# Uradni list C 316/2011

| | ISSN 1977-1045
  doi:10.3000/19771045.C_2011.316.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 316 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5428. oktober 2011 |

ISSN 1977-1045

doi:10.3000/19771045.C_2011.316.slv

Uradni list

Evropske unije

C 316

Slovenska izdaja

Informacije in objave

Zvezek 5428. oktober 2011

---

| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2011/C 316/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2011/C 316/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  ) | 18 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2011/C 316/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

2011/C 316/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  )

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES

ali člena 38 Direktive 2001/82/ES

)

18

| SL | |
| --- | --- |

SL

---

IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 28.10.2011 | SL | Uradni list Evropske unije | C 316/1 |
| --- | --- | --- | --- |

28.10.2011

SL

Uradni list Evropske unije

C 316/1

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2011/C 316/01

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.7.2011 | Benlysta | belimumab | Glaxo Group Limited |
| Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

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

Prašek za koncentrat za raztopino za infundiranje

L04AA26

15.7.2011

13.7.2011

Temozolomide Sun

temozolomida

| 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

Kapsula, trda

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

Rztopina za injiciranje

M05BX04

15.7.2011

13.7.2011

Yervoy

ipilimumaba

| 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

Koncentrat za raztopino za infundiranje

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

Kapsula, trda

J05AE

20.7.2011

20.7.2011

Fampyra

fampridina

| 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

Tablete s podaljšanim sproščanjem

N07XX07

25.7.2011

20.7.2011

TOBI Podhaler

Tobramicin

| 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

Prašek za inhaliranje, trde kapsule

J01GB01

25.7.2011

26.7.2011

Ibandronic acid Sandoz

ibandronska kislina

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/11/685/001-005

Filmsko obložene tablete

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

Filmsko obložene tablete

G03AA14

1.8.2011

18.8.2011

Entacapone Orion

entakapon

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

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708/001-004

Filmsko obložene tablete

N04BX02

22.8.2011

24.8.2011

Levodopa/Carbidopa/Entacapone Orion

Levodopa, Karbidopa, Entacapon

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

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706/001-033

Filmsko obložene tablete

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

Filmsko obložene tablete

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

Filmsko obložene tablete

Peroralna raztopina

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

Filmsko obložene tablete

N03AX14

31.8.2011

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 5.7.2011 | Irbesartan Winthrop | Sanofi-Aventis |
| 174, avenue de France, F-75013 Paris, France |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (2)
  ): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.8.2011 | Proteq West Nile | West Nile rekombinantni Canarypox virus (vCP2017)... | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

5.8.2011

Proteq West Nile

West Nile rekombinantni Canarypox virus (vCP2017)...

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/129/001-004

Suspenzija za injiciranje

QI05AX

10.8.2011

5.8.2011

Zulvac 1 Bovis

Inaktiviran virus modrega jezika, serotip 1, sev 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

Suspenzija za injiciranje

QI02AA08

10.8.2011

5.8.2011

Zulvac 1 Ovis

Inaktiviran virus modrega jezika, serotip 1, sev 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

Suspenzija za injiciranje

QI04AA02

10.8.2011

18.8.2011

Emdocam

Meloksikam

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

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe

EU/2/11/128/001-003

Rztopina za injiciranje

QM01AC06

22.8.2011

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 7.7.2011 | Leucofeligen FeLV/RCP | VIRBAC S.A. |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Ukinitev dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 10.8.2011 | Yarvitan | Janssen Pharmaceutica N.V. |
| Turnhoutseweg 30, B-2340 Beerse, België |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

10.8.2011

Yarvitan

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, B-2340 Beerse, België

EU/2/06/063/001-003

12.8.2011

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| 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)  UL L 136, 30.4.2004, str. 1.

(2)  UL L 136, 30.4.2004, str. 1.

---

| 28.10.2011 | SL | Uradni list Evropske unije | C 316/18 |
| --- | --- | --- | --- |

28.10.2011

SL

Uradni list Evropske unije

C 316/18

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. julij 2011 do 31. avgust 2011

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
   (1)
  ali člena 38 Direktive 2001/82/ES
   (2)
  )

2011/C 316/02

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 24.8.2011 | Clavudale | Glej Prilogo I | Glej Prilogo I | 25.8.2011 |
| 20.7.2011 | Kytril | Glej Prilogo II | Glej Prilogo II | 22.7.2011 |
| 13.7.2011 | Doxycycline 50 % WSP and associated names | Glej Prilogo III | Glej Prilogo III | 14.7.2011 |
| 13.7.2011 | Doxyfar 50 % and associated names | Glej Prilogo IV | Glej Prilogo IV | 14.7.2011 |
| 13.7.2011 | alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid and tiludronic acid | Glej Prilogo V | Glej Prilogo V | 15.7.2011 |
| 13.7.2011 | Dianeal PD4 and Extraneal and associated names | Glej Prilogo VI | Glej Prilogo VI | 15.7.2011 |
| 7.7.2011 | Docetaxel Teva Generics and associated names | Glej Prilogo VII | Glej Prilogo VII | 8.7.2011 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

24.8.2011

Clavudale

Glej Prilogo I

Glej Prilogo I

25.8.2011

20.7.2011

Kytril

Glej Prilogo II

Glej Prilogo II

22.7.2011

13.7.2011

Doxycycline 50 % WSP and associated names

Glej Prilogo III

Glej Prilogo III

14.7.2011

13.7.2011

Doxyfar 50 % and associated names

Glej Prilogo IV

Glej Prilogo IV

14.7.2011

13.7.2011

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

Glej Prilogo V

Glej Prilogo V

15.7.2011

13.7.2011

Dianeal PD4 and Extraneal and associated names

Glej Prilogo VI

Glej Prilogo VI

15.7.2011

7.7.2011

Docetaxel Teva Generics and associated names

Glej Prilogo VII

Glej Prilogo VII

8.7.2011

—   Zavrnitev izdaje nacionalnega dovoljenja za promet z zdravili

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 5.8.2011 | Combimox Lactating Cow Intramammary Suspension and associated names | Glej Prilogo VIII | Glej Prilogo VIII | 9.8.2011 |
| 5.8.2011 | Combisyn Lactating Cow Intramammary suspension | Glej Prilogo IX | Glej Prilogo IX | 9.8.2011 |
| 5.8.2011 | Nisamox Lactating Cow Intramammary Suspension | Glej Prilogo X | Glej Prilogo X | 8.8.2011 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

Glej Prilogo VIII

Glej Prilogo VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

Glej Prilogo IX

Glej Prilogo IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

Glej Prilogo X

Glej Prilogo X

8.8.2011

—   Umik nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 5.8.2011 | Combimox Lactating Cow Intramammary Suspension and associated names | Glej Prilogo VIII | Glej Prilogo VIII | 9.8.2011 |
| 5.8.2011 | Combisyn Lactating Cow Intramammary suspension | Glej Prilogo IX | Glej Prilogo IX | 9.8.2011 |
| 5.8.2011 | Nisamox Lactating Cow Intramammary Suspension | Glej Prilogo X | Glej Prilogo X | 8.8.2011 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

5.8.2011

Combimox Lactating Cow Intramammary Suspension and associated names

Glej Prilogo VIII

Glej Prilogo VIII

9.8.2011

5.8.2011

Combisyn Lactating Cow Intramammary suspension

Glej Prilogo IX

Glej Prilogo IX

9.8.2011

5.8.2011

Nisamox Lactating Cow Intramammary Suspension

Glej Prilogo X

Glej Prilogo X

8.8.2011

---

(1)  UL L 311, 28.11.2001, str. 67.

(2)  UL L 311, 28.11.2001, str. 1.

---

DODATEK I

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI VETERINARSKEGA ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Predlagatelj/imetnik dovoljenja za promet z zdravilom | Ime | Farmacevtska oblika | Jakosti | Živalske vrste | Pogostnost in pot uporabe | Priporočeni odmerek |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Belgija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Češka | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Danska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Finska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Francija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Nemčija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Grčija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Madžarska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Islandija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Irska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Luksemburg | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Nizozemska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Norveška | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Poljska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Portugalska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Slovaška | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Španija | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Švedska | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 40 mg/10 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |
| Združeno kraljestvo | Dechra Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire SY4 4AS, United Kingdom | Clavudale 50 mg tablet for cats and dogs | Tableta | Amoxicillin 40 mg
  Clavulanic acid 10 mg | Mačke in psi | Peroralna uporaba, dvakrat na dan 5–7 dni | Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase |

Država članica EU/EGP

Predlagatelj/imetnik dovoljenja za promet z zdravilom

Ime

Farmacevtska oblika

Jakosti

Živalske vrste

Pogostnost in pot uporabe

Priporočeni odmerek

Avstrija

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Belgija

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Češka

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Danska

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Finska

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Francija

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Nemčija

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Grčija

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Madžarska

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Islandija

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Irska

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Luksemburg

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Nizozemska

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Norveška

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Poljska

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Portugalska

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Slovaška

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Španija

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Švedska

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

Clavudale 40 mg/10 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

Združeno kraljestvo

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

Clavudale 50 mg tablet for cats and dogs

Tableta

Amoxicillin 40 mg

Clavulanic acid 10 mg

Mačke in psi

Peroralna uporaba, dvakrat na dan 5–7 dni

Standardni odmerek 10 mg amoksicilina/2,5 mg klavulanske kisline/kg telesne mase

---

PRILOGA II

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EEA | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | vsebina (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Roche Austria GmbH, Engelhorngasse 3, 1211 Wien |
| Austria |

Država članica EU/EEA

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

vsebina (koncentracija)

Avstrija

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 3 mg - Injektionslösung

3 mg/3 ml

raztopina za injiciranje

intravenska uporaba

3 ml

Avstrija

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

Roche Austria GmbH, Engelhorngasse 3, 1211 Wien

Austria

Kytril 2 mg - Filmtabletten

2 mg

filmsko obložena tableta

peroralna uporaba

Belgija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/1 ml

Belgija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Belgija

| 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

filmsko obložena tableta

peroralna uporaba

Bolgarija

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

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

1 mg / ml

raztopina za injiciranje/infundiranje

intravenska uporaba

1 ml (1 mg/ ml)

3 ml (1 mg/ ml)

Bolgarija

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

Roche Bulgaria EOOD,

16 Bialo Pole Str.

1618 Sofia

Bulgaria

Kytril

2 mg

filmsko obložena tableta

peroralna uporaba

Češka republika

| 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

filmsko obložena tableta

peroralna uporaba

Češka republika

| 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

raztopina za injiciranje/infundiranje

intravenska uporaba

1 mg/1 ml

Estonija

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

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg/ml

koncentrat za raztopino za injiciranje/ infundiranje

intravenska uporaba

1 mg/ml (1 ml and 3 ml)

Estonija

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

Roche Eesti OÜ

Lõõtsa 2, 11415

Tallinn

Estonia

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

2 mg

filmsko obložena tableta

peroralna uporaba

Finska

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

Roche Oy

PL 12

02181 Espoo

Finland

Kytril

1 mg/ml

raztopina za injiciranje

intravenska uporaba

5 × 1 ml and 5 × 3 ml

Francija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Francija

| 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

filmsko obložena tableta

peroralna uporaba

Francija

| 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

filmsko obložena tableta

peroralna uporaba

Nemčija

| 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

raztopina za injiciranje

intravenska uporaba

1 ml

Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

Nemčija

| 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

raztopina za injiciranje

intravenska uporaba

3 ml

Grčija

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

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Grčija

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

Roche (Hellas )

A.E.

Alamanas 4 & Delfon, 15125 Maroussi

Greece

Kytril

2 mg

filmsko obložena tableta

peroralna uporaba

Grčija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/1 ml

Grčija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Madžarska

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

Roche (Hungary) Ltd

H-2040 Budaörs

Edison u. 1.

Hungary

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Madžarska

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Irska

| 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

filmsko obložena tableta

peroralna uporaba

Irska

| 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

filmsko obložena tableta

peroralna uporaba

Irska

| 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

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

1 ml vsebuje 1 mg granisetrona (hidroklorida)

1 mg vsebuje 9 mg natrijevega klorida = 3,54 mg natrija

Irska

| 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

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

3 ml vsebuje 3 mg granisetrona (hidroklorida)

3 ml vsebuje 27 mg natrijevega klorida = 10,62 mg natrija

Italija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Italija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/1 ml

Italija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/5 ml

Italija

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

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Italija

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

Roche S.p.A.

Piazza Durante 11

20131 Milano

Italy

Kytril

2 mg

filmsko obložena tableta

peroralna uporaba

Latvija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Latvija

| 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

filmsko obložena tableta

peroralna uporaba

Litva

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

UAB „Roche Lietuva“

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Litva

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

UAB „Roche Lietuva“

J. Jasinskio 16b, LT-01112 Vilnius

Lithuania

Kytril

1 mg/ml

raztopina za injiciranje/infundiranje

intravenska uporaba

1 mg/1 ml

Litva

| 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

raztopina za injiciranje/infundiranje

intravenska uporaba

3 mg/3 ml

Luksemburg

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/1 ml

Luksemburg

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml

Luksemburg

| 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

filmsko obložena tableta

peroralna uporaba

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

filmsko obložena tableta

peroralna uporaba

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

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

1 ml vsebuje 1 mg granisetrona (hidroklorida)

Nizozemska

| 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 injectie1 mg/ml

1 mg/ml

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Nizozemska

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

Portugalska

| 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

filmsko obložena tableta

peroralna uporaba

Portugalska

| 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

filmsko obložena tableta

peroralna uporaba

Portugalska

| 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

raztopina za injiciranje

intravenska uporaba

1 ml (1 mg/1 ml)

Portugalska

| 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

raztopina za injiciranje

intravenska uporaba

3 ml (3 mg/3 ml)

Romunija

| 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

filmsko obložena tableta

peroralna uporaba

Romunija

| 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

raztopina za injiciranje

intravenska uporaba

3 mg/3 ml (1 mg/ml)

Slovaška republika

| 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

filmsko obložena tableta

peroralna uporaba

Slovaška republika

| 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

filmsko obložena tableta

peroralna uporaba

Slovaška republika

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

F.Hoffmann-La Roche Ltd.

Basel, Switzerland

Kytril INJ/INF

1 mg/1 ml

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

1 mg/1 ml

Slovenija

| 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

filmsko obložena tableta

peroralna uporaba

Slovenija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Slovenija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Španija

| 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

filmsko obložena tableta

peroralna uporaba

Španija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Španija

| 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

raztopina za injiciranje

intravenska uporaba

1 mg/ml

Švedska

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

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg

filmsko obložena tableta

peroralna uporaba

Švedska

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

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

2 mg

filmsko obložena tableta

peroralna uporaba

Švedska

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

Roche AB

Box 47327

100 74 Stockholm

Sweden

Kytril

1 mg/ml

raztopina za injiciranje

intravenska uporaba

5 × 1 ml

5 × 3 ml

Velika Britanija

| 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

filmsko obložena tableta

peroralna uporaba

Velika Britanija

| 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

filmsko obložena tableta

peroralna uporaba

Velika Britanija

| 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

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

1 ml vsebuje 1 mg granisetrona (hidroklorida)

Velika Britanija

| 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

koncentrat za raztopino za infundiranje/ injiciranje

intravenska uporaba

1 mg granisetrona na 1 ml raztopine

---

DODATEK III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET/PREDLAGATELJEV

| Država članica | Imetnik dovoljenja za promet Ime & naslov | Izmišljeno ime | INN Jakost | Farmacevtska oblika | Živalska vrsta |
| --- | --- | --- | --- | --- | --- |
| Belgija | Dopharma Research BV |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| IZOZEMSKA |

Država članica

Imetnik dovoljenja za promet Ime & naslov

Izmišljeno ime

INN Jakost

Farmacevtska oblika

Živalska vrsta

Belgija

Dopharma Research BV

Zalmweg 24

4941 VX Raamsdonksveer

IZOZEMSKA

Doxycycline 50 % Dopharma

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Teleta pred nastopom prežvekovanja, prašiči, kokoši nenesnice

Bolgariji

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

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 % WSP

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Teleta, prašiči, perutnina

Danska

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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxylin Vet.

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Prašiči

Grčija

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

Dopharma B.V

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 % Dopharma

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Piščanci(brojlerji), teleta, prašiči

Madžarska

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

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 % WSP

doksiciklinijev hiklat

500 mg/g

Prašek za peroralno raztopino

Teleta, prašiči, piščanci

Litva

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

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 %

doksiciklinijev hiklat

500 mg/g

Prašek za peroralno raztopino

Teleta, prašiči, perutnina

Nizozemska

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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 % WSP

doksiciklinijev hiklat

500 mg/g

Prašek za dajanje v pitno vodo

Kokoši nenesnice

Poljska

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

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxymed 50

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Teleta, piščanci, prašiči

Portugalska

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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Vetadoxi 50

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Govedo (teleta), prašiči, ptic

Romunija

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

Dopharma B.V.

