# Official Journal C 188/1 Ju

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 188 |
| | |
| English edition | Information and Notices | Volume 611 June 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 188

English edition

Information and Notices

Volume 611 June 2018

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 188/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 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 188/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 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

| 1.6.2018 | EN | Official Journal of the European Union | C 188/1 |
| --- | --- | --- | --- |

1.6.2018

EN

Official Journal of the European Union

C 188/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 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 188/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018 | Alpivab | peramivir | BioCryst UK Ltd
  c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom | EU/1/18/1269 | Concentrate for solution for infusion | J05AH03 | 17.4.2018 |
| 19.4.2018 | Mylotarg | gemtuzumab ozogamicin | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1277 | Powder for concentrate for solution for infusion | L01XC05 | 23.4.2018 |
| 23.4.2018 | Riarify | beclometasone/formoterol/glycopyrronium bromide | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1275 | Pressurised inhalation, solution | R03AL | 26.4.2018 |
| 26.4.2018 | Trydonis | beclometasone/formoterol/glycopyrronium bromide | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1274 | Pressurised inhalation, solution | R03AL | 2.5.2018 |

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

13.4.2018

Alpivab

peramivir

BioCryst UK Ltd

c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom

EU/1/18/1269

Concentrate for solution for infusion

J05AH03

17.4.2018

19.4.2018

Mylotarg

gemtuzumab ozogamicin

Pfizer Limited

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

EU/1/18/1277

Powder for concentrate for solution for infusion

L01XC05

23.4.2018

23.4.2018

Riarify

beclometasone/formoterol/glycopyrronium bromide

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

Pressurised inhalation, solution

R03AL

26.4.2018

26.4.2018

Trydonis

beclometasone/formoterol/glycopyrronium bromide

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

Pressurised inhalation, solution

R03AL

2.5.2018

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

—

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

| 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 |
| --- | --- | --- | --- | --- |
| 6.4.2018 | EnCyzix | Renable Pharma Limited
  20-22 Bedford Row, London WC1R 4JS, United Kingdom | — | 23.4.2018 |

