# Il-Ġurnal Uffiċjali C 66/2020

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 66 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 6328 ta' Frar 2020 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 66

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 6328 ta' Frar 2020

---

| Werrej | Paġna |
| --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2020/C 66/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Jannar 2020 sal-31 ta’ Jannar 2020 (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2020/C 66/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Jannar 2020 sal-31 ta’ Jannar 2020 (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

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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

| 28.2.2020 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 66/1 |
| --- | --- | --- | --- |

28.2.2020

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 66/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Jannar 2020 sal-31 ta’ Jannar 2020

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

(2020/C 66/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2020 | Clopidogrel/Acetylsalicylic acid Mylan | Clopidogrel/Acetylsalicylic acid | Mylan S.A.S. |
| 117 allée des Parcs, 69800 Saint Priest, |
| 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

9.1.2020

Clopidogrel/Acetylsalicylic acid Mylan

Clopidogrel/Acetylsalicylic acid

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

EU/1/19/1395

Pillola miksija b’rita

B01AC30

13.1.2020

9.1.2020

Deferasirox Accord

deferasirox

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, |
| España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona,

España

EU/1/19/1412

Pillola miksija b’rita

V03AC03

13.1.2020

9.1.2020

Isturisa

osilodrostat

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, |
| Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4,

Ireland

EU/1/19/1407

Pillola miksija b’rita

H02CA02

13.1.2020

9.1.2020

TAVLESSE

fostamatinib

| Rigel Pharmaceuticals B.V. |
| --- |
| Avenue Ceramique 223, 6621 KX Maastricht, |
| Nederland |

Rigel Pharmaceuticals B.V.

Avenue Ceramique 223, 6621 KX Maastricht,

Nederland

EU/1/19/1405

Pillola miksija b’rita

B02BX09

13.1.2020

13.1.2020

Mayzent

siponimod

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, |
| Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4,

Ireland

EU/1/19/1414

Pillola miksija b’rita

L04AA42

15.1.2020

16.1.2020

Polivy

polatuzumab vedotin

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, |
| Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen,

Deutschland

EU/1/19/1388

Trab għal konċentrat għal soluzzjoni għall-infużjoni

L01XC37

20.1.2020

16.1.2020

Sunosi

solriamfetol

| Jazz Pharmaceuticals Ireland Ltd |
| --- |
| 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, |
| Ireland |

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7,

Ireland

EU/1/19/1408

Pillola miksija b’rita

N06BA14

20.1.2020

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

—

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 |
| --- | --- | --- | --- | --- |
| 9.1.2020 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd |
| Damastown, Mulhuddart, Dublin 15, |
| Ireland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

9.1.2020

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15,

Ireland

EU/1/15/1001

13.1.2020

9.1.2020

Clopidogrel ratiopharm GmbH

| Archie Samuel s.r.o. |
| --- |
| Slunná 16, 61700 Brno, |
| Česká republika |

Archie Samuel s.r.o.

Slunná 16, 61700 Brno,

Česká republika

EU/1/09/541

13.1.2020

9.1.2020

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/04/296

13.1.2020

9.1.2020

Elebrato Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, |
| Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24,

Ireland

EU/1/17/1237

13.1.2020

9.1.2020

Kigabeq

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, |
| France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris,

France

EU/1/18/1302

13.1.2020

9.1.2020

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/13/901

13.1.2020

9.1.2020

Sivextro

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

EU/1/15/991

13.1.2020

9.1.2020

Taxotere

| Sanofi Mature IP |
| --- |
| 54 Rue de la Boetie, 75008, Paris, |
| FRANCE |

Sanofi Mature IP

54 Rue de la Boetie, 75008, Paris,

FRANCE

EU/1/95/002

13.1.2020

9.1.2020

Tecfidera

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, |
| Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp,

Nederland

EU/1/13/837

13.1.2020

13.1.2020

Abasaglar

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/14/944

15.1.2020

13.1.2020

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, |
| Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam,

Nederland

EU/1/11/749

15.1.2020

13.1.2020

Darunavir Krka d.d.