Zalmweg 24

4941 VX Raamsdonksveer

NIZOZEMSKA

Doxycycline 50 % WSP

doksiciklinijev hiklat

500 mg/g

Vodotopni prašek

Perutnina (ni dovoljeno za uporabo pri pticah nesnicah jajc za prehrano ljudi), teleta, prašiči

---

PRILOGA IV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica/EGP | Imetnik dovoljenja za promet | Izmišljeno ime | Jakost | Farmacevtska oblika | Živalska vrsta |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Eurovet Animal Health B.V., |
| Handelsweg 25, 5531 AE Bladel, |
| The Netherlands |

Država članica/EGP

Imetnik dovoljenja za promet

Izmišljeno ime

Jakost

Farmacevtska oblika

Živalska vrsta

Avstrija

Eurovet Animal Health B.V.,

Handelsweg 25, 5531 AE Bladel,

The Netherlands

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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

piščanci

Avstrija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Belgija

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

Eurovet N.V.

Poorthoevestraat 4, 3

550 Heusen-Zolder

Belgium

Soludox 50 %

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

piščanci

Češka republika

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Denmark

| 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.

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Estoniji

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Estoniji

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Finsko

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Finsko

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Francija

| 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

doksiciklin (kot hiklat)

433 mg/g

prašek za uporabo v pitni vodi

Piščanci

Francija

| 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.

doksiciklin (kot hiklat)

433 mg/g

prašek za uporabo v pitni vodi

Prašiči

Nemčija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Nemčija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Grčija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Madžarska

| 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.

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Italija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Italija

| 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.

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Latvija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Latvija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Litva

| 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,

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Piščanci

Nizozemska

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Piščanci

Nizozemska

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Piščanci

Nizozemska

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Piščanci

Nizozemska

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Poljska

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Piščanci

Slovaška

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Španija

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Španija

| 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.

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Združeno kraljestvo

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

Združeno kraljestvo

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Piščanci

Združeno kraljestvo

| 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

doksiciklinijev hiklat

500 mg/g

prašek za uporabo v pitni vodi

Prašiči

---

DODATEK V

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET V DRŽAVAH ČLANICAH

Zdravila, ki vsebujejo alendronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria | Alemol 70 mg - einmal wöchentlich Tabletten | 70 mg | tableta | peroralna uporaba |
| AT - Avstrija | AB-Consult Handels- und Betriebsberatungs GmbH, Eichenstraße 32, A-1120 Wien, Austria | Alenat 70 mg - einmal wöchentlich Tabletten | 70 mg | tableta | peroralna uporaba |
| AT - Avstrija | Hexal Pharma GmbH, Stella-Klein-Löw-Weg 17, A-1020 Wien, Austria | Alendrohexal 70 mg - einmal wöchentlich Filmtabletten | 70 mg | filmsko obložena tableta | peroralna uporaba |
| AT - Avstrija | Genericon Pharma GmbH, Hafnerstraße 211, A-8054 Graz, Austria | Alendronorm 70 mg - einmal wöchentlich Tabletten | 70 mg | tableta | peroralna uporaba |
| AT - Avstrija | Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK | Alendronsäure Accord 70 mg einmal wöchentlich Tabletten | 70 mg | tableta | peroralna uporaba |
| AT - Avstrija | Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, UK | Alendronsäure Accord 10 mg Tabletten | 10 mg | tableta | peroralna uporaba |
| AT - Avstrija | Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjördur, Iceland | Alendronsäure Actavis 70 mg einmal wöchentlich Tabletten | 70 mg | tableta | peroralna uporaba |
| AT - Avstrija | Arcana Arzneimittel GmbH, |
| Hütteldorfer Straße 299, |
| A-1140 Wien, |
| Austria |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

AT - Avstrija

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

Alemol 70 mg - einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alenat 70 mg - einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendrohexal 70 mg - einmal wöchentlich Filmtabletten

70 mg

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

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

Alendronorm 70 mg - einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure Accord 70 mg einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure Accord 10 mg Tabletten

10 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure Actavis 70 mg einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

Arcana Arzneimittel GmbH,

Hütteldorfer Straße 299,

A-1140 Wien,

Austria

Alendronsäure ‧Arcana‧ 70 mg - einmal wöchentlich - Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure Bluefish 70 mg einmal wöchentlich Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure ‧Interpharm‧ 70 mg einmal wöchentlich - Tabletten

70 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure ‧Interpharm‧ 10 mg - Tabletten

10 mg

tableta

peroralna uporaba

AT - Avstrija

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

Alendronsäure 1A Pharma 70 mg - einmal wöchentlich Filmtabletten

70 mg

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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

tableta

peroralna uporaba

AT - Avstrija

Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria

Alendronsäure Sandoz 70 mg - einmal wöchentlich Filmtabletten

70 mg

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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

tableta

peroralna uporaba

AT - Avstrija

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

tableta

peroralna uporaba

AT - Avstrija

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

Fosamax 10 mg - Tabletten

10 mg

tableta

peroralna uporaba

BE - Belgija

| 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

tableta

peroralna uporaba

BE - Belgija

| 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

tableta

peroralna uporaba

BE - Belgija

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

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

10 mg

tableta

peroralna uporaba

BE - Belgija

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

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Alendronate EG

70 mg

tableta

peroralna uporaba

BE - Belgija

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

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

10 mg

tableta

peroralna uporaba

BE - Belgija

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

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Alendronate Mylan

70 mg

tableta

peroralna uporaba

BE - Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Alendronate teva

70 mg

tableta

peroralna uporaba

BE - Belgija

| 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

tableta

peroralna uporaba

BE - Belgija

| 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

tableta

peroralna uporaba

BG - Bolgarija

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

Tchaikapharma

1172 Sofia

1 G. M. Dimitrov Blvd

Sofia

Bulgaria

Fosanate

70 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg , Germany

Instrel

70 mg

tableta

peroralna uporaba

BG - Bolgarija

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

Smarjeska cesta 6, 8501 Novo mesto –

Slovenia

Lindron

10 mg

tableta

peroralna uporaba

BG - Bolgarija

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

Teva Pharmaceuticals

N.V.Gogol 15

ЕООД

Sofia

Bulgaria

Tevanate

70 mg

tableta

peroralna uporaba

BG - Bolgarija

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

Alendronat Actavis

70 mg

tableta

peroralna uporaba

BG - Bolgarija

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

Forosa

70 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

| 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

tableta

peroralna uporaba

CY - Ciper

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

Fosamax tablet 70 mg

70 mg

tableta

peroralna uporaba

CY - Ciper

Pharmanel Pharmaceuticals SA, 106 Marathons Avenue, Athens, Greece

Difonate tablet 70 mg

70 mg

tableta

peroralna uporaba

CY - Ciper

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

Ledronin tablet 70 mg

70 mg

tableta

peroralna uporaba

CY - Ciper

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

Alendronic -Acid Arrow tablet 10 mg

10 mg

tableta

peroralna uporaba

CY - Ciper

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

Alendronic -Acid Arrow tablet 70 mg

70 mg

tableta

peroralna uporaba

CY - Ciper

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

Alendronic Acid Aurobindo tablet 70 mg

70 mg

tableta

peroralna uporaba

CZ - Češka

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

Aldrion 70 mg

70 mg

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

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

Actavis Group hf.

Reykavikurvegi 76-78

220 Hafnarfirdi

Iceland

Alendronat Actavis 70 mg

70 mg

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

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

Sandoz GmbH, Biochemiestraße 10

6250 Kundl, Austria

Alendronat Sandoz 70

70 mg

tableta

peroralna uporaba

CZ - Češka

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

Ratiopharm GmbH, Graf-Arco-Straße 3

89079 Ulm, Germany

Alendronat-Ratiopharm 70 mg

70 mg

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

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

Merck Sharp & Dohme BV

Waarderweg 39, 2031 BN Haarlem, Netherlands

Fosamax 70 mg 1xtýdně

70 mg

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

CZ - Češka

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

Gendron 70 mg

70 mg

tableta

peroralna uporaba

CZ - Češka

| 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

tableta

peroralna uporaba

DE - Nemčija

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

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevanate 10 mg Tabletten

11,6 mg

tableta

peroralna uporaba

DE - Nemčija

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

TEVA Deutschland GmbH

Wasastr. 50

D-01445 Radebeul

Tevanate 70 mg Tabletten

81,2 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta in mehka kapsula

peroralna uporaba

DE - Nemčija

| 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

tableta in mehka kapsula

peroralna uporaba

DE - Nemčija

| 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

tableta in mehka kapsula

peroralna uporaba

DE - Nemčija

| 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

tableta in mehka kapsula

peroralna uporaba

DE - Nemčija

| 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

tableta in mehka kapsula

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Alendron 10 mg Tabletten

13,05 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

esparma GmbH

Seepark 7

D-39116 Magdeburg

Alendron esparma 70 mg einmal wöchentlich Tabletten

91,36 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Alendron-Hexal 10 mg Tabletten

13,05 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 70 mg Tablette

91,36 mg

tableta

peroralna uporaba

DE - Nemčija

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

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Alendro-Q 10 mg Tabletten

13,05 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Alendromed 70 mg

91,36 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendronsäure Mylan 70 mg Tabletten

91,37 mg

tableta

peroralna uporaba

DE - Nemčija

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

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendrosäure dura 70 mg Tabletten

91,37 mg

tableta

peroralna uporaba

DE - Nemčija

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

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Alendrossa 10 mg

13,05 mg

tableta

peroralna uporaba

DE - Nemčija

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

Orion Corporation

Orionintie 1

FIN-=2200 ESPOO

Alendronsäure Orion 70 mg Tabletten

91,36 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta in filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 2) |
| --- |
| Rua da Tapada Grande, n2 |
| P-2710-089 ABRUNHEIRA, SINTRA |

TECNIMEDE - Sociedade Técnico-Medicinal, S.A. (BS 2)

Rua da Tapada Grande, n2

P-2710-089 ABRUNHEIRA, SINTRA

Alendronsäure Tecnimede 70 mg Filmtabletten

91,35 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DK - Danska

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

Alendronat "1A Farma"

70 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Alendronat "Actavis"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Arrow"

10 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Arrow"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Bluefish"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Mylan"

10 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Mylan"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Orifarm"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Orion"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "PCH"

10 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Ranbaxy"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Sandoz"

70 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Alendronat "Stada"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Teva"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "ratiopharm"

70 mg

tableta

peroralna uporaba

DK - Danska

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

Fasamax Ugetablet

70 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Stada"

10 mg

tableta

peroralna uporaba

DK - Danska

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

Alendronat "Teva"

10 mg

tableta

peroralna uporaba

EL - Grčija

| VIANEX S.A. |
| --- |
| TATIOIOU STREET |
| Nea Erythrea 14671 |

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX

10 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| VIANEX S.A. |
| --- |
| TATIOIOU STREET |
| Nea Erythrea 14671 |

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX

5 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| VIANEX S.A. |
| --- |
| TATIOIOU STREET |
| Nea Erythrea 14671 |

VIANEX S.A.

TATIOIOU STREET

Nea Erythrea 14671

FOSAMAX ONCE WEEKLY

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

FARAN ABEE PRODUCTION AND COMMERCE OF MEDICINAL PRODUCTS

ACHAIAS AND TROIZINIAS, KIFISSIA 14564

OSASTON

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

BIOMEDICA-CHEMICA S.A.

G. LYRA 25

KATW KIFISSIA

AMPINE

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

KLEVA AFBEE

PARNITHOS AVENUE 189

ACHARNES ATTIKIS 13675

DARGOL

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| MED-ONE AFBEE |
| --- |
| AGIOU PETROU 30 & EPAMEINONDA |
| ACHARNES 13675 |

MED-ONE AFBEE

AGIOU PETROU 30 & EPAMEINONDA

ACHARNES 13675

DEBENAL

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

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

ALAPIS ABEE

AUTOKRATOROS NIKOLAOU 2

ATHENS 17671

MELDOZ

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

VELKA HELLAS AEBE

KAPODISTRIOU AND KORINTHOU 12

NEO PSYCHIKO 15451

OSTAVEN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

OSTEONAT

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

MEDARTE PHARMACEUTICALS ΑΒΕΕ

SPYROU VRETTOU 10

METAMORFOSI 14452

OSTALERT

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

VOCATE PHARMACEUTICALS S.A.

GOUNARI 150,

GLYFADA 16674

FOSAZOM

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

GENEPHARM S.A.

18km MARATHONOS AVENUE

PALLINI ATTIKIS 15351

FOSALEN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

SANTA PHARMA S.A.

ASKLIPIOU 4

KRYONERI ATTIKIS 14568

ALEFOS

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

IASIS PHARMAC.HELLAS

137 FYLIS AVENUE

KAMATERO 13451

LEDRONIN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

DIFONATE

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

ANFARM HELLAS S.A.

PERIKLEOUS 53-57

GERAKAS ATTIKIS 15344

RIDON

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

AURORA PHARMACEUTICALS S.A.

EVROU 4 & MESSINIAS 2

GERAKAS 15344

AURODREN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

VIOFAR LTD

ETHNIKIS ANTISTASEWS & TRIZINIAS

ACHARNES 13671

DEPAREX

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

BIOSPRAY ABEE

18KM MARATHONOS AVENUE

PALLINI 15344

ALENDRAL

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

FARMATHEN HELLAS ABEE

MARATHONOS AVENUE 144

PALLINI 15351

POROCALM

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

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

RAFARM AEBE

KORINTHOU 12

NEO PSYCHIKO 15451

MOSMASS

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

ROTTAPHARM HELLAS S.A.

PRDUCTION AND COMMERCE OF PHARMACEUTICALS

ACHAIAS AND TRIZINIAS

NEA KIFISSIA 14564

LOZOSTUN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

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

SPECIFAR ABEE

28TH OCTOBER 1

AGIA VARVARA 123 51

DROFAZ

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

EVANGELOS KALOFOLIAS & CO IAPHARM

MENANDROU 54

ATHENS 10431

FOSANDRON

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

TARGET PHARMA LTD

MENANDROU 54

ATHENS 10431

ARTHROPLUS

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

VIVAX PHARMACEUTICALS LTD,

DERVENAKION 38

GERAKAS ATTIKIS 15344

EN-POR

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| PHARMANEL PHARMACEUTICALS S.A. |
| --- |
| MARATHONOS 106, |
| GERAKAS 15344 |

PHARMANEL PHARMACEUTICALS S.A.

MARATHONOS 106,

GERAKAS 15344

MORALEN

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

FARMEX S.A.

KIFISSOU AVENUE 132

ATHENS 12131

ENIMON

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

ALET PHARMACEUTICALS ABEE

AIDINIOU 26,

CHALANDRI 12461

ALEDROLET

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

PHARMA LINE S.A.

TH. PETALA 41

NEA CHALKIDONA 14343

ZULGAR

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

EL - Grčija

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

HELP ΑΒΕΕ

VALAORITOU 10

METAMORFOSI ATTIKIS 14452

OSTEOS

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

FARMEDIA AE

ATHINAS 22 & APOLLONOS

GERAKAS ATTIKIS 15344

FARMEMAX

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

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

FARMAZAK S.A.