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

6.4.2018

EnCyzix

Renable Pharma Limited

20-22 Bedford Row, London WC1R 4JS, United Kingdom

—

23.4.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.4.2018 | Bondronat | Atnahs Pharma UK Limited
  Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom | EU/1/96/012 | 6.4.2018 |
| 4.4.2018 | Bonviva | Atnahs Pharma UK Limited
  Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom | EU/1/03/265 | 6.4.2018 |
| 4.4.2018 | Esbriet | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/11/667 | 6.4.2018 |
| 4.4.2018 | Kinzalmono | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/98/091 | 6.4.2018 |
| 4.4.2018 | Lacosamide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/17/1230 | 6.4.2018 |
| 4.4.2018 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 6.4.2018 |
| 4.4.2018 | Marixino | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/820 | 6.4.2018 |
| 4.4.2018 | Pandemic influenza vaccine H5N1 AstraZeneca | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1089 | 6.4.2018 |
| 4.4.2018 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 6.4.2018 |
| 6.4.2018 | Fuzeon | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/03/252 | 10.4.2018 |
| 6.4.2018 | Gazyvaro | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/14/937 | 10.4.2018 |
| 6.4.2018 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 10.4.2018 |
| 6.4.2018 | Kineret | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/02/203 | 10.4.2018 |
| 6.4.2018 | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 10.4.2018 |
| 6.4.2018 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 10.4.2018 |
| 6.4.2018 | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 10.4.2018 |
| 6.4.2018 | Tarceva | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/05/311 | 10.4.2018 |
| 6.4.2018 | Zelboraf | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/12/751 | 10.4.2018 |
| 12.4.2018 | Actraphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/02/229 | 16.4.2018 |
| 12.4.2018 | Actrapid | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/02/230 | 16.4.2018 |
| 12.4.2018 | Azopt | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/129 | 16.4.2018 |
| 12.4.2018 | Extavia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/454 | 16.4.2018 |
| 12.4.2018 | Farydak | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1023 | 16.4.2018 |
| 12.4.2018 | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, 2333 CR Leiden, Nederland | EU/1/99/108 | 16.4.2018 |
| 12.4.2018 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/16/1160 | 16.4.2018 |
| 12.4.2018 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 16.4.2018 |
| 12.4.2018 | Galafold | Amicus Therapeutics UK Ltd
  Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom | EU/1/15/1082 | 16.4.2018 |
| 12.4.2018 | Icandra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/484 | 16.4.2018 |
| 12.4.2018 | Kinzalkomb | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/02/214 | 16.4.2018 |
| 12.4.2018 | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 16.4.2018 |
| 12.4.2018 | Lumigan | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/02/205 | 16.4.2018 |
| 12.4.2018 | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 16.4.2018 |
| 12.4.2018 | Neparvis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/16/1103 | 16.4.2018 |
| 12.4.2018 | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 16.4.2018 |
| 12.4.2018 | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 16.4.2018 |
| 12.4.2018 | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 16.4.2018 |
| 12.4.2018 | Sebivo | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/388 | 16.4.2018 |
| 12.4.2018 | Sialanar | Proveca Limited
  Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom | EU/1/16/1135 | 17.4.2018 |
| 12.4.2018 | Signifor | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/753 | 16.4.2018 |
| 12.4.2018 | Simulect | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/084 | 16.4.2018 |
| 12.4.2018 | Sylvant | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/928 | 16.4.2018 |
| 12.4.2018 | Tadalafil Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | 16.4.2018 |
| 12.4.2018 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/488 | 16.4.2018 |
| 12.4.2018 | Zomarist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/483 | 16.4.2018 |
| 13.4.2018 | Bretaris Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/781 | 17.4.2018 |
| 13.4.2018 | Eklira Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/778 | 17.4.2018 |
| 13.4.2018 | Memantine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/13/836 | 17.4.2018 |
| 13.4.2018 | Pritor | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/98/089 | 17.4.2018 |
| 13.4.2018 | PritorPlus | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/02/215 | 17.4.2018 |
| 13.4.2018 | Sialanar | Proveca Limited
  Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom | EU/1/16/1135 | 17.4.2018 |
| 13.4.2018 | Travatan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/199 | 17.4.2018 |
| 19.4.2018 | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/308 | 23.4.2018 |
| 19.4.2018 | Azarga | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/482 | 23.4.2018 |
| 19.4.2018 | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 23.4.2018 |
| 19.4.2018 | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/081 | 23.4.2018 |
| 19.4.2018 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 23.4.2018 |
| 19.4.2018 | Descovy | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/16/1099 | 23.4.2018 |
| 19.4.2018 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 23.4.2018 |
| 19.4.2018 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 23.4.2018 |
| 19.4.2018 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/13/876 | 23.4.2018 |
| 19.4.2018 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 23.4.2018 |
| 19.4.2018 | Movymia | STADA Arzneimittel AG
  Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | EU/1/16/1161 | 23.4.2018 |
| 19.4.2018 | Natpar | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1078 | 23.4.2018 |
| 19.4.2018 | Opatanol | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/02/217 | 23.4.2018 |
| 19.4.2018 | Peyona | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/09/528 | 23.4.2018 |
| 19.4.2018 | Repatha | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1016 | 23.4.2018 |
| 19.4.2018 | Simbrinza | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/933 | 23.4.2018 |
| 19.4.2018 | Stribild | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/13/830 | 23.4.2018 |
| 19.4.2018 | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/16/1157 | 23.4.2018 |
| 19.4.2018 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 23.4.2018 |
| 19.4.2018 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 23.4.2018 |
| 19.4.2018 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 23.4.2018 |
| 19.4.2018 | Yargesa | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom | EU/1/17/1176 | 23.4.2018 |
| 23.4.2018 | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 25.4.2018 |
| 23.4.2018 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 25.4.2018 |
| 23.4.2018 | Daxas | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/10/636 | 25.4.2018 |
| 23.4.2018 | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/745 | 25.4.2018 |
| 23.4.2018 | Duloxetine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | 25.4.2018 |
| 23.4.2018 | Emadine | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/095 | 25.4.2018 |
| 23.4.2018 | Entresto | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1058 | 25.4.2018 |
| 23.4.2018 | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/425 | 25.4.2018 |
| 23.4.2018 | Exelon | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/066 | 25.4.2018 |
| 23.4.2018 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/12/776 | 25.4.2018 |
| 23.4.2018 | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/677 | 25.4.2018 |
| 23.4.2018 | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 25.4.2018 |
| 23.4.2018 | Hycamtin | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/96/027 | 25.4.2018 |
| 23.4.2018 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 25.4.2018 |
| 23.4.2018 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, 3490 Kvistgaard, Danmark | EU/1/13/855 | 25.4.2018 |
| 23.4.2018 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 25.4.2018 |
| 23.4.2018 | NeuroBloc | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/166 | 25.4.2018 |
| 23.4.2018 | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/433 | 25.4.2018 |
| 23.4.2018 | Onbrez Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/593 | 25.4.2018 |
| 23.4.2018 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 25.4.2018 |
| 23.4.2018 | Pregabalin Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1021 | 25.4.2018 |
| 23.4.2018 | Spedra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/13/841 | 25.4.2018 |
| 23.4.2018 | TOBI Podhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/652 | 25.4.2018 |
| 23.4.2018 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/01/200 | 25.4.2018 |
| 23.4.2018 | Zydelig | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/14/938 | 25.4.2018 |
| 23.4.2018 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 25.4.2018 |
| 26.4.2018 | Aloxi | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/04/306 | 30.4.2018 |
| 26.4.2018 | Avonex | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033 | 30.4.2018 |
| 26.4.2018 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 30.4.2018 |
| 26.4.2018 | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 30.4.2018 |
| 26.4.2018 | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, 10117 Berlin, Deutschland | EU/1/08/461 | 30.4.2018 |
| 26.4.2018 | Galvus | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/414 | 30.4.2018 |
| 26.4.2018 | Jalra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/485 | 30.4.2018 |
| 26.4.2018 | Lucentis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/374 | 30.4.2018 |
| 26.4.2018 | Maviret | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/17/1213 | 30.4.2018 |
| 26.4.2018 | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/422 | 30.4.2018 |
| 26.4.2018 | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/16/1167 | 2.5.2018 |
| 26.4.2018 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/13/857 | 30.4.2018 |
| 26.4.2018 | Xiliarx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/486 | 30.4.2018 |
| 26.4.2018 | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 30.4.2018 |
| 26.4.2018 | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/176 | 30.4.2018 |
| 30.4.2018 | Avamys | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/434 | 3.5.2018 |
| 30.4.2018 | Clopidogrel Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/08/465 | 3.5.2018 |
| 30.4.2018 | Entresto | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1058 | 3.5.2018 |
| 30.4.2018 | Hemlibra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/18/1271 | 3.5.2018 |
| 30.4.2018 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 3.5.2018 |
| 30.4.2018 | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 3.5.2018 |
| 30.4.2018 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 3.5.2018 |
| 30.4.2018 | Rydapt | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1218 | 3.5.2018 |

