germany

Pamipro 3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NO - Norvegia

| Meda, postboks 194, 1371 |
| --- |
| Asker Norawy |

Meda, postboks 194, 1371

Asker Norawy

Pamidronat Meda

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NO - Norvegia

| Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 |
| --- |
| 3RW Warwickshire, Great |
| Britain |

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31

3RW Warwickshire, Great

Britain

Pamidronatdinatrium

Hospira

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NO - Norvegia

| Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 |
| --- |
| 3RW Warwickshire, Great |
| Britain |

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31

3RW Warwickshire, Great

Britain

Pamidronatdinatrium

Hospira

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

NO - Norvegia

| Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 |
| --- |
| 3RW Warwickshire, Great |
| Britain |

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31

3RW Warwickshire, Great

Britain

Pamidronatdinatrium

Hospira

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Hospira UK Limited |
| --- |
| Queensway, |
| CV31 3RW, Royal |
| Leamington Spa, Warwickshire, United Kingdom |

Hospira UK Limited

Queensway,

CV31 3RW, Royal

Leamington Spa, Warwickshire, United Kingdom

Pamisol 3 mg/ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Hospira UK Limited |
| --- |
| Queensway, |
| CV31 3RW, Royal |
| Leamington Spa, Warwickshire, United Kingdom |

Hospira UK Limited

Queensway,

CV31 3RW, Royal

Leamington Spa, Warwickshire, United Kingdom

Pamisol 6 mg/ml

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Farmacom Sp. z o.o. Mogilska 80 st. |
| --- |
| 31-546, Cracow, Poland |

Farmacom Sp. z o.o. Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

3 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Farmacom Sp. z o.o. Mogilska 80 st. |
| --- |
| 31-546, Cracow, Poland |

Farmacom Sp. z o.o. Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

6 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Farmacom Sp. z o.o. Mogilska 80 st. |
| --- |
| 31-546, Cracow, Poland |

Farmacom Sp. z o.o. Mogilska 80 st.

31-546, Cracow, Poland

Pamidia

9 mg

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| medac Gesellschaft fur klinische Specialpraparate mbH |
| --- |
| Theaterstrasse 6 |
| 22880 Wedel / Germany |

medac Gesellschaft fur klinische Specialpraparate mbH

Theaterstrasse 6

22880 Wedel / Germany

Pamidronat medac 3 mg / ml

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, |
| 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm,

89073, Germany

Pamidronat- ratiopharm

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| VIPHARM S.A. Przewoźników st.11 |
| --- |
| 03-691 Warsaw, Poland |

VIPHARM S.A. Przewoźników st.11

03-691 Warsaw, Poland

Pamifos-15

15 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| VIPHARM S.A. Przewoźników st.11 |
| --- |
| 03-691 Warsaw, Poland |

VIPHARM S.A. Przewoźników st.11

03-691 Warsaw, Poland

Pamifos-30

30 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| VIPHARM S.A. Przewoźników st.11 |
| --- |
| 03-691 Warsaw, Poland |

VIPHARM S.A. Przewoźników st.11

03-691 Warsaw, Poland

Pamifos-60

60 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| VIPHARM S.A. Przewoźników st.11 |
| --- |
| 03-691 Warsaw, Poland |

VIPHARM S.A. Przewoźników st.11

03-691 Warsaw, Poland

Pamifos-90

90 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| STADA Arzneimittel AG Stadastraße 2-18 |
| --- |
| 61118 Bad Vilbel, Germany |

STADA Arzneimittel AG Stadastraße 2-18

61118 Bad Vilbel, Germany

Pamistad

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Torrex Chiesi Pharma |
| --- |
| GmbH |
| Gonzagagasse 16/16, |
| A-1010 Vienna, Austria |

Torrex Chiesi Pharma

GmbH

Gonzagagasse 16/16,

A-1010 Vienna, Austria

Pamitor

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Novartis Pharma GmbH Roonstraße 25 |
| --- |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH Roonstraße 25

D-90429 Nürnberg, Germany

Aredia

60 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PL - Polonia

| Novartis Pharma GmbH Roonstraße 25 |
| --- |
| D-90429 Nürnberg, |
| Germany |

Novartis Pharma GmbH Roonstraße 25

D-90429 Nürnberg,

Germany

Aredia

90 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais |
| Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais

Portugal

Pamidran

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais |
| Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais

Portugal

Pamidran

6 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais |
| Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais

Portugal

Pamidran

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 15 mg Pó para perfusão

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 30 mg Pó para perfusão

30 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 90 mg Pó para perfusão

90 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 60 mg Pó para perfusão

60 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Teva Pharma - Produtos |
| --- |
| Farmacêuticos, Lda. |
| Edifício Cyprium, Av. 25 de Abril, 15, 2o F, |
| 2795-195 Linda-a-Velha Portugal |

Teva Pharma - Produtos

Farmacêuticos, Lda.

Edifício Cyprium, Av. 25 de Abril, 15, 2o F,

2795-195 Linda-a-Velha Portugal

Pamidronato Teva

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hikma Farmacêutica |
| --- |
| (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 |
| A/B - Fervença, 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica

(Portugal), S.A. Estrada do Rio da Mó, 8 - 8

A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hikma Farmacêutica |
| --- |
| (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 |
| A/B - Fervença, 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica

(Portugal), S.A. Estrada do Rio da Mó, 8 - 8

A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

6 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hikma Farmacêutica |
| --- |
| (Portugal), S.A. Estrada do Rio da Mó, 8 - 8 |
| A/B - Fervença, 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica

(Portugal), S.A. Estrada do Rio da Mó, 8 - 8

A/B - Fervença, 2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais Portugal

Pamidran

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais Portugal

Pamidran

6 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Hospira Portugal, Lda. Rua Amália Rodrigues, |
| --- |
| n.o 240, 2750-228 Cascais Portugal |

Hospira Portugal, Lda. Rua Amália Rodrigues,

n.o 240, 2750-228 Cascais Portugal

Pamidran

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 15 mg Pó para perfusão

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 30 mg Pó para perfusão

30 mg

Powder for solution for infusion

Intravenous use

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 90 mg Pó para perfusão

90 mg

Powder for solution for infusion

Intravenous use

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, |
| --- |
| 148-148 A, Manique de Baixo 2645-436 |
| Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta,

148-148 A, Manique de Baixo 2645-436

Alcabideche Portugal

Pamidronato Azevedos 60 mg Pó para perfusão

60 mg

Powder for solution for infusion

Intravenous use

PT - Portugalia

| Teva Pharma - Produtos |
| --- |
| Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de |
| Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal |

Teva Pharma - Produtos

Farmacêuticos, Lda. Edifício Cyprium, Av. 25 de

Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal

Pamidronato Teva

3 mg/ml

Concentrate for solution for infusion

Intravenous use

PT - Portugalia

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó, 8 - 8 A/B - Fervença, |
| 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - 8 A/B - Fervença,

2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

3 mg/ml

Concentrate for solution for infusion

Intravenous use

PT - Portugalia

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó, 8 - 8 A/B - Fervença, |
| 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - 8 A/B - Fervença,

2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

6 mg/ml

Concentrate for solution for infusion

Intravenous use

PT - Portugalia

| Hikma Farmacêutica (Portugal), S.A. |
| --- |
| Estrada do Rio da Mó, 8 - 8 A/B - Fervença, |
| 2705-906 Terrugem (SNT) Portugal |

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - 8 A/B - Fervença,

2705-906 Terrugem (SNT) Portugal

Pamidronato Hikma

9 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

RO - Romania

| NOVARTIS PHARMA GmbH Roonstrasse 25 |
| --- |
| D-90429 Nürnberg, Germany |

NOVARTIS PHARMA GmbH Roonstrasse 25

D-90429 Nürnberg, Germany

AREDIA 15 mg/ml powder and solvent for solution for infusion

15 mg/ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

RO - Romania

| TORREX CHIESI PHARMA GmbH Gonzagagasse |
| --- |
| 16/16, A-1010, Viena, Austria |

TORREX CHIESI PHARMA GmbH Gonzagagasse

16/16, A-1010, Viena, Austria

PAMIDRONAT TORREX

15 mg/ml powder for solution for infusion

15 mg/ml

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

RO - Romania

| DR. REDDY'S LABORATORIES |
| --- |
| Str. Av. Petre Crețu, nr.74, Sector 1, București, Romania |

DR. REDDY'S LABORATORIES

Str. Av. Petre Crețu, nr.74, Sector 1, București, Romania

PAMIRED 60 powder for solution for infusion

60 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

RO - Romania

| DR. REDDY'S LABORATORIES |
| --- |
| Str. Av. Petre Crețu, nr.74, Sector 1, București, Romania |

DR. REDDY'S LABORATORIES

Str. Av. Petre Crețu, nr.74, Sector 1, București, Romania

PAMIRED 30 powder for solution for infusion

30 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

SE - Suedia

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

Hospira UK Limited Queensway Royal Leamington Spa Warwickshire, CV31 3RW United Kingdom

Pamidronatdinatrium

Hospira

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| Meda AB |
| --- |
| 170 09 Solna |
| Sweden |

Meda AB

170 09 Solna

Sweden

Pamidronat Meda

15 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| Teva Sweden AB Box 1070 |
| --- |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB Box 1070

251 10 Helsingborg

Sweden

Pamidronat Teva

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| DE-61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

DE-61118 Bad Vilbel

Germany

Pamidrocell

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| BMM Pharma AB Blasieholmsgatan 2 |
| --- |
| 111 48 Stockholm |
| Sweden |

BMM Pharma AB Blasieholmsgatan 2

111 48 Stockholm

Sweden

Pamidronate BMM Pharma

3 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| BMM Pharma AB Blasieholmsgatan 2 |
| --- |
| 111 48 Stockholm |
| Sweden |

BMM Pharma AB Blasieholmsgatan 2

111 48 Stockholm

Sweden

Pamidronate BMM Pharma

6 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SE - Suedia

| BMM Pharma AB Blasieholmsgatan 2 |
| --- |
| 111 48 Stockholm |
| Sweden |

BMM Pharma AB Blasieholmsgatan 2

111 48 Stockholm

Sweden

Pamidronate BMM Pharma

9 mg/ml

Concentrat pentru solutie perfuzabila

Intravenoasa

SI - Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany

Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje

15 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

SI - Slovenia

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany

Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje

30 mg

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

SI - Slovenia

| Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 |
| --- |
| Ljubljana, Slovenia |

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000

Ljubljana, Slovenia

Pamitor 30 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

SI - Slovenia

| Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 |
| --- |
| Ljubljana, Slovenia |

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000

Ljubljana, Slovenia

Pamitor 60 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

SI - Slovenia

| Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 |
| --- |
| Ljubljana, Slovenia |

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000

Ljubljana, Slovenia

Pamitor 90 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

Pulbere si solvent pentru solutie perfuzabila

Uz intravenos

SK - Slovacia

| Torrex Chiesi -Pharma |
| --- |
| GmbH, Gonzagagasse |
| 16/16, 1010 Viena, Austria |

Torrex Chiesi -Pharma

GmbH, Gonzagagasse

16/16, 1010 Viena, Austria

Pamitor 15 mg/ml

15 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

SK - Slovacia

| medac GmbH Theaterstraße 6 |
| --- |
| D-22880 Wedel |
| Germany |

medac GmbH Theaterstraße 6

D-22880 Wedel

Germany

PAMIFOS

3 mg/ml

Concentrat pentru solutie perfuzabila

Uz intravenos

UK - Marea Britanie

| Novartis Pharmaceuticals |
| --- |
| UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK |

Novartis Pharmaceuticals

UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

15 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

| Novartis Pharmaceuticals |
| --- |
| UK Limited, Frimly Business |
| Park, Frimley, Camberley, Surrey, GU16 7SR, UK |

Novartis Pharmaceuticals

UK Limited, Frimly Business

Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

30 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

| Novartis Pharmaceuticals |
| --- |
| UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK |

Novartis Pharmaceuticals

UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

90 mg

Pulbere si solvent pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

3 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

6 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

9 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

3 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

6 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

UK - Marea Britanie

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

9 MG/ML

Concentrat pentru solutie perfuzabila

Intravenoasa

Produse medicamentoase care contin acid risedronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | sanofi-aventis GmbH ÖSTERREICH |
| SATURN Tower, Leonard- |
| Bernstein-Straße 10 |
| A-1220 Wien, Austria |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

AT - Austria

sanofi-aventis GmbH ÖSTERREICH

SATURN Tower, Leonard-

Bernstein-Straße 10

A-1220 Wien, Austria

Actonel Combi

Filmtabletten

35 mg (risedronate sodium) + 500 mg/400 UI

Comprimate filmate

orala

AT - Austria

| sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10 |
| --- |
| A-1220 Wien, Austria |

sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10

A-1220 Wien, Austria

Actonel einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10 |
| --- |
| A-1220 Wien, Austria |

sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 30 mg

Filmtabletten

30 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10 |
| --- |
| A-1220 Wien, Austria |

sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 5 mg

Filmtabletten

5 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10 |
| --- |
| A-1220 Wien, Austria |

sanofi-aventis GmbH SATURN Tower, Leonard- Bernstein-Straße 10

A-1220 Wien, Austria

Actonel 75 mg

Filmtabletten

75 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| Arcana Arzneimittel GmbH, Hütteldorfer Straße |
| --- |
| 299, A-1140 Wien, Austria |

Arcana Arzneimittel GmbH, Hütteldorfer Straße

299, A-1140 Wien, Austria

Risedronat Arcana einmal wöchentlich 35 mg - Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17, |
| --- |
| A-1020 Wien, Austria |

Hexal Pharma GmbH, Stella- Klein-Löw-Weg 17,

A-1020 Wien, Austria

Risedronat Hexal einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| 1A Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 Wien, |
| --- |
| Austria |

1A Pharma GmbH, Stella- Klein-Löw-Weg 17, A-1020 Wien,

Austria

Risedronat 1A Pharma einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| Ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |
| Austria |

Ratiopharm Arzneimittel

Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Austria

Risedronat-ratiopharm einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| Sandoz GmbH, Biochemiestraße 10 |
| --- |
| A-6250 Kundl, Austria |

Sandoz GmbH, Biochemiestraße 10

A-6250 Kundl, Austria

Risedronat Sandoz einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| Stada Arzneimittel GmbH Muthgasse 36 |
| --- |
| A-1190 Wien |
| Austria |

Stada Arzneimittel GmbH Muthgasse 36

A-1190 Wien

Austria

Risedronat STADA einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

AT - Austria

| TEVA Pharma B.V. Computerweg 10 |
| --- |
| 3542 DR Utrecht |
| Netherlands |

TEVA Pharma B.V. Computerweg 10

3542 DR Utrecht

Netherlands

Risedronat Teva 35 mg Filmtabletten

35 mg (risedronate sodium)

Comprimate filmate

orala

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

5 mg

Comprimate filmate

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

30 mg

Comprimate filmate

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

35 mg

Comprimate filmate

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

75 mg

Comprimate filmate

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel Combi

35 mg + 1 250 mg calcium

Comprimate filmate

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel Combi D

35 mg + 1 000 mg / 880 IU

Comprimate filmate si granule efervescente

Uz oral

BE - Belgia

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel Plus calcium D

35 mg + 500 mg / 400 UI

Comprimate filmate

Uz oral

BE - Belgia

| TEVA Pharma Belgium N.V, Laarstraat 16, |
| --- |
| B-2610 Wilrijk, Belgium |

TEVA Pharma Belgium N.V, Laarstraat 16,

B-2610 Wilrijk, Belgium

Risedronate Teva 35 mg filmomhulde tabletten

35 mg

Comprimate filmate

orala

BG - Bulgaria

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 |
| Bucharest, Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266

Bucharest, Romania

Juverital

5 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 |
| Bucharest, Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266

Bucharest, Romania

Juverital

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Sanofi-Aventis Bulgaria EOOD |
| --- |
| 103, blvd Al. Stamboliyski |
| Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria |

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria

ACTONEL 5 MG FILM- COATED TABLETS

5 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Sanofi-Aventis Bulgaria EOOD |
| --- |
| 103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria |

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria

ACTONEL 30 MG FILM- COATED TABLETS

30 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Sanofi-Aventis Bulgaria EOOD |
| --- |
| 103, blvd Al. Stamboliyski |
| Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria |

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski

Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria

ACTONEL ONCE A WEEK 35 MG FILM- COATED TABLETS

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Sanofi-Aventis Bulgaria EOOD |
| --- |
| 103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria |

Sanofi-Aventis Bulgaria EOOD

103, blvd Al. Stamboliyski Office Building Sofia Tower Level 8, 1303 Sofia Bulgaria

ACTONEL 75 MG FILM- COATED TABLETS

75 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| ZENTIVA, k.s. |
| --- |
| U kabelovny 130, Dolní |
| Měcholupy 102 37 Praga 10, Czech Republic |

ZENTIVA, k.s.