NAOUSSIS 31

VOTANIKOS 10447

ZAKODRONATE

70 MG/TAB

tableta

peroralna uporaba

EL - Grčija

| 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

tableta

peroralna uporaba

ES - Španija

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

FOSAMAX Semanal 70 mg comprimidos

70 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

FOSAMAX 10 mg Comprimidos

10 mg

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL MYLAN 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL ALTER 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

CALBION SEMANAL 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

BIFOAL SEMANAL 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL RATIOPHARM 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO TEVA 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL MABO 70 mg COMPRIMIDOS

70 mg

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL SANDOZ 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL NORMON 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL RANBAXY 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

SEMANDROL SEMANAL 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRÓNICO SEMANAL QUALIGEN 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL RIMAFAR 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL KERN PHARMA 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL KORHISPANA 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

LEFOSAN SEMANAL 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ADELAN SEMANAL 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

FARMALIDER, S.A. Aragoneses, 15 28108 Alcobendas

ACIDO ALENDRONICO SEMANAL FARMALIDER 70 mg comprimidos recubiertos con película

70 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

ALENDROGYN 70 mg comprimidos recubiertos con película

70 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

FARMALIDER, S.A. Aragoneses, 15 28108 Alcobendas

ALENDROFARM 70 mg comprimidos recubiertos con pelicula

70 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL COMBIX 70 mg comprimidos recubiertos con película

70 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL PENSA 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL RANBAXYGEN 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ÁCIDO ALENDRÓNICO SEMANAL CINFA 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

ACIDO ALENDRONICO SEMANAL LAREQ 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

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

tableta

peroralna uporaba

ES - Španija

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

ALENVIR SEMANAL 70 mg comprimidos

70 mg

tableta

peroralna uporaba

ES - Španija

| 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

tableta

peroralna uporaba

ET - Estonija

| 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

tableta

peroralna uporaba

ET - Estonija

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

ALENDRONIC ACID ACCORD 70 MG

70 mg

tableta

peroralna uporaba

ET - Estonija

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

ALENDRONIC ACID ACCORD 10 MG

10 mg

tableta

peroralna uporaba

ET - Estonija

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

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjördur ICELAND

LENDRATE

70 mg

tableta

peroralna uporaba

ET - Estonija

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

Gedeon Richter Plc. Gyömrõi ut 19-21

1103 Budapest HUNGARY

SEDRON

70 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

tableta

peroralna uporaba

ET - Estonija

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

DENSIDRON

70 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

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

Orion Corporation Orionintie 1

FIN-02200 Espoo FINLAND

ALENDROONHAPE ORION

70 mg

tableta

peroralna uporaba

ET - Estonija

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

RALENOST 70 MG

70 mg

tableta

peroralna uporaba

ET - Estonija

| 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

tableta

peroralna uporaba

ET - Estonija

| 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

tableta

peroralna uporaba

FI - Finska

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

Alendronat Ranbaxy

70 mg

tableta

peroralna uporaba

FI - Finska

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

Alendronat Actavis

70 mg

tableta

peroralna uporaba

FI - Finska

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

Alendronat Arrow

10 mg

tableta

peroralna uporaba

FI - Finska

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

Alendronat Arrow

70 mg

tableta

peroralna uporaba

FI - Finska

Bluefish Pharmaceuticals AB, Torsgatan 11, 11123 STOCKHOLM, Sweden

Alendronat Bluefish

70 mg

tableta

peroralna uporaba

FI - Finska

Hexal A/S, Kanalholmen 8-12, 2650 HVIDOVRE, Denmark

Alendronat Hexal

70 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Alendronat Mylan

70 mg

tableta

peroralna uporaba

FI - Finska

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Alendronat Orifarm

70 mg

tableta

peroralna uporaba

FI - Finska

Orion Corporation, Orion Pharma, Orionintie 1, 02200 Espoo, Finland

Alendronat Orion

70 mg

tableta

peroralna uporaba

FI - Finska

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

Alendronat ratiopharm

70 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark

Alendronat Sandoz

70 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Merck Sharp & Dohme B.V., Waarderweg 39, P.O. BOX 581, 2031 BN HAARLEM, Netherlands

Fosamax

10 mg

tableta

peroralna uporaba

FI - Finska

Merck Sharp & Dohme B.V., Waarderweg 39, P.O. BOX 581, 2031 BN HAARLEM, Netherlands

Fosamax

70 mg

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta in žvečljiva tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta

peroralna uporaba

HU - Madžarska

| 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]

tableta in mehka kapsula

peroralna uporaba

HU - Madžarska

| 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]

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IE - Irska

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Co. Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Co. Tipperary

Ireland

Osteomel Once weekly

70 mg

tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IE - Irska

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |

Rowex Ltd

Bantry

Co. Cork

Romax Once Weekly 70 mg Tablets

70 mg

tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IE - Irska

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

tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IE - Irska

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom

Fosalen 10 mg Tablets

10 mg

tableta

peroralna uporaba

IE - Irska

PLIVA Pharma Ltd. Vision House, Bedford Road, Petersfield, Hants, GU32 3QB, United Kingdom

Fosalen Once Weekly 70 mg Tablets

70 mg

tableta

peroralna uporaba

IE - Irska

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Tevanate Once Weekly 70 mg Tablets

70 mg

tableta

peroralna uporaba

IE - Irska

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, The Netherlands

Fosalen Once Weekly 70 mg Tablets

70 mg

tableta

peroralna uporaba

IE - Irska

Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden.

Alendronic Acid Bluefish Once weekly 70 mg Tablets

70 mg

tableta

peroralna uporaba

IE - Irska

| 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

tableta

peroralna uporaba

IS - Islandija

Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow

10 mg

tableta

peroralna uporaba

IS - Islandija

Arrow Generics Ltd., Unit 2 Eastman Way Stevenage, Hertz SG1 4SZ U.K

Alendroarrow week tablet

70 mg

tableta

peroralna uporaba

IS - Islandija

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Alendronat Actavis

70 mg

tableta

peroralna uporaba

IS - Islandija

Ranbaxy (UK) Limited, C.P. House 97-107 Uxbridge Road, Ealing Londo W5 5TL U.K

Alendronat Ranbaxy

70 mg

tableta

peroralna uporaba

IS - Islandija

Merck Sharp & Dohme B.V., Waaderveg 39, PC Haarlem, The Netherlands

Fosamax week tablet

70 mg

tableta

peroralna uporaba

IS - Islandija

Williams & Halls ehf, Hverfisgata 105 101 Reykjavík, Iceland

Ostacid

70 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

10 mg

tableta

peroralna uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ALENDROS

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| ACTAVIS GROUP PTC EHF |
| --- |
| Reykjavikurvegi 76-78 |

ACTAVIS GROUP PTC EHF

Reykjavikurvegi 76-78

ALENDRONATO ACTAVIS

70 mg

tableta

peroralna uporaba

IT - Italija

| AGIPS FARMACEUTICI Srl |
| --- |
| Via Amendola 4 - 16035 |
| Rapallo (GE) |

AGIPS FARMACEUTICI Srl

Via Amendola 4 - 16035

Rapallo (GE)

GLAMOR

70 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| ALMUS Srl |
| --- |
| Via Cesarea, 11/10 - 16121 |
| Genova |

ALMUS Srl

Via Cesarea, 11/10 - 16121

Genova

ALENDRONATO ALMUS

70 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| ARROW GENERICS LTD |
| --- |
| Unit 2, Eastman way |
| Stevenage, Herts SG1 4SZ |

ARROW GENERICS LTD

Unit 2, Eastman way

Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

10 MG

tableta

peroralna uporaba

IT - Italija

| ARROW GENERICS LTD |
| --- |
| Unit 2, Eastman way |
| Stevenage, Herts SG1 4SZ |

ARROW GENERICS LTD

Unit 2, Eastman way

Stevenage, Herts SG1 4SZ

ALENDRONATO ARROW

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| BIOHEALTH PHARMACEUTICALS Srl |
| --- |
| Via Bolognese, 250 |
| Pistoia - Italy |

BIOHEALTH PHARMACEUTICALS Srl

Via Bolognese, 250

Pistoia - Italy

ASTON

70 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| DOC GENERICI Srl |
| --- |
| Via Manuzio, 7 - 20124 |
| Milano |

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC GENERICI

70 mg

tableta

peroralna uporaba

IT - Italija

| DOC GENERICI Srl |
| --- |
| Via Manuzio, 7 - 20124 |
| Milano |

DOC GENERICI Srl

Via Manuzio, 7 - 20124

Milano

ALENDRONATO DOC

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

10 mg

tableta

peroralna uporaba

IT - Italija

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ALENDRONATO EG

70 mg

tableta

peroralna uporaba

IT - Italija

| EPIFARMA Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ALENIC

70 mg

tableta

peroralna uporaba

IT - Italija

| EPIFARMA Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

EPIFARMA Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO EPIFARMA

70 mg

tableta

peroralna uporaba

IT - Italija

| FG Srl |
| --- |
| Via San Rocco, 6 - 85033 |
| Episcopia (PZ) |

FG Srl

Via San Rocco, 6 - 85033

Episcopia (PZ)

ACIDO ALENDRONICO FG

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| HEXAL SpA |
| --- |
| Via Paracelso, 16 - 20041 |
| Agrate Brianza (MI) |

HEXAL SpA

Via Paracelso, 16 - 20041

Agrate Brianza (MI)

ALENDRONATO HEXAL

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| ISTITUTO GENTILI SpA |
| --- |
| Via San Giuseppe Cottolengo, 15 - 20143 |
| Milano |

ISTITUTO GENTILI SpA

Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

10 mg

tableta

peroralna uporaba

IT - Italija

| ISTITUTO GENTILI SpA |
| --- |
| Via San Giuseppe Cottolengo, 15 - 20143 |
| Milano |

ISTITUTO GENTILI SpA

Via San Giuseppe Cottolengo, 15 - 20143

Milano

GENALEN

70 mg

tableta

peroralna uporaba

IT - Italija

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

ALENDRONATO ALTER

70 mg

tableta

peroralna uporaba

IT - Italija

| MERCK SHARP & DOHME |
| --- |
| Ltd |
| Hertford Road, Hoddesdon |
| Hertfordshire EN119BU |

MERCK SHARP & DOHME

Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

10 mg

tableta

peroralna uporaba

IT - Italija

| MERCK SHARP & DOHME |
| --- |
| Ltd |
| Hertford Road, Hoddesdon |
| Hertfordshire EN119BU |

MERCK SHARP & DOHME

Ltd

Hertford Road, Hoddesdon

Hertfordshire EN119BU

FOSAMAX

70 mg

tableta

peroralna uporaba

IT - Italija

| MYLAN SpA |
| --- |
| Via Vittor Pisani, 20 - 20124 |
| Milano |

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ALENDRONATO MYLAN GENERICS

70 mg

tableta

peroralna uporaba

IT - Italija

| NEOPHARMED Srl |
| --- |
| Via San Giuseppe Cottolengo, 15 - 20143 |
| Milano |

NEOPHARMED Srl

Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

10 mg

tableta

peroralna uporaba

IT - Italija

| NEOPHARMED Srl |
| --- |
| Via San Giuseppe Cottolengo, 15 - 20143 |
| Milano |

NEOPHARMED Srl

Via San Giuseppe Cottolengo, 15 - 20143

Milano

ADRONAT

70 mg

tableta

peroralna uporaba

IT - Italija

| PENSA PHARMA SpA |
| --- |
| Via Rossellini Ippolito, 12 |
| 20124 - Milano |

PENSA PHARMA SpA

Via Rossellini Ippolito, 12

20124 - Milano

ALENDRONATO PENSA

70 mg

tableta

peroralna uporaba

IT - Italija

| PHARMEG Srl |
| --- |
| Via dei Giardini, 24 - 85033 |
| Episcopia (PZ) |

PHARMEG Srl

Via dei Giardini, 24 - 85033

Episcopia (PZ)

PORODRON

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| RATIOPHARM GMBH |
| --- |
| Graf Arco-strasse, 3 |
| Ulm D-89070 |

RATIOPHARM GMBH

Graf Arco-strasse, 3

Ulm D-89070

ALENDRONATO RATIOPHARM

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| SANDOZ SpA |
| --- |
| L.go U. Boccioni, 1 - 21040 |
| Origgio (VA) |

SANDOZ SpA

L.go U. Boccioni, 1 - 21040

Origgio (VA)

ALENDRONATO SANDOZ

70 mg

tableta

peroralna uporaba

IT - Italija

| SEGIX ITALIA Srl |
| --- |
| Via Del Mare, 36 - 00040 |
| Pomezia (RM) |

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

10 mg

tableta

peroralna uporaba

IT - Italija

| SEGIX ITALIA Srl |
| --- |
| Via Del Mare, 36 - 00040 |
| Pomezia (RM) |

SEGIX ITALIA Srl

Via Del Mare, 36 - 00040

Pomezia (RM)

DRALENOS

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano - Italy |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano - Italy

ALENDRONATO TEVA

70 mg

tableta

peroralna uporaba

IT - Italija

| 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

tableta

peroralna uporaba

LT - Litva

KRKA d.d., Šmarješka Cesta 6 8501 Novo mesto, Slovenia

Lindron

10 mg

tableta

peroralna uporaba

LT - Litva

Sandoz d.d., Verovškova 57 SI-1000 Ljubljana Slovenia

Alendon

70 mg

tableta

peroralna uporaba

LT - Litva

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Lendrate

70 mg

tableta

peroralna uporaba

LT - Litva

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

70 mg

tableta

peroralna uporaba

LT - Litva

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Alendronic acid Accord

10 mg

tableta

peroralna uporaba

LT - Litva

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Alenotop

70 mg

tableta

peroralna uporaba

LT - Litva

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Tevanate

70 mg

tableta

peroralna uporaba

LT - Litva

Mepha Lda., Lagoas Park, Edificio 5-A, Piso 2, 2740-298 Porto Salvo, Portugal

Densidron

70 mg

tableta

peroralna uporaba

LT - Litva

Ranbaxy UK Ltd., 20 Balderton Street London W1K 6TL, United Kingdom

Ralenost

70 mg

tableta

peroralna uporaba

LT - Litva

Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary

Sedron

70 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street 83-200 Starogard Gdański, Poland

Ostemax

70 mg

tableta

peroralna uporaba

LT - Litva

UAB „Merck Sharp & Dohme“, Kęstučio 59/27, LT-08124 Vilnius, Lithuania

Fosamax

70 mg

tableta

peroralna uporaba

LT - Litva

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

Alendorion

70 mg

tableta

peroralna uporaba

LU - Luksemburg

| 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

tableta

peroralna uporaba

LV - Latvija

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium Accord

10 mg

tableta

peroralna uporaba

LV - Latvija

Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, united Kingdom

Alendronate sodium Accord

70 mg

tableta

peroralna uporaba

LV - Latvija

Orion Corporation, Orionintie 1, FI-02200 Espoo Finland

Alendorion

70 mg

tableta

peroralna uporaba

LV - Latvija

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Alenotop

70 mg

tableta

peroralna uporaba

LV - Latvija

Mepha Lda., Lagoas Park, 2740-298 Porto Salvo, Portugal

Densidron

70 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 19-21, Hungary

Sedron

70 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Pharmaceutical Works Polpharma SA., 19 Pelplinska Str., 83-200 Starogard Gdanski, Poland

Ostemax

70 mg

tableta

peroralna uporaba

LV - Latvija

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Lendrate

70 mg

tableta

peroralna uporaba

LV - Latvija

SIA"Merck Sharp & Dohme Latvija", Skanstes iela 13, Riga LV-1013, Latvia

Fosamax

70 mg

tableta

peroralna uporaba

MT - Malta

Mepha - Investigação, Desenvolvimento e Fabricação Farmaceutica, Lda.

Densidron

70 mg

filmsko obložena tableta

peroralna uporaba

MT - Malta

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Fosamax

70 mg

tableta

peroralna uporaba

MT - Malta

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.

Alendronic Acid 10 mg tablets

10 mg

tableta

peroralna uporaba

MT - Malta

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, United kingdom.

Alendronic Acid 70 mg tablets

70 mg

tableta

peroralna uporaba

MT - Malta

Aurobindo Pharma (Malta) Ltd, 46/2 South Street, Valletta VLT11, Malta

Alendronic Acid 70 mg tablet

70 mg

tableta

peroralna uporaba

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

tableta

peroralna uporaba

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

tableta

peroralna uporaba

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

tableta

peroralna uporaba

NL - Nizozemska

acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald, Germany

Osteonorm 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| ratiopharm Nederland bv |
| --- |
| Florapark 4 |
| 2012 HK Haarlem Netherlands |

ratiopharm Nederland bv

Florapark 4

2012 HK Haarlem Netherlands

Alendroninezuur ratiopharm 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Alendroninezuur 10 PCH

10 mg

tableta

peroralna uporaba

NL - Nizozemska

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA Haarlem Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem Netherlands

Alendroninezuur 70 PCH

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

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

Alendroninezuur Arrow 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

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

Apotex Europe BV

Darwinweg 20

2333 CR Leiden Netherlands

Alendroninezuur Apotex 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| Ranbaxy Belgium NV |
| --- |
| Leuvensestraat 28b |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendratol 10 mg

10 mg

tableta

peroralna uporaba

NL - Nizozemska

| Ranbaxy Belgium NV |
| --- |
| Leuvensestraat 28b |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendratol 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| Ranbaxy Belgium NV |
| --- |
| Leuvensestraat 28b |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Randronate 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 10 mg

10 mg

tableta

peroralna uporaba

NL - Nizozemska

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Alendroninezuur Sandoz 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| Mylan BV |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten Netherlands |

Mylan BV

Dieselweg 25

3752 LB Bunschoten Netherlands

Alendroninezuur Mylan 10 mg

10 mg

tableta

peroralna uporaba

NL - Nizozemska

| Mylan BV |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten Netherlands |

Mylan BV

Dieselweg 25

3752 LB Bunschoten Netherlands

Alendroninezuur Mylan 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| Apothecon B.V. |
| --- |
| Nijverheidsweg 3, 3771 ME Barneveld Netherlands |

Apothecon B.V.

