# Il-Ġurnal Uffiċjali C 184/2013

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2013.184.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 184 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5628 ta' Ġunju 2013 |

ISSN 1977-0987

doi:10.3000/19770987.C_2013.184.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 184

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5628 ta' Ġunju 2013

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2013/C 184/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  ) | 1 |
| 2013/C 184/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
  ) | 10 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2013/C 184/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  )

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill

)

1

2013/C 184/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
  )

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE

jew l-Artikolu 38 tad-Direttiva 2001/82/KE

)

10

| MT | |
| --- | --- |

MT

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 28.6.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 184/1 |
| --- | --- | --- | --- |

28.6.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 184/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2013/C 184/01

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2013 | HyQvia | Immunoglobulina umana normali | Baxter Innovations GmbH |
| Industriestraße 67, A-1221 Wien, Österreich |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

16.5.2013

HyQvia

Immunoglobulina umana normali

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/13/840

Soluzzjoni għal infużjoni

J06BA

22.5.2013

16.5.2013

Voriconazole Accord

Voriconazole

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom

EU/1/13/835

Pillola miksija b’rita

J02AC03

22.5.2013

24.5.2013

Stribild

elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (bħala fumarate)

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

Pillola miksija b’rita

J05AR09

27.5.2013

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Qsiva | VIVUS BV |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

14.5.2013

Qsiva

VIVUS BV

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

—

16.5.2013

29.5.2013

Kynamro

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

—

31.5.2013

31.5.2013

Raxone

| Santhera Pharmaceuticals (Deutschland) GmbH |
| --- |
| Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland |

Santhera Pharmaceuticals (Deutschland) GmbH

Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland

—

4.6.2013

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.5.2013 | Nevanac | Alcon Laboratories (UK) Ltd. |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

3.5.2013

Nevanac

Alcon Laboratories (UK) Ltd.

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/07/433

7.5.2013

3.5.2013

Votrient

| 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/1/10/628

7.5.2013

6.5.2013

Vibativ

| Theravance UK Limited |
| --- |
| 90 Fetter Lane, London EC4A 1EQ, United Kingdom |

Theravance UK Limited

90 Fetter Lane, London EC4A 1EQ, United Kingdom

EU/1/11/705

8.5.2013

14.5.2013

Hepsera

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/251

16.5.2013

14.5.2013

Olanzapine Cipla

| Cipla (EU) Limited |
| --- |
| Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom |

Cipla (EU) Limited

Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom

EU/1/07/426

16.5.2013

16.5.2013

Ozurdex

| Allergan Pharmaceuticals Ireland, (514125) |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

22.5.2013

16.5.2013

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

22.5.2013

22.5.2013

Adcirca

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/476

24.5.2013

22.5.2013

Aloxi

| Helsinn Birex Pharmaceuticals Ltd |
| --- |
| Damastown, Mulhuddart, Dublin 15, Ireland |

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

27.5.2013

22.5.2013

Leganto

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

27.5.2013

22.5.2013

Olanzapine Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475

24.5.2013

22.5.2013

Xarelto

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

24.5.2013

23.5.2013

Trizivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

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

EU/1/00/156

28.5.2013

27.5.2013

Afinitor

| 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/1/09/538

29.5.2013

27.5.2013

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

29.5.2013

27.5.2013

Combivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

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

EU/1/98/058

29.5.2013

27.5.2013

DuoCover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

29.5.2013

27.5.2013

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

29.5.2013

27.5.2013

Ixiaro

| Intercell Austria AG |
| --- |
| Campus Vienna Biocenter 3, A-1030 Wien, Österreich |

Intercell Austria AG

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

29.5.2013

27.5.2013

Kivexa

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

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

EU/1/04/298

29.5.2013

27.5.2013

Neupro

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

29.5.2013

27.5.2013

PANTECTA Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/518

29.5.2013

27.5.2013

PANTOLOC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/519

29.5.2013

27.5.2013

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

29.5.2013

27.5.2013

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom.