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, |
| Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto,

Slovenija

EU/1/17/1248

15.1.2020

13.1.2020

Dexdor

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

Orion Corporation

Orionintie 1, 02200 Espoo,

Suomi

EU/1/11/718

15.1.2020

13.1.2020

Hizentra

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, |
| Deutschland |

CSL Behring GmbH

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

Deutschland

EU/1/11/687

15.1.2020

13.1.2020

Infanrix hexa

| 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/1/00/152

15.1.2020

13.1.2020

Invokana

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/13/884

15.1.2020

13.1.2020

Orbactiv

| Menarini International Operations Lussemburgu S.A. |
| --- |
| 1 avenue de la Gare, 1611 Lussemburgu, |
| Grand-Duché de Lussemburgu |

Menarini International Operations Lussemburgu S.A.

1 avenue de la Gare, 1611 Lussemburgu,

Grand-Duché de Lussemburgu

EU/1/15/989

15.1.2020

13.1.2020

Tenofovir disoproxil Mylan

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

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

EU/1/16/1129

15.1.2020

13.1.2020

Tenofovir disoproxil Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, |
| Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10,

Česká republika

EU/1/16/1127

15.1.2020

13.1.2020

Vaxelis

| MCM Vaccine B.V. |
| --- |
| Robert Boyleweg 4, 2333 CG Leiden, |
| Nederland |

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden,

Nederland

EU/1/15/1079

16.1.2020

13.1.2020

Yescarta

| Kite Pharma EU B.V. |
| --- |
| Science Park 408, 1098 XH Amsterdam, |
| Nederland |

Kite Pharma EU B.V.

Science Park 408, 1098 XH Amsterdam,

Nederland

EU/1/18/1299

15.1.2020

13.1.2020

Zepatier

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

EU/1/16/1119

15.1.2020

16.1.2020

Gardasil 9

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, |
| France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon,

France

EU/1/15/1007

20.1.2020

16.1.2020

Humalog

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/96/007

20.1.2020

16.1.2020

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/134

20.1.2020

16.1.2020

Lemtrada

| Sanofi Belgium |
| --- |
| Leonardo Da Vincilaan 19, B-1831 Diegem, |
| België |

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem,

België

EU/1/13/869

20.1.2020

16.1.2020

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/01/195

20.1.2020

16.1.2020

Mysimba

| Orexigen Therapeutics Ireland Limited |
| --- |
| 2nd Floor, Palmerston House, Fenian Street, Dublin 2, |
| Ireland |

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2,

Ireland

EU/1/14/988

20.1.2020

16.1.2020

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda,

Nederland

EU/1/10/618

20.1.2020

16.1.2020

Semglee

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

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest,

France

EU/1/18/1270

20.1.2020

16.1.2020

Toujeo

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, |
| Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/133

20.1.2020

16.1.2020

Viread

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, |
| Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77,

Ireland

EU/1/01/200

20.1.2020

16.1.2020

Zirabev

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, |
| België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel,

België

EU/1/18/1344

20.2.2020

17.1.2020

Verzenios

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/18/1307

21.1.2020

20.1.2020

Darzalex

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/16/1101

22.1.2020

20.1.2020

Eurartesim

| Alfasigma S.p.A. |
| --- |
| Via Ragazzi del ‘99, n.5, 40133 Bologna, |
| Italia |

Alfasigma S.p.A.

Via Ragazzi del ‘99, n.5, 40133 Bologna,

Italia

EU/1/11/716

22.1.2020

20.1.2020

Fertavid

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

EU/1/09/510

22.1.2020

20.1.2020

OPDIVO

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, |
| Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15,

Ireland

EU/1/15/1014

22.1.2020

20.1.2020

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/08/494

22.1.2020

20.1.2020

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, |
| Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15,

Ireland

EU/1/11/698

22.1.2020

23.1.2020

Bydureon

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

AstraZeneca AB

151 85 Södertälje,

Sverige

EU/1/11/696

27.1.2020

23.1.2020

Cyramza

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/14/957

27.1.2020

23.1.2020

Hemlibra

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, |
| Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen,

Deutschland

EU/1/18/1271

28.1.2020

23.1.2020

Ketoconazole HRA

| HRA Pharma Rare Diseases |
| --- |
| 200 avenue de Paris, 92320 Chatillon, |
| France |

HRA Pharma Rare Diseases

200 avenue de Paris, 92320 Chatillon,

France

EU/1/14/965

27.1.2020

23.1.2020

Menveo

| GSK Vaccines S.r.l. |
| --- |
| Via Fiorentina 1, 53100 Siena, |
| Italia |

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena,

Italia

EU/1/10/614

27.1.2020

23.1.2020

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/13/901

27.1.2020

23.1.2020

Xeristar

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, |
| Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht,

