# C_2018070EN.01000101.xml

| 23.2.2018 | EN | Official Journal of the European Union | C 70/1 |
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23.2.2018

EN

Official Journal of the European Union

C 70/1

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

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

1

(2018/C 070/01)

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

—

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

Issuing of a marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.1.2018 | ADYNOVI | rurioctocog alfa pegol | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/17/1247 | Powder and solvent for solution for injection | B02BD02 | 10.1.2018 |
| 8.1.2018 | Fasenra | benralizumab | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | Solution for injection | R03DX10 | 10.1.2018 |
| 8.1.2018 | Fulvestrant Mylan | fulvestrant | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1253 | Solution for injection | L02BA03 | 10.1.2018 |
| 8.1.2018 | Intrarosa | prasterone | Endoceutics Ltd.
  Salisbury house, London Wall, London, EC2M 5PS, United Kingdom | EU/1/17/1255 | Pessary | QM01AX92 | 6.2.2018 |
| 8.1.2018 | Jorveza | budesonide | Dr Falk Pharma GmbH
  Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland | EU/1/17/1254 | Orodispersible tablet | A07EA06 | 10.1.2018 |
| 8.1.2018 | Ocrevus | ocrelizumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/17/1231 | Concentrate for solution for infusion | L04AA36 | 10.1.2018 |
| 8.1.2018 | PREVYMIS | letermovir | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/17/1245 | Concentrate for solution for infusion
  Film-coated tablet | J05AX18 | 10.1.2018 |
| 15.1.2018 | Mvasi | bevacizumab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | Concentrate for solution for infusion | L01XC07 | 17.1.2018 |
| 18.1.2018 | Darunavir Krka d.d. | darunavir | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1248 | Film-coated tablet | J05AE10 | 22.1.2018 |
| 26.1.2018 | Darunavir Krka | darunavir | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1249 | Film-coated tablet | J05AE10 | 30.1.2018 |

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

8.1.2018

ADYNOVI

rurioctocog alfa pegol

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/17/1247

Powder and solvent for solution for injection

B02BD02

10.1.2018

8.1.2018

Fasenra

benralizumab

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

Solution for injection

R03DX10

10.1.2018

8.1.2018

Fulvestrant Mylan

fulvestrant

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1253

Solution for injection

L02BA03

10.1.2018

8.1.2018

Intrarosa

prasterone

Endoceutics Ltd.

Salisbury house, London Wall, London, EC2M 5PS, United Kingdom

EU/1/17/1255

Pessary

QM01AX92

6.2.2018

8.1.2018

Jorveza

budesonide

Dr Falk Pharma GmbH

Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland

EU/1/17/1254

Orodispersible tablet

A07EA06

10.1.2018

8.1.2018

Ocrevus

ocrelizumab

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/17/1231

Concentrate for solution for infusion

L04AA36

10.1.2018

8.1.2018

PREVYMIS

letermovir

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/17/1245

Concentrate for solution for infusion

Film-coated tablet

J05AX18

10.1.2018

15.1.2018

Mvasi

bevacizumab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

Concentrate for solution for infusion

L01XC07

17.1.2018

18.1.2018

Darunavir Krka d.d.

darunavir

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

Film-coated tablet

J05AE10

22.1.2018

26.1.2018

Darunavir Krka

darunavir

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1249

Film-coated tablet

J05AE10

30.1.2018

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

—

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

Issuing of a marketing authorisation

Rejected

| 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 |
| --- | --- | --- | --- | --- |
| 8.1.2018 | Onzeald | Nektar Therapeutics UK Limited
  Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom | — | 10.1.2018 |
| 15.1.2018 | Fanaptum | Vanda Pharmaceuticals Limited
  222 Regent Street, London W1B 5TR, United Kingdom | — | 19.1.2018 |