EU/1/09/539

29.5.2013

27.5.2013

Zometa

| 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/1/01/176

29.5.2013

27.5.2013

Zypadhera

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/479

29.5.2013

27.5.2013

Zyprexa

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/96/022

29.5.2013

27.5.2013

Zyprexa Velotab

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/99/125

29.5.2013

29.5.2013

Pritor

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/089

31.5.2013

29.5.2013

PritorPlus

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

31.5.2013

30.5.2013

Clopidogrel Zentiva

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

3.6.2013

30.5.2013

CONTROLOC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/515

3.6.2013

30.5.2013

DuoPlavin

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

3.6.2013

30.5.2013

Epivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, |
| Brentford, Middlesex TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

980 Great West Road,

Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/96/015

3.6.2013

30.5.2013

Iscover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

3.6.2013

30.5.2013

Kinzalkomb

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

3.6.2013

30.5.2013

Kinzalmono

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091

3.6.2013

30.5.2013

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

3.6.2013

30.5.2013

MicardisPlus

| 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/1/02/213

3.6.2013

30.5.2013

PANTOZOL Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/517

3.6.2013

30.5.2013

PegIntron

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

Merck Sharp & Dohme Limited

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

EU/1/00/131

3.6.2013

30.5.2013

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

3.6.2013

30.5.2013

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

3.6.2013

30.5.2013

SOMAC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/516

3.6.2013

30.5.2013

ViraferonPeg

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

Merck Sharp & Dohme Limited

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

EU/1/00/132

3.6.2013

31.5.2013

Imatinib Teva

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/808

4.6.2013

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (2)
  ): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.5.2013 | Oncept IL-2 | Vajrus rikombinat tal-canarypox Feline interleukin-2 (vCP1338) | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

3.5.2013

Oncept IL-2

Vajrus rikombinat tal-canarypox Feline interleukin-2 (vCP1338)

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

Lyophilisate u solvent għal sospensjoni għal injezzjoni

QL03AX

7.5.2013

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 6.5.2013 | BTVPUR AlSap 1 | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

6.5.2013

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/112

13.5.2013

6.5.2013

BTVPUR AlSap 1-8

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

13.5.2013

14.5.2013

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/062

16.5.2013

14.5.2013

Posatex

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

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/08/081

16.5.2013

16.5.2013

Convenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/059

22.5.2013

16.5.2013

Suvaxyn PCV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/099

22.5.2013

16.5.2013

Zulvac 1 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/131

22.5.2013

16.5.2013

Zulvac 8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/104

22.5.2013

22.5.2013

Draxxin

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/03/041

24.5.2013

22.5.2013

Improvac

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/095

25.5.2013

22.5.2013

Pirsue

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/00/027

24.5.2013

22.5.2013

Poulvac E. coli

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/12/140

24.5.2013

22.5.2013

Quadrisol

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/97/005

24.5.2013

22.5.2013

Stronghold

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/99/014

24.5.2013

22.5.2013

Zulvac 1+8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/12/139

24.5.2013

22.5.2013

Zulvac 1 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/130

24.5.2013

22.5.2013

Zulvac 8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/105

24.5.2013

23.5.2013

Naxcel

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/05/053

27.5.2013

23.5.2013

TruScient

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/136

27.5.2013

27.5.2013

Equip WNV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/08/086

29.5.2013

27.5.2013

Fevaxyn Pentofel

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/96/002

29.5.2013

27.5.2013

Palladia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/100

29.5.2013

27.5.2013

Slentrol

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/07/071

29.5.2013

27.5.2013

Zulvac 1+8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/120

29.5.2013

30.5.2013

Trocoxil

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/08/084

3.6.2013

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 22.5.2013 | Nobivac Piro | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/04/046 | 24.5.2013 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

22.5.2013

Nobivac Piro

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/04/046

24.5.2013

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.2004, p. 1.

(2)  ĠU L 136, 30.4.2004, p. 1.

