# C_2019252EN.01000101.xml

| 26.7.2019 | EN | Official Journal of the European Union | C 252/1 |
| --- | --- | --- | --- |

26.7.2019

EN

Official Journal of the European Union

C 252/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2019 to 30 June 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1))

(2019/C 252/01)

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.6.2019 | Pixuvri | pixantrone | CTI Life Sciences Deutschland GmbH
  Universitätsstraβe 71, 50931 Köln, Deutschland | EU/1/12/764 | Powder for concentrate for solution for infusion | L01DB11 | 11.6.2019 |
| 12.6.2019 | Temybric Ellipta | fluticasone furoate / umeclidinium / vilanterol | GlaxoSmithKline Trading Services Limited Currabinny, Co. Cork, Ireland | EU/1/19/1378 | Inhalation powder, pre-dispensed | R03AL08 | 14.6.2019 |
| 20.6.2019 | Ambrisentan Mylan | ambrisentan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/19/1368 | Film-coated tablet | C02KX02 | 24.6.2019 |
| 20.6.2019 | Doptelet | avatrombopag | Dova Pharmaceuticals Ireland Limited
  6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342, Ireland | EU/1/19/1373 | Film-coated tablet | B02BX08 | 24.6.2019 |
| 20.6.2019 | Esperoct | turoctocog alfa pegol | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/19/1374 | Powder and solvent for solution for injection | B02BD02 | 24.6.2019 |
| 20.6.2019 | Grasustek | pegfilgrastim | Juta Pharma GmbH
  Gutenbergstr. 13, 24941, Flensburg, Deutschland | EU/1/19/1375 | Solution for injection | L03AA13 | 24.6.2019 |
| 20.6.2019 | Sixmo | buprenorphine | L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A
  Strada Statale 67, 50018 Scandicci (Firenze), Italia | EU/1/19/1369 | Implant | N07BC01 | 25.6.2019 |
| 20.6.2019 | Talzenna | talazoparib | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/19/1377 | Capsule, hard | L01XX60 | 24.6.2019 |
| 20.6.2019 | Trecondi | treosulfan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/18/1351 | Powder for solution for infusion | L01AB02 | 24.6.2019 |
| 25.6.2019 | Striascan | ioflupane (123I) | CIS bio international
  Boite Postale 32, 91192 Gif-sur-Yvette, France | EU/1/19/1372 | Solution for injection | V09AB03 | 27.6.2019 |
| 28.6.2019 | LIBTAYO | cemiplimab | Regeneron Ireland U.C.
  Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland | EU/1/19/1376 | Concentrate for solution for infusion | Pending | 2.7.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.6.2019

Pixuvri

pixantrone

CTI Life Sciences Deutschland GmbH

Universitätsstraβe 71, 50931 Köln, Deutschland

EU/1/12/764

Powder for concentrate for solution for infusion

L01DB11

11.6.2019

12.6.2019

Temybric Ellipta

fluticasone furoate / umeclidinium / vilanterol

GlaxoSmithKline Trading Services Limited Currabinny, Co. Cork, Ireland

EU/1/19/1378

Inhalation powder, pre-dispensed

R03AL08

14.6.2019

20.6.2019

Ambrisentan Mylan

ambrisentan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/19/1368

Film-coated tablet

C02KX02

24.6.2019

20.6.2019

Doptelet

avatrombopag

Dova Pharmaceuticals Ireland Limited

6th Floor, 2 Grand Canal Square, Dublin 2, D02 A342, Ireland

EU/1/19/1373

Film-coated tablet

B02BX08

24.6.2019

20.6.2019

Esperoct

turoctocog alfa pegol

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/19/1374

Powder and solvent for solution for injection

B02BD02

24.6.2019

20.6.2019

Grasustek

pegfilgrastim

Juta Pharma GmbH

Gutenbergstr. 13, 24941, Flensburg, Deutschland

EU/1/19/1375

Solution for injection

L03AA13

24.6.2019

20.6.2019

Sixmo

buprenorphine

L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A

Strada Statale 67, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

Implant

N07BC01

25.6.2019

20.6.2019

Talzenna

talazoparib

Pfizer Europe MA EEIG

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

EU/1/19/1377

Capsule, hard

L01XX60

24.6.2019

20.6.2019

Trecondi

treosulfan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/18/1351

Powder for solution for infusion

L01AB02

24.6.2019

25.6.2019

Striascan

ioflupane (123I)

CIS bio international

Boite Postale 32, 91192 Gif-sur-Yvette, France

EU/1/19/1372

Solution for injection

V09AB03

27.6.2019

28.6.2019

LIBTAYO

cemiplimab

Regeneron Ireland U.C.

Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland

EU/1/19/1376

Concentrate for solution for infusion

Pending

2.7.2019

| — | Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.6.2019 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 11.6.2019 |
| 6.6.2019 | Advate | Baxter AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/03/271 | 11.6.2019 |
| 6.6.2019 | Alpivab | BioCryst UK Ltd
  c/o Morgan Lewis & Bockius, Condor House, 5 -10 St. Paul's Churchyard, London EC4M 8AL, United Kingdom | EU/1/18/1269 | 10.6.2019 |
| 6.6.2019 | Ammonaps | Immedica Pharma AB
  Norrtullsgatan 15, SE-113 29, Stockholm, Sverige | EU/1/99/120 | 10.6.2019 |
| 6.6.2019 | Axura | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/02/218 | 11.6.2019 |
| 6.6.2019 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 11.6.2019 |
| 6.6.2019 | Azopt | Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/129 | 10.6.2019 |
| 6.6.2019 | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 11.6.2019 |
| 6.6.2019 | Byetta | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/06/362 | 10.6.2019 |
| 6.6.2019 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | EU/1/09/555 | 11.6.2019 |
| 6.6.2019 | Descovy | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1099 | 10.6.2019 |
| 6.6.2019 | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 11.6.2019 |
| 6.6.2019 | Envarsus | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | 10.6.2019 |
| 6.6.2019 | Extavia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/454 | 10.6.2019 |
| 6.6.2019 | Farydak | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1023 | 10.6.2019 |
| 6.6.2019 | Febuxostat Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1194 | 11.6.2019 |
| 6.6.2019 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 10.6.2019 |
| 6.6.2019 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 11.6.2019 |
| 6.6.2019 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 11.6.2019 |
| 6.6.2019 | Glyxambi | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/16/1146 | 11.6.2019 |
| 6.6.2019 | Grepid | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/09/535 | 10.6.2019 |
| 6.6.2019 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 10.6.2019 |
| 6.6.2019 | Ilaris | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/564 | 10.6.2019 |
| 6.6.2019 | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 11.6.2019 |
| 6.6.2019 | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/07/395 | 11.6.2019 |
| 6.6.2019 | Nexavar | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/06/342 | 11.6.2019 |
| 6.6.2019 | Odefsey | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1112 | 10.6.2019 |
| 6.6.2019 | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 11.6.2019 |
| 6.6.2019 | Ravicti | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/15/1062 | 10.6.2019 |
| 6.6.2019 | Rilutek | Sanofi Mature IP
  54 Rue de la Boetie, 75008, Paris, FRANCE | EU/1/96/010 | 11.6.2019 |
| 6.6.2019 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 11.6.2019 |
| 6.6.2019 | Temozolomide HEXAL | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/10/616 | 11.6.2019 |
| 6.6.2019 | Temozolomide Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/10/617 | 11.6.2019 |
| 6.6.2019 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 10.6.2019 |
| 6.6.2019 | Veltassa | Vifor Fresenius Medical Care Renal Pharma France
  100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France | EU/1/17/1179 | 11.6.2019 |
| 6.6.2019 | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 10.6.2019 |
| 6.6.2019 | Zebinix | Bial - Portela & Ca, SA
  À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 11.6.2019 |
| 12.6.2019 | Accofil | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/14/946 | 14.6.2019 |
| 12.6.2019 | Aldara | Meda AB
  Pipers väg 2A, 170 73 Solna, Sverige | EU/1/98/080 | 14.6.2019 |
| 12.6.2019 | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 14.6.2019 |
| 12.6.2019 | Lucentis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/374 | 14.6.2019 |
| 12.6.2019 | Lynparza | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/959 | 14.6.2019 |
| 12.6.2019 | Olanzapine Apotex | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN, Leiden, Nederland | EU/1/10/635 | 14.6.2019 |
| 12.6.2019 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/09/605 | 14.6.2019 |
| 12.6.2019 | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 14.6.2019 |
| 18.6.2019 | Sialanar | Proveca Pharma Limited
  Marine House, Clanwilliam Place, Dublin 2, Ireland | EU/1/16/1135 | 20.6.2019 |
| 18.6.2019 | Telzir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/04/282 | 1.7.2019 |
| 20.6.2019 | Azarga | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/482 | 25.6.2019 |
| 20.6.2019 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 25.6.2019 |
| 20.6.2019 | Busulfan Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/14/951 | 25.6.2019 |
| 20.6.2019 | Eurartesim | Alfasigma S.p.A.
  Via Ragazzi del '99, n.5, 40133 Bologna, Italia | EU/1/11/716 | 25.6.2019 |
| 20.6.2019 | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 25.6.2019 |
| 20.6.2019 | Ocrevus | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1231 | 25.6.2019 |
| 20.6.2019 | Palonosetron Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/16/1100 | 24.6.2019 |
| 20.6.2019 | Potactasol | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/10/660 | 24.6.2019 |
| 20.6.2019 | Saxenda | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/15/992 | 25.6.2019 |
| 20.6.2019 | Skilarence | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/17/1201 | 25.6.2019 |
| 20.6.2019 | Triumeq | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/14/940 | 25.6.2019 |
| 20.6.2019 | Zejula | TESARO Bio Netherlands B.V.
  Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,Nederland | EU/1/17/1235 | 24.6.2019 |
| 25.6.2019 | Cuprior | gmp-orphan SA
  Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France | EU/1/17/1199 | 27.6.2019 |
| 25.6.2019 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 27.6.2019 |
| 25.6.2019 | Neofordex | Laboratoires CTRS
  63 rue de l'Est, 92100 Boulogne-Billancourt,France | EU/1/15/1053 | 27.6.2019 |
| 28.6.2019 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/13/891 | 2.7.2019 |
| 28.6.2019 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 2.7.2019 |
| 28.6.2019 | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/12/770 | 2.7.2019 |
| 28.6.2019 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 2.7.2019 |
| 28.6.2019 | TOBI Podhaler | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/10/652 | 2.7.2019 |
| 28.6.2019 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 2.7.2019 |
| 28.6.2019 | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 2.7.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.6.2019