Nijverheidsweg 3, 3771 ME Barneveld Netherlands

Alendroninezuur 70A

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| 06796 Brehna Germany |

mibe GmbH Arzneimittel

Münchener Str. 15

06796 Brehna Germany

Ostadil 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

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

Actavis Group PTC ehf

Reykjavikurvegur 76-78,220 Hafnarfjordur

Alendroninezuur Actavis 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

Bluefish Pharmaceuticals AB, Torsgatan 11 111 23 Stockholm Sweden

Akendroninezuur Bluefish 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| WILL-PHARMA |
| --- |
| Wilgenlaan 5 |
| 1161 JK Zwanenburg |
| Netherlands |

WILL-PHARMA

Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Bonendro

70 mg / 1 000 mg / 880 IU

tablet + zrnca kombinirano pakiranje

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta

peroralna uporaba

NL - Nizozemska

| WILL-PHARMA |
| --- |
| Wilgenlaan 5 |
| 1161 JK Zwanenburg |
| Netherlands |

WILL-PHARMA

Wilgenlaan 5

1161 JK Zwanenburg

Netherlands

Alendronax 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom

Alendroninezuur Accord 10 mg

10 mg

tableta

peroralna uporaba

NL - Nizozemska

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom

Alendroninezuur Accord 70 mg

70 mg

tableta

peroralna uporaba

NL - Nizozemska

| Ranbaxy Belgium NV |
| --- |
| Leuvensestraat 28b |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Alendroninezuur 70 Ranbaxy

70 mg

tableta

peroralna uporaba

NO - Norveška

Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom

Alendronat Arrrow

10 mg

tableta

peroralna uporaba

NO - Norveška

Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom

Alendronat Arrrow

70 mg

tableta

peroralna uporaba

NO - Norveška

ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm Germany

Alendronate ratiopharm

70 mg

tableta

peroralna uporaba

NO - Norveška

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

10 mg

tableta

peroralna uporaba

NO - Norveška

Merck Sharp and Dohme B.V., Postbus 581, Waarderweg 39, Haarlem, NL-2003 PC, Netherlands

Fosamax

70 mg

tableta

peroralna uporaba

NO - Norveška

Bluefish Pharmaceuticals AB Torsgatan 11, SE-11123 Stockholm, Sweden

Alendronat Bluefish

70 mg

tableta

peroralna uporaba

NO - Norveška

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Alendronat Mylan

70 mg

tableta

peroralna uporaba

NO - Norveška

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Alendronat Mylan

70 mg

tableta

peroralna uporaba

NO - Norveška

Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S, Danmark

Alendronat Sandoz

70 mg

tableta

peroralna uporaba

NO - Norveška

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Alendronat Teva

10 mg

tableta

peroralna uporaba

NO - Norveška

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Alendronat Teva

70 mg

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

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

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Austria

Aldron 70

70 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

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

Orion Corporation

Orionintie 1A, FI-02200 Espoo, Finland

Alendrion

70 mg

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

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

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Austria

AlendroLek 70

70 mg

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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.

tableta

peroralna uporaba

PL - Poljska

| PHARMABILL |
| --- |
| Jægersborg Alle 213 2 th |
| DK-2820 Gentofte |
| Denmark |

PHARMABILL

Jægersborg Alle 213 2 th

DK-2820 Gentofte

Denmark

Alendronat Pharmabill

70 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Alendronat-ratiopharm 70

70 mg

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

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

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Lendrate

70 mg

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198, |
| Poznan, Poalnd |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198,

Poznan, Poalnd

Rekostin 70 mg

70 mg

tablets

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3 1600-875 Lisboa Portugal

Ácido Alendrónico Lendral

70 mg

tableta

peroralna uporaba

PT - Portugalska

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Mylan

70 mg

tableta

peroralna uporaba

PT - Portugalska

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés, Portugal

Ácido Alendrónico Mylan

10 mg

tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia

Ácido Alendrónico Actavis

70 mg

tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour, Islândia

Caldronate

70 mg

tableta

peroralna uporaba

PT - Portugalska

Almus, Lda. Rua Engenheiro Ferreira Dias, 772 4149-014 Porto

Ácido Alendrónico Almus

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Alter

70 mg

tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Alter

10 mg

tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Bifosal 10 mg Comprimidos

10 mg

tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina, Portugal

Ácido Alendrónico Bifosal 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

PT - Portugalska

APceuticals - Farmacêutica, Lda.

Ácido Alendrónico Apceuticals

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Apotex Europe, B.V. Darwinweg 20 2333 CR Leiden Netherland

Ácido Alendrónico Apotex

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Atlantic Pharma - Produções Farmacêuticas, S.A. Zona Industrial da Abrunheira, Rua da Tapada Grande, 2 2710-089 Sintra Portugal

Ácido Alendrónico Blocan

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

70 mg

tableta

peroralna uporaba

PT - Portugalska

Aurobindo Pharma (Portugal), Unipessoal Lda. Av. do Forte, no 3 - Parque Suécia, Edifício. IV, 2o 2794-038 Carnaxide, Portugal

Ácido Alendrónico Glob

10 mg

tableta

peroralna uporaba

PT - Portugalska

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico Nozat

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa, Portugal

Ácido Alendrónico Baldacci

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Bluepharma - Indústria Farmacêutica, S.A. São Martinho do Bispo Apartado 7003 3045-016 Coimbra, Portugal

Ácido Alendrónico Bluepharma

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide, Portugal

Ácido alendrónico Cinfa

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley HU17 OLD East Yorkshire, UK

Ácido Alendrónico Dr. Reddy's

70 mg

tableta

peroralna uporaba

PT - Portugalska

Faribérica - Produtos Farmacêuticos, S.A. Estrada de Luz, 90 - 9o D/E 1600-160 Lisboa, Portugal

Ácido Alendrónico Faribérica

70 mg

tableta

peroralna uporaba

PT - Portugalska

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal

Ácido Alendrónico Rinicas

70 mg

tableta

peroralna uporaba

PT - Portugalska

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra, Portugal

Ácido Alendrónico Farmoz

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal

Ácido Alendrónico Germed

70 mg

tableta

peroralna uporaba

PT - Portugalska

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide, Portugal

Ácido Alendrónico Normon

70 mg

tableta

peroralna uporaba

PT - Portugalska

Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal

Alehelm

70 mg

tableta

peroralna uporaba

PT - Portugalska

Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal

Aleostito

70 mg

tableta

peroralna uporaba

PT - Portugalska

ITF Farma - Produtos Farmacêuticos, Lda. Rua Consiglieri Pedroso, 123 - Queluz de Baixo 2730-056 Barcarena, Portugal

Ácido Alendrónico ITF

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico Labesfal

10 mg

tableta

peroralna uporaba

PT - Portugalska

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros, Portugal

Ácido Alendrónico Labesfal

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche, Portugal

Ácido Alendrónico Azevedos

70 mg

tableta

peroralna uporaba

PT - Portugalska

Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98 3000-312 Coimbra, Portugal

Ácido Alendrónico Basi

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo, Portugal

Ácido Alendrónico Stroban

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Parke-Davis - Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 10 2740-271 Porto Salvo, Portugal

Ácido Alendrónico Parke-Davis

70 mg

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

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

tableta

peroralna uporaba

PT - Portugalska

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Ácido Alendrónico Sandoz 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

PT - Portugalska

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal

Ácido Alendrónico 1Apharma

70 mg

tableta

peroralna uporaba

PT - Portugalska

Sociedade J. Neves, Lda. Parque Industrial do Seixal 2840-068 Paio Pires, Portugal

Ácido Alendrónico J. Neves 70 mg Comprimidos

70 mg

tableta

peroralna uporaba

PT - Portugalska

Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal

Adronat

10 mg

tableta

peroralna uporaba

PT - Portugalska

Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa, Portugal

Adronat 70 mg

70 mg

tableta

peroralna uporaba

PT - Portugalska

Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira 2710-089 Sintra Portugal

Ácido Alendrónico Ecosis 70 mg Comprimidos

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Tetrafarma - Produtos Farmacêuticos, Lda. Rua Helena Aragão, 20 R/C Frente - Massamá 2745-879 Queluz, Portugal

Ácido Alendrónico Tetrafarma

70 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

MERCK SHARP & DOHME ROMÂNIA S.R.L. Bucharest Business Park Șos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 5 mg

5 mg

tableta

peroralna uporaba

RO - Romunija

MERCK SHARP & DOHME ROMÂNIA S.R.L. Bucharest Business Park Șos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 10 mg

10 mg

tableta

peroralna uporaba

RO - Romunija

MERCK SHARP & DOHME ROMÂNIA S.R.L. Bucharest Business Park Șos. București-Ploiești, Nr. 1A,Clădirea C1, Etaj 3,Sector 1, București, România

FOSAMAX 70 mg

70 mg

tableta

peroralna uporaba

RO - Romunija

S.C. TEVA PHARMACEUTICALS S.R.L., Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 10 mg

10 mg

tableta

peroralna uporaba

RO - Romunija

S.C. TEVA PHARMACEUTICALS S.R.L., Str. Domnița Ruxandra nr. 12, Parter, Sectorul 2, București, România

TEVANAT 70 mg

70 mg

tableta

peroralna uporaba

RO - Romunija

SANDOZ S.R.L., Str. Livezeni nr. 7A, Târgu Mureș, România

ALENDRONAT SANDOZ

70 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

GEDEON RICHTER ROMÂNIA S.A., România

SEDRON

70 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD10 mg

10 mg

tableta

peroralna uporaba

RO - Romunija

ACCORD HEALTHCARE LIMITED, Sage house, 319 Pinner road, North Harrow HA1 4 HF, Middlesex, Marea Britanie

ACID ALENDRONIC ACCORD 70 mg

70 mg

tableta

peroralna uporaba

RO - Romunija

TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 10 mg

10 mg

tableta

peroralna uporaba

RO - Romunija

TERAPIA SA, Str. Fabricii nr. 124, Cluj Napoca, România

RANOS 70 mg

70 mg

tableta

peroralna uporaba

RO - Romunija

LABORATOARELE PROF. Dr. MORAIT, Str. Sperantei nr. 29, Bucuresti sector 2, Romania

ANDRONIK

70 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

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

ACID ALENDRONIC BLUEFISH

70 mg

tableta

peroralna uporaba

RO - Romunija

PHARMACEUTICAL WORKS POLPHARMA SA,19 Pelplińska Street, 83-200 Starogard Gdański, Polonia

OSTEMAX

70 mg

tableta

peroralna uporaba

RO - Romunija

Dr. REDDY’S LABORATORIES, Str. Av. Petre Crețu nr. 74, et. 1, ap. 2, sect. 1, București, România

INSTREL

70 mg

tableta

peroralna uporaba

RO - Romunija

| 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

tableta

peroralna uporaba

SE - Švedska

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax

10 mg

tableta

peroralna uporaba

SE - Švedska

Merck Sharp & Dohme BV, PO Box 581, NL-2003 PC Harlem, Netherlands (NLD)

Fosamax veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendronate Arrow

10 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendronate Arrow veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alenat

10 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alenat veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Medarin

10 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Medarin veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

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

Dedarin veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

CT Arzneimittel GmbH, Lengeder Strasse 42 a, DE-13407 Berlin, Germany

Gendarin veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland

Kendarin

10 mg

tableta

peroralna uporaba

SE - Švedska

PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield Hampshire, GU32 3QB, United Kingdom and Northern Ireland

Kendarin veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendroarrow

10 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

Alendroarrow veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

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

Alendronat ratiopharm veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendrostad

10 mg

tableta

peroralna uporaba

SE - Švedska

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendrostad veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendronat STADA

10 mg

tableta

peroralna uporaba

SE - Švedska

STADA Arzneimittel AG, Stadastrasse 2-18, DE-61118 Bad Vilbel, Germany (DEU)

Alendronat STADA veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)

Alendronat Interpharm

10 mg

tableta

peroralna uporaba

SE - Švedska

Interpharm ProduktionsgmbH, Effingerstrasse 21, AT-1160 Wien, Austria (AUT)

Alendronat Interpharm veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal

10 mg

tableta

peroralna uporaba

SE - Švedska

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

AlendroLich

10 mg

tableta

peroralna uporaba

SE - Švedska

Arrow Generics Ltd, Unit 2 Eastman Way, Stevenage, Hertfordshire SGI 4SZ, United Kingdom and Northern Ireland (GBR)

AlendroLich Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Alendronat Orifarm Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Mylan AB Box 23033 104 35 Stockholm Sweden

Alendronat Mylan Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendropol Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendrixen Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Polerixen Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

HELP S.A. Pharmaceuticals 10, Valaoritou Str. Metamorphosis 144 52 Athen Greece

Terixen Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alenpol Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Pharmaceutical Works Polpharma S.A. 19 Pelplinska Str. PL-83-200 Starogard Gdanski Poland

Alendronat Polpharma Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Ranbaxy (UK) Ltd 20 Baldertoon Street London W1K 6TL United Kingdom

Alendronat Ranbaxy Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Mylan AB Box 23033 104 35 Stockholm Sweden

Alendronat Mylan

10 mg

tableta

peroralna uporaba

SE - Švedska

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

Alendronat Sandoz Veckotablett

70 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark

Alendronat Hexal Veckotablett

70 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Denmark

Alendronat 1A Farma Veckotablett

70 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom

Alendronat Accord

10 mg

tableta

peroralna uporaba

SE - Švedska

Accord Healthcare Limited Sage House 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom

Alendronat Accord Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Bluefish Pharmaceuticals AB Torsgatan 11 111 23 Stockholm Sweden

Alendronat Bluefish Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Actavis Group PTC ehf. Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Island

Alendronat Actavis Veckotablett

70 mg

tableta

peroralna uporaba

SE - Švedska

Orion Corporation, Orion Pharma PO Box 65 FI-02101 Espoo Finland

Alendronat Orion Veckotablett

70 mg

tableta

peroralna uporaba

SI - Slovenija

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Alenax 70 mg tablete

70 mg

tableta

peroralna uporaba

SI - Slovenija

Pliva Ljubljana d.o.o., pot k sejmišču 35, SI-1231 Ljubljana- Črnuče, Slovenia

Alendor 70 mg tablete

70 mg

tableta

peroralna uporaba

SI - Slovenija

Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 10 mg

10 mg

tableta

peroralna uporaba

SI - Slovenija

Arrow Generics Limited, 2 Eastman Way, Stevenage, Hertfordshire, UK

Alendronat Arrow 70 mg

70 mg

tableta

peroralna uporaba

SI - Slovenija

Lek farmacevtska družba, d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia

Alendronat Lek 70 mg filmsko obložene tablete

70 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Kemofarmacija d.d., cesta na Brdo 100, SI-1000 Ljubljana Slovenia

Forosa 70 mg filmsko obložene tablete

70 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Merck Sharp& Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, SI-1000 Ljubljana

Fosamax enkrat tedensko 70 mg tablete

70 mg

tableta

peroralna uporaba

SI - Slovenija

Krka, tovarna zdravil, d.d., Šmarješka cesta 6, SI-8501 Novo mesto, Slovenia

Lindron 10 mg tablete

10 mg

tableta

peroralna uporaba

SI - Slovenija

Actavis Group PTC ehf., Reykjavikurvegi 78, 220 Hafnarfjordur, Iceland

Natrijev alendronat Actavis 70 mg tablete

70 mg

tableta

peroralna uporaba

SI - Slovenija

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, NL

Tevanate 70 mg tablete

70 mg

tableta

peroralna uporaba

SK - Slovaška

Merck Sharp & Dohme B.V. Waarderweg 39 P.O. Box 581, Haarlem, 2031 BN Netherlands

FOSAMAX 70 mg 1 x týždenne

70 mg

tableta

peroralna uporaba

SK - Slovaška

Bentley Pharmaceuticals Ireland Limited North Wall Quay 25 - 28 Dublin 1 Ireland

Gendron 70 Tablety

70 mg

tableta

peroralna uporaba

SK - Slovaška

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

Tevalen 70 mg

70 mg

tableta

peroralna uporaba

SK - Slovaška

Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary

Siranin 70 mg filmom obalené tablety

70 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

Generics (UK) Ltd. Station Close, Hertfordshire Potters Bar, EN6 1TL United Kingdom

Alendrogen 70 mg

70 mg

tableta

peroralna uporaba

SK - Slovaška

| 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

tableta

peroralna uporaba

SK - Slovaška

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

Alendronat-ratiopharm 70 mg

70 mg

tableta

peroralna uporaba

SK - Slovaška

| 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

tableta

peroralna uporaba

SK - Slovaška

| 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

peroralna raztopina

peroralna uporaba

SK - Slovaška

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

Actavis Group PTC ehf; Reykjavikurvegi 76-78,

220 Hafnarfjordur

Iceland

Alendronat Actavis

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosamax Once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Adronat Once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alegen Once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Alendros Once Weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

MERCK SHARP & DOHME LIMITED Hertford Road, Hoddesdon, Hertfordshire EN11 UK

Fosatrol Once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE

alendronic acid

70 mg

filmsko obložena tableta

peroralna uporaba

UK - Velika Britanija

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

filmsko obložena tableta

peroralna uporaba

UK - Velika Britanija

Gideon Richter Plc, Gyomrui Utca 19-21, Budapest H-1103, Hungary

alendronic acid

70 mg

filmsko obložena tableta

peroralna uporaba

UK - Velika Britanija

Dr Reddy's Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire HU17 0LD, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

Pliva Pharma Limited, Vision House, Bedford Road, Petersfield, Hampshire GU23 3QB, United Kingdom

alendronic acid once-weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Strandhaven Limited, 600 High Road, Seven Kings, Ilford, Essex IG3 8BS, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Prostrakan Limited, 3 Galabank Business Park, Queen Street, Galashiels, TD1 1QH, United Kingdom

Ostalis

70 mg

filmsko obložena tableta

peroralna uporaba

UK - Velika Britanija

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

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

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

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

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

10 mg

tableta

peroralna uporaba

UK - Velika Britanija

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid once weekly

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex HA1 4HF, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Resource Medical (UK) Limited, 2 Carlton Avenue, Batley, West Yorkshire WF17 7AQ, United Kingdom

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

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

tableta

peroralna uporaba

UK - Velika Britanija

Apotex Europe BV, Darwinweg 20, Leiden, NL 2333 CR, Netherlands

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Wockhardt UK Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK

alendronic acid

70 mg

tableta

peroralna uporaba

UK - Velika Britanija

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

alendronic acid

70 mg

tableta

peroralna uporaba

Zdravila, ki vsebujejo klodronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | Bayer Austria Ges.m.b.H. |
| Herbststraße 6 – 10 |
| A-1160 Wien, Austria |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

AT - Avstrija

Bayer Austria Ges.m.b.H.

