# Il-Ġurnal Uffiċjali C 252/31 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 252 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5831 ta' Lulju 2015 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 252

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5831 ta' Lulju 2015

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2015/C 252/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2015/C 252/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015(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

2015/C 252/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015(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

2015/C 252/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015(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

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

MT

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IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 31.7.2015 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 252/1 |
| --- | --- | --- | --- |

31.7.2015

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 252/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015

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

(2015/C 252/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.6.2015 | Gardasil 9 | Vaċċin b’9 tipi ta’ Papillomavirus Uman (Rikombinanti, adsorbit) | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | Suspensjoni għall-injezzjoni | J07BM03 | 12.6.2015 |
| 19.6.2015 | Duloxetine Mylan | Duloxetine | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/1010 | Kapsula gastro-reżistenti, iebsa | N06AX21 | 24.6.2015 |
| 19.6.2015 | Lixiana | Edoxaban | Daiichi Sankyo Europe GmbH
  Zielstattstrasse 48, 81379 Munich, Deutschland | EU/1/15/993 | Pillola miksija b’rita | B01 | 23.6.2015 |
| 19.6.2015 | Lumark | Lutezju, isotopu ta' massa 177 | IDB Radiopharmacy B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | Prekursur radjufarmaċewtiku, soluzzjoni | Pending | 23.6.2015 |
| 19.6.2015 | Opdivo | Nivolumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | Konċentrat għal soluzzjoni għal infużjoni | L01XC17 | 24.6.2015 |
| 19.6.2015 | Pregabalin Sandoz | Pregabalin | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1011 | Kapsula, iebsa | N03AX16 | 23.6.2015 |
| 19.6.2015 | Pregabalin Sandoz GmbH | Pregabalin | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1012 | Kapsula, iebsa | N03AX16 | 23.6.2015 |
| 25.6.2015 | Aripiprazole Zentiva | Aripiprazole | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | Pillola
  Pilloli li jinħallu fil-ħalq | N05AX12 | 29.6.2015 |
| 25.6.2015 | Pregabalin Mylan | Pregabalin | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | Kapsula, iebsa | N03AX16 | 30.6.2015 |
| 25.6.2015 | Pregabalin Mylan Pharma | Pregabalin | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | Kapsula, iebsa | N03AX16 | 29.6.2015 |
| 30.6.2015 | Aripiprazole Pharmathen | Aripiprazole | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/15/1005 | Pillola | N05AX12 | 2.7.2015 |

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

10.6.2015

Gardasil 9

Vaċċin b’9 tipi ta’ Papillomavirus Uman (Rikombinanti, adsorbit)

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

Suspensjoni għall-injezzjoni

J07BM03

12.6.2015

19.6.2015

Duloxetine Mylan

Duloxetine

Generics [UK] Limited

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

EU/1/15/1010

Kapsula gastro-reżistenti, iebsa

N06AX21

24.6.2015

19.6.2015

Lixiana

Edoxaban

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48, 81379 Munich, Deutschland