U kabelovny 130, Dolní

Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg

35 mg

Comprimate filmate

orala

BG - Bulgaria

ratiopharm GmbH, Graf- Arco-Strasse 3, 89079 Ulm, Germany

Risedronat-ratiopharm

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary |
| --- |
| IRELAND |

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary

IRELAND

RIGAT

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Stada Arzneimittel AG, Stadastrasse 2-18, 61118 |
| --- |
| Bad Vilbel,Germany |

Stada Arzneimittel AG, Stadastrasse 2-18, 61118

Bad Vilbel,Germany

Zilar

5 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Teva Pharmaceuticals |
| --- |
| N.V.Gogol 15 |
| ЕООД |
| Sofia |
| Bulgaria |

Teva Pharmaceuticals

N.V.Gogol 15

ЕООД

Sofia

Bulgaria

Rizida

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, |
| --- |
| Austria |

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz,

Austria

Risedronat Genericon

5 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, |
| --- |
| Austria |

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz,

Austria

Risedronat Genericon

30 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 |
| --- |
| Graz, Austria |

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054

Graz, Austria

Risedronat Genericon

35 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Actavis Group PTC ehf, |
| --- |
| Reykjavikurvegur 76-78, |
| 220 Hafnarjordur, Iceland |

Actavis Group PTC ehf,

Reykjavikurvegur 76-78,

220 Hafnarjordur, Iceland

Risadis

5 mg

Comprimate filmate

Uz oral

BG - Bulgaria

| Actavis Group PTC ehf, |
| --- |
| Reykjavikurvegur 76-78, |
| 220 Hafnarjordur, Iceland |

Actavis Group PTC ehf,

Reykjavikurvegur 76-78,

220 Hafnarjordur, Iceland

Risadis

35 mg

Comprimate filmate

Uz oral

CY - Cipru

| SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 |
| --- |
| STROVOLOS, CYPRUS |

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015

STROVOLOS, CYPRUS

ACTONEL TABLET 5 MG

5 MG

Comprimate

orala

CY - Cipru

| SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 |
| --- |
| STROVOLOS, CYPRUS |

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015

STROVOLOS, CYPRUS

ACTONEL OAW/"ONCE A WEEK" TABLETS

35 MG

35 MG

Comprimate

orala

CY - Cipru

| SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 |
| --- |
| STROVOLOS, CYPRUS |

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015

STROVOLOS, CYPRUS

ACTONEL (2

CONSEQUENTIAL DAYS PER MONTH)

75 MG

Comprimate

orala

CY - Cipru

| ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, |
| --- |
| 220 HAFNAFJORDUR, |
| ICELAND |

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78,

220 HAFNAFJORDUR,

ICELAND

BIFODRON TABLETS

5 MG

5 MG

Comprimate

orala

CY - Cipru

| ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, |
| --- |
| 220 HAFNAFJORDUR, ICELAND |

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78,

220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS

30 MG

30 MG

Comprimate

orala

CY - Cipru

| ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, |
| --- |
| 220 HAFNAFJORDUR, |
| ICELAND |

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78,

220 HAFNAFJORDUR,

ICELAND

BIFODRON TABLETS

35 MG

35 MG

Comprimate

orala

CY - Cipru

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 5 MG

5 MG

Comprimate

orala

CY - Cipru

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE

SODIUM TABLET 30 MG

30 MG

Comprimate

orala

CY - Cipru

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE

SODIUM TABLET 35 MG

35 MG

Comprimate

orala

CY - Cipru

| P T HADJIGEORGIOU CO LTD, 31 YILDIZ, P O |
| --- |
| BOX 53158, 3301 LEMESOS, CYPRUS |

P T HADJIGEORGIOU CO LTD, 31 YILDIZ, P O

BOX 53158, 3301 LEMESOS, CYPRUS

ATRONATE "ONCE A WEEK" TABLETS 35 MG

35 MG

Comprimate

orala

CY - Cipru

| PHARMATHEN SA, DERVENAKION 6, 15351 |
| --- |
| PALLINI ATTIKI, GREECE |

PHARMATHEN SA, DERVENAKION 6, 15351

PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS

5 MG

5 MG

Comprimate

orala

CY - Cipru

| PHARMATHEN SA, DERVENAKION 6, 15351 |
| --- |
| PALLINI ATTIKI, GREECE |

PHARMATHEN SA, DERVENAKION 6, 15351

PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS

30 MG

30 MG

Comprimate

orala

CY - Cipru

| PHARMATHEN SA, DERVENAKION 6, 15351 |
| --- |
| PALLINI ATTIKI, GREECE |

PHARMATHEN SA, DERVENAKION 6, 15351

PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS

35 MG

35 MG

Comprimate

orala

CY - Cipru

| Arrow Generics Limited, Unit |
| --- |
| 2 Eastman |
| Way,Hertfordshire, SG1 |
| 4SZ,Stevenage,UK |

Arrow Generics Limited, Unit

2 Eastman

Way,Hertfordshire, SG1

4SZ,Stevenage,UK

RISEDRONATE ARROW TABLETS 35 MG

35 MG

Comprimate

orala

CZ - Republica Ceha

| Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 |
| --- |
| Praha-Dejvice, |
| Czech Republic |

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00

Praha-Dejvice,

Czech Republic

Actonel 30 mg

30 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 |
| --- |
| Praha-Dejvice, |
| Czech Republic |

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00

Praha-Dejvice,

Czech Republic

Actonel 35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 |
| --- |
| Praha-Dejvice, |
| Czech Republic |

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00

Praha-Dejvice,

Czech Republic

Actonel 5 mg

5 mg

Comprimate filmate

orala

CZ - Republica Ceha

| S.C. LaborMed Pharma S.A., Bd. Theodor Pallady |
| --- |
| nr. 44B, sector 3, Bucharest, Romania |

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady

nr. 44B, sector 3, Bucharest, Romania

Juverital 35 mg potahované tablety

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| S.C. LaborMed Pharma S.A., Bd. Theodor Pallady |
| --- |
| nr. 44B, sector 3, Bucharest, Romania |

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady

nr. 44B, sector 3, Bucharest, Romania

Juverital 5 mg potahované tablety

5 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 |
| --- |
| Praha-Dejvice, Czech |
| Republic |

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00

Praha-Dejvice, Czech

Republic

Norsed 35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Galex d.d., Tišinska ul. 29g, |
| --- |
| 9000 Murska Sobota, Slovenia |

Galex d.d., Tišinska ul. 29g,

9000 Murska Sobota, Slovenia

Risedronat Galex

35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Galex d.d., Tišinska ul. 29g, |
| --- |
| 9000 Murska Sobota, Slovenia |

Galex d.d., Tišinska ul. 29g,

9000 Murska Sobota, Slovenia

Risedronat Galex 5 mg

5 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Generics Ltd., Mylan Albany Gate, Darkes Lane, Potters Bar |
| --- |
| Hertfordshire |
| EN6 1AG |
| United Kingdom |

Generics Ltd., Mylan Albany Gate, Darkes Lane, Potters Bar

Hertfordshire

EN6 1AG

United Kingdom

Risedronat Mylan

35 mg

5 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c |
| --- |
| 150 00 Praha 5 |
| Cezch Republic |

Teva Pharmaceuticals CR, s.r.o., Radlická 3185/1c

150 00 Praha 5

Cezch Republic

Risedronat Teva 35 mg

5 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Ratiopharm GmbH, Graf- Arco-Straße 3 |
| --- |
| 89079 Ulm, Germany |

Ratiopharm GmbH, Graf- Arco-Straße 3

89079 Ulm, Germany

Risedronat-Ratiopharm

35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| ZENTIVA, k.s. |
| --- |
| U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic |

ZENTIVA, k.s.

U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

Risendros 35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Inger s Industrial Solutions, s.r.o. , Slunná 271/16, |
| --- |
| 61700 Brno-Komárov, |
| Czech Republic |

Inger s Industrial Solutions, s.r.o. , Slunná 271/16,

61700 Brno-Komárov,

Czech Republic

Tevanel 35 mg

35 mg

Comprimate filmate

orala

CZ - Republica Ceha

| Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 |
| --- |
| Ksawerow, Poland |

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054

Ksawerow, Poland

NORIFAZ 35 MG POTAHOVANÉ TABLETY

35 mg

Comprimate filmate

Uz oral

DE - Germania

| ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 |
| --- |
| D-89150 Laichingen |

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Risedronat AL 35 mg

Filmtabletten

35 mg

Comprimate filmate

Uz oral

DE - Germania

| Stadapharm GmbH Stadastr. 2 - 18 |
| --- |
| D-61118 Bad Vilbel |

Stadapharm GmbH Stadastr. 2 - 18

D-61118 Bad Vilbel

Risedronat STADA 35 mg Filmtabletten

35 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 5 mg

Filmtabletten

5 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 30 mg

Filmtabletten

30 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 75 mg

Filmtabletten

75 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel einmal wöchentlich 35 mg Filmtabletten

35 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Norsed einmal wöchentlich 35 mg Filmtabletten

35 mg

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel 35 mg plus

Calcium Filmtabletten

35 mg +

1 250 mg calcium

Comprimate filmate

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel plus Calcium D

35 mg + 1 000 mg/880

I.E. Filmtabletten + Brausegranulat

35 mg

+1 000 mg /

800 IU

Comprimate filmate si granule efervescente

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Norsed plus Calcium D

35 mg + 1 000 mg/880

I.E. Filmtabletten + Brausegranulat

35 mg

+1 000 mg /

800 IU

Comprimate filmate si granule efervescente

Uz oral

DE - Germania

| Warner Chilcott Deutschland GmbH |
| --- |
| Dr.-Otto-Röhm-Str. 2 - 4 |
| D-64331 Weiterstadt |

Warner Chilcott Deutschland GmbH

Dr.-Otto-Röhm-Str. 2 - 4

D-64331 Weiterstadt

Actonel plus Calcium D

35 mg + 500 mg/400

I.E. Filmtabletten

35 mg

+ 500 mg / 400

IU

Comprimate filmate

Uz oral

DE - Germania

| Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 |
| --- |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50

D-90449 Nürnberg

Risedronat Heumann

35 mg Filmtabletten

40,17 mg

Comprimate filmate

Uz oral

DK - Danemarca

| Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Risostad

5 mg

Comprimate filmate

orala

DK - Danemarca

| Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Risostad

35 mg

Comprimate filmate

orala

DK - Danemarca

| Mylan AB, P.O.box 23033, Ynglingagatan 14, |
| --- |
| SE-104 35 Stockholm; |
| Sweden |

Mylan AB, P.O.box 23033, Ynglingagatan 14,

SE-104 35 Stockholm;

Sweden

Vionate

5 mg

Comprimate filmate

orala

DK - Danemarca

| Mylan AB, P.O.box 23033, Ynglingagatan 14, |
| --- |
| SE-104 35 Stockholm; |
| Sweden |

Mylan AB, P.O.box 23033, Ynglingagatan 14,

SE-104 35 Stockholm;

Sweden

Vionate

35 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Dimidronat

5 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Dimidronat

30 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Dimidronat

35 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Ellidronat

35 mg

Comprimate filmate

orala

DK - Danemarca

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 Bucharest, |
| Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266 Bucharest,

Romania

Juverital

5 mg

Comprimate filmate

Uz oral

DK - Danemarca

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 Bucharest, |
| Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266 Bucharest,

Romania

Juverital

35 mg

Comprimate filmate

Uz oral

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Karadronat

5 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Karadronat

30 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Karadronat

35 mg

Comprimate filmate

orala

DK - Danemarca

| ZaKlad Farmaceutyczny, Adamed Phama S.a, 33 |
| --- |
| Szkolna Street, PL-95054 |
| Ksawerów; Poland |

ZaKlad Farmaceutyczny, Adamed Phama S.a, 33

Szkolna Street, PL-95054

Ksawerów; Poland

Norifaz

35 mg

Comprimate filmate

orala

DK - Danemarca

| Sanofi-Aventis Denmark |
| --- |
| A/S, Slotsmarken 13, |
| DK-3970 Hørsholm, Denmark |

Sanofi-Aventis Denmark

A/S, Slotsmarken 13,

DK-3970 Hørsholm, Denmark

Optinate

5 mg

Comprimate filmate

orala

DK - Danemarca

| Sanofi-Aventis Denmark |
| --- |
| A/S, Slotsmarken 13, |
| DK-3970 Hørsholm, Denmark |

Sanofi-Aventis Denmark

A/S, Slotsmarken 13,

DK-3970 Hørsholm, Denmark

Optinate

30 mg

Comprimate filmate

orala

DK - Danemarca

| Sanofi-Aventis Denmark |
| --- |
| A/S, Slotsmarken 13, |
| DK-3970 Hørsholm, Denmark |

Sanofi-Aventis Denmark

A/S, Slotsmarken 13,

DK-3970 Hørsholm, Denmark

Optinate

75 mg

Comprimate filmate

orala

DK - Danemarca

| Sanofi-Aventis Denmark |
| --- |
| A/S, Slotsmarken 13, |
| DK-3970 Hørsholm, Denmark |

Sanofi-Aventis Denmark

A/S, Slotsmarken 13,

DK-3970 Hørsholm, Denmark

Optinate Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

DK - Danemarca

| Sanofi-Aventis Denmark |
| --- |
| A/S, Slotsmarken 13, |
| DK-3970 Hørsholm, Denmark |

Sanofi-Aventis Denmark

A/S, Slotsmarken 13,

DK-3970 Hørsholm, Denmark

Optinate Septimum

35 mg

Comprimate filmate

orala

DK - Danemarca

| CT Arzneimittel GmbH, Lengeder Str. 42A, |
| --- |
| DE-13407 Berlin, Germany |

CT Arzneimittel GmbH, Lengeder Str. 42A,

DE-13407 Berlin, Germany

Racidrix

35 mg

Comprimate filmate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Ridracid

35 mg

Comprimate filmate

orala

DK - Danemarca

| Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

Ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Rinon

35 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risdronostad

5 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risdronostad

30 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risdronostad

35 mg

Comprimate filmate

orala

DK - Danemarca

| Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi |
| --- |
| 76-78, IS-220 Hafnarfjördur, |
| Iceland |

Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi

76-78, IS-220 Hafnarfjördur,

Iceland

Risedronatnatrium

"Actavis"

35 mg

Comprimate filmate

orala

DK - Danemarca

| Orifarm Generics A/S, Energivej 15, DK-5260 |
| --- |
| Odense S., Denmark |

Orifarm Generics A/S, Energivej 15, DK-5260

Odense S., Denmark

Risedronatnatrium

"Orifarm"

5 mg

Comprimate filmate

orala

DK - Danemarca

| Orifarm Generics A/S, Energivej 15, DK-5260 |
| --- |
| Odense S., Denmark |

Orifarm Generics A/S, Energivej 15, DK-5260

Odense S., Denmark

Risedronatnatrium

"Orifarm"

30 mg

Comprimate filmate

orala

DK - Danemarca

| Orifarm Generics A/S, Energivej 15, DK-5260 |
| --- |
| Odense S., Denmark |

Orifarm Generics A/S, Energivej 15, DK-5260

Odense S., Denmark

Risedronatnatrium

"Orifarm"

35 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risedronatnatrium

"Stada"