Herbststraße 6 – 10

A-1160 Wien, Austria

Bonefos 800 mg - Filmtabletten

800 mg (Clodronate Disodium)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

koncentrat za raztopino za infundiranje

intravenous

AT - Avstrija

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

Lodronat 520 mg - Filmtabletten

520 mg (Clodronate Disodium)

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Актавис ЕАД, ул. "Атанас Дуков" No 29, София 1407, България

Sindronat

400 mg

trda kapsula

peroralna uporaba

CZ - Češka

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

CZ - Češka

| 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

trda kapsula

peroralna uporaba

CZ - Češka

| 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

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Roche s.r.o., Dukelských hrdinů 567/52, 170 00 Praha-Holešovice, Czech Republic

Lodronat 520

520 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| Bayer Vital GmbH |
| --- |
| Kaiser-Wilhelm-Allee |
| D-51373 Leverkusen |

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Bonefos pro infusione

75 mg

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| Bayer Vital GmbH |
| --- |
| Kaiser-Wilhelm-Allee |
| D-51373 Leverkusen |

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Bonefos

500 mg

trda kapsula

peroralna uporaba

DE - Nemčija

| Bayer Vital GmbH |
| --- |
| Kaiser-Wilhelm-Allee |
| D-51373 Leverkusen |

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

BONEFOS FILMTABLETTEN 800 mg

1 000 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

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

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Clodron beta 800 mg

1 000 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron HEXAL PI

374,9 mg

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg HEXAL Filmtabletten

1 000 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Clodron 800 mg HEXAL Filmtabletten

500 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Bayer AB, Postbox 606, Gustav III:s Boulevard 56, SE-16926 Solna

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

QUIMICA FARMACEUTICA BAYER, S.L. Av. Baix Llobregat, 3-5 08970 Sant Joan Despi

BONEFOS 400 mg cápsulas

400 mg

kapsula

peroralna uporaba

ET - Estonija

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

800 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

400 mg

trda kapsula

peroralna uporaba

ET - Estonija

| Bayer Schering Pharma OY Pansiontie 47 |
| --- |
| 20210 Turku FINLAND |

Bayer Schering Pharma OY Pansiontie 47

20210 Turku FINLAND

BONEFOS

60 mg 1 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

400 mg

trda kapsula

peroralna uporaba

FI - Finska

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Clodrobon

400 mg

trda kapsula

peroralna uporaba

FI - Finska

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Clodrobon

800 mg

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

kapsula

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

HU - Madžarska

| 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

tableta

peroralna uporaba

HU - Madžarska

| 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

trda kapsula

peroralna uporaba

HU - Madžarska

| 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

koncentrat za raztopino za infundiranje

parenteralna uporaba

IE - Irska

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Bonefos 800 mg film-coated tablets.

800 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Bayer Ab, Box 606, Solna, Sweden

Bonefos

800 mg

tableta

peroralna uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba

IT - Italija

| PROMEDICA Srl |
| --- |
| Via Palermo, 26/A - 43100 |
| Parma |

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intravenska uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

300 mg

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

CLASTEON

400 mg

trda kapsula

peroralna uporaba

IT - Italija

| EG SpA |
| --- |
| Via Pavia, 6 - 20136 |
| Milano - Italy |

EG SpA

Via Pavia, 6 - 20136

Milano - Italy

ACIDO CLODRONICO EG

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| FARMACEUTICI CABER SpA |
| --- |
| Viale Città d' Europa, 681 |
| 00144 Roma |

FARMACEUTICI CABER SpA

Viale Città d' Europa, 681

00144 Roma

OSTEONORM

100 mg

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

kapsula

peroralna uporaba

IT - Italija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| LABORATORI ALTER Srl |
| --- |
| Via Lomellina, 39 - 20124 |
| Milano |

LABORATORI ALTER Srl

Via Lomellina, 39 - 20124

Milano

DISODIO CLODRONATO ALTER

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

IT - Italija

| LISAPHARMA SpA |
| --- |
| Via Licinio, 11 |
| 22036 Erba (CO) |

LISAPHARMA SpA

Via Licinio, 11

22036 Erba (CO)

MOTICLOD

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

IT - Italija

| LISAPHARMA SpA |
| --- |
| Via Licinio, 11 |
| 22036 Erba (CO) |

LISAPHARMA SpA

Via Licinio, 11

22036 Erba (CO)

MOTICLOD

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| MYLAN SpA |
| --- |
| Via Vittor Pisani, 20 - 20124 |
| Milano |

MYLAN SpA

Via Vittor Pisani, 20 - 20124

Milano

ACIDO CLODRONICO MYLAN GENERICS

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

IT - Italija

| PROMEDICA Srl |
| --- |
| Via Palermo, 26/A - 43100 |
| Parma |

PROMEDICA Srl

Via Palermo, 26/A - 43100

Parma

CLODY

300 mg/10 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| ROTTAPHARM SpA |
| --- |
| Via Galleria Unione,5 |
| 20122 Milano (MI) |

ROTTAPHARM SpA

Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

100 mg/3,3 ml

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| ROTTAPHARM SpA |
| --- |
| Via Galleria Unione,5 |
| 20122 Milano (MI) |

ROTTAPHARM SpA

Via Galleria Unione,5

20122 Milano (MI)

OSTEOTAB

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA |
| --- |
| Via Biella, 8 |
| 20143 Milano |

SPA - SOCIETA' PRODOTTI ANTIBIOTICI SpA

Via Biella, 8

20143 Milano

DIFOSFONAL

400 mg

kapsula

peroralna uporaba

IT - Italija

| 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

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

CLODRONATO TEVA

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

IT - Italija

| 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

raztopina za injiciranje

IT - Italija

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma

TRAXOVICAL

100 mg/3,3 ml

raztopina za injiciranje

IT - Italija

ATHENA PHARMA ITALIA SRL Viale Citta D'Europa, 681 00144 Roma

TRAXOVICAL

300 mg/10 ml

raztopina za injiciranje

intravenska uporaba

LU - Luksemburg

| 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

raztopina za injiciranje

intravenska uporaba

LV - Latvija

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LV - Latvija

Bayer Schering Pharma Oy, Pansiontie 47, FIN-20210 Turku, Finland

Bonefos

400 mg

kapsula

peroralna uporaba

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

kapsula

peroralna uporaba

NL - Nizozemska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos capsules 400 mg

400 mg

trda kapsula

peroralna uporaba

NL - Nizozemska

Bayer B.V. Energieweg 1 3641 RT Mijdrecht

Bonefos tablets 800 mg

800 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

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

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

400 mg

trda kapsula

peroralna uporaba

PL - Poljska

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

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

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

Bayer Schering Pharma AG

Berlin, D-13342, Germany

Bonefos

800 mg

film coated tablets

peroralna uporaba

PL - Poljska

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

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Sindronat

400 mg

trda kapsula

peroralna uporaba

PT - Portugalska

Roche Farmacêutica Química, Lda. Estrada Nacional 249, 1, 2720-413 Amadora Portugal

Ostac

520 mg

obložena tableta

peroralna uporaba

PT - Portugalska

Lusalfarma - Especialidades Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 400 mg, capsules

400 mg

kapsula

peroralna uporaba

RO - Romunija

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 800 mg, capsules

800 mg

kapsula

peroralna uporaba

RO - Romunija

BAYER SCHERING PHARMA OY, Pansiontie 47, 20210 Turku, Finland

BONEFOS 60 mg/ml concentrate for solution for infusion

60 mg/ml

koncentrat za raztopino za infundiranje

parenteralna uporaba

RO - Romunija

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

koncentrat za raztopino za infundiranje

parenteralna uporaba

SE - Švedska

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

Bayer AB Box 606 169 26 Solna Sweden

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 60 mg/ml koncentrat za raztopine za infundiranje

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Bayer Schering Pharma Oy, Pansiontie 47, 20210 Turku, Finland

Bonefos 800 mg filmsko obložene tablete

800 mg

filmsko obložena tableta

peroralna uporab

SK - Slovaška

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

60 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SK - Slovaška

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

400 mg

trda kapsula

peroralna uporaba

SK - Slovaška

Bayer Schering Pharma Oy, Pansiontie 47, PL 415, 20210 Turku, Finland

Bonefos

800 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

400 mg

kapsula

peroralna uporaba

SK - Slovaška

Bayer Plc, bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA, UK

Bonefos

800 mg

obložena tableta

peroralna uporaba

UK – Velika Britanija

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK

Loron 540

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Clasteon

400 mg

kapsula

peroralna uporaba

UK – Velika Britanija

Beacon Pharmaceuticals Limited, 85, High strret, Tunbridge Wells, TN1 1YG, UK

Sodium clodronate

400 mg

kapsula

peroralna uporaba

UK – Velika Britanija

Caduceus Pharma Limited, 6th floor, 94 Wigmore Street, London W1U 3RF, UK

Disodium Clodronate

60 mg/ml

raztopina za injiciranje

intravenska uporaba

Zdravila, ki vsebujejo etidronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| BE - Belgija | Procter & Gamble Pharmaceuticals SA.NV. |
| Temselaan 100 |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

BE - Belgija

Procter & Gamble Pharmaceuticals SA.NV.

Temselaan 100

Didronel

200 mg

tableta

peroralna uporaba

BE - Belgija

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Osteodidronel

400 mg

tableta

peroralna uporaba

DE - Nemčija

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

mibe GmbH Arznzemittel

Münchener Str. 15

D-06796 Brehna

Etidronat 200 mg Jenapharm

200 mg

tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DE - Nemčija

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Etidron HEXAL Kombi

400 mg

1 250 mg

tableta in šumeča tableta

peroralna uporaba

DE - Nemčija

| 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

tableta

peroralna uporaba

DK - Danska

Procter & Gamble Pharmaceuticals UK Ltd., Rusham Park Technical Centre, Whitehall Lane, GB-TW20 9 NW Egham, Surrey, England

Didronate

200 mg

tableta

peroralna uporaba

DK - Danska

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

tableta

peroralna uporaba

EL - Grčija

| 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

trda kapsula

peroralna uporaba

EL - Grčija

| 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

trda kapsula

peroralna uporaba

EL - Grčija

| 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

trda kapsula

peroralna uporaba

EL - Grčija

PHARMACEUTICAL INDUSTRY PROEL EPAMEINONDAS G. KORONIS S.A.

ANFOZAN

400 MG/CAP

trda kapsula

peroralna uporaba

ES - Španija

LABORATORIOS VIÑAS, S.A. Provenza, 386 08025 Barcelona

OSTEUM

200 mg

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

ETIDRON

300 mg

kapsula

peroralna uporaba

NL - Nizozemska

Procter & Gamble Pharmaceuticals Nederland B.V. Postbus 2507 3000 CM Rotterdam Netherlands

Didronel 400

400 mg

tableta

peroralna uporaba

NL - Nizozemska

| 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

tableta + šumeča tableta

peroralna uporaba

NO - Norveška

Warner Chilcott UK Ltd.; Old Belfast Rd, Larne BT40 2SH, UK

Didronate + Calsium Kombinasjonspakning

400 mg/500 mg

tableta

peroralna uporaba

SE - Švedska

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

Didronate

200 mg

tableta

peroralna uporaba

SE - Švedska

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

tableta

peroralna uporaba

UK – Velika Britanija

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

ETIDRONATE DISODIUM

200 mg

tableta

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL

200 mg

tableta

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

DIDRONEL PMO

400 mg

tableta

peroralna uporaba

UK – Velika Britanija

Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK

TILOETCA COMBI

400 mg

tableta

peroralna uporaba

UK – Velika Britanija

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

DISODIUM ETIDRONATE

200 mg

tableta

peroralna uporaba

UK – Velika Britanija

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

DISODIUM ETIDRONATE

400 mg

tableta

peroralna uporaba

Zdravila, ki vsebujejo neridronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| IT - Italija | ABIOGEN PHARMA SpA |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

IT - Italija

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

25 mg

raztopina za injiciranje

intramuskularna uporaba, intravenska uporaba

IT - Italija

| ABIOGEN PHARMA SpA |
| --- |
| Via Meucci, 36 - 56014 |
| Ospedaletto (PI) |

ABIOGEN PHARMA SpA

Via Meucci, 36 - 56014

Ospedaletto (PI)

NERIXIA

100 mg

koncentrat za raztopino za infundiranje

intravenska uporaba

Zdravila, ki vsebujejo pamidronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | 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) | prašek in vehikel za raztopino za infundiranje | intravenska uporaba |
| AT - Avstrija | 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) | prašek in vehikel za raztopino za infundiranje | intravenska uporaba |
| AT - Avstrija | 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) | prašek in vehikel za raztopino za infundiranje | intravenska uporaba |
| AT - Avstrija | medac |
| Gesellschaft für klinische Spezialpräparate mbH |
| Fehlandtstraße 3 |
| D-20354 Hamburg, Germany |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

AT - Avstrija

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)

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

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)

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

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)

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

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)

koncentrat za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

| 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)

koncentrat za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

| 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)

koncentrat za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

| 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)

koncentrat za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

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

Pamidronat STADA 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung

3 mg/ml (Pamidronate Disodium)

koncentrat za raztopino za infundiranje

intravenska uporaba

AT - Avstrija

| 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)

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| Novartis Pharma N.V. |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma N.V.

Medialaan 40

1800 Vilvoorde

Belgium

Aredia

15 mg/5 ml

prašek za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| Novartis Pharma N.V. |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Novartis Pharma N.V.

Medialaan 40

1800 Vilvoorde

Belgium

Aredia

90 mg/10 ml

prašek za raztopino za infundiranje

intravenska uporaba

BE - Belgija

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

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Pamidrin

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| Hospira Benelux BVBA |
| --- |
| Stallestraat 63 |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| Hospira Benelux BVBA |
| --- |
| Stallestraat 63 |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

| Hospira Benelux BVBA |
| --- |
| Stallestraat 63 |
| 1180 Brussels |
| Belgium |

Hospira Benelux BVBA

Stallestraat 63

1180 Brussels

Belgium

Pamidronaatdinatrium Hospira

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

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

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Pamidronate EG

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BE - Belgija

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

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Pamidronate Mylan

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BG - Bolgarija

Tchaikapharma High Quality Medicines, 1, G.M. Dimitorv Blvd, 1172 Sofia, Bulgaria

Pamitor

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

BG - Bolgarija

Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuernberg, Germany

Aredia

30 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

BG - Bolgarija

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

Clastodron

3 mg/ml,

koncentrat za raztopino za infundiranje, 5 ml

intravenska uporaba

BG - Bolgarija

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

Clastodron

6 mg/ml

koncentrat za raztopino za infundiranje- 10 ml

intravenska uporaba

BG - Bolgarija

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

Clastodron

9 mg/ml

koncentrat za raztopino za infundiranje - 10 ml

intravenska uporaba

CY - Ciper

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

raztopina za infundiranje

intravenska uporaba

CZ - Češka

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

CZ - Češka

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

CZ - Češka

Medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstraße 3, D-20354 Hamburg, Germany

Pamidronate Medac 3 mg/ml

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

CZ - Češka

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

CZ - Češka

Torrex Chiesi CZ, s.r.o. , Na květnici 878/33, 140 00 Praha-Nusle, Czech Republic

Pamitor 15 mg/ml

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

prašek za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

prašek za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

prašek za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

prašek za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DE - Nemčija

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 15 mg

15 mg

prašek in vehikel

intravenska uporaba

DE - Nemčija

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 30 mg

30 mg

prašek in vehikel

intravenska uporaba

DE - Nemčija

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 90 mg

90 mg

prašek in vehikel

intravenska uporaba

DE - Nemčija

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Aredia 60 mg

60 mg

prašek in vehikel

intravenska uporaba

DE - Nemčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Helm AG, Nordkanalstrasse 28D, DE-20097 Hamburg, Germany

Epsilonat

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

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

Pamidrocell

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Hexal AG, Industriestrasse 25, DE-83607 Holzkirchen, Germany

Pamidronat "Hexal"

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Meda AS, Solvang 8, DK-3450 Allerød, Denmark

Pamidronat "Meda"

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

BMM Pharma AB, Blasieholmsgatan 2, SE-11148 Stockholm, Sweden

Pamidronatdinatrium "BMM Pharma"

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

Hospira UK Limited, Queensway, Royal Leamington Spa, GB-CV31 3RW Warwickshire, England

Pamidronatdinatrium "Hospira"

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

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

Pamidronatdinatrium "Teva"

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

DK - Danska

medac, Gesellschaft fur klinisch, Spezialpraeparate mbH, Fehlandstrasse 3, DE-20354 Hamburg, Germany

Pamifos

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| MEDICUS S.A. |
| --- |
| VALAORITOU 10 |
| METAMORFOSI ATTIKIS 14452 |

MEDICUS S.A.