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

4.4.2018

Bondronat

Atnahs Pharma UK Limited

Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

EU/1/96/012

6.4.2018

4.4.2018

Bonviva

Atnahs Pharma UK Limited

Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

EU/1/03/265

6.4.2018

4.4.2018

Esbriet

Roche Registration GmbH

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

EU/1/11/667

6.4.2018

4.4.2018

Kinzalmono

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

6.4.2018

4.4.2018

Lacosamide Accord

Accord Healthcare Limited

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

EU/1/17/1230

6.4.2018

4.4.2018

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

6.4.2018

4.4.2018

Marixino

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/820

6.4.2018

4.4.2018

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

6.4.2018

4.4.2018

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

6.4.2018

6.4.2018

Fuzeon

Roche Registration GmbH

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

EU/1/03/252

10.4.2018

6.4.2018

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

10.4.2018

6.4.2018

Herceptin

Roche Registration GmbH

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

EU/1/00/145

10.4.2018

6.4.2018

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

10.4.2018

6.4.2018

Revolade

Novartis Europharm Limited

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

EU/1/10/612

10.4.2018

6.4.2018

RoActemra

Roche Registration GmbH

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

EU/1/08/492

10.4.2018

6.4.2018

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

10.4.2018

6.4.2018

Tarceva

Roche Registration GmbH

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

EU/1/05/311

10.4.2018

6.4.2018

Zelboraf

Roche Registration GmbH

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

EU/1/12/751

10.4.2018

12.4.2018

Actraphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/229

16.4.2018

12.4.2018

Actrapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/230

16.4.2018

12.4.2018

Azopt

Novartis Europharm Limited

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

EU/1/00/129

16.4.2018

12.4.2018

Extavia

Novartis Europharm Limited

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

EU/1/08/454

16.4.2018

12.4.2018

Farydak

Novartis Europharm Limited

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

EU/1/15/1023

16.4.2018

12.4.2018

Ferriprox

Apotex Europe B.V.