5 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risedronatnatrium

"Stada"

30 mg

Comprimate filmate

orala

DK - Danemarca

| Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118 |
| --- |
| Bad Vilbel, Germany |

Stada Arzneimittel AG, Stadastrasse 2-8, DE-61118

Bad Vilbel, Germany

Risedronatnatrium

"Stada"

35 mg

Comprimate filmate

orala

DK - Danemarca

| Teva Denmark A/S, Parallelvej 10-12, DK-2800 |
| --- |
| Kongens Lyngby, Denmark |

Teva Denmark A/S, Parallelvej 10-12, DK-2800

Kongens Lyngby, Denmark

Risedronatnatrium

"Teva"

35 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Risepallin

5 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Risepallin

30 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., Dervenakion str. 6, |
| --- |
| GR-15351 Pallini Attiki, Greece |

Pharmathen S.A., Dervenakion str. 6,

GR-15351 Pallini Attiki, Greece

Risepallin

35 mg

Comprimate filmate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Riseratio

35 mg

Comprimate filmate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Risonat

35 mg

Comprimate filmate

orala

EL - Grecia

| SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 |
| --- |
| BUILDING A |
| KALITHEA 17674 |

SANOFI-AVENTIS AEBE SYNGROU AVENUE 348

BUILDING A

KALITHEA 17674

ACTONEL

5 MG/TAB

Comprimate filmate

orala

EL - Grecia

| SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 |
| --- |
| BUILDING A KALITHEA 17675 |

SANOFI-AVENTIS AEBE SYNGROU AVENUE 348

BUILDING A KALITHEA 17675

ACTONEL

30 MG/TAB

Comprimate filmate

orala

EL - Grecia

| SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 |
| --- |
| BUILDING A |
| KALITHEA 17676 |

SANOFI-AVENTIS AEBE SYNGROU AVENUE 348

BUILDING A

KALITHEA 17676

ACTONEL OAW

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 |
| --- |
| BUILDING A KALITHEA 17677 |

SANOFI-AVENTIS AEBE SYNGROU AVENUE 348

BUILDING A KALITHEA 17677

ACTONEL 2

CONSECUTIVE DAYS PER MONTH

75 MG/TAB

Comprimate filmate

orala

EL - Grecia

| SANOFI-AVENTIS AEBE SYNGROU AVENUE 348 |
| --- |
| BUILDING A |
| KALITHEA 17678 |

SANOFI-AVENTIS AEBE SYNGROU AVENUE 348

BUILDING A

KALITHEA 17678

RISEDRONATE / WINTHROP

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| ACTAVIS GROUP PTC EHF., ICELAND |
| --- |
| Reykjavikurvegur 76-78, |
| 220, Hafnarfjordur |
| Iceland |

ACTAVIS GROUP PTC EHF., ICELAND

Reykjavikurvegur 76-78,

220, Hafnarfjordur

Iceland

RISEDRONATE SODIUM / ACTAVIS

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| PNG GEROLYMATOS MEDICAL S.A. ASKLIPIOU 13 |
| --- |
| KRYONERI ATTIKIS 14568 |

PNG GEROLYMATOS MEDICAL S.A. ASKLIPIOU 13

KRYONERI ATTIKIS 14568

MOTIVUS

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| DELEGANT HOLDINGS LTD, CYPRUS |
| --- |
| AGIAS ELENIS 36 |
| COMMERCIAL CENTRE GALAXY 401 |
| NICOSIA 1061 |
| CYPRUS |

DELEGANT HOLDINGS LTD, CYPRUS

AGIAS ELENIS 36

COMMERCIAL CENTRE GALAXY 401

NICOSIA 1061

CYPRUS

RISELIB

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| S.J.A. PHARM Ltd |
| --- |
| ARKOLEON 11 |
| 10445 PATISSIA |

S.J.A. PHARM Ltd

ARKOLEON 11

10445 PATISSIA

DIFOSFON-S

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| ELPEN S.A. PHARMACEUTICAL INDUSTRY |
| --- |
| MARATHONOS AVENUE 95 |
| PIKERMI 190 09 |

ELPEN S.A. PHARMACEUTICAL INDUSTRY

MARATHONOS AVENUE 95

PIKERMI 190 09

BONDAPEN

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| AURORA PHARMACEUTICALS A.E. EVROU 4 & MESSINIAS 2 |
| --- |
| GERAKAS 15344 |

AURORA PHARMACEUTICALS A.E. EVROU 4 & MESSINIAS 2

GERAKAS 15344

BONMATE

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| GENERICS (U.K.) LTD - ENGLAND |
| --- |
| STATION CLOSE POTTERS |
| BAR HERTS EN6 1TL ENGLAND |

GENERICS (U.K.) LTD - ENGLAND

STATION CLOSE POTTERS

BAR HERTS EN6 1TL ENGLAND

RISEDRONATE / GENERICS

35 MG/TAB

Comprimate filmate

orala

EL - Grecia

| TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS Computerweg 10, |
| --- |
| 3542 DR, Utrecht, The Netherlands |

TEVA PHARMA B.V., UTRECHT, THE NETHERLANDS Computerweg 10,

3542 DR, Utrecht, The Netherlands

RISEDRONATE / TEVA

35 MG/TAB

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL 30 mg comprimidos recubiertos

30 mg

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL 5 mg comprimidos recubiertos

5 mg

Comprimate filmate

orala

ES - Spania

| Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl. |
| --- |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat |
| (Barcelona) Spain |

Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat

(Barcelona) Spain

ACREL 5 mg comprimidos recubiertos con película

5 mg

Comprimate filmate

orala

ES - Spania

| Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl. |
| --- |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat |
| (Barcelona) Spain |

Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat

(Barcelona) Spain

ACREL SEMANAL 35 mg comprimidos recubiertos con película

35 mg

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL SEMANAL 35 mg comprimidos recubiertos con

película

35 mg

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL 75 mg comprimidos recubiertos con película

75 mg

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

LOSENTRA SEMANAL

35 mg comprimidos recubiertos con película

35 mg

Comprimate filmate

orala

ES - Spania

| Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl. |
| --- |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat |
| (Barcelona) Spain |

Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat

(Barcelona) Spain

ACREL 75 mg comprimidos recubiertos con película

75 mg

Comprimate filmate

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL COMBI 35 mg comprimidos recubiertos con película + 1 000 mg/880 UI granulado efervescente

35 mg + 1 000 mg / 880 IU

Comprimate filmate

orala

ES - Spania

| Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl. |
| --- |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat |
| (Barcelona) Spain |

Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat

(Barcelona) Spain

ACRELCOMBI 35 mg comprimidos recubiertos con pelicula+1 000 mg/880

UI granulado efervescente

35 mg + 1 000 mg / 880 IU

Comprimate filmate si granule efervescente

orala

ES - Spania

| Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl. |
| --- |
| Plaça de la Pau s/n |
| 08940 Cornellà de Llobregat |
| (Barcelona) Spain |

Warner Chilcott Iberia, S.L. WTC Almeda Park, Ed. 1, 2a pl.

Plaça de la Pau s/n

08940 Cornellà de Llobregat

(Barcelona) Spain

ACREL COMBI 35 mg+

500 mg/400 UI

comprimidos recubiertos con

película

35 mg + 500 mg/400 UI

Comprimate filmate si granule efervescente

orala

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

ACTONEL COMBI 35 mg + 500 mg/400 UI comprimidos recubiertos con película

35 mg + 500 mg/400 UI

Comprimate filmate

orala

ES - Spania

QUALIGEN, S.L.Avda. Barcelona, 69 08970Sant Joan Despi, Spain

RISEDRONATO SEMANAL QUALIGEN

35 mg comprimidos recubiertos con

película

Comprimate filmate

orala

ES - Spania

| RATIOPHARM ESPAÑA, |
| --- |
| S.A .Avda. de Burgos, 16 D - 5a Planta 28036 Madrid |

RATIOPHARM ESPAÑA,

S.A .Avda. de Burgos, 16 D - 5a Planta 28036 Madrid

RISEDRONATO SEMANAL RATIOPHARM 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| MYLAN PHARMACEUTICALS, S.L. Plom 2-4, |
| --- |
| 5o Planta |
| 08038 Barcelona |

MYLAN PHARMACEUTICALS, S.L. Plom 2-4,

5o Planta

08038 Barcelona

RISEMYL SEMANAL 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania |
| --- |
| 4oIzq 28003 Madrid |

TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania

4oIzq 28003 Madrid

MIOSEN SEMANAL 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| HEXAL PHARMA GMBH Carlberger Gasse, |
| --- |
| 44 A-1235 Viena |

HEXAL PHARMA GMBH Carlberger Gasse,

44 A-1235 Viena

RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4 |
| --- |
| 28023 Aravaca (Madrid) |

SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, 4

28023 Aravaca (Madrid)

RISEDRONATO SEMANAL SANDOZ 35 mg comprimidos recubiertos con pelicula

Comprimate filmate

orala

ES - Spania

| 1A PHARMA GMBH Eduard |
| --- |
| Kittenberger Gasse, |
| 56 A-1235 Viena |

1A PHARMA GMBH Eduard

Kittenberger Gasse,

56 A-1235 Viena

RISEDRONATO SEMANAL SALUTAS 35 mg comprimidos recubiertos con

película

Comprimate filmate

orala

ES - Spania

| LABORATORIO STADA, S.L. Frederic Mompou, 5 |
| --- |
| 08960 Sant Just Desvern |

LABORATORIO STADA, S.L. Frederic Mompou, 5

08960 Sant Just Desvern

RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| KERN PHARMA, S.L. Venus, |
| --- |
| 72. Poligono Industrial |
| Colon II. 08228 Tarrasa |

KERN PHARMA, S.L. Venus,

72. Poligono Industrial

Colon II. 08228 Tarrasa

RISEDRONATO SEMANAL KERN PHARMA 35 mg comprimidos recubiertos con película

Comprimate filmate

orala

ES - Spania

| LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 |
| --- |
| 08007 Barcelona |

LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9

08007 Barcelona

RISEDRONATO SEMANAL RANBAXY 35 mg comprimidos recubiertos con

película

Comprimate filmate

orala

ES - Spania

| ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. Szkolna, 33 95-054 |
| --- |
| Ksawerow/Lodz |

ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. Szkolna, 33 95-054

Ksawerow/Lodz

NORIFAZ 35 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA

Comprimate filmate

orala

ET - Estonia

| Portfarma ehf |
| --- |
| Kollunarklettsvegur 2, 104 |
| Reykjavik |
| ICELAND |

Portfarma ehf

Kollunarklettsvegur 2, 104

Reykjavik

ICELAND

OSSINAT

5 mg

Comprimate filmate

Uz oral

ET - Estonia

| Portfarma ehf |
| --- |
| Kollunarklettsvegur 2, 104 |
| Reykjavik |
| ICELAND |

Portfarma ehf

Kollunarklettsvegur 2, 104

Reykjavik

ICELAND

OSSINAT

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 |
| --- |
| 11317 Tallinn |
| ESTONIA |

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn

ESTONIA

ACTONEL 35 MG OAW

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Zentiva, k.s. UKabelovny 130 |
| --- |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| CZECH REPUBLIC |

Zentiva, k.s. UKabelovny 130

Dolni Mecholupy

102 37 Prague 10

CZECH REPUBLIC

RISENDROS 35 MG

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| ICELAND |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

ICELAND

RISEDRONATE SODIUM ACTAVIS

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| ratiopharm GmbH Graf-Arco-Strasse 3 |
| --- |
| D-89079 Ulm |
| GERMANY |

ratiopharm GmbH Graf-Arco-Strasse 3

D-89079 Ulm

GERMANY

RIBIDRON

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 |
| --- |
| 11317 Tallinn |
| ESTONIA |

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn

ESTONIA

ACTONEL

75 mg

Comprimate filmate

Uz oral

ET - Estonia

| Zaklad Farmaceutyczny |
| --- |
| Adamed Pharma S.A. 33 |
| Szkolna Street, 95-054 |
| Ksawerow |
| POLAND |

Zaklad Farmaceutyczny

Adamed Pharma S.A. 33

Szkolna Street, 95-054

Ksawerow

POLAND

NORIFAZ

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Teva Pharma B.V. Computerweg 10 |
| --- |
| 3542 DR Utrecht |
| THE NETHERLANDS |

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

THE NETHERLANDS

RISONATE

35 mg

Comprimate filmate

Uz oral

ET - Estonia

| Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary |
| --- |
| IRELAND |

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary

IRELAND

RIGAT

35 mg

Comprimate filmate

Uz oral

FI - Finlanda

| sanofi-Aventis Oy, Huopalahdentie 24, PL 22, |
| --- |
| 00350 Helsinki, Finland |

sanofi-Aventis Oy, Huopalahdentie 24, PL 22,

00350 Helsinki, Finland

Optinate

30 mg

Comprimate filmate

orala

FI - Finlanda

| sanofi-Aventis Oy, Huopalahdentie 24, PL 22, |
| --- |
| 00350 Helsinki, Finland |

sanofi-Aventis Oy, Huopalahdentie 24, PL 22,

00350 Helsinki, Finland

Optinate

5 mg

Comprimate filmate

orala

FI - Finlanda

| sanofi-Aventis Oy, Huopalahdentie 24, PL 22, |
| --- |
| 00350 Helsinki, Finland |

sanofi-Aventis Oy, Huopalahdentie 24, PL 22,

00350 Helsinki, Finland

Optinate Combi D

35 mg + 1 000 mg / 880 IU

Comprimate filmate si granule efervescente

orala

FI - Finlanda

| sanofi-Aventis Oy, Huopalahdentie 24, PL 22, |
| --- |
| 00350 Helsinki, Finland |

sanofi-Aventis Oy, Huopalahdentie 24, PL 22,

00350 Helsinki, Finland

Optinate Septimum

35 mg

Comprimate filmate

orala

FI - Finlanda

| Ranbaxy (UK) Limited, Building 4, Chiswick Park, |
| --- |
| 566 Chiswick High Road, LONDON W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Limited, Building 4, Chiswick Park,

566 Chiswick High Road, LONDON W4 5YE,

United Kingdom

Risedronat Ranbaxy

35 mg

Comprimate filmate

orala

FI - Finlanda

| sanofi-Aventis Oy, Huopalahdentie 24, PL 22, |
| --- |
| 00350 Helsinki, Finland |

sanofi-Aventis Oy, Huopalahdentie 24, PL 22,

00350 Helsinki, Finland

Optinate

75 mg

Comprimate filmate

orala

FI - Finlanda

| Oy Leiras Finland Ab, PL |
| --- |
| 1406, 00101 Helsinki, Finland |

Oy Leiras Finland Ab, PL

1406, 00101 Helsinki, Finland

Riseos

35 mg

Comprimate filmate

orala

FI - Finlanda

ratiopharm GmbH, Graf- Arco-Strasse 3, 89079 Ulm, Germany

Riseratio

35 mg

Comprimate filmate

orala

FI - Finlanda

| Mylan AB, BOX 23033, |
| --- |
| 10435 STOCKHOLM, Sweden |

Mylan AB, BOX 23033,

10435 STOCKHOLM, Sweden

Vionate

35 mg

Comprimate filmate

orala

FI - Finlanda

| Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 |
| --- |
| HAFNARFJORDUR, Iceland |

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220

HAFNARFJORDUR, Iceland

Risedronat Actavis

35 mg

Comprimate filmate

orala

FI - Finlanda

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

30 mg

Comprimate filmate

orala

FI - Finlanda

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

35 mg

Comprimate filmate

orala

FI - Finlanda

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

5 mg

Comprimate filmate

orala

FI - Finlanda

| Sandoz A/S, C. F. Tietgens |
| --- |
| Boulevard 40, 5220 |
| ODENSE SØ, Denmark |

Sandoz A/S, C. F. Tietgens

Boulevard 40, 5220

ODENSE SØ, Denmark

Risedronat Sandoz

35 mg

Comprimate filmate

orala

FI - Finlanda

| Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 |
| --- |
| BAD VILBEL, Germany |

