# Il-Ġurnal Uffiċjali C 428/28 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 428 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5728 ta' Novembru 2014 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 428

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5728 ta' Novembru 2014

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2014/C 428/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2014/C 428/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 7 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2014/C 428/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014(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

2014/C 428/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014(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)

7

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

MT

---

IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 28.11.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 428/1 |
| --- | --- | --- | --- |

28.11.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 428/1

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014

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

(2014/C 428/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.10.2014 | IMBRUVICA | Ibrutinib | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | Kapsula, iebsa | L01XE27 | 23.10.2014 |

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

21.10.2014

IMBRUVICA

Ibrutinib

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

Kapsula, iebsa

L01XE27

23.10.2014

—   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 |
| --- | --- | --- | --- | --- |
| 1.10.2014 | Apidra | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/04/285 | 6.10.2014 |
| 1.10.2014 | Bexsero | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 3.10.2014 |
| 1.10.2014 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 3.10.2014 |
| 1.10.2014 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 3.10.2014 |
| 1.10.2014 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/070 | 3.10.2014 |
| 1.10.2014 | Liprolog | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/01/195 | 3.10.2014 |
| 1.10.2014 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/069 | 3.10.2014 |
| 1.10.2014 | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 3.10.2014 |
| 1.10.2014 | Zoledronic acid Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/771 | 3.10.2014 |
| 3.10.2014 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 7.10.2014 |
| 3.10.2014 | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 7.10.2014 |
| 3.10.2014 | Jakavi | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/12/773 | 7.10.2014 |
| 3.10.2014 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 7.10.2014 |
| 8.10.2014 | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 13.10.2014 |
| 8.10.2014 | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 10.10.2014 |
| 8.10.2014 | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 10.10.2014 |
| 10.10.2014 | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 14.10.2014 |
| 10.10.2014 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 14.10.2014 |
| 10.10.2014 | Keppra | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/00/146 | 14.10.2014 |
| 10.10.2014 | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 14.10.2014 |
| 15.10.2014 | Atosiban SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/852 | 17.10.2014 |
| 15.10.2014 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 20.10.2014 |
| 15.10.2014 | Onglyza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/545 | 17.10.2014 |
| 15.10.2014 | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 17.10.2014 |
| 20.10.2014 | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 23.10.2014 |
| 21.10.2014 | Clopidogrel Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/561 | 23.10.2014 |
| 22.10.2014 | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 24.10.2014 |
| 22.10.2014 | Nevirapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/598 | 24.10.2014 |
| 22.10.2014 | Privigen | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/08/446 | 24.10.2014 |
| 27.10.2014 | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 29.10.2014 |
| 27.10.2014 | BindRen | Mitsubishi Tanabe Pharma Europe Ltd.
  Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom | EU/1/12/804 | 29.10.2014 |
| 27.10.2014 | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 29.10.2014 |
| 27.10.2014 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/00/170 | 29.10.2014 |
| 27.10.2014 | Hexyon | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 29.10.2014 |
| 27.10.2014 | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 29.10.2014 |
| 27.10.2014 | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.10.2014 |
| 27.10.2014 | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 29.10.2014 |
| 27.10.2014 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 29.10.2014 |
| 27.10.2014 | Zavesca | Actelion Registration Ltd
  Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 29.10.2014 |
| 30.10.2014 | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 3.11.2014 |
| 30.10.2014 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 3.11.2014 |
| 30.10.2014 | Mycophenolate mofetil Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/07/439 | 4.11.2014 |
| 30.10.2014 | Myfenax | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/07/438 | 4.11.2014 |
| 30.10.2014 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/06/380 | 3.11.2014 |
| 30.10.2014 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 3.11.2014 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

1.10.2014

Apidra

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285

6.10.2014

1.10.2014

Bexsero

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

3.10.2014

1.10.2014

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

3.10.2014

1.10.2014

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

3.10.2014

1.10.2014

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

3.10.2014

1.10.2014

Liprolog

Eli Lilly Nederland B.V.

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

EU/1/01/195

3.10.2014

1.10.2014

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

3.10.2014

1.10.2014

Voriconazole Accord

Accord Healthcare Limited

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

EU/1/13/835

3.10.2014

1.10.2014

Zoledronic acid Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/771

3.10.2014

3.10.2014

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

7.10.2014

3.10.2014

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

7.10.2014

3.10.2014

Jakavi

Novartis Europharm Limited

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

EU/1/12/773

7.10.2014

3.10.2014

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

7.10.2014

8.10.2014

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

13.10.2014

8.10.2014

Tarceva

Roche Registration Limited

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

EU/1/05/311

10.10.2014

8.10.2014

Yentreve

Eli Lilly Nederland B.V.