Nederland

EU/1/04/297

27.1.2020

23.1.2020

Zynquista

| Navigant Germany GmbH |
| --- |
| Albrechtstrasse 10c, 10117 Berlin, |
| Deutschland |

Navigant Germany GmbH

Albrechtstrasse 10c, 10117 Berlin,

Deutschland

EU/1/19/1363

27.1.2020

27.1.2020

Delstrigo

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

EU/1/18/1333

29.1.2020

27.1.2020

Erleada

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse,

België

EU/1/18/1342

29.1.2020

27.1.2020

Rubraca

| Clovis Oncology Ireland Limited |
| --- |
| Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, |
| Ireland |

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2,

Ireland

EU/1/17/1250

29.1.2020

31.1.2020

Otezla

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda,

Nederland

EU/1/14/981

4.2.2020

31.1.2020

Panretin

| Eisai GmbH |
| --- |
| Lyoner Straße 36, 60528 Frankfurt am Main, |
| Deutschland |

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main,

Deutschland

EU/1/00/149

4.2.2020

31.1.2020

Xeljanz

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, |
| België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel,

België

EU/1/17/1178

4.2.2020

31.1.2020

Zejula

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, |
| Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24,

Ireland

EU/1/17/1235

4.2.2020

| — | Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- |
| 13.1.2020 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o. |
| Slunná 16, 61700 Brno, |
| Česká republika |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

13.1.2020

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, 61700 Brno,

Česká republika

EU/1/09/541

15.1.2020

23.1.2020

Fertavid

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem,

Nederland

EU/1/09/510

27.1.2020

23.1.2020

Varuby

| TESARO Bio Netherlands B.V. |
| --- |
| Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht, |
| Nederland |

TESARO Bio Netherlands B.V.

Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,

Nederland

EU/1/17/1180

27.1.2020

| — | Sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) |
| --- | --- |

—

Sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 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 |
| --- | --- | --- | --- | --- |
| 17.1.2020 | Picato | LEO Laboratories Ltd |
| 285 Cashel Road, Crumlin, Dublin 12, |
| Ireland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

17.1.2020

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12,

Ireland

EU/1/12/796

21.1.2020

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.1.2020 | Stelfonta | tigilanol tiglate | QBiotics Netherlands B.V. |
| Prinses Margrietplantsoen 33, 2595 AM Den Haag, |
| Nederland |

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

15.1.2020

Stelfonta

tigilanol tiglate

QBiotics Netherlands B.V.

Prinses Margrietplantsoen 33, 2595 AM Den Haag,

Nederland

EU/2/19/248

Soluzzjoni għall-injezzjoni

QL01XX91

17.1.2020

28.1.2020

Aservo EquiHaler

ciclesonide

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

EU/2/19/249

Soluzzjoni li tittieħed man-nifs

QR03BA08

30.1.2020

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

—

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 |
| --- | --- | --- | --- | --- |
| 15.1.2020 | BTVPUR | Boehringer Ingelheim Vetmedica GmbH |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

15.1.2020

BTVPUR

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

EU/2/10/113

17.1.2020

15.1.2020

Coliprotec F4

| Prevtec Microbia GmbH |
| --- |
| Geyerspergerstr 27, 80689 München, |
| Deutschland |

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München,

Deutschland

EU/2/14/180

17.1.2020

15.1.2020

Nobilis IB 4-91

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer,

Nederland

EU/2/98/006

17.1.2020

15.1.2020

Pirsue

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, |
| Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve,

Belgique

EU/2/00/027

17.1.2020

15.1.2020

ProteqFlu

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

EU/2/03/037

17.1.2020

15.1.2020

ProteqFlu-Te

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

EU/2/03/038

17.1.2020

15.1.2020

Proteq West Nile

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

EU/2/11/129

17.1.2020

15.1.2020

Purevax Rabies

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein,

Deutschland

EU/2/10/117

17.1.2020

15.1.2020

Semintra

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein,

Deutschland

EU/2/12/146

17.1.2020

15.1.2020

Zulvac SBV

| 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/2/14/178

17.1.2020

20.1.2020

Onsior

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, |
| Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven,

Deutschland

EU/2/08/089

22.1.2020

27.1.2020

ERAVAC

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), |
| España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona),

España

EU/2/16/199

29.1.2020

27.1.2020

Kexxtone

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, |
| Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven,

Deutschland

EU/2/12/145

29.1.2020

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

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  ĠU L 136, 30.4.2004, p. 1.

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