# Official Journal C 309/31 A

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 309 |
| | |
| English edition | Information and Notices | Volume 6131 August 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 309

English edition

Information and Notices

Volume 6131 August 2018

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 309/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2018 to 31 July 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 309/01

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

| 31.8.2018 | EN | Official Journal of the European Union | C 309/1 |
| --- | --- | --- | --- |

31.8.2018

EN

Official Journal of the European Union

C 309/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2018 to 31 July 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 309/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.7.2018 | Tegsedi | inotersen | IONIS USA Limited
  Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom | EU/1/18/1296 | Solution for injection | Pending | 10.7.2018 |
| 6.7.2018 | Verkazia | ciclosporin | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | Eye drops, emulsion | S01XA18 | 10.7.2018 |
| 26.7.2018 | Aimovig | erenumab | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | Solution for injection | N02C | 30.7.2018 |
| 26.7.2018 | Halimatoz | adalimumab | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | Solution for injection | L04AB04 | 30.7.2018 |
| 26.7.2018 | Hefiya | adalimumab | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | Solution for injection | L04AB04 | 30.7.2018 |
| 26.7.2018 | Hyrimoz | adalimumab | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | Solution for injection | L04AB04 | 30.7.2018 |
| 26.7.2018 | Nityr | nitisinone | Cycle Pharmaceuticals Ltd
  Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom | EU/1/18/1290 | Tablet | A16AX04 | 30.7.2018 |
| 26.7.2018 | RXULTI | brexpiprazole | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/18/1294 | Film-coated tablet | N05AX16 | 30.7.2018 |
| 26.7.2018 | Trazimera | trastuzumab | Pfizer Europe MA EEIG
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1295 | Powder for concentrate for solution for infusion | L01XC03 | 30.7.2018 |
| 30.7.2018 | Myalepta | metreleptin | Aegerion Pharmaceuticals B.V.
  Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/18/1276 | Powder for solution for injection | A16AA07 | 1.8.2018 |

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

6.7.2018

Tegsedi

inotersen

IONIS USA Limited

Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom

EU/1/18/1296

Solution for injection

Pending

10.7.2018

6.7.2018

Verkazia

ciclosporin

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

Eye drops, emulsion

S01XA18

10.7.2018

26.7.2018

Aimovig

erenumab

Novartis Europharm Limited

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

EU/1/18/1293

Solution for injection

N02C

30.7.2018

26.7.2018

Halimatoz

adalimumab

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

Solution for injection

L04AB04

30.7.2018

26.7.2018

Hefiya

adalimumab

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

Solution for injection

L04AB04

30.7.2018

26.7.2018

Hyrimoz

adalimumab

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

Solution for injection

L04AB04

30.7.2018

26.7.2018

Nityr

nitisinone

Cycle Pharmaceuticals Ltd

Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom

EU/1/18/1290

Tablet

A16AX04

30.7.2018

26.7.2018

RXULTI

brexpiprazole

Otsuka Pharmaceutical Europe Ltd

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

EU/1/18/1294

Film-coated tablet

N05AX16

30.7.2018

26.7.2018

Trazimera

trastuzumab

Pfizer Europe MA EEIG

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

EU/1/18/1295

Powder for concentrate for solution for infusion

L01XC03

30.7.2018

30.7.2018

Myalepta

metreleptin

Aegerion Pharmaceuticals B.V.

Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

EU/1/18/1276

Powder for solution for injection

A16AA07

1.8.2018

| — | 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

| 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 |
| --- | --- | --- | --- | --- |
| 17.7.2018 | Aplidin | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | — | 19.7.2018 |
| 26.7.2018 | Alsitek | AB Science
  3 avenue George V, 75008 Paris, France | — | 30.7.2018 |

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

17.7.2018

Aplidin

Pharma Mar S.A.