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

11.6.2019

6.6.2019

Advate

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/03/271

11.6.2019

6.6.2019

Alpivab

BioCryst UK Ltd

c/o Morgan Lewis & Bockius, Condor House, 5 -10 St. Paul's Churchyard, London EC4M 8AL, United Kingdom

EU/1/18/1269

10.6.2019

6.6.2019

Ammonaps

Immedica Pharma AB

Norrtullsgatan 15, SE-113 29, Stockholm, Sverige

EU/1/99/120

10.6.2019

6.6.2019

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/02/218

11.6.2019

6.6.2019

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

11.6.2019

6.6.2019

Azopt

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

EU/1/00/129

10.6.2019

6.6.2019

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

11.6.2019

6.6.2019

Byetta

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/06/362

10.6.2019

6.6.2019

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555

11.6.2019

6.6.2019

Descovy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

10.6.2019

6.6.2019

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

11.6.2019

6.6.2019

Envarsus

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

10.6.2019

6.6.2019

Extavia

Novartis Europharm Limited

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

EU/1/08/454

10.6.2019

6.6.2019

Farydak

Novartis Europharm Limited

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

EU/1/15/1023

10.6.2019

6.6.2019

Febuxostat Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1194

11.6.2019

6.6.2019

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

10.6.2019

6.6.2019

Giotrif

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/13/879

11.6.2019

6.6.2019

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

11.6.2019

6.6.2019

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

11.6.2019

6.6.2019

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

10.6.2019

6.6.2019

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

10.6.2019

6.6.2019

Ilaris

Novartis Europharm Limited

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

EU/1/09/564

10.6.2019

6.6.2019

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

11.6.2019

6.6.2019

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/07/395

11.6.2019

6.6.2019

Nexavar

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/06/342

11.6.2019

6.6.2019

Odefsey

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

10.6.2019

6.6.2019

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

11.6.2019

6.6.2019

Ravicti

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/15/1062

10.6.2019

6.6.2019

Rilutek

Sanofi Mature IP

54 Rue de la Boetie, 75008, Paris, FRANCE

EU/1/96/010

11.6.2019

6.6.2019

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

11.6.2019

6.6.2019

Temozolomide HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

11.6.2019

6.6.2019

Temozolomide Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

11.6.2019

6.6.2019

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

10.6.2019

6.6.2019

Veltassa

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/17/1179

11.6.2019

6.6.2019

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

10.6.2019

6.6.2019

Zebinix

Bial - Portela & Ca, SA

À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

EU/1/09/514

11.6.2019

12.6.2019

Accofil

Accord Healthcare S.L.U.

