# Official Journal C 266/27 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 266 |
| | |
| English edition | Information and Notices | Volume 6127 July 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 266

English edition

Information and Notices

Volume 6127 July 2018

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 266/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 266/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 2018(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.7.2018 | EN | Official Journal of the European Union | C 266/1 |
| --- | --- | --- | --- |

27.7.2018

EN

Official Journal of the European Union

C 266/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2018 to 30 June 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 266/01)

| — | 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

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.6.2018 | Blincyto | blinatumomab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | Powder for concentrate for solution for infusion | L01XC19 | 20.6.2018 |
| 21.6.2018 | Biktarvy | bictegravir / emtricitabine / tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/18/1289 | Film-coated tablet | J05AR20 | 25.6.2018 |
| 25.6.2018 | Dzuveo | sufentanil | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/18/1284 | Sublingual tablet | N01AH03 | 27.6.2018 |

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

18.6.2018

Blincyto

blinatumomab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

Powder for concentrate for solution for infusion

L01XC19

20.6.2018

21.6.2018

Biktarvy

bictegravir / emtricitabine / tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/18/1289

Film-coated tablet

J05AR20

25.6.2018

25.6.2018

Dzuveo

sufentanil

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/18/1284

Sublingual tablet

N01AH03

27.6.2018

| — | 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

| 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 |
| --- | --- | --- | --- | --- |
| 4.6.2018 | Copalia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 6.6.2018 |
| 4.6.2018 | Emtriva | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/261 | 6.6.2018 |
| 4.6.2018 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 6.6.2018 |
| 4.6.2018 | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 6.6.2018 |
| 4.6.2018 | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 6.6.2018 |
| 4.6.2018 | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 6.6.2018 |
| 4.6.2018 | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 6.6.2018 |
| 4.6.2018 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 6.6.2018 |
| 4.6.2018 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 6.6.2018 |
| 7.6.2018 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 11.6.2018 |
| 7.6.2018 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 11.6.2018 |
| 7.6.2018 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 11.6.2018 |
| 7.6.2018 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 11.6.2018 |
| 7.6.2018 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 11.6.2018 |
| 7.6.2018 | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland | EU/1/12/801 | 11.6.2018 |
| 7.6.2018 | Dafiro | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 11.6.2018 |
| 7.6.2018 | Exforge HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 11.6.2018 |
| 7.6.2018 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 11.6.2018 |
| 7.6.2018 | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 11.6.2018 |
| 7.6.2018 | Isentress | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/436 | 11.6.2018 |
| 7.6.2018 | Pemetrexed Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | 11.6.2018 |
| 7.6.2018 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 11.6.2018 |
| 7.6.2018 | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 11.6.2018 |
| 7.6.2018 | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 11.6.2018 |
| 7.6.2018 | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 11.6.2018 |
| 7.6.2018 | Uptravi | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | 11.6.2018 |
| 7.6.2018 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 11.6.2018 |
| 7.6.2018 | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 11.6.2018 |
| 7.6.2018 | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 11.6.2018 |
| 7.6.2018 | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 11.6.2018 |
| 7.6.2018 | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 11.6.2018 |
| 7.6.2018 | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 11.6.2018 |
| 12.6.2018 | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 14.6.2018 |
| 12.6.2018 | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 14.6.2018 |
| 12.6.2018 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 14.6.2018 |
| 12.6.2018 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 14.6.2018 |
| 14.6.2018 | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 19.6.2018 |
| 14.6.2018 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/070 | 19.6.2018 |
| 14.6.2018 | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018 |
| 15.6.2018 | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 19.6.2018 |
| 15.6.2018 | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 19.6.2018 |
| 15.6.2018 | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 19.6.2018 |
| 15.6.2018 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 19.6.2018 |
| 15.6.2018 | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 19.6.2018 |
| 15.6.2018 | Zepatier | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1119 | 19.6.2018 |
| 15.6.2018 | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 19.6.2018 |
| 15.6.2018 | ZINPLAVA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1156 | 19.6.2018 |
| 21.6.2018 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 25.6.2018 |
| 21.6.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 25.6.2018 |
| 21.6.2018 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/10/637 | 25.6.2018 |
| 21.6.2018 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 25.6.2018 |
| 21.6.2018 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 25.6.2018 |
| 21.6.2018 | Rolufta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 25.6.2018 |
| 21.6.2018 | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 25.6.2018 |
| 21.6.2018 | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 25.6.2018 |
| 21.6.2018 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 25.6.2018 |
| 25.6.2018 | Copalia HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 27.6.2018 |
| 25.6.2018 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 27.6.2018 |
| 25.6.2018 | Dafiro HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 27.6.2018 |
| 25.6.2018 | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 27.6.2018 |
| 25.6.2018 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 27.6.2018 |
| 25.6.2018 | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 27.6.2018 |
| 25.6.2018 | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 27.6.2018 |
| 25.6.2018 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 27.6.2018 |
| 25.6.2018 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 27.6.2018 |
| 25.6.2018 | Orbactiv | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/15/989 | 27.6.2018 |
| 25.6.2018 | PANTOLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/519 | 27.6.2018 |
| 25.6.2018 | pantoprazole | | | 26.6.2018 |
| 25.6.2018 | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 27.6.2018 |
| 25.6.2018 | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 27.6.2018 |
| 25.6.2018 | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 27.6.2018 |
| 25.6.2018 | Yondelis | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 27.6.2018 |
| 29.6.2018 | Aerius | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/160 | 3.7.2018 |
| 29.6.2018 | Azomyr | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/157 | 3.7.2018 |
| 29.6.2018 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 3.7.2018 |
| 29.6.2018 | Efficib | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/457 | 3.7.2018 |
| 29.6.2018 | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 3.7.2018 |
| 29.6.2018 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 3.7.2018 |
| 29.6.2018 | Janumet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/455 | 3.7.2018 |
| 29.6.2018 | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 3.7.2018 |
| 29.6.2018 | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 3.7.2018 |
| 29.6.2018 | Orgalutran | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/130 | 3.7.2018 |
| 29.6.2018 | Revlimid | Celgene Europe B.V.
  Winthonlaan 6N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 3.7.2018 |
| 29.6.2018 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 3.7.2018 |
| 29.6.2018 | Ristfor | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/620 | 3.7.2018 |
| 29.6.2018 | Samsca | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/09/539 | 3.7.2018 |
| 29.6.2018 | Spectrila | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/15/1072 | 3.7.2018 |
| 29.6.2018 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 3.7.2018 |
| 29.6.2018 | Velmetia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/456 | 3.7.2018 |