---

| 28.6.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 184/10 |
| --- | --- | --- | --- |

28.6.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 184/10

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Mejju 2013 sal-31 ta’ Mejju 2013

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
   (2)
  )

2013/C 184/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 16.5.2013 | Nuflor Swine Once 450 mg/ml | Ara l-Anness I | Ara l-Anness I | 21.5.2013 |
| 27.5.2013 | Simvastatin Vale and associated names | Ara l-Anness II | Ara l-Anness II | 28.5.2013 |
| 23.5.2013 | Florgane | Ara l-Anness III | Ara l-Anness III | 24.5.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

16.5.2013

Nuflor Swine Once 450 mg/ml

Ara l-Anness I

Ara l-Anness I

21.5.2013

27.5.2013

Simvastatin Vale and associated names

Ara l-Anness II

Ara l-Anness II

28.5.2013

23.5.2013

Florgane

Ara l-Anness III

Ara l-Anness III

24.5.2013

—   Rifjut ta’ awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Furosemide | Ara l-Anness IV | Ara l-Anness IV | 15.5.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

14.5.2013

Furosemide

Ara l-Anness IV

Ara l-Anness IV

15.5.2013

—   Sospensjoni ta' awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 29.5.2013 | Tetrazepam | Ara l-Anness V | Ara l-Anness V | 29.5.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

29.5.2013

Tetrazepam

Ara l-Anness V

Ara l-Anness V

29.5.2013

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TA' ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT VETERINARJU MEDIĊINALI, SPEĊI TAL-ANNIMAL,MOD TA'AMMINISTRAZZJONI, APPLIKANT FL-ISTATI MEMBRI.

| StatMembru
  EU/EEA | Applikant | Isem | Isem inventat | Għamla farmaċewtika | Qawwa | Speċi tal- annimal | Mod ta' amministrazzjoni |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Awstrija (1) | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Olanda |

StatMembru

EU/EEA

Applikant

Isem

Isem inventat

Għamla farmaċewtika

Qawwa

Speċi tal- annimal

Mod ta' amministrazzjoni

Awstrija (1)

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Belġjum

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Bulgarija (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Ċipru

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Repubblika Ċeka

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Denmark

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

PigFlor Once

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Estonja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Franza (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Germanja (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Greċja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Ungerija

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Irelanda

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Italja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Suini One, 450 mg/ml soluzione iniettabile per suini

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Latvja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Litwanja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Lussemburgu

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Malta

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Olanda

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Polonja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Portugal

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Rumanija (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Slovakkja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Slovenja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Spanja

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Flomac porcino dosis única 450 mg/ml solución inyectable

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

Renju Unit

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Olanda

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Soluzzjoni għall- injezzjoni

450 mg/ml

ħnieżer

Użu fil-muskolu

---

(1)  Marketing awtorizzazzjoni mogħtija

---

ANNESS II

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru
  EU/EEA | Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Vale Pharmaceuticals Limited |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Stat Membru

EU/EEA

Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 20 mg/5 ml Suspension zum Einnehmen

20 mg/5 ml

suspensjoni orali

użu orali

L-Awstrija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 40 mg/5 ml Suspension zum Einnehmen

40 mg/5 ml

suspensjoni orali

użu orali

Id-Danimarka

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

Id-Danimarka

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

Il-Finlandja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale

20 mg/5 ml

suspensjoni orali

użu orali

Il-Finlandja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale

40 mg/5 ml

suspensjoni orali

użu orali

Franza

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

Franza

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

Il-Ġermanja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

Il-Ġermanja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

Il-Greċja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

Il-Greċja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

L-Irlanda

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

L-Irlanda

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

L-Italja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatina Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

L-Italja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatina Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

L-Olanda

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatine Vale Pharmaceuticals 20 mg/5 ml suspensie voor oraal gebruik

20 mg/5 ml

suspensjoni orali

użu orali

L-Olanda

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatine Vale Pharmaceuticals 40 mg/5 ml suspensie voor oraal gebruik