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

EU/1/14/946

14.6.2019

12.6.2019

Aldara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/98/080

14.6.2019

12.6.2019

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

14.6.2019

12.6.2019

Lucentis

Novartis Europharm Limited

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

EU/1/06/374

14.6.2019

12.6.2019

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

14.6.2019

12.6.2019

Olanzapine Apotex

Apotex Europe B.V.

Archimedesweg 2, 2333 CN, Leiden, Nederland

EU/1/10/635

14.6.2019

12.6.2019

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/09/605

14.6.2019

12.6.2019

Votubia

Novartis Europharm Limited

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

EU/1/11/710

14.6.2019

18.6.2019

Sialanar

Proveca Pharma Limited

Marine House, Clanwilliam Place, Dublin 2, Ireland

EU/1/16/1135

20.6.2019

18.6.2019

Telzir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/04/282

1.7.2019

20.6.2019

Azarga

Novartis Europharm Limited

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

EU/1/08/482

25.6.2019

20.6.2019

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

25.6.2019

20.6.2019

Busulfan Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/14/951

25.6.2019

20.6.2019

Eurartesim

Alfasigma S.p.A.

Via Ragazzi del '99, n.5, 40133 Bologna, Italia

EU/1/11/716

25.6.2019

20.6.2019

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

25.6.2019

20.6.2019

Ocrevus

Roche Registration GmbH

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

EU/1/17/1231

25.6.2019

20.6.2019

Palonosetron Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1100

24.6.2019

20.6.2019

Potactasol

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/10/660

24.6.2019

20.6.2019

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

25.6.2019

20.6.2019

Skilarence

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/17/1201

25.6.2019

20.6.2019

Triumeq

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/14/940

25.6.2019

20.6.2019

Zejula

TESARO Bio Netherlands B.V.

Joop Geeskinkweg 901, 1114AB Amsterdam-Duisvendrecht,Nederland

EU/1/17/1235

24.6.2019

25.6.2019

Cuprior

gmp-orphan SA

Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France

EU/1/17/1199

27.6.2019

25.6.2019

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

27.6.2019

25.6.2019

Neofordex

Laboratoires CTRS

63 rue de l'Est, 92100 Boulogne-Billancourt,France

EU/1/15/1053

27.6.2019

28.6.2019

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

2.7.2019

28.6.2019

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

2.7.2019

28.6.2019

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/12/770

2.7.2019

28.6.2019

Mysimba

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

2.7.2019

28.6.2019

TOBI Podhaler

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/10/652

2.7.2019

28.6.2019

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

2.7.2019

28.6.2019

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

2.7.2019

| — | Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.6.2019 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, 2650 Edegem, België | EU/1/10/651 | 11.6.2019 |
| 6.6.2019 | Ketek | Aventis Pharma S.A.
  20 avenue Raymond Aron, 92165 Antony CEDEX, France | EU/1/01/191 | 11.6.2019 |
| 25.6.2019 | Palonosetron Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/16/1100 | 27.6.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.6.2019

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, 2650 Edegem, België

EU/1/10/651

11.6.2019

6.6.2019

Ketek

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony CEDEX, France

EU/1/01/191

11.6.2019

25.6.2019

Palonosetron Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1100

27.6.2019

| — | Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.6.2019 | HorStem | equine umbilical cord mesenchymal stem cells | EquiCord-YMAS S.L.
  103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España | EU/2/18/226 | Suspension for injection | Pending | 21.6.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.6.2019

HorStem

equine umbilical cord mesenchymal stem cells

EquiCord-YMAS S.L.

103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España

EU/2/18/226

Suspension for injection

Pending

21.6.2019

| — | Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 13.6.2019 | Nobilis IB Primo QX | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/174 | 17.6.2019 |
| 18.6.2019 | Suvaxyn PRRS MLV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/215 | 20.6.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

13.6.2019

Nobilis IB Primo QX

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/174

17.6.2019

18.6.2019

Suvaxyn PRRS MLV

Zoetis Belgium S.A.

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

EU/2/17/215

20.6.2019

| — | Withdrawal of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 18.6.2019 | Bovalto Ibraxion | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/99/017 | 20.6.2019 |
| 18.6.2019 | Ingelvac PCV FLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/17/208 | 21.6.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

18.6.2019

Bovalto Ibraxion

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/99/017

20.6.2019

18.6.2019

Ingelvac PCV FLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/17/208

21.6.2019

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

(1)  OJ L 136, 30.4.2004, p. 1.

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