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

—

19.7.2018

26.7.2018

Alsitek

AB Science

3 avenue George V, 75008 Paris, France

—

30.7.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 2.7.2018 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 4.7.2018 |
| 2.7.2018 | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/515 | 4.7.2018 |
| 2.7.2018 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 4.7.2018 |
| 2.7.2018 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 4.7.2018 |
| 2.7.2018 | Enurev Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/789 | 4.7.2018 |
| 2.7.2018 | Ifirmacombi | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 4.7.2018 |
| 2.7.2018 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 4.7.2018 |
| 2.7.2018 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 4.7.2018 |
| 2.7.2018 | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/517 | 4.7.2018 |
| 2.7.2018 | Prialt | RIEMSER Pharma GmbH
  An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland | EU/1/04/302 | 4.7.2018 |
| 2.7.2018 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 4.7.2018 |
| 2.7.2018 | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/516 | 4.7.2018 |
| 2.7.2018 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 4.7.2018 |
| 2.7.2018 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 4.7.2018 |
| 2.7.2018 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 3.7.2018 |
| 2.7.2018 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 4.7.2018 |
| 6.7.2018 | Adrovance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/06/364 | 10.7.2018 |
| 6.7.2018 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 10.7.2018 |
| 6.7.2018 | Ammonaps | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/99/120 | 10.7.2018 |
| 6.7.2018 | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 10.7.2018 |
| 6.7.2018 | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 10.7.2018 |
| 6.7.2018 | Fertavid | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/510 | 10.7.2018 |
| 6.7.2018 | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 10.7.2018 |
| 6.7.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 10.7.2018 |
| 6.7.2018 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 10.7.2018 |
| 6.7.2018 | Noxafil | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/320 | 10.7.2018 |
| 6.7.2018 | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/16/1115 | 10.7.2018 |
| 6.7.2018 | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1037 | 10.7.2018 |
| 6.7.2018 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 10.7.2018 |
| 6.7.2018 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 10.7.2018 |
| 6.7.2018 | Puregon | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/96/008 | 10.7.2018 |
| 6.7.2018 | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 10.7.2018 |
| 6.7.2018 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 10.7.2018 |
| 6.7.2018 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 10.7.2018 |
| 6.7.2018 | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 10.7.2018 |
| 6.7.2018 | Temozolomide HEXAL | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/10/616 | 10.7.2018 |
| 6.7.2018 | Temozolomide Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/10/617 | 10.7.2018 |
| 6.7.2018 | Visudyne | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/140 | 10.7.2018 |
| 6.7.2018 | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 10.7.2018 |
| 9.7.2018 | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 11.7.2018 |
| 9.7.2018 | Fosavance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/310 | 11.7.2018 |
| 9.7.2018 | MAVENCLAD | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1212 | 11.7.2018 |
| 9.7.2018 | Pylobactell | Torbet Laboratories Limited
  Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom | EU/1/98/064 | 11.7.2018 |
| 9.7.2018 | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 11.7.2018 |
| 9.7.2018 | Seebri Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/788 | 11.7.2018 |
| 9.7.2018 | Tovanor Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/790 | 11.7.2018 |
| 9.7.2018 | Vantavo | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/572 | 11.7.2018 |
| 9.7.2018 | Zavesca | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 11.7.2018 |
| 11.7.2018 | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 13.7.2018 |
| 11.7.2018 | Byetta | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/06/362 | 13.7.2018 |
| 11.7.2018 | Erelzi | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1195 | 13.7.2018 |
| 11.7.2018 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 13.7.2018 |
| 11.7.2018 | Vizamyl | GE Healthcare Ltd
  Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom | EU/1/14/941 | 13.7.2018 |
| 11.7.2018 | Xagrid | Shire Pharmaceutical Contracts Limited
  1 Kingdom Street, London W2 6BD, United Kingdom | EU/1/04/295 | 13.7.2018 |
| 13.7.2018 | Firdapse | BioMarin Europe Ltd
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 17.7.2018 |
| 13.7.2018 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/97/049 | 17.7.2018 |
| 13.7.2018 | Naglazyme | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork P43 R298, Ireland | EU/1/05/324 | 17.7.2018 |
| 13.7.2018 | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063 | 17.7.2018 |
| 19.7.2018 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/11/733 | 23.7.2018 |
| 19.7.2018 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/06/376 | 23.7.2018 |
| 19.7.2018 | Lopinavir/Ritonavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1067 | 23.7.2018 |
| 19.7.2018 | Optruma | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/98/074 | 23.7.2018 |
| 19.7.2018 | PecFent | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/10/644 | 23.7.2018 |