Darwinweg 20, 2333 CR Leiden, Nederland

EU/1/99/108

16.4.2018

12.4.2018

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/16/1160

16.4.2018

12.4.2018

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

16.4.2018

12.4.2018

Galafold

Amicus Therapeutics UK Ltd

Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom

EU/1/15/1082

16.4.2018

12.4.2018

Icandra

Novartis Europharm Limited

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

EU/1/08/484

16.4.2018

12.4.2018

Kinzalkomb

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

16.4.2018

12.4.2018

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

16.4.2018

12.4.2018

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

16.4.2018

12.4.2018

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

16.4.2018

12.4.2018

Neparvis

Novartis Europharm Limited

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

EU/1/16/1103

16.4.2018

12.4.2018

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

16.4.2018

12.4.2018

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

16.4.2018

12.4.2018

RoActemra

Roche Registration GmbH

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

EU/1/08/492

16.4.2018

12.4.2018

Sebivo

Novartis Europharm Limited

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

EU/1/07/388

16.4.2018

12.4.2018

Sialanar

Proveca Limited

Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom

EU/1/16/1135

17.4.2018

12.4.2018

Signifor

Novartis Europharm Limited

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

EU/1/12/753

16.4.2018

12.4.2018

Simulect

Novartis Europharm Limited

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

EU/1/98/084

16.4.2018

12.4.2018

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/928

16.4.2018

12.4.2018

Tadalafil Mylan

Generics [UK] Limited

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

EU/1/14/961

16.4.2018

12.4.2018

Vidaza

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/488

16.4.2018

12.4.2018

Zomarist

Novartis Europharm Limited

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

EU/1/08/483

16.4.2018

13.4.2018

Bretaris Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/781

17.4.2018

13.4.2018

Eklira Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/778

17.4.2018

13.4.2018

Memantine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/13/836

17.4.2018

13.4.2018

Pritor

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/089

17.4.2018

13.4.2018

PritorPlus

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

17.4.2018

13.4.2018

Sialanar

Proveca Limited

Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom

EU/1/16/1135

17.4.2018

13.4.2018

Travatan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/199

17.4.2018

19.4.2018

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

23.4.2018

19.4.2018

Azarga

Novartis Europharm Limited

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

EU/1/08/482

23.4.2018

19.4.2018

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

23.4.2018

19.4.2018

Comtan

Novartis Europharm Limited

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

EU/1/98/081

23.4.2018

19.4.2018

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

23.4.2018

19.4.2018

Descovy

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/16/1099

23.4.2018

19.4.2018

Exjade

Novartis Europharm Limited

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

EU/1/06/356

23.4.2018

19.4.2018

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

23.4.2018

19.4.2018

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/13/876

23.4.2018

19.4.2018

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

23.4.2018

19.4.2018

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

23.4.2018

19.4.2018

Natpar

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1078

23.4.2018

19.4.2018

Opatanol

Novartis Europharm Limited

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

EU/1/02/217

23.4.2018

19.4.2018

Peyona

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

23.4.2018

19.4.2018

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

23.4.2018

19.4.2018

Simbrinza

Novartis Europharm Limited

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

EU/1/14/933

23.4.2018

19.4.2018

Stribild

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/13/830

23.4.2018

19.4.2018

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

23.4.2018

19.4.2018

Sutent

Pfizer Limited

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

EU/1/06/347

23.4.2018

19.4.2018

Volibris

Glaxo Group Ltd

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

EU/1/08/451

23.4.2018

19.4.2018

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

23.4.2018

19.4.2018

Yargesa

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom

EU/1/17/1176

23.4.2018

23.4.2018

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

25.4.2018

23.4.2018

Bosulif

Pfizer Limited

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

EU/1/13/818

25.4.2018

23.4.2018

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

25.4.2018

23.4.2018

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

25.4.2018

23.4.2018

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

25.4.2018

23.4.2018

Emadine

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/095

25.4.2018

23.4.2018

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

25.4.2018

23.4.2018

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

25.4.2018

23.4.2018

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/066

25.4.2018

23.4.2018

Fycompa

Eisai Europe Limited

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

EU/1/12/776

25.4.2018

23.4.2018

GILENYA

Novartis Europharm Limited

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

EU/1/11/677

25.4.2018

23.4.2018

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

25.4.2018

23.4.2018

Hycamtin

Novartis Europharm Limited

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

EU/1/96/027

25.4.2018

23.4.2018

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

25.4.2018

23.4.2018

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

25.4.2018

23.4.2018

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

25.4.2018

23.4.2018

NeuroBloc

Eisai Limited

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

EU/1/00/166

25.4.2018

23.4.2018

Nevanac

Novartis Europharm Limited

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

EU/1/07/433

25.4.2018

23.4.2018

Onbrez Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/593

25.4.2018

23.4.2018

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

25.4.2018

23.4.2018

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

25.4.2018

23.4.2018

Spedra

Menarini International Operations Luxembourg S.A.

