# C_2018433EN.01000601.xml

| 30.11.2018 | EN | Official Journal of the European Union | C 433/6 |
| --- | --- | --- | --- |

30.11.2018

EN

Official Journal of the European Union

C 433/6

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2018 to 31 October 2018

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

(2018/C 433/02)

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

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 31.10.2018 | Symkevi | tezacaftor/ivacaftor | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/18/1306 | Film-coated tablet | R07AX31 | 6.11.2018 |

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

31.10.2018

Symkevi

tezacaftor/ivacaftor

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/18/1306

Film-coated tablet

R07AX31

6.11.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.10.2018 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 8.10.2018 |
| 4.10.2018 | Grastofil | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/13/877 | 8.10.2018 |
| 4.10.2018 | Palonosetron Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1100 | 8.10.2018 |
| 10.10.2018 | Irbesartan Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/06/376 | 12.10.2018 |
| 10.10.2018 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 12.10.2018 |
| 11.10.2018 | Riximyo | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1184 | 15.10.2018 |
| 16.10.2018 | ABILIFY MAINTENA | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/13/882 | 18.10.2018 |
| 16.10.2018 | Kivexa | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/04/298 | 18.10.2018 |
| 16.10.2018 | Leflunomide Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/09/604 | 18.10.2018 |
| 16.10.2018 | Rapamune | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/01/171 | 18.10.2018 |
| 16.10.2018 | Sutent | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/06/347 | 18.10.2018 |
| 18.10.2018 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/334 | 22.10.2018 |
| 18.10.2018 | Forsteo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/03/247 | 22.10.2018 |
| 18.10.2018 | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 22.10.2018 |
| 18.10.2018 | Pemetrexed Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/15/1057 | 22.10.2018 |
| 18.10.2018 | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France | EU/1/14/943 | 22.10.2018 |
| 23.10.2018 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 25.10.2018 |
| 23.10.2018 | Micardis | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/98/090 | 25.10.2018 |
| 23.10.2018 | XALKORI | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/793 | 25.10.2018 |
| 23.10.2018 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/13/846 | 25.10.2018 |
| 23.10.2018 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 25.10.2018 |
| 25.10.2018 | Clopidogrel/Acetylsalicylic acid Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/10/623 | 29.10.2018 |
| 25.10.2018 | Clopidogrel Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/08/465 | 29.10.2018 |
| 25.10.2018 | Cyltezo | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/17/1240 | 29.10.2018 |
| 25.10.2018 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/10/619 | 29.10.2018 |
| 25.10.2018 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/070 | 29.10.2018 |
| 25.10.2018 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/98/069 | 29.10.2018 |
| 25.10.2018 | Replagal | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/01/189 | 29.10.2018 |
| 25.10.2018 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 29.10.2018 |
| 25.10.2018 | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 29.10.2018 |
| 29.10.2018 | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 31.10.2018 |
| 29.10.2018 | Evista | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/98/073 | 31.10.2018 |
| 29.10.2018 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 31.10.2018 |
| 29.10.2018 | Integrilin | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/109 | 31.10.2018 |
| 29.10.2018 | Protopic | Leo Pharma A/S
  Industriparken 55, 2750 Ballerup, Danmark | EU/1/02/201 | 1.11.2018 |
| 29.10.2018 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 31.10.2018 |
| 29.10.2018 | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 31.10.2018 |
| 29.10.2018 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 31.10.2018 |
| 29.10.2018 | Volibris | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/08/451 | 31.10.2018 |
| 31.10.2018 | Arzerra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/625 | 6.11.2018 |
| 31.10.2018 | Elebrato Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1237 | 6.11.2018 |
| 31.10.2018 | Neulasta | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227 | 6.11.2018 |
| 31.10.2018 | Samsca | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/09/539 | 6.11.2018 |
| 31.10.2018 | Trelegy Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1236 | 6.11.2018 |

