# Il-Ġurnal Uffiċjali C 165/29 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 165 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5729 ta' Mejju 2014 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 165

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5729 ta' Mejju 2014

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2014/C 165/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' April 2014 sat-30 ta' April 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 165/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ April 2014 sat-30 April 2014(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 9 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2014/C 165/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' April 2014 sat-30 ta' April 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 165/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ April 2014 sat-30 April 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)

9

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

MT

---

IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 29.5.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 165/1 |
| --- | --- | --- | --- |

29.5.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 165/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' April 2014 sat-30 ta' April 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 165/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.4.2014 | Rivastigmine 3M Health Care Ltd. | rivastigmine | 3M Health Care Limited |
| 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom |

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

3.4.2014

Rivastigmine 3M Health Care Ltd.

rivastigmine

3M Health Care Limited

1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom

EU/1/14/911

Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda

N06DA03

7.4.2014

4.4.2014

Cholic Acid FGK

Aċidu koliku

FGK Representative Service GmbH

Heimeranstraße 35, D-80339 München, Deutschland

EU/1/13/895

Kapsula, iebsa

A05AA03

8.4.2014

7.4.2014

Para-aminosalicylic acid Lucane

Para-aminosalicylic acid

| Lucane Pharma |
| --- |
| 172 rue de Charonne, 75011 Paris, France |

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

Granuli gastro-reżistenti

J04AA01

9.4.2014

10.4.2014

Pregabalin Pfizer

pregabalin

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

Pfizer Limited

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

EU/1/14/916

Kapsula, iebsa

N03AX16

14.4.2014

23.4.2014

Hemangiol

propranolol

| PIERRE FABRE DERMATOLOGIE |
| --- |
| 45 place Abel Gance, F- 92100 Boulogne, France |

PIERRE FABRE DERMATOLOGIE

45 place Abel Gance, F- 92100 Boulogne, France

EU/1/14/919

Soluzzjoni orali

C07AA05

25.4.2014

23.4.2014

Ulunar Breezhaler

indacaterol/glycopyrronium bromide

| 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/1/14/917

Trab li jittieħed man-nifs, kapsula iebsa

R03AL04

25.4.2014

23.4.2014

Vokanamet

canagliflozin/metformin hydrochloride

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

Pillola miksija b’rita

A10BD16

25.4.2014

28.4.2014

BiResp Spiromax

budesonide/formoterol

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/921

Trab li jittieħed man-nifs

R03AK07

1.5.2014

28.4.2014

Deltyba

delamanid

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, D-80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

Pillola miksija b’rita

J04AK06

30.4.2014

28.4.2014

DuoResp Spiromax

budesonide/formoterol

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/920

Trab li jittieħed man-nifs

R03AK07

1.5.2014

28.4.2014

Incruse

umeclidinium bromide

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

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

EU/1/14/922

Trab għall-inalazzjoni, magħmul għal-lest

R03BB07

30.4.2014

28.4.2014

Vimizim

elosulfase alfa

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/14/914

Konċentrat u solvent għal soluzzjoni għall-infużjoni

A16AB12

30.4.2014

—   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 |
| --- | --- | --- | --- | --- |
| 3.4.2014 | Neuraceq | Piramal Imaging Limited |
| Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, 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

3.4.2014

Neuraceq

Piramal Imaging Limited

Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom

EU/1/13/906

9.4.2014

3.4.2014

Xiapex

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/11/671

7.4.2014

7.4.2014

Exelon

| 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/1/98/066

9.4.2014

10.4.2014

Abilify

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

14.4.2014

10.4.2014

Clopidogrel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, F-69800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/09/559

14.4.2014

10.4.2014

Lonquex

| UAB “Sicor Biotech” |
| --- |
| V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania |

UAB “Sicor Biotech”

V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania

EU/1/13/856

15.4.2014

10.4.2014

Pixuvri

| CTI Life Sciences Ltd |
| --- |
| Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom |

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

14.4.2014

10.4.2014

Viramune

| 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/1/97/055

14.4.2014

11.4.2014

Grepid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

15.4.2014

11.4.2014

Mozobil

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

15.4.2014

11.4.2014

Victoza

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

15.4.2014

15.4.2014

Osseor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

17.4.2014

15.4.2014

Protelos

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

17.4.2014

23.4.2014

Aloxi

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

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

25.4.2014

23.4.2014

Betmiga

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

25.4.2014

23.4.2014

Bretaris Genuair

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, E-08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/781

25.4.2014

23.4.2014

CANCIDAS

| 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/1/01/196

25.4.2014

23.4.2014

Eklira Genuair

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, E-08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/778

25.4.2014

23.4.2014

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/06/365

25.4.2014

23.4.2014

Ferriprox

| Apotex Europe B.V. |
| --- |
| Darwinweg 20, NL- 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/99/108

25.4.2014

23.4.2014

Instanyl

| Takeda Pharma A/S |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/09/531