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

EU/1/04/280

10.10.2014

10.10.2014

Ariclaim

Eli Lilly Nederland B.V.

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

EU/1/04/283

14.10.2014

10.10.2014

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

14.10.2014

10.10.2014

Keppra

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

14.10.2014

10.10.2014

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

14.10.2014

15.10.2014

Atosiban SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/852

17.10.2014

15.10.2014

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

20.10.2014

15.10.2014

Onglyza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/545

17.10.2014

15.10.2014

Xeristar

Eli Lilly Nederland B.V.

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

EU/1/04/297

17.10.2014

20.10.2014

Cymbalta

Eli Lilly Nederland B.V.

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

EU/1/04/296

23.10.2014

21.10.2014

Clopidogrel Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/561

23.10.2014

22.10.2014

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

24.10.2014

22.10.2014

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

24.10.2014

22.10.2014

Privigen

CSL Behring GmbH

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

EU/1/08/446

24.10.2014

27.10.2014

Abraxane

Celgene Europe Limited

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

EU/1/07/428

29.10.2014

27.10.2014

BindRen

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom

EU/1/12/804

29.10.2014

27.10.2014

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

29.10.2014

27.10.2014

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/00/170

29.10.2014

27.10.2014

Hexyon

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

29.10.2014

27.10.2014

Invanz

Merck Sharp & Dohme Limited

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

EU/1/02/216

29.10.2014

27.10.2014

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

EU/1/10/647

29.10.2014

27.10.2014

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

29.10.2014

27.10.2014

Vidaza

Celgene Europe Limited

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

EU/1/08/488

29.10.2014

27.10.2014

Zavesca

Actelion Registration Ltd

Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom

EU/1/02/238

29.10.2014

30.10.2014

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

3.11.2014

30.10.2014

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

3.11.2014

30.10.2014

Mycophenolate mofetil Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/07/439

4.11.2014

30.10.2014

Myfenax

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/07/438

4.11.2014

30.10.2014

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

3.11.2014

30.10.2014

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

3.11.2014

—   Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 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 |
| --- | --- | --- | --- | --- |
| 1.10.2014 | FLUENZ | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/10/661 | 3.10.2014 |
| 1.10.2014 | Topotecan Eagle | Eagle Laboratories Limited
  The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom | EU/1/11/744 | 3.10.2014 |
| 21.10.2014 | Clopidogrel Teva Pharma B.V. | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/649 | 23.10.2014 |
| 27.10.2014 | Ipreziv | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/735 | 29.10.2014 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

1.10.2014

FLUENZ

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/10/661

3.10.2014

1.10.2014

Topotecan Eagle

Eagle Laboratories Limited

The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom

EU/1/11/744

3.10.2014

21.10.2014

Clopidogrel Teva Pharma B.V.

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/649

23.10.2014

27.10.2014

Ipreziv

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/735

29.10.2014

—   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 |
| --- | --- | --- | --- | --- |
| 21.10.2014 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 23.10.2014 |
| 27.10.2014 | Apoquel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 29.10.2014 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

21.10.2014

Loxicom

Norbrook Laboratories Ltd

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

EU/2/08/090

23.10.2014

27.10.2014

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

29.10.2014

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK – LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK – LONDON E14 5EU

---

(1)  ĠU L 136, 30.4.04, p. 1.

---

| 28.11.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 428/7 |
| --- | --- | --- | --- |

28.11.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 428/7

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2014 sal-31 ta’ Ottubru 2014

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

(2014/C 428/02)

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

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- |
| 30.10.2014 | Bromocriptine | Ara l-Anness I | Ara l-Anness I | Ara l-Anness I | 3.11.2014 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

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

Stat Membru kkonċernat

Data ta’ notifika

30.10.2014

Bromocriptine

Ara l-Anness I

Ara l-Anness I

Ara l-Anness I

3.11.2014

---

(1)  ĠU L 311, 28.11.01, p. 67.

(2)  ĠU L 311, 28.11.01, p. 1.