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

4.6.2018

Copalia

Novartis Europharm Limited

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

EU/1/06/372

6.6.2018

4.6.2018

Emtriva

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/261

6.6.2018

4.6.2018

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

6.6.2018

4.6.2018

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

6.6.2018

4.6.2018

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

6.6.2018

4.6.2018

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

6.6.2018

4.6.2018

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

6.6.2018

4.6.2018

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

6.6.2018

4.6.2018

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

6.6.2018

7.6.2018

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

11.6.2018

7.6.2018

BeneFIX

Pfizer Limited

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

EU/1/97/047

11.6.2018

7.6.2018

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

11.6.2018

7.6.2018

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

11.6.2018

7.6.2018

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

11.6.2018

7.6.2018

Constella

Allergan Pharmaceuticals International Limited

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

EU/1/12/801

11.6.2018

7.6.2018

Dafiro

Novartis Europharm Limited

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

EU/1/06/371

11.6.2018

7.6.2018

Exforge HCT

Novartis Europharm Limited

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

EU/1/09/569

11.6.2018

7.6.2018

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

11.6.2018

7.6.2018

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

11.6.2018

7.6.2018

Isentress

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

11.6.2018

7.6.2018

Pemetrexed Accord

Accord Healthcare Limited

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

EU/1/15/1071

11.6.2018

7.6.2018

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

11.6.2018

7.6.2018

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

11.6.2018

7.6.2018

SomaKit TOC

Advanced Accelerator Applications

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

EU/1/16/1141

11.6.2018

7.6.2018

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

11.6.2018

7.6.2018

Uptravi

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/15/1083

11.6.2018

7.6.2018

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

11.6.2018

7.6.2018

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

11.6.2018

7.6.2018

Votubia

Novartis Europharm Limited

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

EU/1/11/710

11.6.2018

7.6.2018

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

11.6.2018

7.6.2018

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

11.6.2018

7.6.2018

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

11.6.2018

12.6.2018

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

14.6.2018

12.6.2018

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

14.6.2018

12.6.2018

Incruse

Glaxo Group Ltd

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

EU/1/14/922

14.6.2018

12.6.2018

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

14.6.2018

14.6.2018

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

19.6.2018

14.6.2018

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/070

19.6.2018

14.6.2018

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018

15.6.2018

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

19.6.2018

15.6.2018

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

19.6.2018

15.6.2018

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

19.6.2018

15.6.2018

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

19.6.2018

15.6.2018

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

19.6.2018

15.6.2018

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

19.6.2018

15.6.2018

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

19.6.2018

15.6.2018

ZINPLAVA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

19.6.2018

21.6.2018

Inflectra

Hospira UK Limited

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

EU/1/13/854

25.6.2018

21.6.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

25.6.2018

21.6.2018

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/10/637

25.6.2018

21.6.2018

Panretin

Eisai Limited

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

EU/1/00/149

25.6.2018

21.6.2018

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

25.6.2018

21.6.2018

Rolufta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

25.6.2018

21.6.2018

Targretin

Eisai Limited

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

EU/1/01/178

25.6.2018

21.6.2018

Xeljanz

Pfizer Limited

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

EU/1/17/1178

25.6.2018

21.6.2018

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

25.6.2018

25.6.2018

Copalia HCT

Novartis Europharm Limited

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

EU/1/09/575

27.6.2018

25.6.2018

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

27.6.2018

25.6.2018

Dafiro HCT

Novartis Europharm Limited

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

EU/1/09/574

27.6.2018

25.6.2018

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

27.6.2018

