# Official Journal C 435/2019

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 435 |
| | |
| English edition | Information and Notices | Volume 6227 December 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 435

English edition

Information and Notices

Volume 6227 December 2019

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 435/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2019 to 30 November 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council ) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 435/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2019 to 30 November 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )

1

---

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.12.2019 | EN | Official Journal of the European Union | C 435/1 |
| --- | --- | --- | --- |

27.12.2019

EN

Official Journal of the European Union

C 435/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2019 to 30 November 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 435/01)

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

—

Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.11.2019 | Ervebo | Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live) | Merck Sharp & Dohme B.V. |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

11.11.2019

Ervebo

Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

Solution for injection

J07BX02

13.11.2019

11.11.2019

Qtrilmet

metformin hydrochloride / saxagliptin / dapagliflozin

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/19/1401

Modified-release tablet

A10BD25

13.11.2019

14.11.2019

Arsenic Trioxide Accord

arsenic trioxide

| 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/1/19/1398

Concentrate for solution for infusion

L01XX27

18.11.2019

14.11.2019

Bortezomib Fresenius Kabi

bortezomib

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1397

Powder for solution for injection

L01XX32

18.11.2019

14.11.2019

Ivozall

clofarabine

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

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

Concentrate for solution for infusion

L01BB06

18.11.2019

14.11.2019

Senstend

lidocaine / prilocaine

| Plethora Pharma Solutions Ltd. |
| --- |
| 32 Merrion Street Upper, Dublin 2, Ireland |

Plethora Pharma Solutions Ltd.

32 Merrion Street Upper, Dublin 2, Ireland

EU/1/19/1387

Cutaneous spray, solution

N01BB20

18.11.2019

19.11.2019

Rhokiinsa

netarsudil

| Aerie Pharmaceuticals Ireland Ltd |
| --- |
| Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, IRELAND |

Aerie Pharmaceuticals Ireland Ltd

Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, IRELAND

EU/1/19/1400

Eye drops, solution

S01EX05

21.11.2019

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

—

Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.11.2019 | Efavirenz Teva | Teva B.V. |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

4.11.2019

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

6.11.2019

4.11.2019

Farydak

| Secura Bio Limited |
| --- |
| 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/15/1023

6.11.2019

4.11.2019

PritorPlus

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

6.11.2019

4.11.2019

Tivicay

| ViiV Healthcare BV |
| --- |
| Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

6.11.2019

4.11.2019

Tresiba

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

6.11.2019

4.11.2019

Vosevi

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

6.11.2019

7.11.2019

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37, 58638 Iserlohn, Deutschland |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, 58638 Iserlohn, Deutschland

EU/1/07/412

11.11.2019

7.11.2019

Comtan

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/081

11.11.2019

7.11.2019

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

12.11.2019

7.11.2019

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

12.11.2019

7.11.2019

Targretin

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

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/01/178

11.11.2019

11.11.2019

Abraxane

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

13.11.2019

11.11.2019

Aprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

13.11.2019

11.11.2019

Clopidogrel ratiopharm

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

13.11.2019

11.11.2019

CoAprovel

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

13.11.2019

11.11.2019

DUAVIVE

| 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/1/14/960

13.11.2019

11.11.2019

Erivedge

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

Roche Registration GmbH

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

EU/1/13/848

13.11.2019

11.11.2019

Esbriet

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

Roche Registration GmbH

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

EU/1/11/667

13.11.2019

11.11.2019

Inlyta

| 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/1/12/777

13.11.2019

11.11.2019

Pelmeg

| Mundipharma Biologics S.L. |
| --- |
| Calle García Ximénez, no3-1o, 31002 Pamplona (Navarra), España |

Mundipharma Biologics S.L.

Calle García Ximénez, no3-1o, 31002 Pamplona (Navarra), España

EU/1/18/1328

13.11.2019

11.11.2019

Picato

| LEO Laboratories Ltd |
| --- |
| 285 Cashel Road, Crumlin, Dublin 12, Ireland |

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

13.11.2019

11.11.2019

Sevelamer carbonate Winthrop

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

13.11.2019

14.11.2019

Actelsar HCT

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/817

18.11.2019

14.11.2019

Benepali

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

18.11.2019

14.11.2019

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/07/410

18.11.2019

14.11.2019

Cholestagel

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/03/268

25.11.2019

14.11.2019

Cubicin

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

18.11.2019

14.11.2019

DuoPlavin

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/10/619

18.11.2019

14.11.2019

Enbrel

| 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/1/99/126

18.11.2019

14.11.2019

Epoetin alfa Hexal

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/07/411

18.11.2019

14.11.2019

Erelzi

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

18.11.2019

14.11.2019

Evoltra

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

18.11.2019

14.11.2019

EVOTAZ

| 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/1/15/1025

18.11.2019

14.11.2019

Kentera

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/03/270

18.11.2019

14.11.2019

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

18.11.2019

14.11.2019

Kyprolis

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

18.11.2019

14.11.2019

Plavix

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/069

18.11.2019

14.11.2019

Ritonavir 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/1/17/1242

18.11.2019

14.11.2019

Rixubis

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/14/970

18.11.2019

14.11.2019

Stocrin

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

18.11.2019

14.11.2019

Tasigna

| 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/1/07/422

18.11.2019

14.11.2019

Taxotere

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

Aventis Pharma S.A.