EU/1/15/993

Pillola miksija b’rita

B01

23.6.2015

19.6.2015

Lumark

Lutezju, isotopu ta' massa 177

IDB Radiopharmacy B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

Prekursur radjufarmaċewtiku, soluzzjoni

Pending

23.6.2015

19.6.2015

Opdivo

Nivolumab

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

Konċentrat għal soluzzjoni għal infużjoni

L01XC17

24.6.2015

19.6.2015

Pregabalin Sandoz

Pregabalin

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1011

Kapsula, iebsa

N03AX16

23.6.2015

19.6.2015

Pregabalin Sandoz GmbH

Pregabalin

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1012

Kapsula, iebsa

N03AX16

23.6.2015

25.6.2015

Aripiprazole Zentiva

Aripiprazole

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

Pillola

Pilloli li jinħallu fil-ħalq

N05AX12

29.6.2015

25.6.2015

Pregabalin Mylan

Pregabalin

Generics [UK] Limited

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

EU/1/15/997

Kapsula, iebsa

N03AX16

30.6.2015

25.6.2015

Pregabalin Mylan Pharma

Pregabalin

Generics [UK] Limited

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

EU/1/15/998

Kapsula, iebsa

N03AX16

29.6.2015

30.6.2015

Aripiprazole Pharmathen

Aripiprazole

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/15/1005

Pillola

N05AX12

2.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 2.6.2015 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 4.6.2015 |
| 2.6.2015 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 5.6.2015 |
| 5.6.2015 | Kolbam | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | EU/1/13/895 | 9.6.2015 |
| 5.6.2015 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 9.6.2015 |
| 10.6.2015 | CANCIDAS | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196 | 12.6.2015 |
| 10.6.2015 | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 12.6.2015 |
| 10.6.2015 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 12.6.2015 |
| 11.6.2015 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 16.6.2015 |
| 11.6.2015 | IKERVIS | Santen Oy
  Niittyhaankatu 20, FI-33720 Tampere, Suomi | EU/1/15/990 | 15.6.2015 |
| 11.6.2015 | Insulatard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233 | 15.6.2015 |
| 11.6.2015 | Pramipexole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/728 | 12.6.2015 |
| 11.6.2015 | Protaphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234 | 15.6.2015 |
| 16.6.2015 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 18.6.2015 |
| 19.6.2015 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 23.6.2015 |
| 19.6.2015 | Actrapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230 | 23.6.2015 |
| 19.6.2015 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 23.6.2015 |
| 19.6.2015 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | 23.6.2015 |
| 19.6.2015 | DuoTrav | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/06/338 | 24.6.2015 |
| 19.6.2015 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 23.6.2015 |
| 19.6.2015 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/01/188 | 23.7.2015 |
| 19.6.2015 | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 23.6.2015 |
| 19.6.2015 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 23.6.2015 |
| 19.6.2015 | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 23.6.2015 |
| 19.6.2015 | Rasilamlo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/686 | 24.6.2015 |
| 19.6.2015 | Rasilez | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/405 | 24.6.2015 |
| 19.6.2015 | SonoVue | Bracco International B.V.
  Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland | EU/1/01/177 | 23.6.2015 |
| 19.6.2015 | Telmisartan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/10/639 | 23.6.2015 |
| 19.6.2015 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 24.6.2015 |
| 19.6.2015 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 23.6.2015 |
| 19.6.2015 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 23.6.2015 |
| 19.6.2015 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 23.6.2015 |
| 22.6.2015 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Brussels, Belgique | EU/1/07/420 | 24.6.2015 |
| 22.6.2015 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/12/776 | 24.6.2015 |
| 22.6.2015 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 24.6.2015 |
| 22.6.2015 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 24.6.2015 |
| 22.6.2015 | Kuvan | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/08/481 | 24.6.2015 |
| 22.6.2015 | Prevenar | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/00/167 | 25.6.2015 |
| 22.6.2015 | Rasilez HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/491 | 24.6.2015 |
| 22.6.2015 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 24.6.2015 |
| 22.6.2015 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 24.6.2015 |
| 22.6.2015 | Xolair | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/319 | 24.6.2015 |
| 22.6.2015 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 24.6.2015 |
| 25.6.2015 | Ibandronic Acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/642 | 29.6.2015 |
| 25.6.2015 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 29.6.2015 |
| 30.6.2015 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 2.7.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