---

ANNESS I

Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri

| Stat Membru
  fiż-ŻEE | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem il-prodott | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Meda Pharma GmbH
  Guglgasse 15/II. Stock 1110
  Wien
  Austria | Parlodel 2,5 mg – Tabletten | 2,5 mg | pillola | użu orali |
| Il-Belġju | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel | 2,5 mg | pillola | użu orali |
| Il-Belġju | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 5 mg | 5 mg | kapsula, iebsa | użu orali |
| Il-Belġju | Meda Pharma s.a.
  Chaussée de la Hulpe 166
  1170 Brussels
  Belgium | Parlodel 10 mg | 10 mg | kapsula, iebsa | użu orali |
| Il-Bulgarija | Sopharma AD
  16 “Iliensko shose” Str.
  Sofia 1220
  Bulgaria | Bromocriptine Sopharma | 2,5 mg | pillola | użu orali |
| Il-Bulgarija | Medochemie Ltd.
  1-10 Astronafton Str.
  Limassol 3505
  Cyprus | Medocriptine | 2,5 mg | pillola | użu orali |
| Il-Kroazja | Sandoz d.o.o.
  Maksimirska 120/V
  Zagreb 10  000
  Croatia | Bromergon 2,5 mg tablete | 2,5 mg | pillola | użu orali |
| Ċipru | Codal Synto Ltd
  33 Theklas Lysioti street
  Dorothea Building, 6th floor
  Lemesos 3508 Cyprus | Pirodal | 2,5 mg | pillola | użu orali |
| Ċipru | Remedica Ltd Aharnon Street
  Limassol Industrial Estate
  Lemesos 3508 Cyprus | Brameston | 2,5 mg | pillola | użu orali |
| Ċipru | Medochemie Ltd Constantinoupoleos 1-10 Street
  Lemesos 3501 Cyprus | Medocriptine | 2,5 mg | pillola | użu orali |
| Ir-Repubblika Ċeka | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  110 00 Prague 10
  Czech Republic | Parlodel | 2,5 mg | pillola | użu orali |
| Ir-Repubblika Ċeka | Medochemie Ltd.
  Constantinoupoleos Str. 1_10
  3011 Limassol – Tsiflikoudia
  Cyprus | Medocriptine | 2,5 mg | pillola | użu orali |
| Id-Danimarka | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 10 mg | kapsula, iebsa | użu orali |
| Id-Danimarka | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 5 mg | kapsula, iebsa | użu orali |
| Id-Danimarka | Meda AS
  Solvang 8
  DK-3450 Allerød
  Denmark | Parlodel | 2,5 mg | pillola | użu orali |
| L-Estonja | Gedeon Richter Plc.
  Gyömrõi ut 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2,5 mg | pillola | użu orali |
| Il-Finlandja | Meda Oy
  Vaisalantie 4
  02130 Espoo
  Finland | PARLODEL | 2,5 mg | pillola | użu orali |
| Franza | MEDA PHARMA
  25, boulevard de l'Amiral Bruix 75016 Paris
  France | PARLODEL 2,5 mg inhibition de la lactation | 2,5 mg | pillola | użu orali |
| Franza | SANOFI AVENTIS FRANCE
  1-13 boulevard Romain Rolland
  75014 PARIS
  France | BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin AbZ 2,5 mg | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Bromocriptin beta 2,5 | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | AbZ-Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | bromocriptin-ct 2,5 mg Tabletten | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | bromocriptin-ct 2,5 mg Tabletten | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | MEDA Pharma GmbH & Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Pravidel 2,5 mg Tabletten | 2,5 mg | pillola | użu orali |
| Il-Ġermanja | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Bromocriptin-ratiopharm 2,5 mg Tabletten | 2,5 mg | pillola | użu orali |
| Il-Greċja | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 2,5 mg | pillola | użu orali |
| Il-Greċja | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 5 mg | kapsula, iebsa | użu orali |
| Il-Greċja | MEDA PHARMACEUTICALS S.A. GREECE
  3 Evrytanias Str., Halandri
  15231, Attiki
  Greece | Parlodel | 10 mg | kapsula, iebsa | użu orali |
| L-Ungerija | Gedeon Richter Plc
  Gyömrői út 19-21
  H-1103 Budapest
  Hungary | Bromocriptin-Richter 2,5 mg tabletta | 2,5 mg | pillola | użu orali |
| L-Irlanda | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 2,5 mg Tablets | 2,5 mg | pillola | użu orali |