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

8.1.2018

Onzeald

Nektar Therapeutics UK Limited

Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom

—

10.1.2018

15.1.2018

Fanaptum

Vanda Pharmaceuticals Limited

222 Regent Street, London W1B 5TR, United Kingdom

—

19.1.2018

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

—

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

Modification of a marketing authorisation

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 |
| --- | --- | --- | --- | --- |
| 8.1.2018 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom | EU/1/12/760 | 10.1.2018 |
| 8.1.2018 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 10.1.2018 |
| 8.1.2018 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 10.1.2018 |
| 8.1.2018 | Comtess | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/98/082 | 10.1.2018 |
| 8.1.2018 | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/828 | 10.1.2018 |
| 8.1.2018 | Hexyon | Sanofi Pasteur Europe
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/13/829 | 10.1.2018 |
| 8.1.2018 | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 10.1.2018 |
| 8.1.2018 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/825 | 10.1.2018 |
| 8.1.2018 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 10.1.2018 |
| 8.1.2018 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 10.1.2018 |
| 8.1.2018 | Memantine LEK | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/13/826 | 10.1.2018 |
| 8.1.2018 | Memantine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | 15.1.2018 |
| 8.1.2018 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/824 | 10.1.2018 |
| 8.1.2018 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 10.1.2018 |
| 8.1.2018 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 10.1.2018 |
| 8.1.2018 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, 3446 GR Woerden, Nederland | EU/1/13/832 | 10.1.2018 |
| 8.1.2018 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 10.1.2018 |
| 8.1.2018 | Tolucombi | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 10.1.2018 |
| 8.1.2018 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 10.1.2018 |
| 8.1.2018 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 10.1.2018 |
| 8.1.2018 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 10.1.2018 |
| 8.1.2018 | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 10.1.2018 |
| 11.1.2018 | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/02/246 | 15.1.2018 |
| 11.1.2018 | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 15.1.2018 |
| 11.1.2018 | Cystadrops | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/15/1049 | 15.1.2018 |
| 11.1.2018 | Cystagon | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France | EU/1/97/039 | 15.1.2018 |
| 11.1.2018 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 15.1.2018 |
| 11.1.2018 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 15.1.2018 |
| 11.1.2018 | Levetiracetam Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/701 | 15.1.2018 |
| 11.1.2018 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 15.1.2018 |
| 15.1.2018 | Adasuve | Ferrer Internacional S.A.
  Gran Via Carlos III, 94 08028 Barcelona, España | EU/1/13/823 | 17.1.2018 |
| 15.1.2018 | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/1055 | 17.1.2018 |
| 15.1.2018 | Prialt | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/302 | 17.1.2018 |
| 15.1.2018 | Zostavax | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 17.1.2018 |
| 18.1.2018 | Bortezomib Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/16/1114 | 22.1.2018 |
| 18.1.2018 | Leganto | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/11/695 | 22.1.2018 |
| 18.1.2018 | Marixino | Consilient Health Ltd
  5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | EU/1/13/820 | 22.1.2018 |
| 18.1.2018 | Omidria | Omeros London Limited
  Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | 22.1.2018 |
| 18.1.2018 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 22.1.2018 |
| 18.1.2018 | Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | 22.1.2018 |
| 18.1.2018 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 22.1.2018 |
| 18.1.2018 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 22.1.2018 |
| 24.1.2018 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 26.1.2018 |
| 24.1.2018 | DUAVIVE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | 26.1.2018 |
| 24.1.2018 | IBRANCE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1147 | 26.1.2018 |
| 24.1.2018 | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 26.1.2018 |
| 25.1.2018 | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 29.1.2018 |
| 26.1.2018 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 30.1.2018 |
| 26.1.2018 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 30.1.2018 |
| 30.1.2018 | Cialis | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/02/237 | 31.1.2018 |
| 30.1.2018 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 1.2.2018 |
| 30.1.2018 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 1.2.2018 |
| 30.1.2018 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 1.2.2018 |
| 30.1.2018 | Cresemba | Basilea Medical Ltd
  c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom | EU/1/15/1036 | 1.2.2018 |
| 30.1.2018 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 1.2.2018 |
| 30.1.2018 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 1.2.2018 |
| 30.1.2018 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 1.2.2018 |
| 30.1.2018 | Effentora | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/441 | 1.2.2018 |
| 30.1.2018 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 1.2.2018 |
| 30.1.2018 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/12/776 | 1.2.2018 |
| 30.1.2018 | Granpidam | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1137 | 1.2.2018 |
| 30.1.2018 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 1.2.2018 |
| 30.1.2018 | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 1.2.2018 |
| 30.1.2018 | Nplate | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497 | 1.2.2018 |
| 30.1.2018 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 1.2.2018 |
| 30.1.2018 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 2.2.2018 |
| 30.1.2018 | Vectibix | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 1.2.2018 |

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

8.1.2018

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom

EU/1/12/760

10.1.2018

8.1.2018

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

10.1.2018

8.1.2018

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

10.1.2018

8.1.2018

Comtess

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/98/082

10.1.2018

8.1.2018

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/828

10.1.2018

8.1.2018

Hexyon

Sanofi Pasteur Europe

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/13/829

10.1.2018

8.1.2018

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

10.1.2018

8.1.2018

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/825

10.1.2018

8.1.2018

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

10.1.2018

8.1.2018

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

10.1.2018

8.1.2018

Memantine LEK

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/13/826

10.1.2018

8.1.2018

Memantine Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/13/827

15.1.2018

8.1.2018

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

10.1.2018

8.1.2018

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

10.1.2018

8.1.2018

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

10.1.2018

8.1.2018

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, 3446 GR Woerden, Nederland

EU/1/13/832

10.1.2018

8.1.2018

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

10.1.2018

8.1.2018

Tolucombi

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

10.1.2018

8.1.2018

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

10.1.2018

8.1.2018

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

10.1.2018

8.1.2018

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

10.1.2018

8.1.2018

Zonegran

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/04/307

10.1.2018

11.1.2018

Carbaglu

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/02/246

15.1.2018

11.1.2018

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

15.1.2018

11.1.2018

Cystadrops

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/15/1049

15.1.2018

11.1.2018

Cystagon

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/97/039

15.1.2018

11.1.2018

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

15.1.2018

11.1.2018

Laventair

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/899

15.1.2018

11.1.2018

Levetiracetam Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/701

15.1.2018

11.1.2018

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

15.1.2018

15.1.2018

Adasuve

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona, España

EU/1/13/823

17.1.2018

15.1.2018

Ciambra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/15/1055

17.1.2018

15.1.2018

Prialt

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/04/302

17.1.2018

15.1.2018

Zostavax

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

17.1.2018

18.1.2018

Bortezomib Hospira

Hospira UK Limited

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

EU/1/16/1114

22.1.2018

18.1.2018

Leganto

UCB Pharma S.A.