25.4.2014

23.4.2014

Integrilin

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

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

EU/1/99/109

25.4.2014

23.4.2014

Iressa

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/526

25.4.2014

23.4.2014

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/01/191

25.4.2014

23.4.2014

Nimenrix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

25.4.2014

23.4.2014

Noxafil

| 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/1/05/320

28.4.2014

23.4.2014

Onglyza

| Bristol-Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545

25.4.2014

23.4.2014

Pegasys

| 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/1/02/221

25.4.2014

23.4.2014

Qutenza

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

25.4.2014

23.4.2014

Rivastigmine HEXAL

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

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

25.4.2014

23.4.2014

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

28.4.2014

23.4.2014

Ryzodeg

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

25.4.2014

23.4.2014

Siklos

| Addmedica |
| --- |
| 101 rue Saint Lazare, F-75009 Paris, France |

Addmedica

101 rue Saint Lazare, F-75009 Paris, France

EU/1/07/397

25.4.2014

23.4.2014

Stocrin

| 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/1/99/111

25.4.2014

23.4.2014

Sustiva

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

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

25.4.2014

23.4.2014

Vedrop

| Orphan Europe S.A.R.L. |
| --- |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/09/533

25.4.2014

23.4.2014

Vfend

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

Pfizer Limited

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

EU/1/02/212

28.4.2014

23.4.2014

Volibris

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

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

EU/1/08/451

25.4.2014

28.4.2014

alli

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

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

EU/1/07/401

30.4.2014

28.4.2014

Avamys

| Glaxo Group Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Glaxo Group Ltd

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

EU/1/07/434

30.4.2014

28.4.2014

Exjade

| 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/1/06/356

30.4.2014

28.4.2014

Glybera

| uniQure biopharma B.V. |
| --- |
| Meibergdreef 61, NL-1105 BA Amsterdam, Nederland |

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

30.4.2014

28.4.2014

Orencia

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

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/389

30.4.2014

28.4.2014

Pegasys

| 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/1/02/221

30.4.2014

28.4.2014

Rebetol

| 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/1/99/107

30.4.2014

28.4.2014

Ribavirin 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/1/10/634

30.4.2014

28.4.2014

Ribavirin Teva

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/509

1.5.2014

28.4.2014

Ribavirin Teva Pharma BV

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/527

1.5.2014

28.4.2014

Rivastigmine Sandoz

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/09/599

30.4.2014

28.4.2014

Tepadina

| ADIENNE S.r.l. |
| --- |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia |

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

30.4.2014

28.4.2014

Victoza

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

30.4.2014

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.4.2014 | Parvoduk | Parvovirus ħaj imdgħajjef tal-papra Muscovy | 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

11.4.2014

Parvoduk

Parvovirus ħaj imdgħajjef tal-papra Muscovy

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/14/162

Suspensjoni u dilwent għal suspensjoni għal injezzjoni

QI01BD03

15.4.2014

—   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 |
| --- | --- | --- | --- | --- |
| 7.4.2014 | Aftovaxpur Doe | 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

7.4.2014

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/153

9.4.2014

10.4.2014

Equilis StrepE

| 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/2/04/043

14.4.2014

10.4.2014

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

14.4.2014

11.4.2014

BTVPUR AlSap 2-4

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

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/108

15.4.2014

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 |
| --- |
| 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, 30.4.04, p. 1.

(2)  ĠU L 136, 30.4.04, p. 1.

---

| 29.5.2014 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 165/9 |
| --- | --- | --- | --- |

29.5.2014

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 165/9

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ April 2014 sat-30 April 2014

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

—   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 |
| --- | --- | --- | --- | --- | --- |
| 28.4.2014 | Ribavirin | ribavirin | Mhux applikabbli | Mhux applikabbli | 29.4.2014 |
| 28.4.2014 | methysergide | Ara l-Anness I | Ara l-Anness I | Ara l-Anness I | 29.4.2014 |
| 3.4.2014 | 5-aminolevulinic acid | 5-aminolevulinic acid | Mhux applikabbli | Mhux applikabbli | 7.4.2014 |

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

28.4.2014

Ribavirin

ribavirin

Mhux applikabbli

Mhux applikabbli

29.4.2014

28.4.2014

methysergide

Ara l-Anness I

Ara l-Anness I

Ara l-Anness I

29.4.2014

3.4.2014

5-aminolevulinic acid

5-aminolevulinic acid

Mhux applikabbli

Mhux applikabbli

7.4.2014

---

(1)  ĠU L 311, 28.11.01, p. 67.

(2)  ĠU L 311, 28.11.01, p. 1.

---

ANNESS I

Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, Mnejn għandu jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri

| Stat Membru (fiż-ŻEE) | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn għandu jingħata |
| --- | --- | --- | --- | --- | --- |
| Il-Belġju | Amdipharm Ltd |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Stat Membru (fiż-ŻEE)

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn għandu jingħata

Il-Belġju

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Deseril

1mg

Pillola miksija

Użu orali

Franza

| Amdipharm Ltd |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DESERNIL

1,65mg

Pillola

Użu orali

Il-Pajjiżi l-Baxxi

| Amdipharm Ltd |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Deseril

1mg

Pillola

Użu orali

Ir-Renju Unit

| Alliance Pharmaceuticals Ltd |
| --- |
| Avonbridge House |
| 2 Bath Road, Chippenham |
| Wiltshire, SN15 2BB |
| United Kingdom |

Alliance Pharmaceuticals Ltd

Avonbridge House

2 Bath Road, Chippenham

Wiltshire, SN15 2BB

United Kingdom

Deseril Pilloli 1mg

1mg

Pillola

Użu orali

---