VALAORITOU 10

METAMORFOSI ATTIKIS 14452

PAMIDRONE

60 MG/VIAL

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| MEDICUS S.A. |
| --- |
| VALAORITOU 10 |
| METAMORFOSI ATTIKIS 14453 |

MEDICUS S.A.

VALAORITOU 10

METAMORFOSI ATTIKIS 14453

PAMIDRONE

90 MG/VIAL

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

EL - Grčija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

EL - Grčija

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

ALAPIS ABEE

AUTOKRATOROS NIKOLAOU 2

ATHENS 17671

PAMERIT

15 MG/1 ML

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ES - Španija

NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes, 764 08013 Barcelona

AREDIA 30 mg polvo y disolvente para solución para perfusión

90 mg

raztopina za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ES - Španija

GENERIS FARMACÉUTICA, S.A. MOIÁ, 1, 2o 08006 BARCELONA

PAMIDRONATO GENERIS 15 mg/ml concentrado para solución para perfusión

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

PAMIDRONATO STADA 3 mg/ml concentrado para solución para perfusión

3 mg /ml

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Fehlandtstrasse 3 Hamburgo D-20354

PAMIFOS 3 mg/ml concentrado para solución para perfusión

3 mg /ml

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

PAMIDRONATO TEVA 3 mg/ml, concentrado para solución para perfusión

3 mg /ml

koncentrat za raztopino za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ES - Španija

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

raztopina za infundiranje

intravenska uporaba

ET - Estonija

| Novartis Finland OY Metsänneidonkuja 10 |
| --- |
| FIN-02130 Espoo FINLAND |

Novartis Finland OY Metsänneidonkuja 10

FIN-02130 Espoo FINLAND

AREDIA

15 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

ET - Estonija

Torrex Chiesi Pharma GmbH Gonzagagasse 16/16, 1010 Vienna AUSTRIA

PAMITOR 15 MG/ML

15 mg 1 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, 20354 Hamburg, Germany

Pamifos

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Paminject

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Meda Oy, Vaisalantie 4, 02130 Espoo, Finland

Pamidronat Meda

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

Hospira UK Limited, Queensway, Royal Leamington Spa, WARWICKSHIRE CV313RW, United Kingdom

Pamidronatdinatrium Hospira

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FI - Finska

BMM Pharma AB, Blasieholmsgatan 2, 11148 Stockholm, Sweden

Pamidronate BMM Pharma

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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,

raztopina

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

raztopina

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

FR - Francija

| 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

prašek in vehikel

intravenska uporaba

HU - Madžarska

| 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

prašek in vehikel za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

HU - Madžarska

| 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)

koncentrat za raztopino za infundiranje

parenteralna uporaba

IE - Irska

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

30 mg

prašek in vehikel za raztopino za infundiranje

počasna intravenska infuzija

IE - Irska

Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Aredia

90 mg

prašek in vehikel za raztopino za infundiranje

počasna intravenska infuzija

IS - Islandija

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 3 mg/ml

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IS - Islandija

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 6 mg/ml

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IS - Islandija

Hospira UK Limited, Queensway Royale Leamington Spa, Warwickshire CV31 3RW United Kingdom

Pamidronatdinatrium Hospira 9 mg/ml

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| HIKMA ITALIA SpA |
| --- |
| Viale Certosa, 10 |
| 27100 Pavia |

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

15 mg/5 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| HIKMA ITALIA SpA |
| --- |
| Viale Certosa, 10 |
| 27100 Pavia |

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

30 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| HIKMA ITALIA SpA |
| --- |
| Viale Certosa, 10 |
| 27100 Pavia |

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

60 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| HIKMA ITALIA SpA |
| --- |
| Viale Certosa, 10 |
| 27100 Pavia |

HIKMA ITALIA SpA

Viale Certosa, 10

27100 Pavia

PAMIDRONATO DISODICO HIKMA

90 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| 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

raztopina za infundiranje

intravenska uporaba

IT - Italija

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| HOSPIRA ITALIA Srl |
| --- |
| Via Orazio, 20/22 |
| 80122 Napoli |

HOSPIRA ITALIA Srl

Via Orazio, 20/22

80122 Napoli

PAMIDRONATO DISODICO HOSPIRA

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

IT - Italija

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

15 mg/5 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

30 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

60 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| PHARMATEX ITALIA Srl |
| --- |
| Via Appiani, 22 |
| 20121 Milano |

PHARMATEX ITALIA Srl

Via Appiani, 22

20121 Milano

TEXPAMI

90 mg/10 ml

raztopina za infundiranje

intravenska uporaba

IT - Italija

| RATIOPHARM GMBH |
| --- |
| Graf Arco-strasse, 3 |
| Ulm D-89070 |

RATIOPHARM GMBH

Graf Arco-strasse, 3

Ulm D-89070

PAMIDRONATO RATIOPHARM

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| TEVA ITALIA Srl |
| --- |
| Via Messina, 38 - 20154 |
| Milano |

TEVA ITALIA Srl

Via Messina, 38 - 20154

Milano

PAMIDRONATO TEVA

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| CRINOS SpA |
| --- |
| Via Pavia, 6 |
| 20136 Milano |

CRINOS SpA

Via Pavia, 6

20136 Milano

AMIDROX

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

IT - Italija

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

60 mg/4 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

90 mg/6 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

30 mg/2 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

9 mg/ ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

6 mg/ ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LT - Litva

Hospira UK Limited, Queensway Royal Leamington Spa Warwickshire CV 31 3RW, United Kingdom

Pamidronate disodium Hospira

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LU - Luksemburg

| NOVARTIS PHARMA GMBH |
| --- |
| 25, ROONSTRASSE |
| D 90429 NUERNBERG |

NOVARTIS PHARMA GMBH

25, ROONSTRASSE

D 90429 NUERNBERG

Aredia

15 mg

prašek za raztopino za infundiranje

intravenska uporaba

LU - Luksemburg

| EUROGENERICS S.A |
| --- |
| ESPLANADE HEYSEL, B. 22 |
| B 1020 BRUXELLES |

EUROGENERICS S.A

ESPLANADE HEYSEL, B. 22

B 1020 BRUXELLES

Paminject

3 mg/ml

raztopina za infundiranje

intravenska uporaba

LU - Luksemburg

| 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

raztopina za infundiranje

intravenska uporaba

LU - Luksemburg

| 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

raztopina za infundiranje

intravenska uporaba

LU - Luksemburg

| TEVA PHARMA BELGIUM S.A. |
| --- |
| 16, LAARSTRAAT |
| B 2610 WILRIJK |

TEVA PHARMA BELGIUM S.A.

16, LAARSTRAAT

B 2610 WILRIJK

Pamidrin

3 mg/ml

raztopina za infundiranje

intravenska uporaba

LV - Latvija

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LV - Latvija

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

30 mg/2 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LV - Latvija

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

60 mg/4 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

LV - Latvija

Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria

PAMITOR

90 mg/6 ml

koncentrat za raztopino za infundiranje

intravenska uporaba

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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

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

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

prašek za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

prašek za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

prašek za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

prašek za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 3 mg/ml

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 6 mg/ml

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

All-gen Pharmaceuticals & Generics B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands

Pamidronaatdinatrium Allgen 9 mg/ml

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 3 mg/ml

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 6 mg/ml

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

Hospira Benelux BVBA, Stallestraat 63 1180 Brussel Belgium

Pamidronaatdinatrium Hospira 9 mg/ml

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NL - Nizozemska

Medac Gesellschaft für klinische Spezialpreparate mbH Fehlandtstr. 3 20354 Hamburg Germany

Pamipro 3 mg/ml

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NO - Norveška

Meda, postboks 194, 1371 Asker Norawy

Pamidronat Meda

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NO - Norveška

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NO - Norveška

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

NO - Norveška

Hospira UK Limited, Queensway, Royal Leamington Spa, CV31 3RW Warwickshire, Great Britain

Pamidronatdinatrium Hospira

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Pamidronat-ratiopharm

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| VIPHARM S.A. |
| --- |
| Przewoźników st. 11 |
| 03-691 Warsaw, Poland |

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-15

15 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| VIPHARM S.A. |
| --- |
| Przewoźników st. 11 |
| 03-691 Warsaw, Poland |

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-30

30 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| VIPHARM S.A. |
| --- |
| Przewoźników st. 11 |
| 03-691 Warsaw, Poland |

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-60

60 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| VIPHARM S.A. |
| --- |
| Przewoźników st. 11 |
| 03-691 Warsaw, Poland |

VIPHARM S.A.

Przewoźników st. 11

03-691 Warsaw, Poland

Pamifos-90

90 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel, Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Pamistad

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| 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

koncentrat za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Aredia

60 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PL - Poljska

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg, Germany |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg, Germany

Aredia

90 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Hospira Portugal, Lda. Rua Amália Rodrigues, n.o 240, 2750-228 Cascais Portugal

Pamidran

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Pamidronato APS

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

prašek za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

PT - Portugalska

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

koncentrat za raztopino za infundiranje

intravenska uporaba

RO - Romunija

NOVARTIS PHARMA GmbH Roonstrasse 25 D-90429 Nürnberg, Germany

AREDIA 15 mg/ml powder and solvent for solution for infusion

15 mg/ml

prašek in vehikel za raztopino za infundiranje

parenteralna uporaba

RO - Romunija

TORREX CHIESI PHARMA GmbH Gonzagagasse 16/16, A-1010, Viena, Austria

PAMIDRONAT TORREX 15 mg/ml powder for solution for infusion

15 mg/ml

prašek in vehikel za raztopino za infundiranje

parenteralna uporaba

RO - Romunija

DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania

PAMIRED 60 powder for solution for infusion

60 mg

prašek in vehikel za raztopino za infundiranje

parenteralna uporaba

RO - Romunija

DR. REDDY'S LABORATORIES Str. Av. Petre Crețu, nr. 74, Sector 1, București, Romania

PAMIRED 30 powder for solution for infusion

30 mg

prašek in vehikel za raztopino za infundiranje

parenteralna uporaba

SE - Švedska

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

Pamidronatdinatrium Hospira

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

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

Pamidronatdinatrium Hospira

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

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

Pamidronatdinatrium Hospira

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

Meda AB 170 09 Solna Sweden

Pamidronat Meda

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

Teva Sweden AB Box 1070 251 10 Helsingborg Sweden

Pamidronat Teva

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

STADA Arzneimittel AG Stadastrasse 2-18 DE-61118 Bad Vilbel Germany

Pamidrocell

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

6 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SE - Švedska

BMM Pharma AB Blasieholmsgatan 2 111 48 Stockholm Sweden

Pamidronate BMM Pharma

9 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany

Aredia 15 mg prašek in vehikel za koncentrat za raztopino za infundiranje

15 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany

Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje

30 mg

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 30 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 60 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

SI - Slovenija

Torrex Chiesi Slovenija d.o.o., Trdinova 4, SI-1000 Ljubljana, Slovenia

Pamitor 90 mg koncentrat za raztopino za infundiranje

12,6 mg/ ml

prašek in vehikel za raztopino za infundiranje

intravenska uporaba

SK - Slovaška

Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria

Pamitor 15 mg/ml

15 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

SK - Slovaška

| medac GmbH Theaterstraße 6 |
| --- |
| D-22880 Wedel Germany |

medac GmbH Theaterstraße 6

D-22880 Wedel Germany

PAMIFOS

3 mg/ml

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

15 mg

prašek za raztopino za injiciranje

intravenska uporaba

UK – Velika Britanija

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

30 mg

prašek za raztopino za injiciranje

intravenska uporaba

UK – Velika Britanija

Novartis Pharmaceuticals UK Limited, Frimly Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

AREDIA DRY POWDER

90 mg

prašek za raztopino za injiciranje

intravenska uporaba

UK – Velika Britanija

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

3 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

6 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Actavis Group PTC EHF, Reykjavikurvegi 76-78, Hafnarfirdi IS-220 Iceland

PAMIDRONATE DISODIUM

9 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

3 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

6 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

UK – Velika Britanija

Apsala Limited, bayview House, 49 Northstrand Road,Dublin 3, Ireland

DISODIUM PAMIDRONATE

9 MG/ML

koncentrat za raztopino za infundiranje

intravenska uporaba

Zdravila, ki vsebujejo risedronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | sanofi-aventis GmbH ÖSTERREICH |
| SATURN Tower, Leonard-Bernstein-Straße 10 |
| A-1220 Wien, Austria |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

AT - Avstrija

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

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

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

Risedronat Hexal einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

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

Risedronat 1A Pharma einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

Sandoz GmbH, Biochemiestraße 10 A-6250 Kundl, Austria

Risedronat Sandoz einmal wöchentlich 35 mg Filmtabletten

35 mg (risedronate sodium)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

AT - Avstrija

| 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)

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

5 mg

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

30 mg

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

35 mg

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| 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

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| 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

filmsko obložena tablet in šumeča zrnca

peroralna uporaba

BE - Belgija

| 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

filmsko obložena tableta

peroralna uporaba

BE - Belgija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

| 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

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

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

Risedronat-ratiopharm

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND

RIGAT

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Zilar

5 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

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

Teva Pharmaceuticals

N.V. Gogol 15

ЕООД

Sofia

Bulgaria

Rizida

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

5 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

30 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Genericon Pharma Gesellschaft m.b.H, Hafnerstabe 211, 8054 Graz, Austria

Risedronat Genericon

35 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland

Risadis

5 mg

filmsko obložena tableta

peroralna uporaba

BG - Bolgarija

Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarjordur, Iceland

Risadis

35 mg

filmsko obložena tableta

peroralna uporaba

CY - Ciper

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL TABLET 5 MG

5 MG

tableta

peroralna uporaba

CY - Ciper

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL OAW/"ONCE A WEEK" TABLETS 35 MG

35 MG

tableta

peroralna uporaba

CY - Ciper

SANOFI AVENTIS CYPRUS LTD, CHARALAMBOU MOUSKOU 14, 2015 STROVOLOS, CYPRUS

ACTONEL (2 CONSEQUENTIAL DAYS PER MONTH)

75 MG

tableta

peroralna uporaba

CY - Ciper

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 5 MG

5 MG

tableta

peroralna uporaba

CY - Ciper

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 30 MG

30 MG

tableta

peroralna uporaba

CY - Ciper

ACTAVIS GROUP PTC ehf., REYKJAVIKURVEGUR 76-78, 220 HAFNAFJORDUR, ICELAND

BIFODRON TABLETS 35 MG

35 MG

tableta

peroralna uporaba

CY - Ciper

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 5 MG

5 MG

tableta

peroralna uporaba

CY - Ciper

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 30 MG

30 MG

tableta

peroralna uporaba

CY - Ciper

BEACON PHARMACEUTICAL LIMITED, 85 HIGH STREET, TUNBIDGE WELLS TN1 1YG, UK

RISEDRONATE SODIUM TABLET 35 MG

35 MG

tableta

peroralna uporaba

CY - Ciper

P T HADJIGEORGIOU CO LTD, 31 YILDIZ, P O BOX 53158, 3301 LEMESOS, CYPRUS

ATRONATE "ONCE A WEEK" TABLETS 35 MG

35 MG

tableta

peroralna uporaba

CY - Ciper

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 5 MG

5 MG

tableta

peroralna uporaba

CY - Ciper

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 30 MG

30 MG

tableta

peroralna uporaba

CY - Ciper

PHARMATHEN SA, DERVENAKION 6, 15351 PALLINI ATTIKI, GREECE

RISEPALLIN TABLETS 35 MG

35 MG

tableta

peroralna uporaba

CY - Ciper

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

RISEDRONATE ARROW TABLETS 35 MG

35 MG

tableta

peroralna uporaba

CZ - Češka

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 30 mg

30 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Actonel 5 mg

5 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital 35 mg potahované tablety

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

S.C. LaborMed Pharma S.A., Bd. Theodor Pallady nr. 44B, sector 3, Bucharest, Romania