40 mg/5 ml

suspensjoni orali

użu orali

In-Norveġja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

In-Norveġja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

Il-Portugall

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Sinvastatina Vale

20 mg/5 ml

suspensjoni orali

użu orali

Il-Portugall

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Sinvastatina Vale

40 mg/5 ml

suspensjoni orali

użu orali

Spanja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 20 mg/5 ml suspensión oral

20 mg/5 ml

suspensjoni orali

użu orali

Spanja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 40 mg/5 ml suspensión oral

40 mg/5 ml

suspensjoni orali

użu orali

L-Iżvezja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

L-Iżvezja

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

Ir-Renju Unit

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

suspensjoni orali

użu orali

Ir-Renju Unit

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

suspensjoni orali

użu orali

---

ANNESS III

LISTA TAL-ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT VETERINARJU MEDIĊINALI, SPEĊI TAL-ANNIMALI, MOD TA’ KIF JINGĦATA, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru
  UE/ŻEE | Applikant | Isem | INN | Għamla farmaċewtika | Qawwa | Speċi tal-annimali | Mod ta’ kif jingħata |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Emdoka bvba |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Stat Membru

UE/ŻEE

Applikant

Isem

INN

Għamla farmaċewtika

Qawwa

Speċi tal-annimali

Mod ta’ kif jingħata

L-Awstrija

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Il-Belġju

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens/suspension injectable pour bovins et porcs

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Bulgaria

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml инжекционна суспензия за говеда и прасета

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Ir-Repubblika Ċeka

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml injekční suspenze pro skot a prasata

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Id-Danimarka

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml, injektionsvæske, suspension til kvæg og svin

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Franza (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspension injectable pour bovins et porcins

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Il-Ġermanja (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Il-Greċja

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml Ενέσιμο εναιώρημα για Βοοειδή και χοίρους

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

L-Ungerija

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml injekció szarvasmarha és sertés részére A.U.V.

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

L-Irlanda

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspension for injection for cattle and pigs

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

L-Italja

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml sospensione iniettabile per bovini e suini

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Litwanja

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml injekcinė suspensija galvijams ir kiaulėms

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Lussemburgu

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 Mg/Ml suspension injectable pour bovins et porcins

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Il-Pajjiżi l-Baxxi

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Il-Polonja

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Portugall

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspensão injectável para bovinos e suínos

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Ir-Rumanija

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspensie injectabilă pentru bovine și porcine

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Slovakkja

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml injekčná suspenzia pre hovädzí dobytok a ošípané

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Spanja (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspensión inyectable para bovino y porcino

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

Ir-Renju Unit

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Il-Belġju |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Il-Belġju

Florgane 300 mg/ml suspension for injection for cattle and pigs

florfenicol

Likwidu b’ħafna partiċelli żgħar għall-injezzjoni

300 mg/ml

Baqar u majjali

Użu għal ġol-muskoli

---

(1)  Awtorizzazzjoni għat-Tqegħid fis-Suq ingħatat

---

ANNESS IV

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT FL-ISTATI MEMBRI

| Stat Membru
  UE/ŻEE | Applikant | Isem (Inventat) | Qawwa | Kompożizzjoni farmaċewtika | Metodu ta’ amministrazzjoni |
| --- | --- | --- | --- | --- | --- |
| Ir-Repubblika Ċeka | Vitabalans Oy Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Stat Membru

UE/ŻEE

Applikant

Isem (Inventat)

Qawwa

Kompożizzjoni farmaċewtika

Metodu ta’ amministrazzjoni

Ir-Repubblika Ċeka

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tablety

40 mg

pillola

Użu orali

Id-Danimarka

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

L-Estonja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

Il-Finlandja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

L-Ungerija

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans

40 mg

pillola

Użu orali

Il-Latvja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tabletes

40 mg

pillola

Użu orali

Il-Litwanja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

In-Norveġja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

Il-Polonja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

Is-Slovakkja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablety

40 mg

pillola

Użu orali

Slovenja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablete

40 mg

pillola

Użu orali

L-Isvezja

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

pillola

Użu orali

---

ANNESS V

LISTA TA' ISMIJIET, GĦAMLIET FARMEĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN GĦANDHOM JINGĦATAW, DETENTURI TAL-AWTORIZZAZZJONI FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Sanofi-Aventis GmbH |
| Leonard-Bernstein-Str. 10 |
| Vienna DC |
| A-1220 Vienna |
| Austria |