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

4.10.2018

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

8.10.2018

4.10.2018

Grastofil

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/13/877

8.10.2018

4.10.2018

Palonosetron Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1100

8.10.2018

10.10.2018

Irbesartan Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

12.10.2018

10.10.2018

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

12.10.2018

11.10.2018

Riximyo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

15.10.2018

16.10.2018

ABILIFY MAINTENA

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/13/882

18.10.2018

16.10.2018

Kivexa

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/04/298

18.10.2018

16.10.2018

Leflunomide Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/09/604

18.10.2018

16.10.2018

Rapamune

Pfizer Europe MA EEIG

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

EU/1/01/171

18.10.2018

16.10.2018

Sutent

Pfizer Europe MA EEIG

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

EU/1/06/347

18.10.2018

18.10.2018

Evoltra

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/334

22.10.2018

18.10.2018

Forsteo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/03/247

22.10.2018

18.10.2018

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

22.10.2018

18.10.2018

Pemetrexed Hospira

Pfizer Europe MA EEIG

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

EU/1/15/1057

22.10.2018

18.10.2018

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

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

EU/1/14/943

22.10.2018

23.10.2018

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

25.10.2018

23.10.2018

Micardis

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/98/090

25.10.2018

23.10.2018

XALKORI

Pfizer Europe MA EEIG

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

EU/1/12/793

25.10.2018

23.10.2018

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

25.10.2018

23.10.2018

Zinbryta

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/16/1107

25.10.2018

25.10.2018

Clopidogrel/Acetylsalicylic acid Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/10/623

29.10.2018

25.10.2018

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

29.10.2018

25.10.2018

Cyltezo

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/17/1240

29.10.2018

25.10.2018

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/10/619

29.10.2018

25.10.2018

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/070

29.10.2018

25.10.2018

Plavix

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/069

29.10.2018

25.10.2018

Replagal

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/01/189

29.10.2018

25.10.2018

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110

29.10.2018

25.10.2018

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

29.10.2018

29.10.2018

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

31.10.2018

29.10.2018

Evista

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/98/073

31.10.2018

29.10.2018

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

31.10.2018

29.10.2018

Integrilin

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/109

31.10.2018

29.10.2018

Protopic

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/02/201

1.11.2018

29.10.2018

RoActemra

Roche Registration GmbH

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

EU/1/08/492

31.10.2018

29.10.2018

Taxespira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/15/1017

31.10.2018

29.10.2018

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

31.10.2018

29.10.2018

Volibris

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/08/451

31.10.2018

31.10.2018

Arzerra

Novartis Europharm Limited

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

EU/1/10/625

6.11.2018

31.10.2018

Elebrato Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1237

6.11.2018

31.10.2018

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

6.11.2018

31.10.2018

Samsca

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/09/539

6.11.2018

31.10.2018

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1236

6.11.2018

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

—

Withdrawal of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 29.10.2018 | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 31.10.2018 |
| 30.10.2018 | Taxespira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/15/1017 | 1.11.2018 |

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

29.10.2018

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

31.10.2018

30.10.2018

Taxespira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/15/1017

1.11.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 17.10.2018 | Recocam | Bimeda Animal Health Limited
  2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland | EU/2/11/133 | 19.10.2018 |
| 18.10.2018 | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 22.10.2018 |
| 18.10.2018 | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/177 | 22.10.2018 |
| 23.10.2018 | Canigen L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/183 | 25.10.2018 |
| 30.10.2018 | Dexdomitor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/02/033 | 1.11.2018 |
| 30.10.2018 | Improvac | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/095 | 5.11.2018 |
| 30.10.2018 | Zolvix | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/09/101 | 1.11.2018 |

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

17.10.2018

Recocam

Bimeda Animal Health Limited

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

EU/2/11/133

19.10.2018

18.10.2018

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

22.10.2018

18.10.2018

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

22.10.2018

23.10.2018

Canigen L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/183

25.10.2018

30.10.2018

Dexdomitor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/02/033

1.11.2018

30.10.2018

Improvac

Zoetis Belgium S.A.

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

EU/2/09/095

5.11.2018

30.10.2018

Zolvix

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/09/101

1.11.2018

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 |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

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

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