| 19.7.2018 | Plegridy | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/14/934 | 23.7.2018 |
| 19.7.2018 | Qarziba | EUSA Pharma (UK) Limited
  Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom | EU/1/17/1191 | 23.7.2018 |
| 19.7.2018 | Rituzena | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1206 | 23.7.2018 |
| 19.7.2018 | SANCUSO | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/12/766 | 23.7.2018 |
| 19.7.2018 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 23.7.2018 |
| 23.7.2018 | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/13/909 | 25.7.2018 |
| 23.7.2018 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 25.7.2018 |
| 23.7.2018 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 25.7.2018 |
| 23.7.2018 | Ivemend | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/437 | 25.7.2018 |
| 23.7.2018 | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 25.7.2018 |
| 23.7.2018 | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 25.7.2018 |
| 23.7.2018 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 25.7.2018 |
| 23.7.2018 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 25.7.2018 |
| 23.7.2018 | Ultibro Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/862 | 25.7.2018 |
| 23.7.2018 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 25.7.2018 |
| 23.7.2018 | Viread | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/01/200 | 25.7.2018 |
| 23.7.2018 | Xoterna Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/863 | 25.7.2018 |
| 26.7.2018 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 30.7.2018 |
| 26.7.2018 | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 30.7.2018 |
| 26.7.2018 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 30.7.2018 |
| 26.7.2018 | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 30.7.2018 |
| 26.7.2018 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 30.7.2018 |
| 26.7.2018 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/884 | 30.7.2018 |
| 26.7.2018 | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 30.7.2018 |
| 26.7.2018 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 30.7.2018 |
| 26.7.2018 | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 30.7.2018 |
| 26.7.2018 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 30.7.2018 |
| 26.7.2018 | Procysbi | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/13/861 | 30.7.2018 |
| 26.7.2018 | Rasagiline ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | 30.7.2018 |
| 26.7.2018 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 30.7.2018 |
| 26.7.2018 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 30.7.2018 |
| 26.7.2018 | Segluromet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1265 | 30.7.2018 |
| 26.7.2018 | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 30.7.2018 |
| 26.7.2018 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 30.7.2018 |
| 26.7.2018 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 30.7.2018 |
| 30.7.2018 | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 1.8.2018 |
| 30.7.2018 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/97/046 | 1.8.2018 |
| 30.7.2018 | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 1.8.2018 |
| 30.7.2018 | Bridion | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/466 | 1.8.2018 |
| 30.7.2018 | Champix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/06/360 | 1.8.2018 |
| 30.7.2018 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Bruxelles, Belgique /Louizalaan 480, 1050 Brussel, België | EU/1/07/420 | 1.8.2018 |
| 30.7.2018 | Enbrel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/99/126 | 1.8.2018 |
| 30.7.2018 | Eylea | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/12/797 | 1.8.2018 |
| 30.7.2018 | Grastofil | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/13/877 | 1.8.2018 |
| 30.7.2018 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/11/678 | 1.8.2018 |
| 30.7.2018 | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1147 | 1.8.2018 |
| 30.7.2018 | Ilaris | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/564 | 1.8.2018 |
| 30.7.2018 | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 1.8.2018 |
| 30.7.2018 | Inflectra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/854 | 1.8.2018 |
| 30.7.2018 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 1.8.2018 |
| 30.7.2018 | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/04/279 | 1.8.2018 |
| 30.7.2018 | Mylotarg | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/18/1277 | 1.8.2018 |
| 30.7.2018 | Nimenrix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/767 | 1.8.2018 |
| 30.7.2018 | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 1.8.2018 |
| 30.7.2018 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 1.8.2018 |
| 30.7.2018 | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 1.8.2018 |
| 30.7.2018 | Revatio | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/05/318 | 1.8.2018 |
| 30.7.2018 | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 1.8.2018 |
| 30.7.2018 | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 1.8.2018 |
| 30.7.2018 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 1.8.2018 |
| 30.7.2018 | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 1.8.2018 |
| 30.7.2018 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 1.8.2018 |
| 30.7.2018 | Toviaz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/386 | 1.8.2018 |
| 30.7.2018 | Tygacil | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/06/336 | 1.8.2018 |
| 30.7.2018 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 1.8.2018 |
| 30.7.2018 | Ucedane | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/17/1202 | 1.8.2018 |
| 30.7.2018 | Viagra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/98/077 | 1.8.2018 |
| 30.7.2018 | Vidaza | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/488 | 1.8.2018 |

