# C_2020253EN.01000101.xml

| 31.7.2020 | EN | Official Journal of the European Union | C 253/1 |
| --- | --- | --- | --- |

31.7.2020

EN

Official Journal of the European Union

C 253/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2020 to 30 June 2020

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

(2020/C 253/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.6.2020 | Paliperidone Janssen-Cilag International | paliperidone | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/20/1453 | Prolonged release suspension for injection | N05AX13 | 19.6.2020 |
| 25.6.2020 | Fingolimod Accord | fingolimod | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/20/1450 | Capsule, hard | L04AA27 | 6.7.2020 |
| 25.6.2020 | Insulin aspart Sanofi | insulin aspart | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/20/1447 | Solution for injection | A10AB05 | 26.6.2020 |
| 25.6.2020 | Reblozyl | luspatercept | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/20/1452 | Powder for solution for injection | B03XA06 | 26.6.2020 |
| 26.6.2020 | Daurismo | glasdegib | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/20/1451 | Film-coated tablet | L01XX63 | 29.6.2020 |

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

18.6.2020

Paliperidone Janssen-Cilag International

paliperidone

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1453

Prolonged release suspension for injection

N05AX13

19.6.2020

25.6.2020

Fingolimod Accord

fingolimod

Accord Healthcare S.L.U.