| L-Irlanda | Meda Health Sales Ireland Limited
  Unit 34/35, Block A
  Dunboyne Business Park
  Dunboyne Co. Meath
  Ireland | Parlodel 5 mg Hard Capsules. | 5 mg | kapsula, iebsa | użu orali |
| Il-Litwanja | Gedeon Richter Plc.
  Gyömröi út 19-21
  1103 Budapest
  Hungary | BROMOCRIPTIN-RICHTER | 2,5 mg | pillola | użu orali |
| Il-Lussemburgu | MEDA Pharma GmbH & Co. KG
  Benzstraße 1
  61352 Bad Homburg
  Germany | Pravidel | 2,5 mg | pillola | użu orali |
| In-Norveġja | Meda AS
  Askerveien 61
  Postboks 194
  1371 Asker
  Norway | Parlodel | 2,5 mg | pillola | użu orali |
| Il-Polonja | Sandoz GmbH
  Biochemiestrasse 10
  Kundl
  6250 Tyrol
  Austria | Bromergon | 2,5 mg | pillola | użu orali |
| Il-Polonja | Farmaceutyczna Spółdzielnia Pracy FILOFARM
  ul. Pułaskiego 39
  85-619 Bydgoszcz
  Poland | Bromocorn | 2,5 mg | pillola | użu orali |
| Il-Polonja | Meda Aktiebolag
  Pipers vag 2
  170 09 Solna
  Box 906
  Sweden | Parlodel | 2,5 mg | pillola | użu orali |
| Il-Portugall | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 5 mg | kapsula | użu orali |
| Il-Portugall | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Parlodel | 10 mg | kapsula | użu orali |
| Il-Portugall | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Parlodel | 2,5 mg | pillola | użu orali |
| Il-Portugall | S.C. BIOFARM S.A.
  Str. Logofăt Tăutu nr. 99
  sector 3, Bucureşti 031212
  Romania | Bromocriptina Generis 2,5 mg comprimidos | 2,5 mg | pillola | użu orali |
| Ir-Rumanija | MEDA Pharma s.r.o.
  Kodaňská 1441/46
  100 00 Praha 10
  Czech Republic | BROMOCRIPTIN | 2,5 mg | pillola miksija b'rita | użu orali |
| Ir-Repubblika Slovakka | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  3011 Limassol
  Cyprus | Parlodel | 2,5 mg | pillola | użu orali |
| Ir-Repubblika Slovakka | Lek farmacevtska družba d.d. Verovškova 57
  1526 Ljubljana Slovenia | MEDOCRIPTINE 2,5 mg | 2,5 mg | pillola | użu orali |
| Is-Slovenja | Meda Pharma – Produtos farmacêuticos, S.A.
  Rua do Centro Cultural, 13
  Lisboa, 1749-066
  Portugal | Bromergon 2,5 mg tablete | 2,5 mg | pillola | użu orali |
| Spanja | MEDA PHARMA, S.A.U. Avda. Castilla 2
  Edificio Berlín 2a planta
  Parque Empresarial San Fernando 28830 San Fernando de Henares Madrid
  Spain | Parlodel 2,5 mg comprimidos | 2,5 mg | pillola | użu orali |
| L-Iżvezja | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 2,5 mg | pillola | użu orali |
| L-Iżvezja | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 10 mg | kapsula, iebsa | użu orali |
| L-Iżvezja | Meda AB
  Box 906
  170 09 Solna
  Sweden | Pravidel | 5 mg | kapsula, iebsa | użu orali |
| L-Olanda | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 10 mg capsules | 10 mg | kapsula, iebsa | użu orali |
| L-Olanda | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 2,5 mg | 2,5 mg | pillola | użu orali |
| L-Olanda | Meda Pharma B.V.
  Krijgsman 20
  1186 DM AMSTELVEEN
  The Netherlands | Parlodel 5 mg capsules | 5 mg | kapsula, iebsa | użu orali |
| Ir-Renju Unit | Teva UK Limited
  Brampton Road, Hampden Park Eastbourne, East Sussex
  BN22 9AG
  United Kingdom | Teva UK Bromocriptine Tablets | 2,5 mg | pillola | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road
  Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 1 mg Tablets | 1 mg | pillola | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 2,5 mg Tablets | 2,5 mg | pillola | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House, Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 5 mg Tablets | 5 mg | kapsula | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Parlodel 10 mg Tablets | 10 mg | kapsula | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 1 mg Tablets | 1 mg | pillola | użu orali |
| Ir-Renju Unit | Meda Pharmaceuticals Limited
  Skyway House Parsonage Road Takeley Bishops Stortford
  CM22 6PU
  United Kingdom | Bromocriptine 2,5 mg Tablets | 2,5 mg | pillola | użu orali |