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118

BAD VILBEL, Germany

Risedronat Stada

35 mg

Comprimate filmate

orala

FI - Finlanda

| Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 |
| --- |
| BAD VILBEL, Germany |

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118

BAD VILBEL, Germany

Risedronat Stada

5 mg

Comprimate filmate

orala

FI - Finlanda

| TEVA Sweden AB, Järnvägsgatan 11, BOX |
| --- |
| 1070, 25110 |
| HELSINGBORG, Sweden |

TEVA Sweden AB, Järnvägsgatan 11, BOX

1070, 25110

HELSINGBORG, Sweden

Risedronat Teva

35 mg

Comprimate filmate

orala

FR - Franta

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

RISEDRONATE ALMUS

35 mg, comprimé pelliculé

35 mg

Comprimate

Uz oral

FR - Franta

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

RISEDRONATE BGR 35 mg, comprimé

pelliculé

35 mg

Comprimate

Uz oral

FR - Franta

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

RISEDRONATE RANBAXY 35 mg, comprimé pelliculé

35 mg

Comprimate

Uz oral

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

RISEDRONATE WINTHROP 35 mg, comprimé pelliculé

35 mg

Comprimate filmate

Uz oral

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

RISEDRONATE WINTHROP 75 mg, comprimé pelliculé

75 mg

Comprimate filmate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONEL 30 mg, comprimé pelliculé

30 mg

Comprimate filmate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONEL 35 mg, comprimé pelliculé

35 mg

Comprimate filmate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONEL 5 mg, comprimé pelliculé

5 mg

Comprimate filmate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONELCOMBI 35 mg + 1 000 mg/880

UI, comprimé pelliculé et granulés effervescents

35 mg + 1 000 mg/800 UI

Comprimate filmate si granule efervescente

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONEL 75 mg, comprimé pelliculé

75 mg

Comprimate

Uz oral

FR - Franta

| Warner Chilcott France |
| --- |
| Immeuble "Le Jean Monnet" |
| 11, Place des Vosges |
| 92061 Paris La Défense |
| Cedex |
| France |

Warner Chilcott France

Immeuble "Le Jean Monnet"

11, Place des Vosges

92061 Paris La Défense

Cedex

France

ACTONELCOMBI 35

mg + 500 mg/400 UI, comprimé pelliculé

35 mg + 500 mg/400 UI

Comprimate

Uz oral

HU - Ungaria

| sanofi-aventis zrt. Tó u. 1-5. |
| --- |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt. Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 5 mg filmtabletta

5,00 mg Risedronate sodium (equivalent to

4,64 mg

Risendronic acid)

Comprimate filmate

orala

HU - Ungaria

| sanofi-aventis zrt. Tó u. 1-5. |
| --- |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt. Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 35 mg filmtabletta

35,00 mg Risedronate sodium (equivalent to

32,5 mg

Risendronic acid)

Comprimate filmate

orala

HU - Ungaria

| sanofi-aventis zrt. Tó u. 1-5. |
| --- |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt. Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL TRIO 35 mg film- és rágótabletta

35,00 mg Risedronate sodium (equivalent to

69,6 mg Risendronic acid)

Comprimate filmate si comprimate masticabile

orala

HU - Ungaria

| sanofi-aventis zrt. Tó u. 1-5. |
| --- |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt. Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL TRIO 75 mg film- és rágótabletta

75,00 mg Risedronate sodium

(as Risendronic acid)

Comprimate filmate si comprimate masticabile

orala

HU - Ungaria

| Vera Pharma Kft. Rákos köz 22. |
| --- |
| 1028 Budapest |
| Hungary |

Vera Pharma Kft. Rákos köz 22.

1028 Budapest

Hungary

BONEACT 35 mg filmtabletta

35,00 mg Risedronate sodium

(as Risendronic acid)

Comprimate filmate

orala

HU - Ungaria

| Vera Pharma Kft. Rákos köz 22. |
| --- |
| 1028 Budapest |
| Hungary |

Vera Pharma Kft. Rákos köz 22.

1028 Budapest

Hungary

BONEACT 755 mg filmtabletta

75,00 mg Risedronate sodium

(as Risendronic acid)

Comprimate filmate

orala

HU - Ungaria

| Aramis Pharma Kft. Mester u. 28. III/5. |
| --- |
| 1095 Budapest |
| Hungary |

Aramis Pharma Kft. Mester u. 28. III/5.

1095 Budapest

Hungary

NORIFAZ Trio 35 mg film- és rágótabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate si comprimate masticabile

orala

HU - Ungaria

| Zentiva k.s. |
| --- |
| Dolny Mecholupy, U |
| kabelovny 130. |
| 10237 Prague 10. Czech Republic |

Zentiva k.s.

Dolny Mecholupy, U

kabelovny 130.

10237 Prague 10. Czech Republic

RISENDROS 35 mg filmtabletta

35,0 mg Risedronate sodium

Comprimate filmate

orala

HU - Ungaria

| Vera Pharma Kft. Rákos köz 22. |
| --- |
| 1028 Budapest |
| Hungary |

Vera Pharma Kft. Rákos köz 22.

1028 Budapest

Hungary

RISETACT 35 mg filmtabletta

35,0 mg Risedronate sodium

Comprimate filmate

orala

HU - Ungaria

| sanofi-aventis zrt. Tó u. 1-5. |
| --- |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt. Tó u. 1-5.

1045 Budapest

Hungary

ACTONEL 75 mg filmtabletta

75,00 mg Risedronate sodium (equal to Risendronic acid)

Comprimate filmate

orala

HU - Ungaria

| Ozone Laboratories BV |
| --- |
| 2 Martinus Nijhofflaan |
| 2624 ES Delft |
| Holland |

Ozone Laboratories BV

2 Martinus Nijhofflaan

2624 ES Delft

Holland

JUVERITAL 5 mg filmtabletta

5,0 mg Risedronate sodium (equivalent to

5,74 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| Ozone Laboratories BV |
| --- |
| 2 Martinus Nijhofflaan |
| 2624 ES Delft |
| Holland |

Ozone Laboratories BV

2 Martinus Nijhofflaan

2624 ES Delft

Holland

JUVERITAL 35 mg filmtabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg Risedronate sodium hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| Aramis Pharma Kft. Mester u. 28. III/5. |
| --- |
| 1095 Budapest |
| Hungary |

Aramis Pharma Kft. Mester u. 28. III/5.

1095 Budapest

Hungary

NORIFAZ 35 mg filmtabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| GALEX d.d. Tisinška ulica 29g |
| --- |
| 9000 Murska Sobota |
| Slovenia |

GALEX d.d. Tisinška ulica 29g

9000 Murska Sobota

Slovenia

RISEDRONAT GALEX

35 mg filmtabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| Actavis Group PTC ehf. Reykjavikurvegur 76-78. |
| --- |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf. Reykjavikurvegur 76-78.

220 Hafnarfjordur

Iceland

RISEDRONATE ACTAVIS 35 mg filmtabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg Risedronate sodium hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| Generics (UK) Ltd. |
| --- |
| Albany Gate, Darkes Lane, Potters bar |
| EN61AG Hertfordshire |
| UK |

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

RISEDRONATE GENERICS (UK) 5 mg filmtabletta

5,0 mg Risedronate sodium (equivalent to

5,74 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| Generics (UK) Ltd. |
| --- |
| Albany Gate, Darkes Lane, Potters bar |
| EN61AG Hertfordshire |
| UK |

Generics (UK) Ltd.

Albany Gate, Darkes Lane, Potters bar

EN61AG Hertfordshire

UK

RISEDRONATE GENERICS (UK) 35 mg filmtabletta

35,0 mg Risedronate sodium (equivalent to

40,17 mg

Risedronate sodium

hemipentahydrate

Comprimate filmate

orala

HU - Ungaria

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 Bucharest, |
| Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266 Bucharest,

Romania

Juverital

5 mg

Comprimate filmate

Uz oral

HU - Ungaria

| LABORMED-PHARMA S.A., Theodor Pallady |
| --- |
| Boulevard 44B, Sector 3, RO-032266 Bucharest, |
| Romania |

LABORMED-PHARMA S.A., Theodor Pallady

Boulevard 44B, Sector 3, RO-032266 Bucharest,

Romania

Juverital

35 mg

Comprimate filmate

Uz oral

IE - Irlanda

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |

Rowex Ltd

Bantry

Co. Cork

Ridate Once a Week

35 mg film-coated tablets

35 mg

Comprimate filmate

orala

IE - Irlanda

| TEVA Pharma B.V. Computerweg 10 |
| --- |
| 3542 DR Utrecht |
| The Netherlands |

TEVA Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Risonate Once Weekly

35 mg Film-Coated

Tablets.

35 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim BT40 2SH United Kingdom

Actonel 5 mg film coated tablets

5 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim |
| BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH United Kingdom

Actonel 30 mg film coated tablets

30 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim BT40 2SH United Kingdom

Actonel Once A Week

35 mg film-coated tablets

35 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim |
| BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH United Kingdom

Actonel 75 Milligram

Film Coated Tablets

75 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim BT40 2SH United Kingdom

Actonel Combi 35 mg +

500 mg film-coated tablets

35 mg + 1 250 mg calcium

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim |
| BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH United Kingdom

Actonel Plus Ca & D

35 mg film-coated tablet + 1 000 mg/800

IU Effervescent

Granules

35 mg +1 000 mg/880IU

Comprimate filmate si granule efervescente

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim |
| BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH United Kingdom

Actonel Plus Ca & D Tablet 35 mg and

500 mg/400 IU Film-Coated Tablets.

35 mg + (risedronate sodium) +

500 mg/400UI

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim BT40 2SH United Kingdom

Optinate Once a Week

35 mg Film-coated

Tablets

35 mg

Comprimate filmate

orala

IE - Irlanda

| Warner Chilcott UK Limited |
| --- |
| Old Belfast Road |
| Millbrook |
| Larne |
| County Antrim |
| BT40 2SH United Kingdom |

Warner Chilcott UK Limited

Old Belfast Road

Millbrook

Larne

County Antrim

BT40 2SH United Kingdom

Optinate 75 mg Film- coated Tablets

75 mg

Comprimate filmate

orala

IE - Irlanda

| Ranbaxy Ireland Ltd. Spafield, Cork Road, Cashel, Co. Tipperary |
| --- |
| Ranbaxy Ireland Ltd |

Ranbaxy Ireland Ltd. Spafield, Cork Road, Cashel, Co. Tipperary

Ranbaxy Ireland Ltd

Risedronate Sodium

35 mg Once A Week

Film-Coated Tablets

35 mg

Comprimate filmate

orala

IE - Irlanda

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Co. Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Co. Tipperary

Ireland

Risontel Once a week

35 mg film-coated tablets

35 mg

Comprimate filmate

orala

IE - Irlanda

| Actavis Group PTC ehf |
| --- |
| Reykjavíkurvegi 76-78, 220 |
| Hafnarfjordur, Iceland |
| Actavis Group PTC ehf |

Actavis Group PTC ehf

Reykjavíkurvegi 76-78, 220

Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium

Actavis 5 mg

film-coated tablets

5 mg

Comprimate filmate

orala

IE - Irlanda

| Actavis Group PTC ehf |
| --- |
| Reykjavíkurvegi 76-78, 220 |
| Hafnarfjordur, Iceland |
| Actavis Group PTC ehf |

Actavis Group PTC ehf

Reykjavíkurvegi 76-78, 220

Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium

Actavis 30 mg

film-coated tablets

30 mg

Comprimate filmate

orala

IE - Irlanda

| Actavis Group PTC ehf |
| --- |
| Reykjavíkurvegi 76-78, 220 |
| Hafnarfjordur, Iceland |
| Actavis Group PTC ehf |

Actavis Group PTC ehf

Reykjavíkurvegi 76-78, 220

Hafnarfjordur, Iceland

Actavis Group PTC ehf

Risedronate Sodium

Actavis 35 mg

film-coated tablets

35 mg

Comprimate filmate

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate

5 mg

Comprimate filmate

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate

30 mg

Comprimate filmate

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate

75 mg

Comprimate filmate

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate Combi D

35 mg and

1 000 mg/880

IU

Comprimate filmate si granule efervescente

orala

IS - Islanda

| Sanofi-aventis Norge AS, Strandveien 15 Box 133, |
| --- |
| 1325 Lysaker, Norway |

Sanofi-aventis Norge AS, Strandveien 15 Box 133,

1325 Lysaker, Norway

Optinate Septimum

35 mg

Comprimate filmate

orala

IS - Islanda

| Portfarma ehf., Borgartúni |
| --- |
| 26, 105 Reykjavík, Iceland |

Portfarma ehf., Borgartúni

26, 105 Reykjavík, Iceland

Risedronat Sodium

Portfarma

5 mg

Comprimate filmate

orala

IS - Islanda

Qualigen S.L., Avda. Barcelona 69 08970 , Sant Joan Despi, (Barcelona) Spain

Risedronat Qualigen

35 mg

Comprimate filmate

orala

IT - Italia

| GRUPPO LEPETIT Srl |
| --- |
| VIALE LUIGI BODIO, 37/B |
| 20158 Milano - Italy |

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano - Italy

OPTINATE

5 mg

Comprimate filmate

Uz oral

IT - Italia

| GRUPPO LEPETIT Srl |
| --- |
| VIALE LUIGI BODIO, 37/B |
| 20158 Milano - Italy |

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano - Italy

OPTINATE

30 mg

Comprimate filmate

Uz oral

IT - Italia

| GRUPPO LEPETIT Srl |
| --- |
| VIALE LUIGI BODIO, 37/B |
| 20158 Milano - Italy |

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano - Italy

OPTINATE

35 mg

Comprimate filmate

Uz oral

IT - Italia

| GRUPPO LEPETIT Srl |
| --- |
| VIALE LUIGI BODIO, 37/B |
| 20158 Milano - Italy |

GRUPPO LEPETIT Srl

VIALE LUIGI BODIO, 37/B

20158 Milano - Italy

OPTINATE

75 mg

Comprimate filmate

Uz oral

IT - Italia

| SANOFI-AVENTIS SpA Viale L. Bodio, 37/B |
| --- |
| 20158 Milano |

SANOFI-AVENTIS SpA Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop

5 mg compresse rivestite con film

5 mg

Comprimate filmate

Uz oral

IT - Italia

| SANOFI-AVENTIS SpA Viale L. Bodio, 37/B |
| --- |
| 20158 Milano |

SANOFI-AVENTIS SpA Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop

30 mg compresse rivestite con film

30 mg

Comprimate filmate

Uz oral

IT - Italia

| SANOFI-AVENTIS SpA Viale L. Bodio, 37/B |
| --- |
| 20158 Milano |

SANOFI-AVENTIS SpA Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop

35 mg compresse rivestite con film

35 mg

Comprimate filmate

Uz oral

IT - Italia

| SANOFI-AVENTIS SpA Viale L. Bodio, 37/B |
| --- |
| 20158 Milano |

SANOFI-AVENTIS SpA Viale L. Bodio, 37/B

20158 Milano

Risedronato Winthrop

75 mg compresse rivestite con film

75 mg

Comprimate filmate

Uz oral

IT - Italia

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

5 mg

Comprimate filmate

Uz oral

IT - Italia

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

30 mg

Comprimate filmate

Uz oral

IT - Italia

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

35 mg

Comprimate filmate

Uz oral

IT - Italia

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

75 mg

Comprimate filmate

Uz oral

IT - Italia

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTOCALCIO D3

35 mg + 1 000 mg/880 IU

Comprimate filmate si granule efervescente

Uz oral

IT - Italia

| SANOFI-AVENTIS SpA Viale L. Bodio, 37/B |
| --- |
| 20158 Milano |

SANOFI-AVENTIS SpA Viale L. Bodio, 37/B

20158 Milano

OPTICALCIO D3

35 mg + 1 000 mg/880 IU

Comprimate filmate si granule efervescente

Uz oral

LT - Lituania

| ZENTIVA, k.s., Ukabelovny |
| --- |
| 130 Dolní Měcholupy 102 |
| 37, Praha 10, Czechia |