20 avenue Raymond Aron, 92165 Antony CEDEX, France

EU/1/95/002

18.11.2019

14.11.2019

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

18.11.2019

14.11.2019

Trevicta

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/971

18.11.2019

14.11.2019

Xenical

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Ziegelhof 24, 17489 Greifswald, Deutschland |

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/98/071

18.11.2019

19.11.2019

Alunbrig

| Takeda Pharma A/S |
| --- |
| Dybendal Alle 10, 2630 Taastrup, Danmark |

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

21.11.2019

19.11.2019

BeneFIX

| 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/1/97/047

21.11.2019

19.11.2019

Brineura

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

21.11.2019

19.11.2019

Darzalex

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

21.11.2019

19.11.2019

Efient

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

21.11.2019

19.11.2019

Fulphila

| 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/1/18/1329

21.11.2019

19.11.2019

Hulio

| 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/1/18/1319

21.11.2019

19.11.2019

IBRANCE

| 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/1/16/1147

21.11.2019

19.11.2019

Juluca

| ViiV Healthcare BV |
| --- |
| Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/18/1282

21.11.2019

19.11.2019

Prevenar 13

| 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/1/09/590

21.11.2019

19.11.2019

Repatha

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

21.11.2019

19.11.2019

SCENESSE

| Clinuvel Europe Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/14/969

21.11.2019

19.11.2019

Xermelo

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

21.11.2019

19.11.2019

Xgeva

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

21.11.2019

22.11.2019

Feraccru

| Norgine B.V. |
| --- |
| Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland |

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/15/1075

26.11.2019

22.11.2019

Lamivudine Teva Pharma B.V.

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

26.11.2019

22.11.2019

Myozyme

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/333

26.11.2019

22.11.2019

Neulasta

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

26.11.2019

22.11.2019

Olumiant

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

26.11.2019

22.11.2019

Pelgraz

| Accord Healthcare S.L.U. |
| --- |
| Edificio Est Planta 6, Word trade Center, Moll De Barcelona S/N, Edifici Est 6a planta, 08039 Barcelona, Spain |

Accord Healthcare S.L.U.

Edificio Est Planta 6, Word trade Center, Moll De Barcelona S/N, Edifici Est 6a planta, 08039 Barcelona, Spain

EU/1/18/1313

26.11.2019

22.11.2019

Remsima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

26.11.2019

22.11.2019

Senshio

| Shionogi B.V. |
| --- |
| Kingsfordweg 151, 1043GR Amsterdam, Nederland |

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

EU/1/14/978

26.11.2019

22.11.2019

Udenyca

| ERA Consulting GmbH |
| --- |
| Lange Straße 70, 29664 Walsrode, Deutschland |

ERA Consulting GmbH

Lange Straße 70, 29664 Walsrode, Deutschland

EU/1/18/1303

26.11.2019

22.11.2019

Vyndaqel

| 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/1/11/717

26.11.2019

28.11.2019

Fabrazyme

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

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/01/188

2.12.2019

28.11.2019

Foclivia

| Seqirus S.r.l., |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia |

Seqirus S.r.l.,

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia

EU/1/09/577

2.12.2019

28.11.2019

Pemetrexed Pfizer

| 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/1/17/1183

2.12.2019

28.11.2019

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

2.12.2019

28.11.2019

Xiapex

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

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/11/671

2.12.2019

28.11.2019

Ziextenzo

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

2.12.2019

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

—

Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.11.2019 | GUMBOHATCH | Avian infectious bursal disease vaccine (live) | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

12.11.2019

GUMBOHATCH

Avian infectious bursal disease vaccine (live)

Laboratorios Hipra, S.A.

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

EU/2/19/245

Lyophilisate and solvent for suspension for injection

QI01AD09

14.11.2019

19.11.2019

Nobivac Myxo-RHD PLUS

Myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant)

| 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/2/19/244

Lyophilisate and solvent for suspension for injection

QI08AD

21.11.2019

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

—

Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.11.2019 | Bovela | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

11.11.2019

Bovela

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/176

13.11.2019

11.11.2019

Cerenia

| 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/2/06/062

13.11.2019

11.11.2019

NEXGARD SPECTRA

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

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

13.11.2019

11.11.2019

Suvaxyn CSF Marker

| 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/2/14/179

13.11.2019

12.11.2019

Naxcel

| 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/2/05/053

14.11.2019

12.11.2019

RHINISENG

| 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/2/10/109

14.11.2019

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.

---