Stat Membru

fiż-ŻEE

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem il-prodott

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

Meda Pharma GmbH

Guglgasse 15/II. Stock 1110

Wien

Austria

Parlodel 2,5 mg – Tabletten

2,5 mg

pillola

użu orali

Il-Belġju

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel

2,5 mg

pillola

użu orali

Il-Belġju

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 5 mg

5 mg

kapsula, iebsa

użu orali

Il-Belġju

Meda Pharma s.a.

Chaussée de la Hulpe 166

1170 Brussels

Belgium

Parlodel 10 mg

10 mg

kapsula, iebsa

użu orali

Il-Bulgarija

Sopharma AD

16 “Iliensko shose” Str.

Sofia 1220

Bulgaria

Bromocriptine Sopharma

2,5 mg

pillola

użu orali

Il-Bulgarija

Medochemie Ltd.

1-10 Astronafton Str.

Limassol 3505

Cyprus

Medocriptine

2,5 mg

pillola

użu orali

Il-Kroazja

Sandoz d.o.o.

Maksimirska 120/V

Zagreb 10  000

Croatia

Bromergon 2,5 mg tablete

2,5 mg

pillola

użu orali

Ċipru

Codal Synto Ltd

33 Theklas Lysioti street

Dorothea Building, 6th floor

Lemesos 3508 Cyprus

Pirodal

2,5 mg

pillola

użu orali

Ċipru

Remedica Ltd Aharnon Street

Limassol Industrial Estate

Lemesos 3508 Cyprus

Brameston

2,5 mg

pillola

użu orali

Ċipru

Medochemie Ltd Constantinoupoleos 1-10 Street

Lemesos 3501 Cyprus

Medocriptine

2,5 mg

pillola

użu orali

Ir-Repubblika Ċeka

MEDA Pharma s.r.o.

Kodaňská 1441/46

110 00 Prague 10

Czech Republic

Parlodel

2,5 mg

pillola

użu orali

Ir-Repubblika Ċeka

Medochemie Ltd.

Constantinoupoleos Str. 1_10

3011 Limassol – Tsiflikoudia

Cyprus

Medocriptine

2,5 mg

pillola

użu orali

Id-Danimarka

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

10 mg

kapsula, iebsa

użu orali

Id-Danimarka

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

5 mg

kapsula, iebsa

użu orali

Id-Danimarka

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Parlodel

2,5 mg

pillola

użu orali

L-Estonja

Gedeon Richter Plc.

Gyömrõi ut 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2,5 mg

pillola

użu orali

Il-Finlandja

Meda Oy

Vaisalantie 4

02130 Espoo

Finland

PARLODEL

2,5 mg

pillola

użu orali

Franza

MEDA PHARMA

25, boulevard de l'Amiral Bruix 75016 Paris

France

PARLODEL 2,5 mg inhibition de la lactation

2,5 mg

pillola

użu orali

Franza

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 PARIS

France

BROMOCRIPTINE ZENTIVA 2,5 mg lNHIBITION DE LA LACTATION

2,5 mg

pillola

użu orali

Il-Ġermanja

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin AbZ 2,5 mg

2,5 mg

pillola

użu orali

Il-Ġermanja

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Bromocriptin beta 2,5

2,5 mg

pillola

użu orali

Il-Ġermanja

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

bromocriptin-ct 2,5 mg Tabletten

2,5 mg

pillola

użu orali

Il-Ġermanja

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

bromocriptin-ct 2,5 mg Tabletten

2,5 mg

pillola

użu orali

Il-Ġermanja

MEDA Pharma GmbH & Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Pravidel 2,5 mg Tabletten

2,5 mg

pillola

użu orali

Il-Ġermanja

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Bromocriptin-ratiopharm 2,5 mg Tabletten

2,5 mg

pillola

użu orali

Il-Greċja

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

2,5 mg

pillola

użu orali

Il-Greċja

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

5 mg

kapsula, iebsa

użu orali

Il-Greċja

MEDA PHARMACEUTICALS S.A. GREECE

3 Evrytanias Str., Halandri

15231, Attiki

Greece

Parlodel

10 mg

kapsula, iebsa

użu orali

L-Ungerija

Gedeon Richter Plc

Gyömrői út 19-21

H-1103 Budapest

Hungary

Bromocriptin-Richter 2,5 mg tabletta

2,5 mg

pillola

użu orali

L-Irlanda

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 2,5 mg Tablets

2,5 mg

pillola

użu orali

L-Irlanda

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne Co. Meath

Ireland

Parlodel 5 mg Hard Capsules.