2.6.2015

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

4.6.2015

2.6.2015

Optimark

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland

EU/1/07/398

5.6.2015

5.6.2015

Kolbam

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

EU/1/13/895

9.6.2015

5.6.2015

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

9.6.2015

10.6.2015

CANCIDAS

Merck Sharp & Dohme Limited

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

EU/1/01/196

12.6.2015

10.6.2015

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

12.6.2015

10.6.2015

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

12.6.2015

11.6.2015

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

16.6.2015

11.6.2015

IKERVIS

Santen Oy

Niittyhaankatu 20, FI-33720 Tampere, Suomi

EU/1/15/990

15.6.2015

11.6.2015

Insulatard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

15.6.2015

11.6.2015

Pramipexole Accord

Accord Healthcare Limited

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

EU/1/11/728

12.6.2015

11.6.2015

Protaphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

15.6.2015

16.6.2015

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

18.6.2015

19.6.2015

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

23.6.2015

19.6.2015

Actrapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230

23.6.2015

19.6.2015

APTIVUS

Boehringer Ingelheim International GmbH

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

EU/1/05/315

23.6.2015

19.6.2015

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

23.6.2015

19.6.2015

DuoTrav

Alcon Laboratories (UK) Ltd

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

EU/1/06/338

24.6.2015

19.6.2015

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

23.6.2015

19.6.2015

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188

23.7.2015

19.6.2015

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

23.6.2015

19.6.2015

Leflunomide ratiopharm

ratiopharm GmbH

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

EU/1/10/654

23.6.2015

19.6.2015

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

23.6.2015

19.6.2015

Rasilamlo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/686

24.6.2015

19.6.2015

Rasilez

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/405

24.6.2015

19.6.2015

SonoVue

Bracco International B.V.

Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland

EU/1/01/177

23.6.2015

19.6.2015

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/639

23.6.2015

19.6.2015

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

24.6.2015

19.6.2015

VPRIV

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

23.6.2015

19.6.2015

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

23.6.2015

19.6.2015

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

23.6.2015

22.6.2015

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Brussels, Belgique

EU/1/07/420

24.6.2015

22.6.2015

Fycompa

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/12/776

24.6.2015

22.6.2015

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

24.6.2015

22.6.2015

Kivexa

ViiV Healthcare UK Limited

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

EU/1/04/298

24.6.2015

22.6.2015

Kuvan

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/08/481

24.6.2015

22.6.2015

Prevenar

Pfizer Limited

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

EU/1/00/167

25.6.2015

22.6.2015

Rasilez HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/491

24.6.2015

22.6.2015

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

24.6.2015

22.6.2015

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

24.6.2015

22.6.2015

Xolair

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/319

24.6.2015

22.6.2015

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

24.6.2015

25.6.2015

Ibandronic Acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/642

29.6.2015

25.6.2015

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

29.6.2015

30.6.2015

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

2.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 25.6.2015 | Rasilamlo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/686 | 29.6.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

25.6.2015

Rasilamlo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/686

29.6.2015

—   Ħruġ 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.6.2015 | Sileo | Dexmedetomidine hydrochloride | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/2/15/181 | Ġell oromukożali | QN05CM18 | 12.6.2015 |

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

10.6.2015

Sileo

Dexmedetomidine hydrochloride

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/2/15/181

Ġell oromukożali

QN05CM18

12.6.2015

—   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 |
| --- | --- | --- | --- | --- |
| 5.6.2015 | Bovilis BTV8 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/106 | 9.6.2015 |
| 5.6.2015 | Equisolon | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/14/161 | 9.6.2015 |
| 5.6.2015 | Recuvyra | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/11/127 | 9.6.2015 |
| 10.6.2015 | Cerenia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/062 | 12.6.2015 |
| 10.6.2015 | Equilis Te | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/05/055 | 12.6.2015 |
| 10.6.2015 | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 12.6.2015 |
| 10.6.2015 | Previcox | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/045 | 12.6.2015 |
| 11.6.2015 | Prac-Tic | Novartis Sanidad Animal S.L.
  Calle de la Marina, 206, E-08013 Barcelona, España | EU/2/06/066 | 12.6.2015 |
| 19.6.2015 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 23.6.2015 |
| 30.6.2015 | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/10/109 | 2.7.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

5.6.2015

Bovilis BTV8

Intervet International B.V.

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

EU/2/10/106

9.6.2015

5.6.2015

Equisolon

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/14/161

9.6.2015

5.6.2015

Recuvyra

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/11/127

9.6.2015

10.6.2015

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

12.6.2015

10.6.2015

Equilis Te

Intervet International B.V.