Juverital 5 mg potahované tablety

5 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Sanofi-Aventis s.r.o., Evropská 846/176a, 160 00 Praha-Dejvice, Czech Republic

Norsed 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia

Risedronat Galex 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Galex d.d., Tišinska ul. 29g, 9000 Murska Sobota, Slovenia

Risedronat Galex 5 mg

5 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

| 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

filmsko obložena tableta

peroralna uporaba

CZ - Češka

| 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

filmsko obložena tableta

peroralna uporaba

CZ - Češka

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

Ratiopharm GmbH, Graf-Arco-Straße 3

89079 Ulm, Germany

Risedronat-Ratiopharm 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

| 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

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Ingers Industrial Solutions, s.r.o. , Slunná 271/16, 617 00 Brno-Komárov, Czech Republic

Tevanel 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

CZ - Češka

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

NORIFAZ 35 MG POTAHOVANÉ TABLETY

35 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DK - Danska

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Risostad

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Risostad

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Vionate

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Vionate

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Dimidronat

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Ellidronat

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Karadronat

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

ZaKlad Farmaceutyczny, Adamed Phama S.a, 33 Szkolna Street, PL-95054 Ksawerów; Poland

Norifaz

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate

75 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

DK - Danska

Sanofi-Aventis Denmark A/S, Slotsmarken 13, DK-3970 Hørsholm, Denmark

Optinate Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

CT Arzneimittel GmbH, Lengeder Str. 42A, DE-13407 Berlin, Germany

Racidrix

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Ridracid

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Ratiopharm GmbH, Graf-Arco-Strasse 3, DE-89079 Ulm, Germany

Rinon

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risdronostad

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risdronostad

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risdronostad

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Actavis Group PTC ehf., PO Box 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Risedronatnatrium "Actavis"

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Orifarm"

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Orifarm"

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Orifarm"

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Stada"

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Stada"

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Stada"

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risedronatnatrium "Teva"

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

5 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

30 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., Dervenakion str. 6, GR-15351 Pallini Attiki, Greece

Risepallin

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Riseratio

35 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Risonat

35 mg

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| SANOFI-AVENTIS AEBE |
| --- |
| SYNGROU AVENUE 348 BUILDING A |
| KALITHEA 17674 |

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17674

ACTONEL

5 MG/TAB

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| SANOFI-AVENTIS AEBE |
| --- |
| SYNGROU AVENUE 348 BUILDING A |
| KALITHEA 17675 |

SANOFI-AVENTIS AEBE

SYNGROU AVENUE 348 BUILDING A

KALITHEA 17675

ACTONEL

30 MG/TAB

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| PNG GEROLYMATOS MEDICAL S.A. |
| --- |
| ASKLIPIOU 13 |
| KRYONERI ATTIKIS 14568 |

PNG GEROLYMATOS MEDICAL S.A.

ASKLIPIOU 13

KRYONERI ATTIKIS 14568

MOTIVUS

35 MG/TAB

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| S.J.A. PHARM Ltd |
| --- |
| ARKOLEON 11 |
| 10445 PATISSIA |

S.J.A. PHARM Ltd

ARKOLEON 11

10445 PATISSIA

DIFOSFON-S

35 MG/TAB

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

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

AURORA PHARMACEUTICALS A.E.

EVROU 4 & MESSINIAS 2

GERAKAS 15344

BONMATE

35 MG/TAB

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

EL - Grčija

| 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

filmsko obložena tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

ACTONEL 30 mg comprimidos recubiertos

30 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

ACTONEL 5 mg comprimidos recubiertos

5 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

| 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

filmsko obložena tableta

peroralna uporaba

ES - Španija

| 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

filmsko obložena tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

ACTONEL SEMANAL 35 mg comprimidos recubiertos con película

35 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

ACTONEL 75 mg comprimidos recubiertos con película

75 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

LOSENTRA SEMANAL 35 mg comprimidos recubiertos con película

35 mg

filmsko obložena tableta

peroralna uporaba

ES - Španija

| 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

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

filmsko obložena tableta

peroralna uporaba

ES - Španija

| 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/880UI granulado efervescente

35 mg + 1 000 mg / 880 IU

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

ES - Španija

| 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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

ES - Španija

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

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL QUALIGEN 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL RATIOPHARM 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEMYL SEMANAL 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

MIOSEN SEMANAL 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

HEXAL PHARMA GMBH Carlberger Gasse, 44 A-1235 Viena

RISEDRONATO SEMANAL HEXAL 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL SANDOZ 35 mg comprimidos recubiertos con pelicula

filmsko obložena tableta

peroralna uporaba

ES - Španija

1A PHARMA GMBH Eduard Kittenberger Gasse, 56 A-1235 Viena

RISEDRONATO SEMANAL SALUTAS 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL STADA 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL KERN PHARMA 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

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

RISEDRONATO SEMANAL RANBAXY 35 mg comprimidos recubiertos con película

filmsko obložena tableta

peroralna uporaba

ES - Španija

ZAKLAD FARMACEUTYCZNY ADAMED PHARMA, S.A. ul. Szkolna, 33 95-054 Ksawerow/Lodz

NORIFAZ 35 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA

filmsko obložena tableta

peroralna uporaba

ET - Estonija

Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND

OSSINAT

5 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

Portfarma ehf Kollunarklettsvegur 2, 104 Reykjavik ICELAND

OSSINAT

35 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| ratiopharm GmbH Graf-Arco-Strasse 3 |
| --- |
| D-89079 Ulm GERMANY |

ratiopharm GmbH Graf-Arco-Strasse 3

D-89079 Ulm GERMANY

RIBIDRON

35 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

filmsko obložena tableta

peroralna uporaba

ET - Estonija

Zaklad Farmaceutyczny Adamed Pharma S.A. 33 Szkolna Street, 95-054 Ksawerow POLAND

NORIFAZ

35 mg

filmsko obložena tableta

peroralna uporaba

ET - Estonija

| 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

filmsko obložena tableta

peroralna uporaba

ET - Estonija

Vale Pharmaceuticals Ltd 1B Gurtnafleur Business Park, Gurtnafleur, clonmel, Co. Tipperary IRELAND

RIGAT

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

30 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

5 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate Combi D

35 mg + 1 000 mg / 880 IU

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

FI - Finska

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, LONDON W4 5YE, United Kingdom

Risedronat Ranbaxy

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

sanofi-Aventis Oy, Huopalahdentie 24, PL 22, 00350 Helsinki, Finland

Optinate

75 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Oy Leiras Finland Ab, PL 1406, 00101 Helsinki, Finland

Riseos

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

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

Riseratio

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Vionate

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

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

Risedronat Actavis

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

30 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Risedronat Orifarm

5 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Sandoz A/S, C. F. Tietgens Boulevard 40, 5220 ODENSE SØ, Denmark

Risedronat Sandoz

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Risedronat Stada

35 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Stada Arzneimittel AG, Stadastrasse 2 - 18, 61118 BAD VILBEL, Germany

Risedronat Stada

5 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

TEVA Sweden AB, Järnvägsgatan 11, BOX 1070, 25110 HELSINGBORG, Sweden

Risedronat Teva

35 mg

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta in žvečljiva tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta in žvečljiva tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta in žvečljiva tableta

peroralna uporaba

HU - Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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)

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 5,74 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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 mgRisedronate sodium

(equivalent to 40,17 mg Risedronate

sodium hemipentahydrate

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

| 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

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

filmsko obložena tableta

peroralna uporaba

HU - Madžarska

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

filmsko obložena tableta

peroralna uporaba

IE - Irska

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |

Rowex Ltd

Bantry

Co. Cork

Ridate Once a Week 35 mg film-coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta + šumeče granule

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IE - Irska

| 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

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

5 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

30 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate

75 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Combi D

35 mg and 1 000 mg/880 IU

filmsko obložena tablet in šumeče granule

peroralna uporaba

IS - Islandija

Sanofi-aventis Norge AS, Strandveien 15 Box 133, 1325 Lysaker, Norway

Optinate Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland

Risedronat Sodium Portfarma

5 mg

filmsko obložena tableta

peroralna uporaba

IS - Islandija

Qualigen S.L., Avda. Barcelona 69 08970 , Sant Joan Despi, (Barcelona) Spain

Risedronat Qualigen

35 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta

peroralna uporaba

IT - Italija

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

5 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

30 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

35 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| WARNER CHILCOTT ITALY Srl |
| --- |
| Viale Giorgio Ribotta, 11 |
| 00144 Roma |

WARNER CHILCOTT ITALY Srl

Viale Giorgio Ribotta, 11

00144 Roma

ACTONEL

75 mg

filmsko obložena tableta

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta + šumeče granule

peroralna uporaba

IT - Italija

| 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

filmsko obložena tableta + šumeče granule

peroralna uporaba

LT - Litva

ZENTIVA, k.s., Ukabelovny 130 Dolní Měcholupy 102 37, Praha 10, Czechia

Risendros

35 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

UAB „SANOFI-AVENTIS LIETUVA“, A. Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

UAB „SANOFI-AVENTIS LIETUVA“, A. Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

5 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

Teva Pharma B.V., Computerweg 10 3542 DR Utrecht, The Netherlands

Risonate

35 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

Zakład Farmaceutyczny Adamed Pharma S.A, Ul. Szkolna 33, 95-054 Ksawerów, Poland

Norifaz

35 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Islandia

Risedronate sodium Actavis

35 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

UAB „SANOFI-AVENTIS LIETUVA“, A. Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

UAB „SANOFI-AVENTIS LIETUVA“, A. Juozapavičiaus g. 6/2 LT-09310 Vilnius, Lithuania

Actonel

35 mg + 1 000 mg/880 IU

filmsko obložena tableta + šumeče granule

peroralna uporaba

LT - Litva

ratiopharm GmbH, Graf-Arco-Strasse 3, Ulm D-89079, Germany

Ribidron

35 mg

filmsko obložena tableta

peroralna uporaba

LU - Luksemburg

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

5 mg

filmsko obložena tableta

peroralna uporaba

LU - Luksemburg

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

30 mg

filmsko obložena tableta

peroralna uporaba

LU - Luksemburg

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

LU - Luksemburg

| 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

filmsko obložena tableta + šumeče granule

peroralna uporaba

LU - Luksemburg

| 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

filmsko obložena tableta

peroralna uporaba

LU - Luksemburg

| Warner Chilcott Pharmaceuticals BVBA |
| --- |
| Pegasuslaan 5 |
| 1831 Diegem, |
| Belgium |

Warner Chilcott Pharmaceuticals BVBA

Pegasuslaan 5

1831 Diegem,

Belgium

Actonel hebdomadaire

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland

Risedronate sodium Portfarma

5 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Portfarma ehf, Köllunarklettsvegi 2, 104 Reykjavík, Iceland

Risedronate sodium Portfarma

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Praha 10, Czech Republic

Risendros

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel Combi

35 mg + 1 000 mg/880 IU

filmsko obložena tableta + šumeče granule

peroralna uporaba

LV - Latvija

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel OAW

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Vale Pharmaceuticals Ltd., 1B Gurtnafleur Business Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland

Rigat

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

Ribidron

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Netherlands

Risonate

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Zakład Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33, 95-054 Ksawerow, Poland

Norifaz

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Risedronate Sodium Actavis

35 mg

filmsko obložena tableta

peroralna uporaba

LV - Latvija

sanofi-aventis Latvia SIA, Kr. Valdemara iela 33-8, Riga LV 1010, Latvia

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

5 mg

filmsko obložena tableta

peroralna uporaba

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

30 mg

filmsko obložena tableta

peroralna uporaba

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Once a Week

35 mg

filmsko obložena tableta

peroralna uporaba

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

tableta

peroralna uporaba

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

tableta

peroralna uporaba

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

tableta

peroralna uporaba

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

MT - Malta

Sanofi-Aventis Malta Ltd, Triq Kan. K. Pirotta, Birkirkara, BKR 1114, Malta

Actonel Plus Ca & D

35 mg + 1 000 mg/880IU

filmsko obložena tableta + šumeče granule

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta + šumeče granule

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| Ranbaxy Belgium NV |
| --- |
| Leuvensestraat 28b |
| 1800 Vilvoorde Belgium |

Ranbaxy Belgium NV

Leuvensestraat 28b

1800 Vilvoorde Belgium

Natriumrisedronaat 35 mg Ranbaxy

35 mg

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

Sandoz B.V., Veluwezoom 22 1327 AH Almere Netherlands

Natriumrisedronaat Sandoz® wekelijks 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten Netherlands

Risedronaatnatrium Mylan 5 mg

5 mg

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NL - Nizozemska

| 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

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate

5 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate

30 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Sanofi-aventis, Strandveien 15, 1366 Lysaker Norway

Optinate Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

5 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

30 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Orifarm Energivej 15, POB 69, DK-5260 Odense S Danmark

Risedronat Orifarm

35 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

Norifaz

35 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Risedronat Actavis

35 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Teva Sweden AB, Box 1070, 25110 Helsingborg, Sweden

Risedronat Teva

35 mg

filmsko obložena tableta

peroralna uporaba

NO - Norveška

Mylan AB, Box 23033, 10435 Stockholm, Sweden

Vionate

35 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

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

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfirdi, Iceland

Bifodron

35 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, 89073, Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm, 89073, Germany

Risedronat-ratiopharm

35 mg

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PL - Poljska

| 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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Norsed

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Risedronato de sódio Generis

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo, 3045-016 Coimbra Portugal

Risedronato de sódio Bluepharma

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

obložena tableta

peroralna uporaba

PT - Portugalska

GP - Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 - Venda Nova, 2700-451 Amadora Portugal

Risedronato de sódio GP

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira, 2710-089 Sintra Portugal

Risedronato de sódio Farmoz

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Alter, S.A. Estrada Marco do Grilo - Zemouto, 2830 Coina Portugal

Risedronato de sódio Alter

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Solufarma - Produtos Farmacêuticos Unipessoal, Lda. Av. dos Bombeiros Voluntários, no 146 - 1o, 2765-201 Estoril Portugal

Risedronato de sódio Riseflore

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B, 1549-005 Lisboa Portugal

Risedronato de sódio Medilusa

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9G - Escritório 3, 1600-875 Lisboa Portugal

Risedronato de sódio Rizat

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo, 3465-157 Santiago de Besteiros Portugal

Risedronato de sódio Labesfal

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark, 2790-221 Carnaxide Portugal

Risedronato de sódio Cinfa

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Atral

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo Portugal

Risedronato de sódio Vida

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Decomed Farmacêutica, S.A. Rua Sebastião e Silva, 56, 2745-838 Massamá Portugal

Zectoel

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Risedronato de sódio Germed

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o, 2740-244 Porto Salvo Portugal

Actonel

75 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Risedronato de sódio Actavis

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Laboratórios Azevedos - Indústria Farmacêutica, S.A. Estrada da Quinta, 148-148 A, Manique de Baixo 2645-436 Alcabideche Portugal

Norifaz

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio Mylan

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Algés Portugal

Risedronato de sódio Mylan

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Qualigen, S.L. Avenida Barcelona, 69, Sant Joan Despí, 08970 Barcelona Espanha

Risedronato de sódio Qualigen

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio Sandoz

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Risedronato de sódio 1APharma

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

5 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

30 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia

Claronate

35 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Arrow Generics, Ltd. Unit 2 - Eastman Way, SG1 4SZ Stevenage - Hertfordshire Reino Unido

Risedronato de sódio Arrow

35 mg

tableta

peroralna uporaba

PT - Portugalska

Zaklad Farmaceutyczny Adamed Pharma S.A., Szkolna Street 33, 95-054 Ksawerow, Poland

Norifaz, 35 mg, comprimidos revestidos por pelicula

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

AVENTIS PHARMA AB Bryggvagen 16-18, 11768 Stockholm, Sweden

ACTONEL 5 mg film coated tablets

5 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

| 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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

| 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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

TERAPIA SA Str. Fabricii nr. 124, Cluj-Napoca, Romania

OSODENS 35 mg film coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

| 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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

Actavis Group PTC ehf Reykjavikurvegi 76-78, 220 Hafnarfjordur, Island

OSTEORON 35 mg film coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

Antibiotice S.A. Valea Lupului nr. 1, 707410 Iași, Romania

LORINE 35 mg film coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

TEVA PHARMACEUTICALS S.R.L. Str. Domnița Ruxandra, nr. 12 parter, sector 2București, Romania

RISEDRONAT TEVA 35 mg film coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

STADA Hemofarm SRL Zugrav Nedelcu nr. 3, Timișoara, Romania

RISEDRONAT SODIC HF 35 mg, film coated tablets

35 mg

filmsko obložena tableta

peroralna uporaba

RO - Romunija

| 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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

| 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

filmsko obložena tableta

peroralna uporaba

RO - Romunija

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

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan

5 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan

30 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

5 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

30 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

5 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

30 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

5 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

30 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Septimum

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan Combi

35 mg + 1 250 mg calcium

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi D

35 mg + 1 000 mg/880 IE

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

SE - Švedska

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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi D