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

EU/1/20/1450

Capsule, hard

L04AA27

6.7.2020

25.6.2020

Insulin aspart Sanofi

insulin aspart

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1447

Solution for injection

A10AB05

26.6.2020

25.6.2020

Reblozyl

luspatercept

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/20/1452

Powder for solution for injection

B03XA06

26.6.2020

26.6.2020

Daurismo

glasdegib

Pfizer Europe MA EEIG

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

EU/1/20/1451

Film-coated tablet

L01XX63

29.6.2020

—   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 |
| --- | --- | --- | --- | --- |
| 2.6.2020 | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 3.6.2020 |
| 2.6.2020 | Aripiprazole Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | 14.6.2020 |
| 2.6.2020 | Braftovi | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1314 | 3.6.2020 |
| 2.6.2020 | Brinavess | Correvio
  15 rue du Bicentenaire, 92800 Puteaux, France | EU/1/10/645 | 3.6.2020 |
| 2.6.2020 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 8.6.2020 |
| 2.6.2020 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | EU/1/09/555 | 4.6.2020 |
| 2.6.2020 | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland | EU/1/12/801 | 3.6.2020 |
| 2.6.2020 | Efavirenz/Emtricitabine/Tenofovir disoproxil Krka | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1263 | 4.6.2020 |
| 2.6.2020 | Farydak | Secura Bio Limited
  32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland | EU/1/15/1023 | 8.6.2020 |
| 2.6.2020 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 11.6.2020 |
| 2.6.2020 | Lyrica | Upjohn EESV
  Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland | EU/1/04/279 | 3.6.2020 |
| 2.6.2020 | Memantine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/880 | 3.6.2020 |
| 2.6.2020 | Multaq | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/09/591 | 3.6.2020 |
| 2.6.2020 | Nustendi | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/20/1424 | 3.6.2020 |
| 2.6.2020 | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 3.6.2020 |
| 2.6.2020 | Praluent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/15/1031 | 4.6.2020 |
| 2.6.2020 | Pregabalin Pfizer | Upjohn EESV
  Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland | EU/1/14/916 | 3.6.2020 |
| 2.6.2020 | Revatio | Upjohn EESV
  Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland | EU/1/05/318 | 3.6.2020 |
| 2.6.2020 | Revlimid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 3.6.2020 |
| 2.6.2020 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 11.6.2020 |
| 2.6.2020 | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 3.6.2020 |
| 2.6.2020 | Viagra | Upjohn EESV
  Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland | EU/1/98/077 | 3.6.2020 |
| 3.6.2020 | Carmustine Obvius | Obvius Investment B.V.
  De Cuserstraat 93, 1081 CN Amsterdam, Nederland | EU/1/18/1278 | 4.6.2020 |
| 3.6.2020 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 4.6.2020 |
| 3.6.2020 | Ecalta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/416 | 4.6.2020 |
| 3.6.2020 | Imnovid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/13/850 | 4.6.2020 |
| 3.6.2020 | Zyllt | KRKA d d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553 | 8.6.2020 |
| 9.6.2020 | Cablivi | Ablynx N.V.
  Technologiepark 21, 9052 Zwijnaarde, België | EU/1/18/1305 | 11.6.2020 |
| 9.6.2020 | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 10.6.2020 |
| 9.6.2020 | Jakavi | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/773 | 10.6.2020 |
| 9.6.2020 | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/12/782 | 10.6.2020 |
| 9.6.2020 | Kiovig | Takeda Manufacturing Austria AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/05/329 | 6.7.2020 |
| 9.6.2020 | Qarziba | EUSA Pharma (Netherlands) B.V.
  Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland | EU/1/17/1191 | 6.7.2020 |
| 9.6.2020 | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/11/690 | 10.6.2020 |
| 12.6.2020 | Buvidal | Camurus AB
  Ideon Science Park, 223 70 Lund, Sverige | EU/1/18/1336 | 15.6.2020 |
| 12.6.2020 | Deferiprone Lipomed | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | EU/1/18/1310 | 15.6.2020 |
| 12.6.2020 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 15.6.2020 |
| 12.6.2020 | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 15.6.2020 |
| 12.6.2020 | Holoclar | Holostem Terapie Avanzate S.r.l.
  Via Glauco Gottardi 100, Modena, MO 41125, Italia | EU/1/14/987 | 15.6.2020 |
| 12.6.2020 | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 15.6.2020 |
| 12.6.2020 | Nilemdo | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/20/1425 | 17.6.2020 |
| 12.6.2020 | PHEBURANE | Eurocept International BV
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/822 | 29.6.2020 |
| 17.6.2020 | Exforge HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 18.6.2020 |
| 17.6.2020 | Ogivri | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1341 | 18.6.2020 |
| 17.6.2020 | Ratiograstim | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/08/444 | 18.6.2020 |
| 18.6.2020 | Copalia HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 19.6.2020 |
| 18.6.2020 | Dafiro HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 22.6.2020 |
| 18.6.2020 | Hexacima | Sanofi Pasteur
  14 Espace Henry Vallée, 69007 Lyon, France | EU/1/13/828 | 19.6.2020 |
| 18.6.2020 | Hexyon | Sanofi Pasteur
  14 Espace Henry Vallée, 69007 Lyon, France | EU/1/13/829 | 19.6.2020 |
| 18.6.2020 | Idacio | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/19/1356 | 19.6.2020 |
| 18.6.2020 | IDELVION | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1095 | 25.6.2020 |
| 18.6.2020 | Ovaleap | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/13/871 | 19.6.2020 |
| 18.6.2020 | PecFent | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/10/644 | 19.6.2020 |
| 18.6.2020 | Tevagrastim | Teva GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/08/445 | 19.6.2020 |
| 18.6.2020 | Trumenba | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1187 | 19.6.2020 |
| 18.6.2020 | VPRIV | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/10/646 | 19.6.2020 |
| 18.6.2020 | Xagrid | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland | EU/1/04/295 | 19.6.2020 |
| 19.6.2020 | Pregabalin Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1011 | 6.7.2020 |
| 19.6.2020 | Pregabalin Sandoz GmbH | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1012 | 3.7.2020 |
| 25.6.2020 | Aflunov | Seqirus S.r.l.
  Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy | EU/1/10/658 | 29.6.2020 |
| 25.6.2020 | Cotellic | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/15/1048 | 26.6.2020 |
| 25.6.2020 | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 26.6.2020 |
| 25.6.2020 | Entresto | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1058 | 29.6.2020 |
| 25.6.2020 | Erbitux | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/04/281 | 29.6.2020 |
| 25.6.2020 | Intuniv | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/15/1040 | 26.6.2020 |
| 25.6.2020 | Kisplyx | Eisai GmbH
  Lyoner Strasse 36, 60528 Frankfurt am Main, Deutschland | EU/1/16/1128 | 4.7.2020 |
| 25.6.2020 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 29.6.2020 |
| 25.6.2020 | Mysildecard | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1134 | 6.7.2020 |
| 25.6.2020 | Neofordex | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/15/1053 | 29.6.2020 |
| 25.6.2020 | Olanzapine Apotex | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN, Leiden, Nederland | EU/1/10/635 | 1.7.2020 |
| 25.6.2020 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 26.6.2020 |
| 25.6.2020 | Ultomiris | Alexion Europe SAS
  103-105 Rue Anatole France, 92300 Levallois-Perret, France | EU/1/19/1371 | 26.6.2020 |
| 25.6.2020 | Wakix | Bioprojet Pharma
  9 rue Rameau, 75002 Paris, France | EU/1/15/1068 | 26.6.2020 |
| 25.6.2020 | Zejula | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/17/1235 | 26.6.2020 |
| 26.6.2020 | AJOVY | Teva GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/19/1358 | 30.6.2020 |
| 26.6.2020 | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1029 | 30.6.2020 |
| 26.6.2020 | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 6.7.2020 |
| 26.6.2020 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 30.6.2020 |
| 26.6.2020 | Copalia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 29.6.2020 |
| 26.6.2020 | Dafiro | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 29.6.2020 |
| 26.6.2020 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/884 | 29.6.2020 |
| 26.6.2020 | LIBTAYO | Regeneron Ireland Designated Activity Company (DAC)
  Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland | EU/1/19/1376 | 29.6.2020 |
| 26.6.2020 | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 30.6.2020 |
| 26.6.2020 | Sivextro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/991 | 7.7.2020 |
| 26.6.2020 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 30.6.2020 |
| 26.6.2020 | Talzenna | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1377 | 29.6.2020 |