ZENTIVA, k.s., Ukabelovny

130 Dolní Měcholupy 102

37, Praha 10, Czechia

Risendros

35 mg

Comprimate filmate

Uz oral

LT - Lituania

UAB „SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg

Comprimate filmate

Uz oral

LT - Lituania

UAB „SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

5 mg

Comprimate filmate

Uz oral

LT - Lituania

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Risonate

35 mg

Comprimate filmate

Uz oral

LT - Lituania

| Zakład Farmaceutyczny Adamed Pharma S.A, Ul. Szkolna 33, 95-054 |
| --- |
| Ksawerów, Poland |

Zakład Farmaceutyczny Adamed Pharma S.A, Ul. Szkolna 33, 95-054

Ksawerów, Poland

Norifaz

35 mg

Comprimate filmate

Uz oral

LT - Lituania

| Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Islandia |

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220

Hafnarfjordur, Islandia

Risedronate sodium

Actavis

35 mg

Comprimate filmate

Uz oral

LT - Lituania

UAB „SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

75 mg

Comprimate filmate

Uz oral

LT - Lituania

UAB „SANOFI-AVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg + 1 000 mg/880 IU

Comprimate filmate si granule efervescente

Uz oral

LT - Lituania

| ratiopharm GmbH, Graf- Arco-Strasse 3, Ulm |
| --- |
| D-89079, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, Ulm

D-89079, Germany

Ribidron

35 mg

Comprimate filmate

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

5 mg

Comprimate filmate

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

30 mg

Comprimate filmate

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel

75 mg

Comprimate filmate

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel Combi D

35 mg + 1 000 mg/880 IU

Comprimate filmate si granule efervescente

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel Combi

35 mg + 1 250 mg calcium

Comprimate filmate

Uz oral

LU - Luxemburg

| Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5 |
| --- |
| 1831 Diegem, Belgium |

Warner Chilcott Pharmaceuticals BVBA Pegasuslaan 5

1831 Diegem, Belgium

Actonel hebdomadaire

35 mg

Comprimate filmate

Uz oral

LV - Latvia

| Portfarma ehf, Köllunarklettsvegi 2, 104 |
| --- |
| Reykjavík, Iceland |

Portfarma ehf, Köllunarklettsvegi 2, 104

Reykjavík, Iceland

Risedronate sodium

Portfarma

5 mg

Comprimate filmate

Uz oral

LV - Latvia

| Portfarma ehf, Köllunarklettsvegi 2, 104 |
| --- |
| Reykjavík, Iceland |

Portfarma ehf, Köllunarklettsvegi 2, 104

Reykjavík, Iceland

Risedronate sodium

Portfarma

35 mg

Comprimate filmate

Uz oral

LV - Latvia

| Zentiva k.s., U kabelovny |
| --- |
| 130, Dolní Měcholupy, 102 |
| 37 Praha 10, Czech Republic |

Zentiva k.s., U kabelovny

130, Dolní Měcholupy, 102

37 Praha 10, Czech Republic

Risendros

35 mg

Comprimate filmate

Uz oral

LV - Latvia

sanofi-aventis Latvia SIA, Kr.Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel Combi

35 mg + 1 000 mg/880 IU

Comprimate filmate si granule efervescente granules

Uz oral

LV - Latvia

sanofi-aventis Latvia SIA, Kr.Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel OAW

35 mg

Comprimate filmate

Uz oral

LV - Latvia

| Vale Pharmaceuticals Ltd., |
| --- |
| 1B Gurtnafleur Business |
| Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland |

Vale Pharmaceuticals Ltd.,

1B Gurtnafleur Business

Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland

Rigat

35 mg

Comprimate filmate

Uz oral

LV - Latvia

ratiopharm GmbH, Graf- Arco-Str.3, 89079 Ulm, Germany

Ribidron

35 mg

Comprimate filmate

Uz oral

LV - Latvia

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Risonate

35 mg

Comprimate filmate

Uz oral

LV - Latvia

| Zakład Farmaceutyczny Adamed Pharma S.A., ul.Szkolna 33, 95-054 |
| --- |
| Ksawerow, Poland |

Zakład Farmaceutyczny Adamed Pharma S.A., ul.Szkolna 33, 95-054

Ksawerow, Poland

Norifaz

35 mg

Comprimate filmate

Uz oral

LV - Latvia

| Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220

Hafnarfjordur, Iceland

Risedronate Sodium

Actavis

35 mg

Comprimate filmate

Uz oral

LV - Latvia

sanofi-aventis Latvia SIA, Kr.Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel

75 mg

Comprimate filmate

Uz oral

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

5 mg

Comprimate filmate

orala

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

30 mg

Comprimate filmate

orala

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Once a Week

35 mg

Comprimate filmate

orala

MT - Malta

| Beacon Pharmaceuticals Ltd |
| --- |
| 85 High Street |
| Tunbridge Wells |
| TN1 1YG |
| United Kingdom |

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

TN1 1YG

United Kingdom

Risedronate 5 mg film coated tablets

5 mg

Comprimate

orala

MT - Malta

| Beacon Pharmaceuticals Ltd |
| --- |
| 85 High Street Tunbridge Wells TN1 1YG |
| United Kingdom |

Beacon Pharmaceuticals Ltd

85 High Street Tunbridge Wells TN1 1YG

United Kingdom

Risedronate 30 mg film coated tablets

30 mg

Comprimate

orala

MT - Malta

| Beacon Pharmaceuticals Ltd |
| --- |
| 85 High Street |
| Tunbridge Wells |
| TN1 1YG |
| United Kingdom |

Beacon Pharmaceuticals Ltd

85 High Street

Tunbridge Wells

TN1 1YG

United Kingdom

Risedronate 35 mg film coated tablets

35 mg

Comprimate

orala

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

75 mg

Comprimate filmate

orala

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Plus Ca & D

35 mg + 1 000 mg/880IU

Comprimate filmate si granule efervescente

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actokit D, combinatieverpakking

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actonel® 30 mg, filmomhulde tabletten

30 mg

Comprimate filmate

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actonel® 5 mg, filmomhulde tabletten

5 mg

Comprimate filmate

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actonel® Wekelijks 35 mg, filmomhulde tabletten

35 mg

Comprimate filmate

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actokit

35 mg + 1 250 mg calcium

Comprimate filmate

Uz oral

NL - Olanda

| Ranbaxy Belgium NV Leuvensestraat 28b |
| --- |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV Leuvensestraat 28b

1800 Vilvoorde Belgium

Natriumrisedronaat 35 mg Ranbaxy

35 mg

Comprimate filmate

orala

NL - Olanda

| Ceft Limited |
| --- |
| 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium |

Ceft Limited

65 Delamere Road, Hayes Middlesex UB4 0NN Belgium

Natriumrisedronaat

Ceft 30 mg

30 mg

Comprimate filmate

orala

NL - Olanda

| Ceft Limited |
| --- |
| 65 Delamere Road, Hayes |
| Middlesex UB4 0NN Belgium |

Ceft Limited

65 Delamere Road, Hayes

Middlesex UB4 0NN Belgium

Natriumrisedronaat

Ceft 35 mg

35 mg

Comprimate filmate

orala

NL - Olanda

| Ceft Limited |
| --- |
| 65 Delamere Road, Hayes Middlesex UB4 0NN Belgium |

Ceft Limited

65 Delamere Road, Hayes Middlesex UB4 0NN Belgium

Natriumrisedronaat

Ceft 5 mg

5 mg

Comprimate filmate

orala

NL - Olanda

| Sandoz B.V., Veluwezoom 22 |
| --- |
| 1327 AH Almere |
| Netherlands |

Sandoz B.V., Veluwezoom 22

1327 AH Almere

Netherlands

Natriumrisedronaat Sandoz® wekelijks 35 mg

35 mg

Comprimate filmate

orala

NL - Olanda

| Centrafarm Services B.V. Nieuwe Donk 9 |
| --- |
| 47879 AC Etten-Leur |
| Netherlands |

Centrafarm Services B.V. Nieuwe Donk 9

47879 AC Etten-Leur

Netherlands

Risedronaatnatrium CF

30 mg

30 mg

Comprimate filmate

orala

NL - Olanda

| Centrafarm Services B.V. Nieuwe Donk 9 |
| --- |
| 47879 AC Etten-Leur |
| Netherlands |

Centrafarm Services B.V. Nieuwe Donk 9

47879 AC Etten-Leur

Netherlands

Risedronaatnatrium CF

wekelijks 35 mg

35 mg

Comprimate filmate

orala

NL - Olanda

| Centrafarm Services B.V. Nieuwe Donk 9 |
| --- |
| 47879 AC Etten-Leur |
| Netherlands |

Centrafarm Services B.V. Nieuwe Donk 9

47879 AC Etten-Leur

Netherlands

Risedronaatnatrium CF

5 mg

5 mg

Comprimate filmate

orala

NL - Olanda

| Mylan B.V. Dieselweg 25 |
| --- |
| 3752 LB Bunschoten |
| Netherlands |

Mylan B.V. Dieselweg 25

3752 LB Bunschoten

Netherlands

Risedronaatnatrium

Mylan 5 mg

5 mg

Comprimate filmate

orala

NL - Olanda

| Mylan B.V. Dieselweg 25 |
| --- |
| 3752 LB Bunschoten |
| Netherlands |

Mylan B.V. Dieselweg 25

3752 LB Bunschoten

Netherlands

Risedronaatnatrium

Mylan Wekelijks 35 mg

35 mg

Comprimate filmate

orala

NL - Olanda

| Pharmachemie B.V. Swensweg 5 |
| --- |
| 2031 GA Haarlem |
| Netherlands |

Pharmachemie B.V. Swensweg 5

2031 GA Haarlem

Netherlands

Risedronaatnatrium

Wekelijks 35 mg PCH

35 mg

Comprimate filmate

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

ActoCalD tabletten

35 mg + 500 mg / 400

IE filmomhulde tabletten,

combinatieverpakking

35 mg + 500 mg / 400 IE

Comprimate filmate

orala

NL - Olanda

| Warner Chilcott Nederland BV |
| --- |
| Lichtenauerlaan 102-120 |
| 3062 ME Rotterdam |
| Netherlands |

Warner Chilcott Nederland BV

Lichtenauerlaan 102-120

3062 ME Rotterdam

Netherlands

Actonel® 75 mg, filmomhulde tabletten

75 mg

Comprimate filmate

orala

NO - Norvegia

| Sanofi-aventis, Strandveien |
| --- |
| 15, 1366 Lysaker Norway |

Sanofi-aventis, Strandveien

15, 1366 Lysaker Norway

Optinate

5 mg

Comprimate filmate

orala

NO - Norvegia

| Sanofi-aventis, Strandveien |
| --- |
| 15, 1366 Lysaker Norway |

Sanofi-aventis, Strandveien

15, 1366 Lysaker Norway

Optinate

30 mg

Comprimate filmate

orala

NO - Norvegia

| Sanofi-aventis, Strandveien |
| --- |
| 15, 1366 Lysaker Norway |

Sanofi-aventis, Strandveien

15, 1366 Lysaker Norway

Optinate Septimum

35 mg

Comprimate filmate

orala

NO - Norvegia

| Orifarm Energivej 15, POB |
| --- |
| 69, DK-5260 Odense S Danmark |

Orifarm Energivej 15, POB

69, DK-5260 Odense S Danmark

Risedronat Orifarm

5 mg

Comprimate filmate

orala

NO - Norvegia

| Orifarm Energivej 15, POB |
| --- |
| 69, DK-5260 Odense S Danmark |

Orifarm Energivej 15, POB

69, DK-5260 Odense S Danmark

Risedronat Orifarm

30 mg

Comprimate filmate

orala

NO - Norvegia

| Orifarm Energivej 15, POB |
| --- |
| 69, DK-5260 Odense S Danmark |

Orifarm Energivej 15, POB

69, DK-5260 Odense S Danmark

Risedronat Orifarm

35 mg

Comprimate filmate

orala

NO - Norvegia

| Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 |
| --- |
| Ksawerow, Poland |

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054

Ksawerow, Poland

Norifaz

35 mg

Comprimate filmate

orala

NO - Norvegia

| Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 |
| --- |
| Hafnarfjordur, Iceland |

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220

Hafnarfjordur, Iceland

Risedronat Actavis

35 mg

Comprimate filmate

orala

NO - Norvegia

| Teva Sweden AB, Box 1070, |
| --- |
| 25110 Helsingborg, Sweden |

Teva Sweden AB, Box 1070,

25110 Helsingborg, Sweden

Risedronat Teva

35 mg

Comprimate filmate

orala

NO - Norvegia

| Mylan AB, Box 23033, |
| --- |
| 10435 Stockholm, Sweden |

Mylan AB, Box 23033,

10435 Stockholm, Sweden

Vionate

35 mg

Comprimate filmate

orala

PL - Polonia

| Sanofi-Aventis AB Gustavslundsvägen 139 |
| --- |
| Box 14142 |
| 167 14 BROMMA, Sweden |

Sanofi-Aventis AB Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

5 mg

Comprimate filmate

orala

PL - Polonia

| Ranbaxy (Poland) Sp. z o.o. Kubickiego st. 11, |
| --- |
| 02-954 Warsaw, Poland |

Ranbaxy (Poland) Sp. z o.o. Kubickiego st. 11,

02-954 Warsaw, Poland

Resorpate

35 mg

Comprimate filmate

orala

PL - Polonia

| Sanofi-Aventis AB Gustavslundsvägen 139 |
| --- |
| Box 14142 |
| 167 14 BROMMA, Sweden |

Sanofi-Aventis AB Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

30 mg

Comprimate filmate

orala

PL - Polonia

| Sanofi-Aventis AB Gustavslundsvägen 139 |
| --- |
| Box 14142 |
| 167 14 BROMMA, Sweden |

Sanofi-Aventis AB Gustavslundsvägen 139

Box 14142

167 14 BROMMA, Sweden

Actonel

35 mg

Comprimate filmate

orala

PL - Polonia

| ZENTIVA, k.s. |
| --- |
| U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic |

ZENTIVA, k.s.

U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

Risendros 35

35 mg

Comprimate filmate

orala

PL - Polonia

| Actavis Group PTC ehf. Reykjavikurvegi 76-78 |
| --- |
| 220 Hafnarfirdi, Iceland |

Actavis Group PTC ehf. Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Bifodron

35 mg

Comprimate filmate

orala

PL - Polonia

| Teva Pharmaceuticals Polska |
| --- |
| Sp. z o.o. |
| 53 Emilii Plater St., |
| 00-113, Warsaw, Poland |

Teva Pharmaceuticals Polska

Sp. z o.o.

53 Emilii Plater St.,

00-113, Warsaw, Poland

Nofemix

35 mg

Comprimate filmate

orala

PL - Polonia

| Zakład Farmaceutyczny Adamed Pharma S.A. Szkolna st. 33, |
| --- |
| 95-054 Ksawerów, Poland |

Zakład Farmaceutyczny Adamed Pharma S.A. Szkolna st. 33,

95-054 Ksawerów, Poland

Norifaz

35 mg

Comprimate filmate

orala

PL - Polonia

| Vale Pharmaceuticals Ltd |
| --- |
| 1G Gurtnafleur Business |
| Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland |

Vale Pharmaceuticals Ltd

1G Gurtnafleur Business

Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland

Rigat

35 mg

Comprimate filmate

orala

PL - Polonia

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, |
| 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm,

89073, Germany

Risedronat-ratiopharm

35 mg

Comprimate filmate

orala

PL - Polonia

| Labormed Pharma S.A. Bd. Theodor Pallady nr. |
| --- |
| 44B, sector 3, Bucharest, |
| Romania |

Labormed Pharma S.A. Bd. Theodor Pallady nr.

44B, sector 3, Bucharest,

Romania

Juverital

5 mg

Comprimate filmate

orala

PL - Polonia

| Labormed Pharma S.A. Bd. Theodor Pallady nr. |
| --- |
| 44B, sector 3, Bucharest, Romania |

Labormed Pharma S.A. Bd. Theodor Pallady nr.