25.6.2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

27.6.2018

25.6.2018

Exforge

Novartis Europharm Limited

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

EU/1/06/370

27.6.2018

25.6.2018

Glivec

Novartis Europharm Limited

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

EU/1/01/198

27.6.2018

25.6.2018

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

27.6.2018

25.6.2018

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

27.6.2018

25.6.2018

Orbactiv

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/15/989

27.6.2018

25.6.2018

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

27.6.2018

25.6.2018

pantoprazole

26.6.2018

25.6.2018

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

27.6.2018

25.6.2018

Xeljanz

Pfizer Limited

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

EU/1/17/1178

27.6.2018

25.6.2018

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

27.6.2018

25.6.2018

Yondelis

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

27.6.2018

29.6.2018

Aerius

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/160

3.7.2018

29.6.2018

Azomyr

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/157

3.7.2018

29.6.2018

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

3.7.2018

29.6.2018

Efficib

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/457

3.7.2018

29.6.2018

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

3.7.2018

29.6.2018

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

3.7.2018

29.6.2018

Janumet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

3.7.2018

29.6.2018

Jinarc

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

3.7.2018

29.6.2018

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

3.7.2018

29.6.2018

Orgalutran

Merck Sharp & Dohme Limited

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

EU/1/00/130

3.7.2018

29.6.2018

Revlimid

Celgene Europe B.V.

Winthonlaan 6N, 3526 KV Utrecht, Nederland

EU/1/07/391

3.7.2018

29.6.2018

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

3.7.2018

29.6.2018

Ristfor

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

3.7.2018

29.6.2018

Samsca

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/09/539

3.7.2018

29.6.2018

Spectrila

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

3.7.2018

29.6.2018

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

3.7.2018

29.6.2018

Velmetia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

3.7.2018

| — | 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)

| 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 |
| --- | --- | --- | --- | --- |
| 15.6.2018 | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018 |
| 21.6.2018 | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 25.6.2018 |
| 29.6.2018 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 3.7.2018 |

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

15.6.2018

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018

21.6.2018

Angiox

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

25.6.2018

29.6.2018

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

3.7.2018

| — | 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

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.6.2018 | Dany's BienenWohl | oxalic acid dihydrate | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/18/225 | Powder and solution for bee-hive dispersion | QP53AG03 | 19.6.2018 |

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

14.6.2018

Dany's BienenWohl

oxalic acid dihydrate

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/18/225

Powder and solution for bee-hive dispersion

QP53AG03

19.6.2018

| — | 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

| 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 |
| --- | --- | --- | --- | --- |
| 4.6.2018 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 6.6.2018 |
| 4.6.2018 | Cepedex | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/16/200 | 6.6.2018 |
| 11.6.2018 | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 13.6.2018 |
| 14.6.2018 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 19.6.2018 |
| 18.6.2018 | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/109 | 20.6.2018 |
| 27.6.2018 | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/157 | 29.6.2018 |
| 27.6.2018 | Evalon | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/194 | 29.6.2018 |
| 27.6.2018 | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 29.6.2018 |

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

4.6.2018

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

6.6.2018

4.6.2018

Cepedex

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

6.6.2018

11.6.2018

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

13.6.2018

14.6.2018

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

19.6.2018

18.6.2018

Rhiniseng

Laboratorios Hipra, S.A.

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

EU/2/10/109

20.6.2018

27.6.2018

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/157

29.6.2018

27.6.2018

Evalon

Laboratorios Hipra, S.A.

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

EU/2/16/194

29.6.2018

27.6.2018

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

29.6.2018

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

---

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

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