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

2.7.2018

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

4.7.2018

2.7.2018

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

4.7.2018

2.7.2018

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

4.7.2018

2.7.2018

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

4.7.2018

2.7.2018

Enurev Breezhaler

Novartis Europharm Limited

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

EU/1/12/789

4.7.2018

2.7.2018

Ifirmacombi

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

4.7.2018

2.7.2018

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

4.7.2018

2.7.2018

Mysimba

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

4.7.2018

2.7.2018

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

4.7.2018

2.7.2018

Prialt

RIEMSER Pharma GmbH

An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland

EU/1/04/302

4.7.2018

2.7.2018

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

4.7.2018

2.7.2018

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

4.7.2018

2.7.2018

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

4.7.2018

2.7.2018

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

4.7.2018

2.7.2018

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

3.7.2018

2.7.2018

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

4.7.2018

6.7.2018

Adrovance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/364

10.7.2018

6.7.2018

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

10.7.2018

6.7.2018

Ammonaps

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/99/120

10.7.2018

6.7.2018

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

10.7.2018

6.7.2018

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

10.7.2018

6.7.2018

Fertavid

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/510

10.7.2018

6.7.2018

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

10.7.2018

6.7.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

10.7.2018

6.7.2018

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

10.7.2018

6.7.2018

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

10.7.2018

6.7.2018

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

10.7.2018

6.7.2018

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

10.7.2018

6.7.2018

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

10.7.2018

6.7.2018

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

10.7.2018

6.7.2018

Puregon

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/96/008

10.7.2018

6.7.2018

Revolade

Novartis Europharm Limited

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

EU/1/10/612

10.7.2018

6.7.2018

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

10.7.2018

6.7.2018

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

10.7.2018

6.7.2018

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

10.7.2018

6.7.2018

Temozolomide HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

10.7.2018

6.7.2018

Temozolomide Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

10.7.2018

6.7.2018

Visudyne

Novartis Europharm Limited

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

EU/1/00/140

10.7.2018

6.7.2018

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

10.7.2018

9.7.2018

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

11.7.2018

9.7.2018

Fosavance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/310

11.7.2018

9.7.2018

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

11.7.2018

9.7.2018

Pylobactell

Torbet Laboratories Limited

Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom

EU/1/98/064

11.7.2018

9.7.2018

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

11.7.2018

9.7.2018

Seebri Breezhaler

Novartis Europharm Limited

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

EU/1/12/788

11.7.2018

9.7.2018

Tovanor Breezhaler

Novartis Europharm Limited

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

EU/1/12/790

11.7.2018

9.7.2018

Vantavo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/572

11.7.2018

9.7.2018

Zavesca

Actelion Registration Ltd

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

EU/1/02/238

11.7.2018

11.7.2018

Briviact

UCB Pharma S.A.

