# C_2020135EN.01000101.xml

| 24.4.2020 | EN | Official Journal of the European Union | C 135/1 |
| --- | --- | --- | --- |

24.4.2020

EN

Official Journal of the European Union

C 135/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 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 135/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.3.2020 | Givlaari | givosiran | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/20/1428 | Solution for injection | Pending | 4.3.2020 |
| 24.3.2020 | Azacitidine Betapharm | Azacitidine | betapharm Arzneimittel GmbH
  Kobelweg 95, 86156 Augsburg, Deutschland | EU/1/19/1416 | Powder for suspension for injection | L01BC07 | 25.3.2020 |
| 24.3.2020 | Liumjev | Insulin lispro | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/20/1422 | Solution for injection | A10AB04 | 26.3.2020 |
| 27.3.2020 | Azacitidine Mylan | Azacitidine | Mylan Ireland Limited
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/20/1426 | Powder for suspension for injection | L01BC07 | 30.3.2020 |
| 27.3.2020 | NUBEQA | darolutamide | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/20/1432 | Film-coated tablet | L02BB06 | 30.3.2020 |
| 27.3.2020 | Nustendi | bempedoic acid/ezetimibe | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/20/1424 | Film-coated tablet | Pending | 31.3.2020 |
| 27.3.2020 | Staquis | crisaborole | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1421 | Ointment | D11AH06 | 1.4.2020 |