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

EU/2/05/055

12.6.2015

10.6.2015

Kexxtone

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/12/145

12.6.2015

10.6.2015

Previcox

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/045

12.6.2015

11.6.2015

Prac-Tic

Novartis Sanidad Animal S.L.

Calle de la Marina, 206, E-08013 Barcelona, España

EU/2/06/066

12.6.2015

19.6.2015

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

23.6.2015

30.6.2015

Rhiniseng

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/10/109

2.7.2015

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, 30.4.2004, p. 1.

---

| 31.7.2015 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 252/10 |
| --- | --- | --- | --- |

31.7.2015

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 252/10

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ġunju 2015 sat-30 ta’ Ġunju 2015

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

(2015/C 252/02)

| 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 |
| --- | --- | --- | --- | --- | --- |
| 5.6.2015 | Ikorel and Dancor | Ara l-Anness I | Ara l-Anness I | Ara l-Anness I | 6.6.2015 |
| 25.6.2015 | Merisone | Ara l-Anness II | Ara l-Anness II | Ara l-Anness II | 26.6.2015 |
| 25.6.2015 | Myoson | Ara l-Anness III | Ara l-Anness III | Ara l-Anness III | 26.6.2015 |

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

5.6.2015

Ikorel and Dancor

Ara l-Anness I

Ara l-Anness I

Ara l-Anness I

6.6.2015

25.6.2015

Merisone

Ara l-Anness II

Ara l-Anness II

Ara l-Anness II

26.6.2015

25.6.2015

Myoson

Ara l-Anness III

Ara l-Anness III

Ara l-Anness III

26.6.2015

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Istati Membri

| Stat Membru (fl-EEA) | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem Ivvintat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | MERCK Gesellschaft mbH
  Zimbagasse 5
  1147 Wien
  Austria | Dancor 10 mg – Tabletten | 10 mg | Pillola | Użu Orali |
| L-Awstrija | MERCK Gesellschaft mbH
  Zimbagasse 5
  1147 Wien
  Austria | Dancor 20 mg – Tabletten | 20 mg | Pillola | Użu Orali |
| Id-Denimarka | Sanofi-Aventis Denmark A/S
  Slotsmarken 13
  DK-2970 Hørsholm
  Denmak | ANGICOR | 10 mg | Pillola | Użu Orali |
| Id-Denimarka | Sanofi-Aventis Denmark A/S
  Slotsmarken 13
  DK-2970 Hørsholm
  Denmark | ANGICOR | 20 mg | Pillola | Użu Orali |
| Franza | Sanofi-Aventis Franza
  1-13 boulevard Romain Rolland
  75014 Paris
  France | IKOREL | 10 mg | Pillola bil-qasma | Użu Orali |
| Franza | Sanofi-Aventis Franza
  1-13 boulevard Romain Rolland
  75014 Paris
  France | IKOREL | 20 mg | Pillola | Użu Orali |
| Franza | Sanofi-Aventis Franza
  1-13 boulevard Romain Rolland
  75014 Paris
  France | NICORANDIL ZENTIVA | 10 mg | Pillola bil-qasma | Użu Orali |
| Franza | Sanofi-Aventis Franza
  1-13 boulevard Romain Rolland
  75014 Paris
  France | NICORANDIL ZENTIVA | 20 mg | Pillola | Użu Orali |
| Franza | Merck Santé
  37, Rue Saint-Romain
  69379 Lyon Cedex 08
  France | Adancor | 10 mg | Pillola bil-qasma | Użu Orali |
| Franza | Merck Santé
  37, Rue Saint-Romain
  69379 Lyon Cedex 08
  France | Adancor | 20 mg | Pillola | Użu Orali |
| L-Irlanda | Sanofi-Aventis L-Irlanda L Ltd., T/A SANOFI
  Citywest Business Campus Dublin 24
  Ireland | IKOREL | 10 mg | Pillola | Użu Orali |
| L-Irlanda | Sanofi-Aventis L-Irlanda L Ltd., T/A SANOFI
  Citywest Business Campus Dublin 24
  Ireland | IKOREL | 20 mg | Pillola | Użu Orali |
| L-Olanda | Sanofi-Aventis L-Olanda B.V.
  Kampenringweg 45 D-E Gouda
  Netherlands | IKOREL 10 mg | 10 mg | Pillola | Użu Orali |
| Il-Portugall | Merck, S.A.
  Edifício DUO Miraflores
  Alameda Fernão Lopes, no 12 – 4o B,
  1495-190 Algés
  Portugal | Dancor | 10 mg | Pillola | Użu Orali |
| Il-Portugall | Merck, S.A.
  Edifício DUO Miraflores
  Alameda Fernão Lopes, no 12 – 4o B,
  1495-190 Algés
  Portugal | Dancor | 20 mg | Pillola | Użu Orali |
| Ir-Renju Unit | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  UK | IKOREL | 10 mg | Pillola | Użu Orali |
| Ir-Renju Unit | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  UK | IKOREL | 20 mg | Pillola | Użu Orali |