5 mg

kapsula, iebsa

użu orali

Il-Litwanja

Gedeon Richter Plc.

Gyömröi út 19-21

1103 Budapest

Hungary

BROMOCRIPTIN-RICHTER

2,5 mg

pillola

użu orali

Il-Lussemburgu

MEDA Pharma GmbH & Co. KG

Benzstraße 1

61352 Bad Homburg

Germany

Pravidel

2,5 mg

pillola

użu orali

In-Norveġja

Meda AS

Askerveien 61

Postboks 194

1371 Asker

Norway

Parlodel

2,5 mg

pillola

użu orali

Il-Polonja

Sandoz GmbH

Biochemiestrasse 10

Kundl

6250 Tyrol

Austria

Bromergon

2,5 mg

pillola

użu orali

Il-Polonja

Farmaceutyczna Spółdzielnia Pracy FILOFARM

ul. Pułaskiego 39

85-619 Bydgoszcz

Poland

Bromocorn

2,5 mg

pillola

użu orali

Il-Polonja

Meda Aktiebolag

Pipers vag 2

170 09 Solna

Box 906

Sweden

Parlodel

2,5 mg

pillola

użu orali

Il-Portugall

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

5 mg

kapsula

użu orali

Il-Portugall

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Parlodel

10 mg

kapsula

użu orali

Il-Portugall

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Parlodel

2,5 mg

pillola

użu orali

Il-Portugall

S.C. BIOFARM S.A.

Str. Logofăt Tăutu nr. 99

sector 3, Bucureşti 031212

Romania

Bromocriptina Generis 2,5 mg comprimidos

2,5 mg

pillola

użu orali

Ir-Rumanija

MEDA Pharma s.r.o.

Kodaňská 1441/46

100 00 Praha 10

Czech Republic

BROMOCRIPTIN

2,5 mg

pillola miksija b'rita

użu orali

Ir-Repubblika Slovakka

Medochemie Ltd.

1-10 Constantinoupoleos St.

3011 Limassol

Cyprus

Parlodel

2,5 mg

pillola

użu orali

Ir-Repubblika Slovakka

Lek farmacevtska družba d.d. Verovškova 57

1526 Ljubljana Slovenia

MEDOCRIPTINE 2,5 mg

2,5 mg

pillola

użu orali

Is-Slovenja

Meda Pharma – Produtos farmacêuticos, S.A.

Rua do Centro Cultural, 13

Lisboa, 1749-066

Portugal

Bromergon 2,5 mg tablete

2,5 mg

pillola

użu orali

Spanja

MEDA PHARMA, S.A.U. Avda. Castilla 2

Edificio Berlín 2a planta

Parque Empresarial San Fernando 28830 San Fernando de Henares Madrid

Spain

Parlodel 2,5 mg comprimidos

2,5 mg

pillola

użu orali

L-Iżvezja

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

2,5 mg

pillola

użu orali

L-Iżvezja

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

10 mg

kapsula, iebsa

użu orali

L-Iżvezja

Meda AB

Box 906

170 09 Solna

Sweden

Pravidel

5 mg

kapsula, iebsa

użu orali

L-Olanda

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 10 mg capsules

10 mg

kapsula, iebsa

użu orali

L-Olanda

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 2,5 mg

2,5 mg

pillola

użu orali

L-Olanda

Meda Pharma B.V.

Krijgsman 20

1186 DM AMSTELVEEN

The Netherlands

Parlodel 5 mg capsules

5 mg

kapsula, iebsa

użu orali

Ir-Renju Unit

Teva UK Limited

Brampton Road, Hampden Park Eastbourne, East Sussex

BN22 9AG

United Kingdom

Teva UK Bromocriptine Tablets

2,5 mg

pillola

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House Parsonage Road

Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 1 mg Tablets

1 mg

pillola

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 2,5 mg Tablets

2,5 mg

pillola

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House, Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 5 mg Tablets

5 mg

kapsula

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Parlodel 10 mg Tablets

10 mg

kapsula

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 1 mg Tablets

1 mg

pillola

użu orali

Ir-Renju Unit

Meda Pharmaceuticals Limited

Skyway House Parsonage Road Takeley Bishops Stortford

CM22 6PU

United Kingdom

Bromocriptine 2,5 mg Tablets

2,5 mg

pillola

użu orali

---