44B, sector 3, Bucharest, Romania

Juverital

35 mg

Comprimate filmate

orala

PL - Polonia

| Galex d.d. Tišinska ul. 29g, |
| --- |
| 9000 Murska Sobota, |
| Slovenia |

Galex d.d. Tišinska ul. 29g,

9000 Murska Sobota,

Slovenia

Risedrolex 35 mg

35 mg

Comprimate filmate

orala

PT - Portugalia

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, |
| --- |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o,

2740-244 Porto Salvo

Portugal

Actonel

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, |
| --- |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o,

2740-244 Porto Salvo

Portugal

Actonel

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, |
| --- |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o,

2740-244 Porto Salvo

Portugal

Actonel 35 mg

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, |
| --- |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o,

2740-244 Porto Salvo

Portugal

Norsed

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Risedronato de sódio

Generis

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Risedronato de sódio

Generis

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Risedronato de sódio

Generis

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. |
| --- |
| Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo |
| Portugal |

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.

Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo

Portugal

Risedronato de sódio

Mepha

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Bluepharma Genéricos - Comércio de Medicamentos, S.A. |
| --- |
| São Martinho do Bispo, |
| 3045-016 Coimbra |
| Portugal |

Bluepharma Genéricos - Comércio de Medicamentos, S.A.

São Martinho do Bispo,

3045-016 Coimbra

Portugal

Risedronato de sódio

Bluepharma

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, |
| --- |
| 1495-139 Miraflores - Algés |
| Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31,

1495-139 Miraflores - Algés

Portugal

Risedronato de sódio

Pharmakern

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova, |
| --- |
| 2700-451 Amadora |
| Portugal |

GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova,

2700-451 Amadora

Portugal

Risedronato de sódio

GP

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira, |
| --- |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira,

2710-089 Sintra

Portugal

Risedronato de sódio

Farmoz

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto, |
| 2830 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto,

2830 Coina

Portugal

Risedronato de sódio

Alter

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto, |
| 2830 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto,

2830 Coina

Portugal

Risedronato de sódio

Alter

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio

Alter

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Rua do Campo Alegre, |
| 1306, 3o - Sala 301/302 - Edifício Botânico, |
| 4150-174 Porto Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Rua do Campo Alegre,

1306, 3o - Sala 301/302 - Edifício Botânico,

4150-174 Porto Portugal

Risedronato de sódio

Ranbaxy

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Av. dos Bombeiros |
| Voluntários, no 146 - 1o, |
| 2765-201 Estoril Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda.

Av. dos Bombeiros

Voluntários, no 146 - 1o,

2765-201 Estoril Portugal

Risedronato de sódio

Riseflore

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, |
| --- |
| 84-B, 1549-005 Lisboa Portugal |

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo,

84-B, 1549-005 Lisboa Portugal

Risedronato de sódio

Medilusa

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3, |
| --- |
| 1600-875 Lisboa Portugal |

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3,

1600-875 Lisboa Portugal

Risedronato de sódio

Rizat

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. Zona Industrial do Lagedo, |
| 3465-157 Santiago de Besteiros Portugal |

Labesfal - Laboratórios

Almiro, S.A. Zona Industrial do Lagedo,

3465-157 Santiago de Besteiros Portugal

Risedronato de sódio

Labesfal

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Cinfa Portugal, Lda. |
| --- |
| Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark, |
| 2790-221 Carnaxide Portugal |

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark,

2790-221 Carnaxide Portugal

Risedronato de sódio

Cinfa

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, |
| --- |
| 2600-726 Castanheira do Ribatejo Portugal |

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Atral

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, |
| --- |
| 2600-726 Castanheira do Ribatejo Portugal |

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Atral

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, |
| --- |
| 2600-726 Castanheira do Ribatejo Portugal |

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Atral

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Vida - Produtos Farmacêuticos, S.A. |
| --- |
| Rua da Estação, 42 - Vala do Carregado, |
| 2600-726 Castanheira do Ribatejo Portugal |

Vida - Produtos Farmacêuticos, S.A.

Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Vida

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Vida - Produtos Farmacêuticos, S.A. |
| --- |
| Rua da Estação, 42 - Vala do Carregado, |
| 2600-726 Castanheira do Ribatejo Portugal |

Vida - Produtos Farmacêuticos, S.A.

Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Vida

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Vida - Produtos Farmacêuticos, S.A. |
| --- |
| Rua da Estação, 42 - Vala do Carregado, |
| 2600-726 Castanheira do Ribatejo Portugal |

Vida - Produtos Farmacêuticos, S.A.

Rua da Estação, 42 - Vala do Carregado,

2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio

Vida

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Decomed Farmacêutica, S.A. |
| --- |
| Rua Sebastião e Silva, 56, |
| 2745-838 Massamá Portugal |

Decomed Farmacêutica, S.A.

Rua Sebastião e Silva, 56,

2745-838 Massamá Portugal

Zectoel

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Decomed Farmacêutica, S.A. |
| --- |
| Rua Sebastião e Silva, 56, |
| 2745-838 Massamá Portugal |

Decomed Farmacêutica, S.A.

Rua Sebastião e Silva, 56,

2745-838 Massamá Portugal

Zectoel

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Decomed Farmacêutica, S.A. |
| --- |
| Rua Sebastião e Silva, 56, |
| 2745-838 Massamá Portugal |

Decomed Farmacêutica, S.A.

Rua Sebastião e Silva, 56,

2745-838 Massamá Portugal

Zectoel

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto |
| --- |
| 2790-012 Portela de Carnaxide Portugal |

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto

2790-012 Portela de Carnaxide Portugal

Risedronato de sódio

Germed

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto |
| --- |
| 2790-012 Portela de Carnaxide Portugal |

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto

2790-012 Portela de Carnaxide Portugal

Risedronato de sódio

Germed

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto |
| --- |
| 2790-012 Portela de Carnaxide Portugal |

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto

2790-012 Portela de Carnaxide Portugal

Risedronato de sódio

Germed

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, |
| --- |
| 2740-244 Porto Salvo Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o,

2740-244 Porto Salvo Portugal

Actonel

75 mg

Comprimate filmate

Uz oral

PT - Portugalia

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Risedronato de sódio Actavis

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 |
| --- |
| A, Manique de Baixo 2645-436 Alcabideche Portugal |

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148

A, Manique de Baixo 2645-436 Alcabideche Portugal

Norifaz

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso, 2790-143 Carnaxide Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso, 2790-143 Carnaxide Portugal

Risedronato de sódio

Ratiopharm

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque |
| 1, R/C Esqo, 1499-016 Algés Portugal |

Mylan, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque

1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio

Mylan

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque |
| 1, R/C Esqo, 1499-016 Algés Portugal |

Mylan, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque

1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio

Mylan

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Qualigen, S.L. |
| --- |
| Avenida Barcelona, 69, Sant |
| Joan Despí, 08970 Barcelona Espanha |

Qualigen, S.L.

Avenida Barcelona, 69, Sant

Joan Despí, 08970 Barcelona Espanha

Risedronato de sódio

Qualigen

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Teva Pharma - Produtos |
| --- |
| Farmacêuticos, Lda. |
| Edifício Cyprium, Av. 25 de |
| Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal |

Teva Pharma - Produtos

Farmacêuticos, Lda.

Edifício Cyprium, Av. 25 de

Abril, 15, 2o F, 2795-195 Linda-a-Velha Portugal

Risedronato de sódio

Teva

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício |
| --- |
| 1, 2o - Escritório 15, 2710-693 Sintra Portugal |

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício

1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio

Sandoz

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício |
| --- |
| 1, 2o - Escritório 15, 2710-693 Sintra Portugal |

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício

1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio

1APharma

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor |
| Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, |
| 2770-229 Paço de Arcos Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor

Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B,

2770-229 Paço de Arcos Portugal

Risedronato de sódio

Ciclum

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, |
| 2770-229 Paço de Arcos Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B,

2770-229 Paço de Arcos Portugal

Risedronato de sódio

Ciclum

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

5 mg

Comprimate filmate

Uz oral

PT - Portugalia

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

30 mg

Comprimate filmate

Uz oral

PT - Portugalia

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

35 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Arrow Generics, Ltd. |
| --- |
| Unit 2 - Eastman Way, SG1 |
| 4SZ Stevenage - Hertfordshire |
| Reino Unido |

Arrow Generics, Ltd.

Unit 2 - Eastman Way, SG1

4SZ Stevenage - Hertfordshire

Reino Unido

Risedronato de sódio

Arrow

35 mg

Comprimate

Uz oral

PT - Portugalia

| Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 |
| --- |
| Ksawerow, Poland |

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054

Ksawerow, Poland

Norifaz, 35 mg, comprimidos revestidos por pelicula

35 mg

Comprimate filmate

Uz oral

RO - Romania

| AVENTIS PHARMA AB Bryggvagen 16-18, 11768 |
| --- |
| Stockholm, Sweden |

AVENTIS PHARMA AB Bryggvagen 16-18, 11768

Stockholm, Sweden

ACTONEL 5 mg film coated tablets

5 mg

Comprimate filmate

orala

RO - Romania

| SANOFI-AVENTIS ROMÂNIA S.R.L. |
| --- |
| Str. Izvor, nr 80, etajele 6- |
| 11, sector 5 Bucharest, Romania |

SANOFI-AVENTIS ROMÂNIA S.R.L.

Str. Izvor, nr 80, etajele 6-

11, sector 5 Bucharest, Romania

ACTONEL SAPTAMANAL 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| SANOFI-AVENTIS ROMÂNIA S.R.L. |
| --- |
| Str. Izvor, nr 80, etajele 6- |
| 11, sector 5 Bucharest, Romania |

SANOFI-AVENTIS ROMÂNIA S.R.L.

Str. Izvor, nr 80, etajele 6-

11, sector 5 Bucharest, Romania

ACTONEL 75 mg film coated tablets

75 mg

Comprimate filmate

orala

RO - Romania

| TERAPIA SA |
| --- |
| Str. Fabricii nr. 124, Cluj- Napoca, Romania |

TERAPIA SA

Str. Fabricii nr. 124, Cluj- Napoca, Romania

OSODENS 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| ZENTIVA, k.s. |
| --- |
| U kabelovny 130, Dolní |
| Měcholupy 102 37 Praga 10, Czech Republic |

ZENTIVA, k.s.

U kabelovny 130, Dolní

Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78, 220 |
| Hafnarfjordur, Island |

Actavis Group PTC ehf

Reykjavikurvegi 76-78, 220

Hafnarfjordur, Island

OSTEORON 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| Antibiotice S.A. |
| --- |
| Valea Lupului nr. 1, 707410 |
| Iași, Romania |

Antibiotice S.A.

Valea Lupului nr. 1, 707410

Iași, Romania

LORINE 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra, nr. 12 parter, sector 2 |
| București, Romania |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra, nr. 12 parter, sector 2

București, Romania

RISEDRONAT TEVA 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

STADA Hemofarm SRL Zugrav Nedelcu nr.3, Timișoara, Romania

RISEDRONAT SODIC HF 35 mg, film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| LABORMED PHARMA S.A. |
| --- |
| Theodor Pallady Boulevard 44B, Sector 3, |
| RO-032266 |
| Bucharest, Romania |

LABORMED PHARMA S.A.

Theodor Pallady Boulevard 44B, Sector 3,

RO-032266

Bucharest, Romania

JUVERITAL 5 mg film coated tablets

5 mg

Comprimate filmate

orala

RO - Romania

| LABORMED PHARMA S.A. |
| --- |
| Theodor Pallady Boulevard 44B, Sector 3, |
| RO-032266 |
| Bucharest, Romania |

LABORMED PHARMA S.A.

Theodor Pallady Boulevard 44B, Sector 3,

RO-032266

Bucharest, Romania

JUVERITAL 35 mg film coated tablets

35 mg

Comprimate filmate

orala

RO - Romania

| Sanofi-aventis AB Gustavslundsvägen 139, Box |
| --- |
| 141 42, 167 14 Bromma, |
| Sweden |

Sanofi-aventis AB Gustavslundsvägen 139, Box

141 42, 167 14 Bromma,

Sweden

ACTONEL COMBI D

35 mg + 500 mg/400

UI film coated tablets

35 mg + 500 mg/400 UI

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan

5 mg

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan

30 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate

5 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate

30 mg

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra

5 mg

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra

30 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed

5 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed

30 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate Septimum

35 mg

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan Septimum

35 mg

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra Septimum

35 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed Septimum

35 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan Combi

35 mg + 1 250 mg calcium

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate Combi D

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan Combi D

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra Combi D

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed Combi D

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

orala

SE - Suedia

| Sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate

75 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed

75 mg

Comprimate filmate

orala

SE - Suedia

| Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Norsed Combi D

35 mg + 500 mg/400 IE

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra Combi D

35 mg + 500 mg/400 IE

Comprimate filmate

orala

SE - Suedia

| Ranbaxy (UK) Ltd |
| --- |
| 3rd floor, CP house |
| 97-107, Uxbridge Road |
| Ealing, London W5 5TL United Kngdom |

Ranbaxy (UK) Ltd

3rd floor, CP house

97-107, Uxbridge Road

Ealing, London W5 5TL United Kngdom

Risedronate Ranbaxy

35 mg

Comprimate filmate

orala

SE - Suedia

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 Köpenhamn S Danmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 Köpenhamn S Danmark

Risedronat Sandoz

35 mg

Comprimate filmate

orala

SE - Suedia

| Orifarm Generics A/S Energivej 15 |
| --- |
| POB 69 |
| DK-5260 Odense S Denmark |

Orifarm Generics A/S Energivej 15

POB 69

DK-5260 Odense S Denmark

Risedronat Orifarm

5 mg

Comprimate filmate

orala

SE - Suedia

| Orifarm Generics A/S Energivej 15 |
| --- |
| POB 69 |
| DK-5260 Odense S Denmark |

Orifarm Generics A/S Energivej 15

POB 69

DK-5260 Odense S Denmark

Risedronat Orifarm

30 mg

Comprimate filmate

orala

SE - Suedia

| Orifarm Generics A/S Energivej 15 |
| --- |
| POB 69 |
| DK-5260 Odense S Denmark |

Orifarm Generics A/S Energivej 15

POB 69

DK-5260 Odense S Denmark

Risedronat Orifarm

35 mg

Comprimate filmate

orala

SE - Suedia

| Ratiopharm GmbH Graf-Arco-Strasse 3 |
| --- |
| DE-89079 Ulm |
| Germany |

Ratiopharm GmbH Graf-Arco-Strasse 3

DE-89079 Ulm

Germany

Riseratio

35 mg

Comprimate filmate

orala

SE - Suedia

| Teva Sweden AB Box 1070 |
| --- |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB Box 1070

251 10 Helsingborg

Sweden

Risedronat Teva

35 mg

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan

75 mg

Comprimate filmate

orala

SE - Suedia

| Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano |
| --- |
| Italy |

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano

Italy

Avestra

75 mg

Comprimate filmate

orala

SE - Suedia

| sanofi-aventis AB Box 14142 |
| --- |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB Box 14142

167 14 Bromma

Sweden

Optinate Combi D

35 mg + 500 mg/400 IE

Comprimate filmate

orala

SE - Suedia

| Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40 |
| --- |
| 2SH, United Kingdom |

Warner Chilcott UK Limited Old Belfast Road Millbrook Larne County Antrim BT40

2SH, United Kingdom

Fortipan Combi D

35 mg + 500 mg/400 IE

Comprimate filmate

orala

SE - Suedia

| Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054 |
| --- |
| Ksawerow , Polen |

Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054

Ksawerow , Polen

Risedronat Adamed

Pharma

35 mg

Comprimate filmate

orala

SI - Slovenia

| Sanofi-aventis d.o.o., Dunajska cesta 151, |
| --- |
| SI-1000 Ljubljana |

Sanofi-aventis d.o.o., Dunajska cesta 151,

SI-1000 Ljubljana

Actonel 30 mg filmsko obložene tablete

30 mg

Comprimate filmate

Uz oral

SI - Slovenia

| Sanofi-aventis d.o.o., Dunajska cesta 151, |
| --- |
| SI-1000 Ljubljana |

Sanofi-aventis d.o.o., Dunajska cesta 151,

SI-1000 Ljubljana

Actonel 5 mg filmsko obložene tablete

5 mg

Comprimate filmate

Uz oral

SI - Slovenia

| Sanofi-aventis d.o.o., Dunajska cesta 151, |
| --- |
| SI-1000 Ljubljana |

Sanofi-aventis d.o.o., Dunajska cesta 151,

SI-1000 Ljubljana

Actonel 75 mg filmsko obložene tablete

75 mg

Comprimate filmate

Uz oral

SI - Slovenia

| Sanofi-aventis d.o.o., Dunajska cesta 151, |
| --- |
| SI-1000 Ljubljana |

Sanofi-aventis d.o.o., Dunajska cesta 151,

SI-1000 Ljubljana

Actonel enkrat tedensko 35 mg filmsko obložene tablete

35 mg

Comprimate filmate

Uz oral

SI - Slovenia

| Sanofi-aventis d.o.o., Dunajska cesta 151, |
| --- |
| SI-1000 Ljubljana |

Sanofi-aventis d.o.o., Dunajska cesta 151,

SI-1000 Ljubljana

Actonel Combi D

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

SI - Slovenia

| Galex, d.d., Tišinska ulica |
| --- |
| 29g, Murska Sobota, Slovenia |

Galex, d.d., Tišinska ulica

29g, Murska Sobota, Slovenia

Riserdonat Galex 35 mg filmsko obložene tablete

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| Bad Vilbel, 61118 |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

Bad Vilbel, 61118

Germany

Risedronat STADA 35 mg

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Actavis Group PTC ehf |
| --- |
| Dalshraun 1 |
| 220 Hafnarfjordur |
| Iceland |

Actavis Group PTC ehf

Dalshraun 1

220 Hafnarfjordur

Iceland

Bifodron 35 mg

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Zaklad Farmaceutyczny |
| --- |
| Adamed Pharma SA |
| 33 Szkolna Street |
| Ksawerów, 95-054 |
| Poland |

Zaklad Farmaceutyczny

Adamed Pharma SA

33 Szkolna Street

Ksawerów, 95-054

Poland

Norifaz 35 mg

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Gedeon Richter Plc. Gyômrôi út 19-21 |
| --- |
| 1103, Budapest |
| Hungary |

Gedeon Richter Plc. Gyômrôi út 19-21

1103, Budapest

Hungary

Nurrid 35 mg

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| ZENTIVA, k.s. |
| --- |
| U kabelovny 130, Dolní |
| Měcholupy 102 37 Praga 10, Czech Republic |

ZENTIVA, k.s.

U kabelovny 130, Dolní

Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg - TBL FLM

35 mg

Comprimate filmate

orala

SK - Slovacia

| LABORMED-PHARMA S.A., Theodor Pallady Boulevard |
| --- |
| 44B, Sector 3, RO-032266 |
| Bucharest, Romania |

LABORMED-PHARMA S.A., Theodor Pallady Boulevard

44B, Sector 3, RO-032266

Bucharest, Romania

Juverital

5 mg

Comprimate filmate

Uz oral

SK - Slovacia

| LABORMED-PHARMA S.A., Theodor Pallady Boulevard |
| --- |
| 44B, Sector 3, RO-032266 |
| Bucharest, Romania |

LABORMED-PHARMA S.A., Theodor Pallady Boulevard

44B, Sector 3, RO-032266

Bucharest, Romania

Juverital

35 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Sanofi-aventis Slovakia s.r.o. |
| --- |
| Einsteinova 24 |
| SK – 851 01 BRATISLAVA |

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL 5 MG

5 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Sanofi-aventis Slovakia s.r.o. |
| --- |
| Einsteinova 24 |
| SK – 851 01 BRATISLAVA |

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL 75 MG

75 mg

Comprimate filmate

Uz oral

SK - Slovacia

| Sanofi-aventis Slovakia s.r.o. |
| --- |
| Einsteinova 24 |
| SK – 851 01 BRATISLAVA |

Sanofi-aventis Slovakia s.r.o.

Einsteinova 24

SK – 851 01 BRATISLAVA

ACTONEL COMBI

35 mg + 500 mg/400 UI

Comprimate filmate

Uz oral

SK - Slovacia

| TEVA Pharmaceuticals Slovakia s.r.o., Teslova 26, |
| --- |
| 82102 Bratislava, Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o., Teslova 26,

82102 Bratislava, Slovak Republic

Risedronat Teva 35 mg filmom obalené tablety

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Sandoz Limited, 37 |
| --- |
| Woolmer Way, Bordon, Hampshire GU35 9QE |

Sandoz Limited, 37

Woolmer Way, Bordon, Hampshire GU35 9QE

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium

5 mg tablets

5 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel 5 mg Tablets

5 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel 30 mg Tablets

30 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel Once a Week

35 mg Tablet

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel Combi 35 mg film-coated tablets

+1 000 mg / 880 IU

effervescent granules

35 mg + 1 000 mg/880 IE

Comprimate filmate si granule efervescente

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel 75 mg tablet

75 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 |
| --- |
| 2SH, UK |

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40

2SH, UK

Actonel Combi 35 mg

+ 500 mg / 400 IU

film-coated tablets

35 mg + 500 mg/400 UI

Comprimate filmate

Uz oral

UK - Marea Britanie

Winthrop Pharmaceuticals UK Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Norsed Once a Week

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Ranbaxy (UK) Limited, 95 |
| --- |
| Park Lane, Mayfair. London |
| W1K 7TE, United Kingdom |

Ranbaxy (UK) Limited, 95

Park Lane, Mayfair. London

W1K 7TE, United Kingdom

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Ratiopharm GmbH, 5 |
| --- |
| Jackson Close, Grove Road, Cosham, Portsmouth, |
| Hampshire, PO6 1UP |

Ratiopharm GmbH, 5

Jackson Close, Grove Road, Cosham, Portsmouth,

Hampshire, PO6 1UP

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Pharmathen SA, 6 |
| --- |
| Dervenakion Street, Pallini, Athens, GR-153 51, Greece |

Pharmathen SA, 6

Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium

5 mg tablets

5 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Pharmathen SA, 6 |
| --- |
| Dervenakion Street, Pallini, Athens, GR-153 51, Greece |

Pharmathen SA, 6

Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium

30 mg tablets

30 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Pharmathen SA, 6 |
| --- |
| Dervenakion Street, Pallini, Athens, GR-153 51, Greece |

Pharmathen SA, 6

Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Beacon Pharmaceuticals Ltd, |
| --- |
| 85 High Street, Tunbridge |
| Wells, Kent TN1 1YG, UK |

Beacon Pharmaceuticals Ltd,

85 High Street, Tunbridge

Wells, Kent TN1 1YG, UK

Risedronate sodium

5 mg tablets

5 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Beacon Pharmaceuticals Ltd, |
| --- |
| 85 High Street, Tunbridge |
| Wells, Kent TN1 1YG, UK |

Beacon Pharmaceuticals Ltd,

85 High Street, Tunbridge

Wells, Kent TN1 1YG, UK

Risedronate sodium

30 mg tablets

30 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Beacon Pharmaceuticals Ltd, |
| --- |
| 85 High Street, Tunbridge |
| Wells, Kent TN1 1YG, UK |

Beacon Pharmaceuticals Ltd,

85 High Street, Tunbridge

Wells, Kent TN1 1YG, UK

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

| Zaklad Farmaceutyczny Adamed Pharma SA, ul. Szkolna 33, 95-054 |
| --- |
| Ksawerow, Poland |

Zaklad Farmaceutyczny Adamed Pharma SA, ul. Szkolna 33, 95-054

Ksawerow, Poland

Norifaz 35 mg tablet

35 mg

Comprimate filmate

Uz oral

UK - Marea Britanie

Apotex Europe BV, Darwinweg 20, 2333 C R Leiden, The Netherlands

Risedronate sodium

35 mg tablets

35 mg

Comprimate filmate

Uz oral

Produse medicamentoase care contin acid tiludronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| BE - Belgia | Sanofi-Aventis Belgium NV Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

BE - Belgia

Sanofi-Aventis Belgium NV Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

Comprimate

Uz oral

ES - Spania

| SANOFI AVENTIS, S.A.Josep |
| --- |
| Plá, 2 08019 Barcelona |

SANOFI AVENTIS, S.A.Josep

Plá, 2 08019 Barcelona

SKELID 200 mg comprimidos

200 mg

Comprimate

orala

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

ACIDE TILUDRONIQUE SANOFI PHARMA 200 mg, comprimé

200 mg

Comprimate

Uz oral

FR - Franta

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

SKELID 200 mg, comprimé

200 mg

Comprimate

Uz oral

LU - Luxemburg

| Sanofi-Aventis Belgium NV Culliganlaan 1C |
| --- |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium NV Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

Comprimate

Uz oral

UK - Marea Britanie

Sanofi-Synthelabo Limited, One Onslow Street, Guildford, Surry GU1 4YS, UK

Skelid

200 mg

Comprimate

Uz oral

Produse medicamentoase care contin acid ibandronic, autorizate in Uniunea Europeana

| Stat membru UE/AEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutica | Cale de administrare |
| --- | --- | --- | --- | --- | --- |
| DE - Germania | Mylan dura GmbH Wittichstr. 6 |
| D-64295 Darmstadt |

Stat membru UE/AEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutica

Cale de administrare

DE - Germania

Mylan dura GmbH Wittichstr. 6

D-64295 Darmstadt

Ibandronsäure dura

150 mg Filmtabletten

169,32 mg

Comprimate filmate

Uz oral

DE - Germania

| Orifarm Generixs A/S Energivej 15 |
| --- |
| DK-7260ODENSE S Denmark |

Orifarm Generixs A/S Energivej 15

DK-7260ODENSE S Denmark

Ibandronat Orifarm 50 mg Filmtabletten

65,4 mg

Comprimate filmate

Uz oral

DK - Danemarca

| Pharmathen S.A., 6, Dervenakion str., GR-15351 |
| --- |
| Pallini Attiki, Greece |

Pharmathen S.A., 6, Dervenakion str., GR-15351

Pallini Attiki, Greece

Baxogar

150 mg

Comprimate filmate

orala

DK - Danemarca

| Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 |
| --- |
| Budapest, Hungary |

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103

Budapest, Hungary

Etanorden

50 mg

Comprimate filmate

orala

DK - Danemarca

| Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 |
| --- |
| Budapest, Hungary |

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103

Budapest, Hungary

Etanorden

150 mg

Comprimate filmate

orala

DK - Danemarca

| Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 |
| --- |
| 35 Stockholm, Sweden |

Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104

35 Stockholm, Sweden

Ibamyl

150 mg

Comprimate filmate

orala

DK - Danemarca

| Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, |
| --- |
| IS-220 Hafnarfjördur, Iceland |

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78,

IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

50 mg

Comprimate filmate

orala

DK - Danemarca

| Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, |
| --- |
| IS-220 Hafnarfjördur, Iceland |

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78,

IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

150 mg

Comprimate filmate

orala

DK - Danemarca

| Arrow ApS, Hovedgaden 41, |
| --- |
| 2, DK-2970 Hørsholm, Denmark |

Arrow ApS, Hovedgaden 41,

2, DK-2970 Hørsholm, Denmark

Ibandronate "Arrow"

150 mg

Comprimate

orala

DK - Danemarca

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

Comprimate filmate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Ibandronate

"ratiopharm"

50 mg

Comprimate filmate

orala

DK - Danemarca

| ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079 |
| --- |
| Ulm, Germany |

ratiopharm GmbH, Graf- Arco-Strasse 3, DE-89079

Ulm, Germany

Ibandronate

"ratiopharm"

150 mg

Comprimate filmate

orala

DK - Danemarca

| Pharmathen S.A., 6, Dervenakion str., GR-15351 |
| --- |
| Pallini Attiki, Greece |

Pharmathen S.A., 6, Dervenakion str., GR-15351

Pallini Attiki, Greece

Quodixor

150 mg

Comprimate filmate

orala

DK - Danemarca

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

Comprimate filmate

orala

FI - Finlanda

| Arrow Pharma ApS, Hovedgaden 41. 2. sal, |
| --- |
| 2970 HØRSHOLM, Denmark |

Arrow Pharma ApS, Hovedgaden 41. 2. sal,

2970 HØRSHOLM, Denmark

Ibandronate Arrow

150 mg

Comprimate

orala

FI - Finlanda

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Ibandronate Orifarm

50 mg

Comprimate filmate

orala

FI - Finlanda

Ratiopharm GmbH, Graf- Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

150 mg

Comprimate filmate

orala

FI - Finlanda

Ratiopharm GmbH, Graf- Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

50 mg

Comprimate filmate

orala

FI - Finlanda

Gedeon Richter Plc, Gyömrõi út 19-21, 1103 Budabest, Hungary

Etanorden

150 mg

Comprimate filmate

orala

FI - Finlanda

| Mylan AB, BOX 23033, |
| --- |
| 10435 STOCKHOLM, Sweden |

Mylan AB, BOX 23033,

10435 STOCKHOLM, Sweden

Ibamyl

150 mg

Comprimate filmate

orala

FR - Franta

| GEDEON RICHTER Gyömroi ut 19-21 |
| --- |
| 1103 Budapest X |
| HONGRIE |

GEDEON RICHTER Gyömroi ut 19-21

1103 Budapest X

HONGRIE

KALOSSO 50 mg, comprimé pelliculé

50 mg

Comprimate

Uz oral

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

ACIDE IBANDRONIQUE MYLAN 150 mg, comprimé pelliculé

150 mg

Comprimate

Uz oral

FR - Franta

| GEDEON RICHTER Gyömroi ut 19-21 |
| --- |
| 1103 Budapest X |
| HONGRIE |

GEDEON RICHTER Gyömroi ut 19-21

1103 Budapest X

HONGRIE

ETANORDEN 150 mg, comprimé pelliculé

150 mg

Comprimate

Uz oral

FR - Franta

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

IBANDROMYLAN 150 mg, comprimé pelliculé

150 mg

Comprimate

Uz oral

FR - Franta

| GEDEON RICHTER Gyömroi ut 19-21 |
| --- |
| 1103 Budapest X |
| HONGRIE |

GEDEON RICHTER Gyömroi ut 19-21

1103 Budapest X

HONGRIE

KALOSSO 150 mg, comprimé pelliculé

150 mg

Comprimate

Uz oral

IS - Islanda

| Portfarma ehf., Borgartúni |
| --- |
| 26, 105 Reykjavík, Iceland |

Portfarma ehf., Borgartúni

26, 105 Reykjavík, Iceland

Ziveteno

150 mg

Comprimate filmate

orala

LT - Lituania

| Gedeon Richter Plc., 1103 |
| --- |
| Budapest Gyömrői út 19-21, Hungary |

Gedeon Richter Plc., 1103

Budapest Gyömrői út 19-21, Hungary

Etanorden

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, |
| --- |
| 2710-444 Sintra Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8,

2710-444 Sintra Portugal

Ácido Ibandrónico

Generis

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 |
| --- |
| A - Piso 2, |
| 2740-298 Porto Salvo |
| Portugal |

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5

A - Piso 2,

2740-298 Porto Salvo

Portugal

Ácido ibandrónico

Ombene

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Optimal Regulatory |
| --- |
| Solutions, S.L. Via Augusta, |
| 59, 08006 Barcelona |
| Espanha |

Optimal Regulatory

Solutions, S.L. Via Augusta,

59, 08006 Barcelona

Espanha

Ácido ibandrónico

Orsfelt

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor |
| Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor

Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B,

2770-229 Paço de Arcos

Portugal

Ácido ibandrónico

Ciclum

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31, |
| --- |
| 1495-139 Miraflores - Algés |
| Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31,

1495-139 Miraflores - Algés

Portugal

Ácido Ibandrónico

Pharmakern

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Gedeon Richter, Plc. Gyömröi út, 19-21, H-1103 |
| --- |
| Budapest Hungria |

Gedeon Richter, Plc. Gyömröi út, 19-21, H-1103

Budapest Hungria

Etanorden

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro |
| Borges, Edíficio Arquiparque |
| 1, R/C Esqo, |
| 1499-016 Álges |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro

Borges, Edíficio Arquiparque

1, R/C Esqo,

1499-016 Álges

Portugal

Ácido Ibandrónico

Mylan

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

| Arrow ApS Hovedgaden 41, 2, |
| --- |
| 2970 Horsholm |
| Dinamarca |

Arrow ApS Hovedgaden 41, 2,

2970 Horsholm

Dinamarca

Ácido Ibandrónico

Arrow

150 mg

Comprimate

Uz oral

PT - Portugalia

| Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício |
| --- |
| 1, 2o - Escritório 15, 2710- |
| 693 Sintra Portugal |

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício

1, 2o - Escritório 15, 2710-

693 Sintra Portugal

Ácido Ibandrónico

Sandoz

150 mg

Comprimate filmate

Uz oral

PT - Portugalia

Pharmathen - Pharmaceutical Industry, S.A. 6, Dervenakion Street, GR-15351 Pallini Attiki Grécia

Quodixor

150 mg

Comprimate filmate

Uz oral

SE - Suedia

| Orifarm Generics A/S Energivej 15 |
| --- |
| POB 69 |
| DK-5260 Odense S Denmark |

Orifarm Generics A/S Energivej 15

POB 69

DK-5260 Odense S Denmark

Ibandronate Orifarm

50 mg

Comprimate filmate

orala

SI - Slovenia

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Ibandronska kislina Mylan 150 mg filmsko obložene tablete

150 mg

Comprimate filmate

Uz oral

---

ANEXA VI

LISTA CU DENUMIRILE COMERCIALE, FORMA(ELE) FARMACEUTICĂ(E), CONCENTRAȚIA(IILE), CALEA(CĂILE) DE ADMINISTRARE A(ALE) MEDICAMENTULUI (ELOR), DEȚINĂTORUL(II) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter Healthcare GmbH |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml- Peritonealdialyselösung

glucoză anhidră 13,6 g/L, Clorură de sodiu 5,38 g/L, Lactat-L (+) de sodiu 4,48 g/L, Clorură de calciu dihidrat 0,184 g/L, Clorură de magneziu hexahidrat 0,051 g/L

Soluție pentru dializă peritoneală

Intraperitoneală

Austria

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml- Peritonealdialyselösung

glucoză anhidră 22,7 g/L, Clorură de sodiu 5,38 g/L, Lactat-L (+) de sodiu 4,48 g/L, Clorură de calciu dihidrat 0,184 g/L, Clorură de magneziu hexahidrat 0,051 g/L

Soluție pentru dializă peritoneală

Intraperitoneală

Austria

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml- Peritonealdialyselösung

glucoză anhidră 38,6 g/L, Clorură de sodiu 5,38 g/L, Lactat-L (+) de sodiu 4,48 g/L, Clorură de calciu dihidrat 0,184 g/L, Clorură de magneziu hexahidrat 0,051 g/L

Soluție pentru dializă peritoneală

Intraperitoneală

Austria

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

EXTRANEAL- Peritonealdialyselösung

75 g/L

Soluție pentru dializă peritoneală

Intraperitoneală

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale

13,6 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 2,27 % (22,7 mg/ml). solution pour dialyse péritonéale

22,7 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale

38,6 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Belgia

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Extraneal 7,5 % solution pour dialyse péritonéale

75,00 g/l Icodextrină

Soluție pentru dializă peritoneală

Intraperitoneală

Bulgaria

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose 1,36 % w/v/ 13,6 mg/ml

1,36 % w/v/ 13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Bulgaria

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/ 22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Bulgaria

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/ 38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Bulgaria

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Soluție pentru dializă peritoneală

Intraperitoneală

Republica Cehă

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Republica Cehă

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v/22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Republica Cehă

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v/38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Republica Cehă

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

EXTRANEAL

7,5 % 75 g/1 000 ml

Soluție pentru dializă peritoneală

Intraperitoneală

Danemarca

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Danemarca

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Danemarca

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Danemarca

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Extraneal

75 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Estonia

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

7,50 %

Soluție pentru dializă peritoneală

Intraperitoneală

Finlanda

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Finlanda

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Finlanda

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Finland

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

Extraneal

7,5 %

Soluție pentru dializă peritoneală

Intraperitoneală

Franța

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36 %

Soluție pentru dializă peritoneală

Intraperitoneală

Franța

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27 %

Soluție pentru dializă peritoneală

Intraperitoneală

Franța

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86 %

Soluție pentru dializă peritoneală

Intraperitoneală

Franța

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| France |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 1,36 % w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 2,27 % w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 3,86 %

38,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Germania

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Extraneal

75 g/l

5,4 g/l

4,5 g/l

0,257 g/l

0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Grecia

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

DIANEAL PD4

1,36 %

Soluție pentru dializă peritoneală

Intraperitoneală

Grecia

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

Extraneal

(7,5+0,54+0,45+0,0257+0,0051) % w/v

Soluție pentru dializă peritoneală

Intraperitoneală

Ungaria

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Soluție pentru dializă peritoneală

Intraperitoneală

Ungaria

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Soluție pentru dializă peritoneală

Intraperitoneală

Ungaria

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Soluție pentru dializă peritoneală

Intraperitoneală

Ungaria

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (Icodextrină)

Soluție pentru dializă peritoneală

Intraperitoneală

Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, County Mayo Ireland |

Baxter Healthcare SA

Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36 % w/v (13,6 mg/ml)

Soluție pentru dializă peritoneală

Intraperitoneală

Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27 % w/v (22,7 mg/ml)

Soluție pentru dializă peritoneală

Intraperitoneală

Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86 % w/v (38,6 mg/ml)

Soluție pentru dializă peritoneală

Intraperitoneală

Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, Norfolk, IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford, Norfolk, IP24 3SE

United Kingdom

EXTRANEAL Solution for peritoneal dialysis

Soluție pentru dializă peritoneală

Intraperitoneală

Italia

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma |
| Italy |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

Italy

EXTRANEAL

7,5 %

Soluție pentru dializă peritoneală

Intraperitoneală

Italia

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma |
| Italy |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l – 49,54 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Letonia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml- solution for peritoneal dialysis

2,27 % w/v

0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Soluție pentru dializă peritoneală

Intraperitoneală

Letonia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml- solution for peritoneal dialysis

3,86 % w/v 0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Soluție pentru dializă peritoneală

Intraperitoneală

Letonia

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml- solution for peritoneal dialysis

1,36 % w/v 0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Soluție pentru dializă peritoneală

Intraperitoneală

Letonia

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

Extraneal solution for peritoneal dialysis

75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L

Soluție pentru dializă peritoneală

Intraperitoneală

Lituania

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

13,6g+5,38g+4,48g+0,184g+0,051g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Lituania

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

22,7g+5,38g+4,48g+0,184g+0,051g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Lituania

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

38,6g+5,38g+4,48g+0,184g+0,051g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Lituania

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Finland |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

75g+5,4g+4,5g+0,257g+0,051g/1 000ml

Soluție pentru dializă peritoneală

Intraperitoneală

Luxemburg

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Belgium |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % dextrosă anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Luxemburg

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Belgium |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Icodextrină

Soluție pentru dializă peritoneală

Intraperitoneală

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 %w/v 13,6 mg/ml

1,36 %w/v 13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 %w/v 22,7 mg/ml

2,27 %w/v 22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 %w/v 38,6 mg/ml

3,86 %w/v 38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Extraneal (Icodextrin 7,5 %)

N/A

Soluție pentru dializă peritoneală

Intraperitoneală

Norvegia

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo, Norway

Extraneal

75 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Polonia

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

Soluție pentru dializă peritoneală

Intraperitoneală

Polonia

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

Soluție pentru dializă peritoneală

Intraperitoneală

Polonia

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

Soluție pentru dializă peritoneală

Intraperitoneală

Polonia

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Soluție pentru dializă peritoneală

Intraperitoneală

Portugalia

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Soluție pentru dializă peritoneală

Intraperitoneală

Portugalia

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Soluție pentru dializă peritoneală

Intraperitoneală

Portugalia

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Soluție pentru dializă peritoneală

Intraperitoneală

Portugalia

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Portugal |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Extraneal

75 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

România

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml)

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

România

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

România

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

România

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE, United Kingdom |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL

Soluție pentru dializă peritoneală

Intraperitoneală

Sloval republică

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 1,36 % w/v /13,6 mg/ml

13,6 mg/1 ml

Soluție pentru dializă peritoneală

Intraperitoneală

Sloval republică

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 2,27 % w/v /22,7 mg/ml

22,7 mg/1 ml

Soluție pentru dializă peritoneală

Intraperitoneală

Sloval republică

Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland

Dianeal® PD4 glucose 3,86 % w/v /38,6 mg/ml

38,6 mg/1 ml

Soluție pentru dializă peritoneală

Intraperitoneală

Sloval republică

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE

EXTRANEAL

Soluție pentru dializă peritoneală

Intraperitoneală

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 %

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 %

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 %

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Spania

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

EXTRANEAL Solución para diálisis peritoneal

75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l

Soluție pentru dializă peritoneală

Intraperitoneală

Suedia

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Suedia

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Suedia

| Baxter Healthare SA |
| --- |
| Moneen Road |
| Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road

Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Suedia

| Baxter AB |
| --- |
| Box 63 |
| 16494 Kista |
| Sverige |

Baxter AB

Box 63

16494 Kista

Sverige

Extraneal

7,5 %

Soluție pentru dializă peritoneală

Intraperitoneală

Țările de Jos

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeist of

13,6 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Țările de Jos

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeist of

22,7 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Țările de Jos

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeist of

38,6 g/l glucoză anhidră

Soluție pentru dializă peritoneală

Intraperitoneală

Țările de Jos

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l Icodextrină

Soluție pentru dializă peritoneală

Intraperitoneală

Regatul Unit al Marii Britanii

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v /13,6 mg/ml

1,36 % w/v /13,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Regatul Unit al Marii Britanii

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v /22,7 mg/ml

2,27 % w/v /22,7 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Regatul Unit al Marii Britanii

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v /38,6 mg/ml

3,86 % w/v /38,6 mg/ml

Soluție pentru dializă peritoneală

Intraperitoneală

Regatul Unit al Marii Britanii

| Baxter Healthcare Limited |
| --- |
| Caxton Way, |
| Thetford IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way,

Thetford IP24 3SE

United Kingdom

Extraneal (lcodextrin 7,5 %) Solution for peritoneal dialysis

Soluție pentru dializă peritoneală

Intraperitoneală

---

ANEXA VII

LISTA CU DENUMIRI COMERCIALE, FORME FARMACEUTICE, CONCENTRAȚII ALE MEDICAMENTELOR, CALEA DE ADMINISTRARE ȘI APLICANTUL ÎN STATELE MEMBRE

| Statul Membru European/SEE | Aplicant | Denumirea comercială | Concentrația | Forma farmaceutică | Calea de administrare | Conținut
  (concentrația) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Statul Membru European/SEE

Aplicant

Denumirea comercială

Concentrația

Forma farmaceutică

Calea de administrare

Conținut

(concentrația)

Austria

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 20 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Austria

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 80 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Belgia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Belgia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Bulgaria

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Доцетаксел Тева Генерикс

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Bulgaria

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Доцетаксел Тева Генерикс

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Cipru

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Cipru

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Republica Cehă

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Tevadoxel

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Republica Cehă

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Tevadoxel

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Danemarca

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Danemarca

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Estonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Estonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Finlanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Finlanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Franța

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Franța

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Germania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Germania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Grecia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Grecia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Ungaria

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Ungaria

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Irlanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Irlanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Italia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Italia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Letonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Letonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Lituania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Lituania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Luxemburg

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Luxemburg

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Malta

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Malta

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Olanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Olanda

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Norvegia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Norvegia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Polonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Polonia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

România

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

România

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Republica Slovacia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Republica Slovacia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Slovenia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 20 mg prašek in vehikel za koncentrat za raztopino za infundiranje

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Slovenia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics 80 mg prašek in vehikel za koncentrat za raztopino za infundiranje

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Spania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Spania

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Suedia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Suedia

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

Marea Britanie

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

20 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

20 mg

Marea Britanie

| Teva Generics B.V. |
| --- |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Teva Generics B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Docetaxel Teva Generics

80 mg

Concentrat și solvent pentru soluție perfuzabilă

Administrare intravenoasă

80 mg

---

ANEXA VIII

LISTA CU DENUMIREA COMERCIALĂ, FORMA FARMACEUTICĂ, CONCENTRAȚIA PRODUSULUI MEDICAMENTOS DE UZ VETERINAR, SPECIA DE ANIMALE, CALEA DE ADMINISTRARE, TIMPUL DE AȘTEPTARE, SOLICITANTUL ȘI DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ DIN STATELE MEMBRE

| Statul membru UE/SEE | Solicitantul/deținătorul autorizației de punere pe piață | Denumirea inventată | Forma farmaceutică | Concentrații | Specii de animale | Doza recomandată, frecvența și calea de administrare | Timpul de așteptare
  (carne și lapte) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Irlanda | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Statul membru UE/SEE

Solicitantul/deținătorul autorizației de punere pe piață

Denumirea inventată

Forma farmaceutică

Concentrații

Specii de animale

Doza recomandată, frecvența și calea de administrare

Timpul de așteptare

(carne și lapte)

Irlanda

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Noroclav Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Regatul Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combimox Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Carne: 7 zile

Lapte: 60 ore

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ANEXA IX

LISTA CU DENUMIREA COMERCIALĂ, FORMA FARMACEUTICĂ, CONCENTRAȚIA PRODUSULUI MEDICAMENTOS DE UZ VETERINAR, SPECIA DE ANIMALE, CALEA DE ADMINISTRARE, TIMPUL DE AȘTEPTARE, SOLICITANTUL ȘI DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ DIN STATELE MEMBRE

| Statul membru UE/SEE | Solicitantul/deținătorul autorizației de punere pe piață | Denumirea inventată | Forma farmaceutică | Concentrații | Specii de animale | Doza recomandată, frecvența și calea de administrare | Timpul de așteptare
  (carne și lapte) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Statul membru UE/SEE

Solicitantul/deținătorul autorizației de punere pe piață

Denumirea inventată

Forma farmaceutică

Concentrații

Specii de animale

Doza recomandată, frecvența și calea de administrare

Timpul de așteptare

(carne și lapte)

Austria

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Belgia

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Danemarca

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Finlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Franța

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Portugalia

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Spania

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Regatul Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Carne: 7 zile

Lapte: 60 ore

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ANEXA X

LISTA CU DENUMIREA COMERCIALĂ, FORMA FARMACEUTICĂ, CONCENTRAȚIA PRODUSULUI MEDICAMENTOS DE UZ VETERINAR, SPECIA DE ANIMALE, CALEA DE ADMINISTRARE, TIMPUL DE AȘTEPTARE, SOLICITANTUL ȘI DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ DIN STATELE MEMBRE

| Statul membru UE/SEE | Solicitantul/deținătorul autorizației de punere pe piață | Denumirea inventată | Forma farmaceutică | Concentrații | Specii de animale | Doza recomandată, frecvența și calea de administrare | Timpul de așteptare
  (carne și lapte) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Țările de Jos | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down |
| BT35 6JP |
| Northern Ireland |

Statul membru UE/SEE

Solicitantul/deținătorul autorizației de punere pe piață

Denumirea inventată

Forma farmaceutică

Concentrații

Specii de animale

Doza recomandată, frecvența și calea de administrare

Timpul de așteptare

(carne și lapte)

Țările de Jos

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Northern Ireland

Nisamox Lactating Cow Intramammary Suspension

Suspensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Nestabilit

Regatul Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down |
| BT35 6JP |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Northern Ireland

Nisamox Lactating Cow Intramammary Suspension

Sispensie intramamară

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Bovine aflate în perioada de lactație

Administrare intramamară la bovine aflate în perioada de lactație la o rată a dozei de 3 seringi per sfert afectat, administrate separat, la intervale de 12 ore

Carne: 7 zile

Lapte: 60 ore

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