35 mg + 1 000 mg/880 IE

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi D

35 mg + 1 000 mg/880 IE

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

SE - Švedska

Sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate

75 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed

75 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sanofi-aventis S.p.A. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Norsed Combi D

35 mg + 500 mg/400 IE

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra Combi D

35 mg + 500 mg/400 IE

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Ranbaxy (UK) Ltd 3rd floor, CP house 97-107, Uxbridge Road Ealing, London W5 5TL United Kngdom

Risedronate Ranbaxy

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark

Risedronat Sandoz

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

5 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

30 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Risedronat Orifarm

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany

Riseratio

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Teva Sweden AB Box 1070 251 10 Helsingborg Sweden

Risedronat Teva

35 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan

75 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Gruppo LePetit S.r.l. Viale Luigi Bodio 37/b IT-20158 Milano Italy

Avestra

75 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

sanofi-aventis AB Box 14142 167 14 Bromma Sweden

Optinate Combi D

35 mg + 500 mg/400 IE

filmsko obložena tableta

peroralna uporaba

SE - Švedska

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

Fortipan Combi D

35 mg + 500 mg/400 IE

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Zaklad Farmaceutyczny Adamed Pharma S.A., ul. Szkolna 33 95-054 Ksawerow , Polen

Risedronat Adamed Pharma

35 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 30 mg filmsko obložene tablete

30 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 5 mg filmsko obložene tablete

5 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel 75 mg filmsko obložene tablete

75 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel enkrat tedensko 35 mg filmsko obložene tablete

35 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Sanofi-aventis d.o.o., Dunajska cesta 151, SI-1000 Ljubljana

Actonel Combi D

35 mg + 1 000 mg/880 IE

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

SI - Slovenija

Galex, d.d., Tišinska ulica 29g, Murska Sobota, Slovenia

Riserdonat Galex 35 mg filmsko obložene tablete

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel, 61118 Germany

Risedronat STADA 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

Actavis Group PTC ehf Dalshraun 1 220 Hafnarfjordur Iceland

Bifodron 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

Zaklad Farmaceutyczny Adamed Pharma SA 33 Szkolna Street Ksawerów, 95-054 Poland

Norifaz 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

Gedeon Richter Plc. Gyômrôi út 19-21 1103, Budapest Hungary

Nurrid 35 mg

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

ZENTIVA, k.s. U kabelovny 130, Dolní Měcholupy 102 37 Praga 10, Czech Republic

RISENDROS 35 mg - TBL FLM

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

5 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266 Bucharest, Romania

Juverital

35 mg

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

SK - Slovaška

| 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

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Sandoz Limited, 37 Woolmer Way, Bordon, Hampshire GU35 9QE

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium 5 mg tablets

5 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 5 mg Tablets

5 mg'

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 30 mg Tablets

30 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel Once a Week 35 mg Tablet

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

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

filmsko obložena tableta in šumeča zrnca

peroralna uporaba

UK – Velika Britanija

Warner Chilcott UK Limted, Old Belfast Road, Millbrook, Larne, Co. Antrim BT40 2SH, UK

Actonel 75 mg tablet

75 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

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

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Winthrop Pharmaceuticals UK Ltd, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Norsed Once a Week

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Ranbaxy (UK) Limited, 95 Park Lane, Mayfair. London W1K 7TE, United Kingdom

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Ratiopharm GmbH, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hampshire, PO6 1UP

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 5 mg tablets

5 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 30 mg tablets

30 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Pharmathen SA, 6 Dervenakion Street, Pallini, Athens, GR-153 51, Greece

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 5 mg tablets

5 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 30 mg tablets

30 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells, Kent TN1 1YG, UK

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Zaklad Farmaceutyczny Adamed Pharma SA, ul. Szkolna 33, 95-054 Ksawerow, Poland

Norifaz 35 mg tablet

35 mg

filmsko obložena tableta

peroralna uporaba

UK – Velika Britanija

Apotex Europe BV, Darwinweg 20, 2333 C R Leiden, The Netherlands

Risedronate sodium 35 mg tablets

35 mg

filmsko obložena tableta

peroralna uporaba

Zdravila, ki vsebujejo tiludronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| BE - Belgija | Sanofi-Aventis Belgium NV |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

BE - Belgija

Sanofi-Aventis Belgium NV

Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

tableta

peroralna uporaba

ES - Španija

SANOFI AVENTIS, S.A. Josep Plá, 2 08019 Barcelona

SKELID 200 mg comprimidos

200 mg

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

LU - Luksemburg

| Sanofi-Aventis Belgium NV |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium NV

Culliganlaan 1C

1831 Diegem

Belgium

Skelid

200 mg

tableta

peroralna uporaba

UK – Velika Britanija

Sanofi-Synthelabo Limited, One Onslow Street, Guildford, Surry GU1 4YS, UK

Skelid

200 mg

tableta

peroralna uporaba

Zdravila, ki vsebujejo ibandronsko kislino in so pridobila dovoljenje za promet v Evropski uniji

| Država članica EU/EGP | Imetnik dovoljenja za promet | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| DE - Nemčija | Mylan dura GmbH |
| Wittichstr. 6 |
| D-64295 Darmstadt |

Država članica EU/EGP

Imetnik dovoljenja za promet

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

DE - Nemčija

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Ibandronsäure dura 150 mg Filmtabletten

169,32 mg

filmsko obložena tableta

peroralna uporaba

DE - Nemčija

| 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

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece

Baxogar

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary

Etanorden

50 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Gedeon Richter Plc., Gyömröí út 19-21, HU-1103 Budapest, Hungary

Etanorden

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Mylan AB, Postbox 230 33, Ynglingagatan 14, Se-104 35 Stockholm, Sweden

Ibamyl

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

50 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Actavis Group PTC ehf., Postbox 425, Reykjavikurvegi 76-78, IS-220 Hafnarfjördur, Iceland

Ibandronat "Actavis"

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Arrow ApS, Hovedgaden 41, 2, DK-2970 Hørsholm, Denmark

Ibandronate "Arrow"

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Ibandronate "ratiopharm"

50 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

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

Ibandronate "ratiopharm"

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece

Quodixor

150 mg

filmsko obložena tableta

peroralna uporaba

DK - Danska

Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S, Denmark

Ibandronate "Orifarm"

50 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Arrow Pharma ApS, Hovedgaden 41. 2. sal, 2970 HØRSHOLM, Denmark

Ibandronate Arrow

150 mg

tableta

peroralna uporaba

FI - Finska

Orifarm Generics A/S, Energivej 15, 5260 ODENSE S, Denmark

Ibandronate Orifarm

50 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

150 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany

Ibandronate ratiopharm

50 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Gedeon Richter Plc, Gyömrõi út 19-21, 1103 Budabest, Hungary

Etanorden

150 mg

filmsko obložena tableta

peroralna uporaba

FI - Finska

Mylan AB, BOX 23033, 10435 STOCKHOLM, Sweden

Ibamyl

150 mg

filmsko obložena tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

FR - Francija

| 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

tableta

peroralna uporaba

IS - Islandija

Portfarma ehf., Borgartúni 26, 105 Reykjavík, Iceland

Ziveteno

150 mg

filmsko obložena tableta

peroralna uporaba

LT - Litva

Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21, Hungary

Etanorden

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Generis Farmacêutica, S.A. Office Park da Beloura, Edificio 4 - Piso 1, Escrit. 8, 2710-444 Sintra Portugal

Ácido Ibandrónico Generis

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2, 2740-298 Porto Salvo Portugal

Ácido ibandrónico Ombene

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Optimal Regulatory Solutions, S.L. Via Augusta, 59, 08006 Barcelona Espanha

Ácido ibandrónico Orsfelt

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

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

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Gedeon Richter, Plc. Gyömröi út, 19-21, H-1103 Budapest Hungria

Etanorden

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo, 1499-016 Álges Portugal

Ácido Ibandrónico Mylan

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Arrow ApS Hovedgaden 41, 2, 2970 Horsholm Dinamarca

Ácido Ibandrónico Arrow

150 mg

tableta

peroralna uporaba

PT - Portugalska

Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15, 2710-693 Sintra Portugal

Ácido Ibandrónico Sandoz

150 mg

filmsko obložena tableta

peroralna uporaba

PT - Portugalska

Pharmathen - Pharmaceutical Industry, S.A. 6, Dervenakion Street, GR-15351 Pallini Attiki Grécia

Quodixor

150 mg

filmsko obložena tableta

peroralna uporaba

SE - Švedska

Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibandronate Orifarm

50 mg

filmsko obložena tableta

peroralna uporaba

SI - Slovenija

Generics UK Ltd., Station Close, Potters Bar, Hertford Shire EN6 1AG, UK

Ibandronska kislina Mylan 150 mg filmsko obložene tablete

150 mg

filmsko obložena tableta

peroralna uporaba

---

PRILOGA VI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Baxter Healthcare GmbH |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Država članica

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml- Peritonealdialyselösung

Brezvodna glukoza 13,6 g/L, natrijev klorid 5,38 g/L, natrijev S laktat 4,48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 0,051 g/L

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Avstrija

| 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

Brezvodna glukoza 22,7 g/L, natrijev klorid 5,38 g/L, natrijev S laktat 4,48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 0,051 g/L

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Avstrija

| 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

Brezvodna glukoza 38,6 g/L, natrijev klorid 5,38 g/L, natrijev S laktat 4,48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 0,051 g/L

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Avstrija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Belgija

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Belgija

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Belgija

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Belgija

| 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 Ikodekstrin

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Bolgariji

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Bolgariji

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/ 22,7 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Bolgariji

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/ 38,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Bolgariji

BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Češka republika

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Češka republika

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Češka republika

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Češka republika

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland

EXTRANEAL

7,5 % 75 g/1 000 ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Dansko

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Dansko

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Dansko

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Dansko

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Extraneal

75 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Estoniji

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Finsko

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

13,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Finsko

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

22,7 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Finsko

Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland

Dianeal PD4 Glucose

38,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Finsko

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Francija

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Francija

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Francija

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Francija

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nemčiji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Grčijo

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

DIANEAL PD4

1,36 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Grčijo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Madžarskem

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Madžarskem

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Madžarskem

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Madžarskem

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (ikodekstrin)

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Islandijo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Islandijo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Islandijo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Irska

| 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)

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Irska

| 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)

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Irska

| 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)

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Irska

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Italijo

| 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 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Italijo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Latviji

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Latviji

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Latviji

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Latviji

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Litvo

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

13,6g+5,38g+4,48g+0,184g+0,051g/l

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Litvo

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

22,7g+5,38g+4,48g+0,184g+0,051g/l

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Litvo

Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo Ireland

Dianeal PD4 Glucose

38,6g+5,38g+4,48g+0,184g+0,051g/l

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Litvo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Luksemburg

| 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 % Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Luksemburg

| 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 Ikodekstrin

Raztopina za peritonealno dializo

za intraperitonealno uporabo

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Norveško

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo, Norway

Extraneal

75 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Poljskem

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Poljskem

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Poljskem

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Poljskem

Baxter Polska SP. z.o.o. Kruczkowskiego 8 st., 00-380 Warszawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Portugalskem

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Portugalskem

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Portugalskem

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Portugalskem

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Romunije

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE, United Kingdom |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Romunije

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml)

13,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Romunije

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Romunije

Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovaška

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovaška

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovaška

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovaška

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, Norfolk, IP24 3SE |

Baxter Healthcare Ltd

Caxton Way,

Thetford, Norfolk, IP24 3SE

EXTRANEAL

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovenija

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovenija

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovenija

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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Slovenija

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI -1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Španija

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Švedsko

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Švedsko

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Švedsko

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Švedsko

| Baxter AB |
| --- |
| Box 63 |
| 16494 Kista |
| Sverige |

Baxter AB

Box 63

16494 Kista

Sverige

Extraneal

7,5 %

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nizozemsko

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nizozemsko

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nizozemsko

| 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 Brezvodna glukoza

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Nizozemsko

| 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 ikodekstrin

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Združeno kraljestvo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Združeno kraljestvo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Združeno kraljestvo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

Združeno kraljestvo

| 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

Raztopina za peritonealno dializo

za intraperitonealno uporabo

---

ANEKS VII

SEZNAM IMEN ZDRAVIL, FARMACEVTSKIH OBLIK, JAKOSTI, POTI UPORABE IN PREDLAGATELJEV DRŽAV ČLANIC

| Države članice EU/EGP | Predlagatelj | (izmišljeno) ime | jakost | Farmacevtska oblika | Pot uporabe | vsebnost
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Teva Generics B.V. |
| Computerweg 10, 3542 DR Utrecht |
| The Netherlands |

Države članice EU/EGP

Predlagatelj

(izmišljeno) ime

jakost

Farmacevtska oblika

Pot uporabe

vsebnost

(koncentracija)

Avstrija

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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

20 mg

Avstrija

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

80 mg

Belgija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Belgija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Bulgarija

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

20 mg

Bulgarija

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

80 mg

Ciper

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Ciper

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Češka

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

20 mg

Češka

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

80 mg

Danska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Danska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Estonija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Estonija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Finska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Finska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Francija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Francija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Nemčija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Nemčija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Grčija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Grčija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Madžarska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Madžarska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Irska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Irska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Italija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Italija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Latvija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Latvija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Litva

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Litva

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Luksemburg

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Luksemburg

| 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 raztopino za infundiranje

Intravenska uporaba

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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

80 mg

Nizozemska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Nizozemska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Norveška

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Norveška

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Poljska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Poljska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Romunija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Romunija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Slovaška

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Slovaška

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Slovenija

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

20 mg

Slovenija

| 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

prašek in vehikel za koncentrat raztopino za infundiranje

Intravenska uporaba

80 mg

Španija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Španija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Švedska

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Švedska

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

Velika Britanija

| 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 raztopino za infundiranje

Intravenska uporaba

20 mg

Velika Britanija

| 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 raztopino za infundiranje

Intravenska uporaba

80 mg

---

DODATEK VIII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI VETERINARSKEGA ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, KARENC, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Predlagatelj/imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Farmacevtska oblika | Jakosti | Živalska vrsta | Priporočeni odmerek, pogostnost in pot uporabe zdravila | Karenca
  (meso in mleko) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Irska | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Severna Irska |

Država članica EU/EGP

Predlagatelj/imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Farmacevtska oblika

Jakosti

Živalska vrsta

Priporočeni odmerek, pogostnost in pot uporabe zdravila

Karenca

(meso in mleko)

Irska

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Severna Irska

Noroclav Lactating Cow Intramammary Suspension

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Združeno kraljestvo

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Severna Irska |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Severna Irska

Combimox Lactating Cow Intramammary Suspension

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Meso: 7 dni

Mleko: 60 ur

---

PRILOGA IX

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI VETERINARSKEGA ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, KARENC, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Predlagatelj/imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Farmacevtska oblika | Jakosti | Živalska vrsta | Priporočeni odmerek, pogostnost in pot uporabe zdravila | Karenca
  (meso in mleko) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down, BT35 6JP |
| Northern Ireland |

Država članica EU/EGP

Predlagatelj/imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Farmacevtska oblika

Jakosti

Živalska vrsta

Priporočeni odmerek, pogostnost in pot uporabe zdravila

Karenca

(meso in mleko)

Avstrija

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down, BT35 6JP

Northern Ireland

Combisyn Lactating Cow Intramammary Suspension

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Belgija

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Danska

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Finska

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Francija

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Portugalska

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Španija

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Združeno kraljestvo

| 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

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Meso: 7 dni

Mleko: 60 ur

---

DODATEK X

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI VETERINARSKEGA ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE, KARENC, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Predlagatelj/imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Farmacevtska oblika | Jakosti | Živalska vrsta | Priporočeni odmerek, pogostnost in pot uporabe zdravila | Karenca
  (meso in mleko) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Nizozemska | Norbrook Laboratories Limited |
| Station Works, |
| Newry, |
| Co. Down |
| BT35 6JP |
| Severna Irska |

Država članica EU/EGP

Predlagatelj/imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Farmacevtska oblika

Jakosti

Živalska vrsta

Priporočeni odmerek, pogostnost in pot uporabe zdravila

Karenca

(meso in mleko)

Nizozemska

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Severna Irska

Nisamox Lactating Cow Intramammary Suspension

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Ni ugotovljeno

Združeno kraljestvo

| Norbrook Laboratories Limited |
| --- |
| Station Works, |
| Newry, |
| Co. Down |
| BT35 6JP |
| Severna Irska |

Norbrook Laboratories Limited

Station Works,

Newry,

Co. Down

BT35 6JP

Severna Irska

Nisamox Lactating Cow Intramammary Suspension

Intramamarna suspenzija

Amoxicillin 200 mg

Clavulanic acid 50 mg

Prednisolone 10 mg

Govedo v obdobju laktacije

Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur

Meso: 7 dni

Mleko: 60 ur

---