Stat Membru (fl-EEA)

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem Ivvintat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

MERCK Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Dancor 10 mg – Tabletten

10 mg

Pillola

Użu Orali

L-Awstrija

MERCK Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Dancor 20 mg – Tabletten

20 mg

Pillola

Użu Orali

Id-Denimarka

Sanofi-Aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmak

ANGICOR

10 mg

Pillola

Użu Orali

Id-Denimarka

Sanofi-Aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

ANGICOR

20 mg

Pillola

Użu Orali

Franza

Sanofi-Aventis Franza

1-13 boulevard Romain Rolland

75014 Paris

France

IKOREL

10 mg

Pillola bil-qasma

Użu Orali

Franza

Sanofi-Aventis Franza

1-13 boulevard Romain Rolland

75014 Paris

France

IKOREL

20 mg

Pillola

Użu Orali

Franza

Sanofi-Aventis Franza

1-13 boulevard Romain Rolland

75014 Paris

France

NICORANDIL ZENTIVA

10 mg

Pillola bil-qasma

Użu Orali

Franza

Sanofi-Aventis Franza

1-13 boulevard Romain Rolland

75014 Paris

France

NICORANDIL ZENTIVA

20 mg

Pillola

Użu Orali

Franza

Merck Santé

37, Rue Saint-Romain

69379 Lyon Cedex 08

France

Adancor

10 mg

Pillola bil-qasma

Użu Orali

Franza

Merck Santé

37, Rue Saint-Romain

69379 Lyon Cedex 08

France

Adancor

20 mg

Pillola

Użu Orali

L-Irlanda

Sanofi-Aventis L-Irlanda L Ltd., T/A SANOFI

Citywest Business Campus Dublin 24

Ireland

IKOREL

10 mg

Pillola

Użu Orali

L-Irlanda

Sanofi-Aventis L-Irlanda L Ltd., T/A SANOFI

Citywest Business Campus Dublin 24

Ireland

IKOREL

20 mg

Pillola

Użu Orali

L-Olanda

Sanofi-Aventis L-Olanda B.V.

Kampenringweg 45 D-E Gouda

Netherlands

IKOREL 10 mg

10 mg

Pillola

Użu Orali

Il-Portugall

Merck, S.A.

Edifício DUO Miraflores

Alameda Fernão Lopes, no 12 – 4o B,

1495-190 Algés

Portugal

Dancor

10 mg

Pillola

Użu Orali

Il-Portugall

Merck, S.A.