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

EU/1/13/841

25.4.2018

23.4.2018

TOBI Podhaler

Novartis Europharm Limited

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

EU/1/10/652

25.4.2018

23.4.2018

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200

25.4.2018

23.4.2018

Zydelig

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/14/938

25.4.2018

23.4.2018

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

25.4.2018

26.4.2018

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

30.4.2018

26.4.2018

Avonex

Biogen Idec Limited

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

EU/1/97/033

30.4.2018

26.4.2018

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

30.4.2018

26.4.2018

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

30.4.2018

26.4.2018

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, 10117 Berlin, Deutschland

EU/1/08/461

30.4.2018

26.4.2018

Galvus

Novartis Europharm Limited

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

EU/1/07/414

30.4.2018

26.4.2018

Jalra

Novartis Europharm Limited

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

EU/1/08/485

30.4.2018

26.4.2018

Lucentis

Novartis Europharm Limited

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

EU/1/06/374

30.4.2018

26.4.2018

Maviret

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/17/1213

30.4.2018

26.4.2018

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

30.4.2018

26.4.2018

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

2.5.2018

26.4.2018

Voncento

CSL Behring GmbH

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

EU/1/13/857

30.4.2018

26.4.2018

Xiliarx

Novartis Europharm Limited

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

EU/1/08/486

30.4.2018

26.4.2018

Xolair

Novartis Europharm Limited

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

EU/1/05/319

30.4.2018

26.4.2018

Zometa

Novartis Europharm Limited

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

EU/1/01/176

30.4.2018

30.4.2018

Avamys

Glaxo Group Ltd

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

EU/1/07/434

3.5.2018

30.4.2018

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

3.5.2018

30.4.2018

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

3.5.2018

30.4.2018

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

3.5.2018

30.4.2018

Perjeta

Roche Registration GmbH

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

EU/1/13/813

3.5.2018

30.4.2018

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

3.5.2018

30.4.2018

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

3.5.2018

30.4.2018

Rydapt

Novartis Europharm Limited

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

EU/1/17/1218

3.5.2018

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

—

Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018 | Clevor | Ropinirole | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/17/222 | Eye drops, solution | QN04BC04 | 17.4.2018 |

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

13.4.2018

Clevor

Ropinirole

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

Eye drops, solution

QN04BC04

17.4.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.4.2018 | Convenia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/059 | 6.4.2018 |
| 4.4.2018 | Stronghold | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/99/014 | 6.4.2018 |
| 4.4.2018 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 6.4.2018 |
| 4.4.2018 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 6.4.2018 |
| 4.4.2018 | Zulvac 8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/105 | 6.4.2018 |
| 6.4.2018 | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 10.4.2018 |
| 6.4.2018 | Stronghold Plus | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/16/204 | 10.4.2018 |
| 11.4.2018 | Zulvac 8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/104 | 13.4.2018 |
| 13.4.2018 | Equip WNV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/086 | 17.4.2018 |
| 13.4.2018 | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 17.4.2018 |
| 16.4.2018 | BTVPUR | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/113 | 18.4.2018 |
| 16.4.2018 | Equilis West Nile | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/151 | 18.4.2018 |
| 20.4.2018 | Meloxidolor | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/13/148 | 24.4.2018 |
| 26.4.2018 | Naxcel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 30.4.2018 |
| 26.4.2018 | Onsior | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/08/089 | 30.4.2018 |

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

4.4.2018

Convenia

Zoetis Belgium S.A.

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

EU/2/06/059

6.4.2018

4.4.2018

Stronghold

Zoetis Belgium S.A.

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

EU/2/99/014

6.4.2018

4.4.2018

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

6.4.2018

4.4.2018

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

6.4.2018

4.4.2018

Zulvac 8 Bovis

Zoetis Belgium S.A.

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

EU/2/09/105

6.4.2018

6.4.2018

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

10.4.2018

6.4.2018

Stronghold Plus

Zoetis Belgium S.A.

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

EU/2/16/204

10.4.2018

11.4.2018

Zulvac 8 Ovis

Zoetis Belgium S.A.

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

EU/2/09/104

13.4.2018

13.4.2018

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

17.4.2018

13.4.2018

ProZinc

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

17.4.2018

16.4.2018

BTVPUR

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/113

18.4.2018

16.4.2018

Equilis West Nile

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/151

18.4.2018

20.4.2018

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

24.4.2018

26.4.2018

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

30.4.2018

26.4.2018

Onsior

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/08/089

30.4.2018

| — | Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 38 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 |
| --- | --- | --- | --- | --- |
| 26.4.2018 | CERTIFECT | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/11/125 | 30.4.2018 |

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

26.4.2018

CERTIFECT

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/11/125

30.4.2018

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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