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

2.3.2020

Givlaari

givosiran

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/20/1428

Solution for injection

Pending

4.3.2020

24.3.2020

Azacitidine Betapharm

Azacitidine

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

Powder for suspension for injection

L01BC07

25.3.2020

24.3.2020

Liumjev

Insulin lispro

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

Solution for injection

A10AB04

26.3.2020

27.3.2020

Azacitidine Mylan

Azacitidine

Mylan Ireland Limited

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

EU/1/20/1426

Powder for suspension for injection

L01BC07

30.3.2020

27.3.2020

NUBEQA

darolutamide

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/1432

Film-coated tablet

L02BB06

30.3.2020

27.3.2020

Nustendi

bempedoic acid/ezetimibe

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/20/1424

Film-coated tablet

Pending

31.3.2020

27.3.2020

Staquis

crisaborole

Pfizer Europe MA EEIG

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

EU/1/19/1421

Ointment

D11AH06

1.4.2020

—   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 |
| --- | --- | --- | --- | --- |
| 3.3.2020 | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 5.3.2020 |
| 3.3.2020 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 5.3.2020 |
| 9.3.2020 | Alkindi | Diurnal Europe B.V.
  Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland | EU/1/17/1260 | 11.3.2020 |
| 9.3.2020 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | EU/1/11/740 | 11.3.2020 |
| 9.3.2020 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 11.3.2020 |
| 9.3.2020 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 11.3.2020 |
| 9.3.2020 | Duloxetine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | 11.3.2020 |
| 9.3.2020 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 11.3.2020 |
| 9.3.2020 | Fortacin | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/13/881 | 11.3.2020 |
| 9.3.2020 | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/15/990 | 11.3.2020 |
| 9.3.2020 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, 3490 Kvistgaard, Danmark | EU/1/13/855 | 11.3.2020 |
| 9.3.2020 | Integrilin | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/109 | 11.3.2020 |
| 9.3.2020 | Iressa | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/09/526 | 11.3.2020 |
| 9.3.2020 | Kineret | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/02/203 | 11.3.2020 |
| 9.3.2020 | Lojuxta | Amryt Pharmaceuticals DAC
  90 Harcourt Street, Dublin 2, Ireland | EU/1/13/851 | 11.3.2020 |
| 9.3.2020 | Luxturna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1331 | 11.3.2020 |
| 9.3.2020 | Nyxoid | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/17/1238 | 11.3.2020 |
| 9.3.2020 | Oncaspar | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/15/1070 | 11.3.2020 |
| 9.3.2020 | Onpattro | Alnylam Netherlands B.V.
  Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland | EU/1/18/1320 | 11.3.2020 |
| 9.3.2020 | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 11.3.2020 |
| 9.3.2020 | Pelmeg | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/18/1328 | 11.3.2020 |
| 9.3.2020 | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 11.3.2020 |
| 9.3.2020 | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1108 | 11.3.2020 |
| 9.3.2020 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 11.3.2020 |
| 9.3.2020 | Ristaben | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/621 | 18.3.2020 |
| 9.3.2020 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 11.3.2020 |
| 9.3.2020 | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/16/1157 | 11.3.2020 |
| 9.3.2020 | TAKHZYRO | Shire Pharmaceuticals Ireland Limited
  Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland | EU/1/18/1340 | 11.3.2020 |
| 9.3.2020 | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 11.3.2020 |
| 9.3.2020 | Tesavel | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/435 | 11.3.2020 |
| 9.3.2020 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 11.3.2020 |
| 9.3.2020 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 11.3.2020 |
| 9.3.2020 | Ulunar Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/917 | 11.3.2020 |
| 9.3.2020 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 11.3.2020 |
| 9.3.2020 | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 11.3.2020 |
| 9.3.2020 | Xelevia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/382 | 11.3.2020 |
| 9.3.2020 | Xoterna Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/863 | 11.3.2020 |
| 10.3.2020 | Epivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/96/015 | 12.3.2020 |
| 10.3.2020 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 12.3.2020 |
| 10.3.2020 | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1037 | 12.3.2020 |
| 10.3.2020 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/08/462 | 12.3.2020 |
| 16.3.2020 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | 18.3.2020 |
| 16.3.2020 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o.
  Hvězdova 1716/2b, 14078 Praha 4, Česká republika | EU/1/09/592 | 18.3.2020 |
| 16.3.2020 | Pandemic influenza vaccine H5N1 AstraZeneca | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1089 | 18.3.2020 |
| 16.3.2020 | Waylivra | Akcea Therapeutics Ireland Limited
  Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland | EU/1/19/1360 | 18.3.2020 |
| 24.3.2020 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/12/792 | 25.3.2020 |
| 24.3.2020 | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 25.3.2020 |
| 24.3.2020 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 30.3.2020 |
| 24.3.2020 | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 26.3.2020 |
| 24.3.2020 | Shingrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | 25.3.2020 |
| 24.3.2020 | Voriconazole Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 26.3.2020 |
| 27.3.2020 | Alofisel | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/17/1261 | 6.4.2020 |
| 27.3.2020 | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1025 | 6.4.2020 |
| 27.3.2020 | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | 5.4.2020 |
| 27.3.2020 | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | 6.4.2020 |
| 27.3.2020 | Hyrimoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | 5.4.2020 |
| 27.3.2020 | Lenalidomide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/18/1316 | 31.3.2020 |
| 27.3.2020 | Ozempic | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/17/1251 | 31.3.2020 |
| 27.3.2020 | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 6.4.2020 |
| 27.3.2020 | Vaborem | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Luxembourg | EU/1/18/1334 | 30.3.2020 |

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

3.3.2020

Mabthera

Roche Registration GmbH

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

EU/1/98/067

5.3.2020

3.3.2020

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

5.3.2020

9.3.2020

Alkindi

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/17/1260

11.3.2020

9.3.2020

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

11.3.2020

9.3.2020

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

11.3.2020

9.3.2020

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

11.3.2020

9.3.2020

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

11.3.2020

9.3.2020

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

11.3.2020

9.3.2020

Fortacin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

11.3.2020

9.3.2020

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

11.3.2020

9.3.2020

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

11.3.2020

9.3.2020

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

11.3.2020

9.3.2020

Iressa

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/526

11.3.2020

9.3.2020

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

11.3.2020

9.3.2020

Lojuxta

Amryt Pharmaceuticals DAC

90 Harcourt Street, Dublin 2, Ireland

EU/1/13/851

11.3.2020

9.3.2020

Luxturna

Novartis Europharm Limited

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

EU/1/18/1331

11.3.2020

9.3.2020

Nyxoid

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

11.3.2020

9.3.2020

Oncaspar

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

11.3.2020

9.3.2020

Onpattro

Alnylam Netherlands B.V.

Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland

EU/1/18/1320

11.3.2020

9.3.2020

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

11.3.2020

9.3.2020

Pelmeg

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/18/1328

11.3.2020

9.3.2020

Pregabalin Pfizer

Pfizer Europe MA EEIG

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

EU/1/14/916

11.3.2020

9.3.2020

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

11.3.2020

9.3.2020

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

11.3.2020

9.3.2020

Ristaben

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/621

18.3.2020

9.3.2020

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

11.3.2020

9.3.2020

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

11.3.2020

9.3.2020

TAKHZYRO

Shire Pharmaceuticals Ireland Limited

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

EU/1/18/1340

11.3.2020

9.3.2020

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

11.3.2020

9.3.2020

Tesavel

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/435

11.3.2020

9.3.2020

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

11.3.2020

9.3.2020

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

11.3.2020

9.3.2020

Ulunar Breezhaler

Novartis Europharm Limited

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

EU/1/14/917

11.3.2020

9.3.2020

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

11.3.2020

9.3.2020

XALKORI

Pfizer Europe MA EEIG

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

EU/1/12/793

11.3.2020

9.3.2020

Xelevia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/382

11.3.2020

9.3.2020

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

11.3.2020

10.3.2020

Epivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/96/015

12.3.2020

10.3.2020

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

12.3.2020

10.3.2020

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

12.3.2020

10.3.2020

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/08/462

12.3.2020

16.3.2020

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

18.3.2020

16.3.2020

Olazax Disperzi

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 14078 Praha 4, Česká republika

EU/1/09/592

18.3.2020

16.3.2020

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

18.3.2020

16.3.2020

Waylivra

Akcea Therapeutics Ireland Limited

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/19/1360

18.3.2020

24.3.2020

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

25.3.2020

24.3.2020

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

25.3.2020

24.3.2020

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

30.3.2020

24.3.2020

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

26.3.2020

24.3.2020

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

25.3.2020

24.3.2020

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

26.3.2020

27.3.2020

Alofisel

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/17/1261

6.4.2020

27.3.2020

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

6.4.2020

27.3.2020

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

5.4.2020

27.3.2020

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

6.4.2020

27.3.2020

Hyrimoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

5.4.2020

27.3.2020

Lenalidomide Accord

Accord Healthcare S.L.U.

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

EU/1/18/1316

31.3.2020

27.3.2020

Ozempic

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1251

31.3.2020

27.3.2020

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

6.4.2020

27.3.2020

Vaborem

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Luxembourg

EU/1/18/1334

30.3.2020

—   Suspension of a marketing authorisation (Article 20 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 |
| --- | --- | --- | --- | --- |
| 25.3.2020 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 27.3.2020 |

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

25.3.2020

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

27.3.2020

—   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 |
| --- | --- | --- | --- | --- |
| 4.3.2020 | Rabitec | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | 6.3.2020 |
| 4.3.2020 | Respiporc Flu3 | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/09/103 | 6.3.2020 |
| 9.3.2020 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/137 | 11.3.2020 |
| 9.3.2020 | Clomicalm | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/98/007 | 11.3.2020 |
| 9.3.2020 | ECOPORC SHIGA | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/13/149 | 11.3.2020 |
| 24.3.2020 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 25.3.2020 |
| 27.3.2020 | CLYNAV | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/16/197 | 31.3.2020 |
| 27.3.2020 | MS-H vaccine | Pharmsure Veterinary Products Europe Ltd
  4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland | EU/2/11/126 | 31.3.2020 |

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

4.3.2020

Rabitec

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

6.3.2020

4.3.2020

Respiporc Flu3

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/09/103

6.3.2020

9.3.2020

Activyl Tick Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/137

11.3.2020

9.3.2020

Clomicalm

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/98/007

11.3.2020

9.3.2020

ECOPORC SHIGA

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/13/149

11.3.2020

24.3.2020

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

25.3.2020

27.3.2020

CLYNAV

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

31.3.2020

27.3.2020

MS-H vaccine

Pharmsure Veterinary Products Europe Ltd

4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland

EU/2/11/126

31.3.2020

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

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

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