Edifício DUO Miraflores

Alameda Fernão Lopes, no 12 – 4o B,

1495-190 Algés

Portugal

Dancor

20 mg

Pillola

Użu Orali

Ir-Renju Unit

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

IKOREL

10 mg

Pillola

Użu Orali

Ir-Renju Unit

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

IKOREL

20 mg

Pillola

Użu Orali

---

ANNESS II

Lista ta’ ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mod ta’ amministrazzjoni u applikanti fl- Istati Membri

| Stat Membru EU/EEA | Applikant | (Ivvintat)Isem | Qawwa | Għamla Farmaċewtika | Mod ta’ kif jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Ġermanja | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H-2097 Pilisborosjenő,
  Hungary | Tolperison-neuraxpharm 50 mg Filmtabletten | 50 mg | pillola miksija b’rita | Użu orali |
| Il-Ġermanja | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H-2097 Pilisborosjenő,
  Hungary | Tolperison-neuraxpharm 150 mg Filmtabletten | 150 mg | pillola miksija b’rita | Użu orali |
| L-Ungerija | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H-2097 Pilisborosjenő,
  Hungary | MERISONE | 50 mg | pillola miksija b’rita | Użu orali |
| L-Ungerija | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H-2097 Pilisborosjenő,
  Hungary | MERISONE | 150 mg | pillola miksija b’rita | Użu orali |

Stat Membru EU/EEA

Applikant

(Ivvintat)Isem

Qawwa

Għamla Farmaċewtika

Mod ta’ kif jingħata

Il-Ġermanja

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H-2097 Pilisborosjenő,

Hungary

Tolperison-neuraxpharm 50 mg Filmtabletten

50 mg

pillola miksija b’rita

Użu orali

Il-Ġermanja

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H-2097 Pilisborosjenő,

Hungary

Tolperison-neuraxpharm 150 mg Filmtabletten

150 mg

pillola miksija b’rita

Użu orali

L-Ungerija

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H-2097 Pilisborosjenő,

Hungary

MERISONE

50 mg

pillola miksija b’rita

Użu orali

L-Ungerija

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H-2097 Pilisborosjenő,

Hungary

MERISONE

150 mg

pillola miksija b’rita

Użu orali

---

ANNESS III

Lista ta’ ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mod ta’ amministrazzjoni u applikanti fl- Istati Membri

| Stat Membru EU/EEA | Applikant | (Ivvintat)Isem | Qawwa | Għamla Farmaċewtika | Mod ta’ kif jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Belġju | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 50 mg comprimés pelliculés | 50 mg | pillola miksija b’rita | Użu orali |
| Il-Belġju | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 150 mg comprimés pelliculés | 150 mg | pillola miksija b’rita | Użu orali |
| L-Ungerija | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | MYOSON | 50 mg | pillola miksija b’rita | Użu orali |
| L-Ungerija | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | MYOSON | 150 mg | pillola miksija b’rita | Użu orali |
| Il-Lussemburgu | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Epsipam | 50 mg | pillola miksija b’rita | Użu orali |
| Il-Lussemburgu | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Epsipam | 150 mg | pillola miksija b’rita | Użu orali |
| L-Olanda | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 50 mg filmomhulde tabletten | 50 mg | pillola miksija b’rita | Użu orali |
| L-Olanda | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 150 mg filmomhulde tabletten | 150 mg | pillola miksija b’rita | Użu orali |

Stat Membru EU/EEA

Applikant

(Ivvintat)Isem

Qawwa

Għamla Farmaċewtika

Mod ta’ kif jingħata

Il-Belġju

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 50 mg comprimés pelliculés

50 mg

pillola miksija b’rita

Użu orali

Il-Belġju

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 150 mg comprimés pelliculés

150 mg

pillola miksija b’rita

Użu orali

L-Ungerija

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

MYOSON

50 mg

pillola miksija b’rita

Użu orali

L-Ungerija

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

MYOSON

150 mg

pillola miksija b’rita

Użu orali

Il-Lussemburgu

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Epsipam

50 mg

pillola miksija b’rita

Użu orali

Il-Lussemburgu

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Epsipam

150 mg

pillola miksija b’rita

Użu orali

L-Olanda

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 50 mg filmomhulde tabletten

50 mg

pillola miksija b’rita

Użu orali

L-Olanda

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 150 mg filmomhulde tabletten

150 mg

pillola miksija b’rita

Użu orali

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