Stat Membru EU/EEA

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Sanofi-Aventis GmbH

Leonard-Bernstein-Str. 10

Vienna DC

A-1220 Vienna

Austria

Myolastan 50 mg - Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

L-Awstrija

| MIP Pharma GmbH |
| --- |
| Kirkeler Straße 41 |
| D-66440 Blieskastel-Niederwürzbach |
| Germany |

MIP Pharma GmbH

Kirkeler Straße 41

D-66440 Blieskastel-Niederwürzbach

Germany

Tetrazepam-MIP 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Belġju

| Will Pharma S.A. |
| --- |
| Monplaisirlaan 33 |
| B-1030 Brussel |
| Belgium |

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Pillola miksija b’rita

Użu orali

Il-Belġju

| Sanofi Aventis Belgium N.V |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Pillola miksija b’rita

Użu orali

Il-Belġju

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Pillola miksija b’rita

Użu orali

Il-Bulgarija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP

50 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

| Sanofi-Aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| Praha 6 - Vokovice, 160 00 |
| Czech Republic |

Sanofi-Aventis, s.r.o.

Evropská 846/176a

Praha 6 - Vokovice, 160 00

Czech Republic

MYOLASTAN

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

MYOLASTAN 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Daiichi Sankyo France SAS |
| --- |
| Immeuble le Corosa |
| 1, rue Eugene et Armand Peugeot |
| 92508 Rueil Malmaison |
| France |

Daiichi Sankyo France SAS

Immeuble le Corosa

1, rue Eugene et Armand Peugeot

92508 Rueil Malmaison

France

PANOS 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Sandoz |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

TETRAZEPAM SANDOZ 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Zydus France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 923752 Nanterre |
| France |

Zydus France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

923752 Nanterre

France

TETRAZEPAM ZYDUS 50 mg, comprimé enrobé sécable

50 mg

Pillola miksija

Użu orali

Franza

| Teva Sante |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

Teva Sante

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

TETRAZEPAM TEVA 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Cristers |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

Cristers

22 quai Gallieni

92150 Suresnes

France

TETRAZEPAM CRISTERS 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Ranbaxy Pharmacie Generiques |
| --- |
| 11-15 Quai Dion Bouton |
| 92816 Puteaux |
| France |

Ranbaxy Pharmacie Generiques

11-15 Quai Dion Bouton

92816 Puteaux

France

TETRAZEPAM RPG 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

TETRAZEPAM ZENTIVA 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

TETRAZEPAM MYLAN 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| 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

TETRAZEPAM EG 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

TETRAZEPAM RATIOPHARM 50 mg, comprimé enrobé sécable

50 mg

Pillola miksija

Użu orali

Franza

| Arrow Generiques |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

TETRAZEPAM ALMUS 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Arrow Generiques |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

TETRAZEPAM ARROW 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Franza

| Biogaran |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

Biogaran

15, boulevard Charles de Gaulle

92700 Colombes

France

TETRAZEPAM BIOGARAN 50 mg, comprimé pelliculé sécable

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

1 A Pharma GmbH

Keltenring 1+3

82041 Oberhaching

Germany

Tetrazepam - 1 A Pharma

50 mg

Pillola

Użu orali

Il-Ġermanja

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazepam AbZ 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

| Aliud Pharma GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| 89150 Laichingen |
| Germany |

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Tetrazepam AL 50

50 mg

Pillola

Użu orali

Il-Ġermanja

| Aristo Pharma GmbH |
| --- |
| Wallenroder Str. 8-10 |
| 13435 Berlin |
| Germany |

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Spasmorelax 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Ġermanja

| Aristo Pharma GmbH |
| --- |
| Wallenroder Str. 8-10 |
| 13435 Berlin |
| Germany |