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

2.6.2020

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

3.6.2020

2.6.2020

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

14.6.2020

2.6.2020

Braftovi

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1314

3.6.2020

2.6.2020

Brinavess

Correvio

15 rue du Bicentenaire, 92800 Puteaux, France

EU/1/10/645

3.6.2020

2.6.2020

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

8.6.2020

2.6.2020

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555

4.6.2020

2.6.2020

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/12/801

3.6.2020

2.6.2020

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1263

4.6.2020

2.6.2020

Farydak

Secura Bio Limited

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

EU/1/15/1023

8.6.2020

2.6.2020

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

11.6.2020

2.6.2020

Lyrica

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/04/279

3.6.2020

2.6.2020

Memantine Accord

Accord Healthcare S.L.U.

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

EU/1/13/880

3.6.2020

2.6.2020

Multaq

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/09/591

3.6.2020

2.6.2020

Nustendi

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1424

3.6.2020

2.6.2020

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

3.6.2020

2.6.2020

Praluent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/15/1031

4.6.2020

2.6.2020

Pregabalin Pfizer

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/14/916

3.6.2020

2.6.2020

Revatio

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/05/318

3.6.2020

2.6.2020

Revlimid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/391

3.6.2020

2.6.2020

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

11.6.2020

2.6.2020

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

3.6.2020

2.6.2020

Viagra

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/98/077

3.6.2020

3.6.2020

Carmustine Obvius

Obvius Investment B.V.

De Cuserstraat 93, 1081 CN Amsterdam, Nederland

EU/1/18/1278

4.6.2020

3.6.2020

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

4.6.2020

3.6.2020

Ecalta

Pfizer Europe MA EEIG

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

EU/1/07/416

4.6.2020

3.6.2020

Imnovid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/13/850

4.6.2020

3.6.2020

Zyllt

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

8.6.2020

9.6.2020

Cablivi

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

11.6.2020

9.6.2020

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

10.6.2020

9.6.2020

Jakavi

Novartis Europharm Limited

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

EU/1/12/773

10.6.2020

9.6.2020

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

10.6.2020

9.6.2020

Kiovig

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/05/329

6.7.2020

9.6.2020

Qarziba

EUSA Pharma (Netherlands) B.V.

Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

EU/1/17/1191

6.7.2020

9.6.2020

Zoely

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

10.6.2020

12.6.2020

Buvidal

Camurus AB

Ideon Science Park, 223 70 Lund, Sverige

EU/1/18/1336

15.6.2020

12.6.2020

Deferiprone Lipomed

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

15.6.2020

12.6.2020

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

15.6.2020

12.6.2020

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

15.6.2020

12.6.2020

Holoclar

Holostem Terapie Avanzate S.r.l.