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

EU/1/11/695

22.1.2018

18.1.2018

Marixino

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

22.1.2018

18.1.2018

Omidria

Omeros London Limited

Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

22.1.2018

18.1.2018

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

22.1.2018

18.1.2018

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

22.1.2018

18.1.2018

XALKORI

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/12/793

22.1.2018

18.1.2018

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

22.1.2018

24.1.2018

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

26.1.2018

24.1.2018

DUAVIVE

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/14/960

26.1.2018

24.1.2018

IBRANCE

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/16/1147

26.1.2018

24.1.2018

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

26.1.2018

25.1.2018

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

29.1.2018

26.1.2018

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

30.1.2018

26.1.2018

Mysimba

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

30.1.2018

30.1.2018

Cialis

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/02/237

31.1.2018

30.1.2018

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

1.2.2018

30.1.2018

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

1.2.2018

30.1.2018

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

1.2.2018

30.1.2018

Cresemba

Basilea Medical Ltd

c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom

EU/1/15/1036

1.2.2018

30.1.2018

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

1.2.2018

30.1.2018

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

1.2.2018

30.1.2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

1.2.2018

30.1.2018

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

1.2.2018

30.1.2018

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

1.2.2018

30.1.2018

Fycompa

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/12/776

1.2.2018

30.1.2018

Granpidam

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/16/1137

1.2.2018

30.1.2018

Hizentra

CSL Behring GmbH

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

EU/1/11/687

1.2.2018

30.1.2018

Ivemend

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437

1.2.2018

30.1.2018

Nplate

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

1.2.2018

30.1.2018

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

1.2.2018

30.1.2018

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

2.2.2018

30.1.2018

Vectibix

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

1.2.2018

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

—

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

Withdrawal of a marketing authorisation

| 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 |
| --- | --- | --- | --- | --- |
| 11.1.2018 | Daliresp | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/668 | 15.1.2018 |
| 11.1.2018 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 15.1.2018 |
| 11.1.2018 | Libertek | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/11/666 | 15.1.2018 |
| 18.1.2018 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 22.1.2018 |
| 30.1.2018 | LeukoScan | Immunomedics GmbH
  Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland | EU/1/97/032 | 1.2.2018 |

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

11.1.2018

Daliresp

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/668

15.1.2018

11.1.2018

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

15.1.2018

11.1.2018

Libertek

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/666

15.1.2018

18.1.2018

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

22.1.2018

30.1.2018

LeukoScan

Immunomedics GmbH

Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland

EU/1/97/032

1.2.2018

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

—

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

Issuing of a marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2018 | GALLIPRANT | grapiprant | Aratana Therapeutics NV
  Ambachtenlaan 1, 3001 Heverlee, België | EU/2/17/221 | Tablet | QM01AX92 | 11.1.2018 |
| 31.1.2018 | MiPet Easecto | sarolaner | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/220 | Chewable tablet | QP53BE03 | 2.2.2018 |

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

9.1.2018

GALLIPRANT

grapiprant

Aratana Therapeutics NV

Ambachtenlaan 1, 3001 Heverlee, België

EU/2/17/221

Tablet

QM01AX92

11.1.2018

31.1.2018

MiPet Easecto

sarolaner

Zoetis Belgium S.A.

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

EU/2/17/220

Chewable tablet

QP53BE03

2.2.2018

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

—

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

Modification of a marketing authorisation

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 |
| --- | --- | --- | --- | --- |
| 9.1.2018 | Cortavance | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France | EU/2/06/069 | 11.1.2018 |
| 9.1.2018 | Ypozane | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France | EU/2/06/068 | 11.1.2018 |
| 12.1.2018 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 16.1.2018 |
| 12.1.2018 | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France | EU/2/09/097 | 16.1.2018 |
| 12.1.2018 | Virbagen Omega | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France | EU/2/01/030 | 16.1.2018 |
| 12.1.2018 | Zactran | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/08/082 | 16.1.2018 |
| 16.1.2018 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 18.1.2018 |
| 31.1.2018 | Meloxoral | Le Vet B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/10/111 | 2.2.2018 |

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

9.1.2018

Cortavance

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/06/069

11.1.2018

9.1.2018

Ypozane

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/06/068

11.1.2018

12.1.2018

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

16.1.2018

12.1.2018

Leucofeligen FeLV/RCP

Virbac

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/09/097

16.1.2018

12.1.2018

Virbagen Omega

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/01/030

16.1.2018

12.1.2018

Zactran

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/08/082

16.1.2018

16.1.2018

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

18.1.2018

31.1.2018

Meloxoral

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/10/111

2.2.2018

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.

1

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