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Tetrazepam-Aristo 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Ġermanja

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetra-saar 50 mg

50 mg

Pillola

Użu orali

Il-Ġermanja

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 100 mg Tabletten

100 mg

Pillola

Użu orali

Il-Ġermanja

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 25 mg Tabletten

25 mg

Pillola

Użu orali

Il-Ġermanja

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Ġermanja

| CT Arzneimttel GmbH |
| --- |
| Geschäftsanschrift - |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

CT Arzneimttel GmbH

Geschäftsanschrift -

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazep-CT 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

| Hexal Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Tetrazepam HEXAL

50 mg

Pillola

Użu orali

Il-Ġermanja

| Krewel Meuselbach GmbH |
| --- |
| Krewelstr. 2 |
| 53783 Eitorf |
| Germany |

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Musapam

50 mg

Pillola

Użu orali

Il-Ġermanja

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

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Tetrazepam KSK

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Tetramdura 50 mg

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH |
| --- |
| Elisabeth-Selbert-Str. 23 |
| 40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Tetrazepam-neuraxpharm 100 mg

100 mg

Pillola

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH |
| --- |
| Elisabeth-Selbert-Str. 23 |
| 40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Tetrazepam-neuraxpharm 50 mg

50 mg

Pillola

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazepam-ratiopharm 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Ġermanja

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Pillola

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| 65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Musaril, 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

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

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Tetrazepam STADA 50 mg Filmtabletten

50 mg

Pillola miksija b’rita

Użu orali

Il-Latvja

| Sanofi – Aventis Latvia SIA |
| --- |
| Kr. Valdemara str. 33-8 |
| Riga LV 1010 |
| Latvia |

Sanofi – Aventis Latvia SIA

Kr. Valdemara str. 33-8

Riga LV 1010

Latvia

Myolastan 50 mg film-coated tablets

50 mg

Pillola miksija b’rita

Użu orali

Il-Litwanja

| UAB “Sanofi-Aventis Lietuva” |
| --- |
| A. Juozapavičiaus g. 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB “Sanofi-Aventis Lietuva”

A. Juozapavičiaus g. 6/2

LT-09310 Vilnius

Lithuania

Myolastan

50 mg

Pillola miksija b’rita

Użu orali

Il-Lussemburgu

| Will Pharma S.A. |
| --- |
| Monplaisirlaan 33 |
| B-1030 Brussel |
| Belgium |

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Pillola miksija b’rita

Użu orali

Il-Lussemburgu

| Sanofi Aventis Belgium N.V |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Pillola miksija b’rita

Użu orali

Il-Lussemburgu

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| Wincentego st. Pola 21 |
| 58-500, Jelenia Góra, Poland |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

Wincentego st. Pola 21

58-500, Jelenia Góra, Poland

Miozepam

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Myolastan

50 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 25

25 mg

Pillola

Użu orali

Il-Polonja

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 50

50 mg

Pillola

Użu orali

Il-Polonja

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 100

100 mg

Pillola

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetraratio

50 mg

Pillola miksija b’rita

Użu orali

Ir-Rumanija

| S.C. A.C. Helcor Pharma S.R.L. |
| --- |
| Str. Victor Babeș nr. 50, Baia Mare |
| Jud. Maramureș |
| România |

S.C. A.C. Helcor Pharma S.R.L.

Str. Victor Babeș nr. 50, Baia Mare

Jud. Maramureș

România

RELAXAM 50 mg, comprimate filmate

50 mg

Pillola miksija b’rita

Użu orali

Is-Slovakkja

| Sanofi-Aventis Slovakia s.r.o. |
| --- |
| Einsteinova 24 |
| 85101 Bratislava |
| Slovak Republic |

Sanofi-Aventis Slovakia s.r.o.

Einsteinova 24

85101 Bratislava

Slovak Republic

MYOLASTAN

50 mg

Pillola miksija b’rita

Użu orali

Spanja

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

MYOLASTAN 50 mg comprimidos recubiertos

50 mg

Pillola miksija b’rita

Użu orali

---