Via Glauco Gottardi 100, Modena, MO 41125, Italia

EU/1/14/987

15.6.2020

12.6.2020

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

15.6.2020

12.6.2020

Nilemdo

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1425

17.6.2020

12.6.2020

PHEBURANE

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/822

29.6.2020

17.6.2020

Exforge HCT

Novartis Europharm Limited

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

EU/1/09/569

18.6.2020

17.6.2020

Ogivri

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1341

18.6.2020

17.6.2020

Ratiograstim

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/444

18.6.2020

18.6.2020

Copalia HCT

Novartis Europharm Limited

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

EU/1/09/575

19.6.2020

18.6.2020

Dafiro HCT

Novartis Europharm Limited

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

EU/1/09/574

22.6.2020

18.6.2020

Hexacima

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/828

19.6.2020

18.6.2020

Hexyon

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/829

19.6.2020

18.6.2020

Idacio

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1356

19.6.2020

18.6.2020

IDELVION

CSL Behring GmbH

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

EU/1/16/1095

25.6.2020

18.6.2020

Ovaleap

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/13/871

19.6.2020

18.6.2020

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

19.6.2020

18.6.2020

Tevagrastim

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445

19.6.2020

18.6.2020

Trumenba

Pfizer Europe MA EEIG

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

EU/1/17/1187

19.6.2020

18.6.2020

VPRIV

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/10/646

19.6.2020

18.6.2020

Xagrid

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/04/295

19.6.2020

19.6.2020

Pregabalin Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

6.7.2020

19.6.2020

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1012

3.7.2020

25.6.2020

Aflunov

Seqirus S.r.l.

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

EU/1/10/658

29.6.2020

25.6.2020

Cotellic

Roche Registration GmbH

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

EU/1/15/1048

26.6.2020

25.6.2020

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

26.6.2020

25.6.2020

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

29.6.2020

25.6.2020

Erbitux

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/04/281

29.6.2020

25.6.2020

Intuniv

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1040

26.6.2020

25.6.2020

Kisplyx

Eisai GmbH

Lyoner Strasse 36, 60528 Frankfurt am Main, Deutschland

EU/1/16/1128

4.7.2020

25.6.2020

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

29.6.2020

25.6.2020

Mysildecard

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1134

6.7.2020

25.6.2020

Neofordex

Laboratoires CTRS

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

EU/1/15/1053

29.6.2020

25.6.2020

Olanzapine Apotex

Apotex Europe B.V.

Archimedesweg 2, 2333 CN, Leiden, Nederland

EU/1/10/635

1.7.2020

25.6.2020

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

26.6.2020

25.6.2020

Ultomiris

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/19/1371

26.6.2020

25.6.2020

Wakix

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/15/1068

26.6.2020

25.6.2020

Zejula

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

26.6.2020

26.6.2020

AJOVY

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/19/1358

30.6.2020

26.6.2020

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

30.6.2020

26.6.2020

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

6.7.2020

26.6.2020

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

30.6.2020

26.6.2020

Copalia

Novartis Europharm Limited

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

EU/1/06/372

29.6.2020

26.6.2020

Dafiro

Novartis Europharm Limited

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

EU/1/06/371

29.6.2020

26.6.2020

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

29.6.2020

26.6.2020

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

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

EU/1/19/1376

29.6.2020

26.6.2020

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

30.6.2020

26.6.2020

Sivextro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

7.7.2020

26.6.2020

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

30.6.2020

26.6.2020

Talzenna

Pfizer Europe MA EEIG

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

EU/1/19/1377

29.6.2020

—   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 |
| --- | --- | --- | --- | --- |
| 22.6.2020 | Zerit | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/96/009 | 25.6.2020 |

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

22.6.2020

Zerit

Bristol-Myers Squibb Pharma EEIG

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

EU/1/96/009

25.6.2020

—   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 |
| --- | --- | --- | --- | --- |
| 5.6.2020 | Recocam | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland | EU/2/11/133 | 9.6.2020 |
| 17.6.2020 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 18.6.2020 |
| 17.6.2020 | Zulvac 1 + 8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 19.6.2020 |
| 24.6.2020 | Aivlosin | ECO Animal Health Europe Limited
  6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland | EU/2/04/044 | 25.6.2020 |
| 24.6.2020 | Mirataz | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | EU/2/19/247 | 25.6.2020 |
| 24.6.2020 | UpCard | Vétoquinol SA
  Magny-Vernois, 70200 Lure, France | EU/2/15/184 | 1.7.2020 |
| 24.6.2020 | Zulvac BTV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/207 | 29.6.2020 |

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

5.6.2020

Recocam

Bimeda Animal Health Limited

2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland

EU/2/11/133

9.6.2020

17.6.2020

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

18.6.2020

17.6.2020

Zulvac 1 + 8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

19.6.2020

24.6.2020

Aivlosin

ECO Animal Health Europe Limited

6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland

EU/2/04/044

25.6.2020

24.6.2020

Mirataz

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/19/247

25.6.2020

24.6.2020

UpCard

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/15/184

1.7.2020

24.6.2020

Zulvac BTV

Zoetis Belgium S.A.

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

EU/2/17/207

29.6.2020

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 |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

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