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

EU/1/15/1073

13.7.2018

11.7.2018

Byetta

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/06/362

13.7.2018

11.7.2018

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

13.7.2018

11.7.2018

Imnovid

Celgene Europe Limited

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

EU/1/13/850

13.7.2018

11.7.2018

Vizamyl

GE Healthcare Ltd

Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom

EU/1/14/941

13.7.2018

11.7.2018

Xagrid

Shire Pharmaceutical Contracts Limited

1 Kingdom Street, London W2 6BD, United Kingdom

EU/1/04/295

13.7.2018

13.7.2018

Firdapse

BioMarin Europe Ltd

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

17.7.2018

13.7.2018

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

17.7.2018

13.7.2018

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

17.7.2018

13.7.2018

Rebif

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063

17.7.2018

19.7.2018

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/11/733

23.7.2018

19.7.2018

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/06/376

23.7.2018

19.7.2018

Lopinavir/Ritonavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1067

23.7.2018

19.7.2018

Optruma

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

23.7.2018

19.7.2018

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

23.7.2018

19.7.2018

Plegridy

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

23.7.2018

19.7.2018

Qarziba

EUSA Pharma (UK) Limited

Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom

EU/1/17/1191

23.7.2018

19.7.2018

Rituzena

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1206

23.7.2018

19.7.2018

SANCUSO

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/12/766

23.7.2018

19.7.2018

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

23.7.2018

23.7.2018

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/13/909

25.7.2018

23.7.2018

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

25.7.2018

23.7.2018

Exjade

Novartis Europharm Limited

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

EU/1/06/356

25.7.2018

23.7.2018

Ivemend

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/437

25.7.2018

23.7.2018

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

25.7.2018

23.7.2018

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

25.7.2018

23.7.2018

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

25.7.2018

23.7.2018

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

25.7.2018

23.7.2018

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

25.7.2018

23.7.2018

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

25.7.2018

23.7.2018

Viread

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

25.7.2018

23.7.2018

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

25.7.2018

26.7.2018

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

30.7.2018

26.7.2018

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

30.7.2018

26.7.2018

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

30.7.2018

26.7.2018

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

30.7.2018

26.7.2018

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

30.7.2018

26.7.2018

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

30.7.2018

26.7.2018

Jinarc

Otsuka Pharmaceutical Europe Ltd

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

EU/1/15/1000

30.7.2018

26.7.2018

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

30.7.2018

26.7.2018

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

30.7.2018

26.7.2018

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

30.7.2018

26.7.2018

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

30.7.2018

26.7.2018

Rasagiline ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

30.7.2018

26.7.2018

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

30.7.2018

26.7.2018

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

30.7.2018

26.7.2018

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

30.7.2018

26.7.2018

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

30.7.2018

26.7.2018

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

30.7.2018

26.7.2018

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

30.7.2018

30.7.2018

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

1.8.2018

30.7.2018

Aprovel

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

1.8.2018

30.7.2018

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

1.8.2018

30.7.2018

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

1.8.2018

30.7.2018

Champix

Pfizer Europe MA EEIG

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

EU/1/06/360

1.8.2018

30.7.2018

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique /Louizalaan 480, 1050 Brussel, België

EU/1/07/420

1.8.2018

30.7.2018

Enbrel

Pfizer Europe MA EEIG

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

EU/1/99/126

1.8.2018

30.7.2018

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

1.8.2018

30.7.2018

Grastofil

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/13/877

1.8.2018

30.7.2018

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

1.8.2018

30.7.2018

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

1.8.2018

30.7.2018

Ilaris

Novartis Europharm Limited

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

EU/1/09/564

1.8.2018

30.7.2018

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

1.8.2018

30.7.2018

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

1.8.2018

30.7.2018

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

1.8.2018

30.7.2018

Lyrica

Pfizer Europe MA EEIG

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

EU/1/04/279

1.8.2018

30.7.2018

Mylotarg

Pfizer Europe MA EEIG

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

EU/1/18/1277

1.8.2018

30.7.2018

Nimenrix

Pfizer Europe MA EEIG

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

EU/1/12/767

1.8.2018

30.7.2018

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

1.8.2018

30.7.2018

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

1.8.2018

30.7.2018

Pregabalin Pfizer

Pfizer Europe MA EEIG

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

EU/1/14/916

1.8.2018

30.7.2018

Revatio

Pfizer Europe MA EEIG

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

EU/1/05/318

1.8.2018

30.7.2018

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

1.8.2018

30.7.2018

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

1.8.2018

30.7.2018

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

1.8.2018

30.7.2018

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

1.8.2018

30.7.2018

Thalidomide Celgene

Celgene Europe Limited

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

EU/1/08/443

1.8.2018

30.7.2018

Toviaz

Pfizer Europe MA EEIG

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

EU/1/07/386

1.8.2018

30.7.2018

Tygacil

Pfizer Europe MA EEIG

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

EU/1/06/336

1.8.2018

30.7.2018

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

1.8.2018

30.7.2018

Ucedane

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/17/1202

1.8.2018

30.7.2018

Viagra

Pfizer Europe MA EEIG

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

EU/1/98/077

1.8.2018

30.7.2018

Vidaza

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

1.8.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 6.7.2018 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 10.7.2018 |
| 9.7.2018 | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 11.7.2018 |
| 19.7.2018 | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 23.7.2018 |

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

6.7.2018

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

10.7.2018

9.7.2018

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

11.7.2018

19.7.2018

Trobalt

Glaxo Group Ltd

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

EU/1/11/681

23.7.2018

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 26.7.2018 | UBAC | Streptococcus uberis vaccine (inactivated) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/18/227 | Emulsion for injection | QI02AB | 30.7.2018 |

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

26.7.2018

UBAC

Streptococcus uberis vaccine (inactivated)

Laboratorios Hipra, S.A.

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

EU/2/18/227

Emulsion for injection

QI02AB

30.7.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 2.7.2018 | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/167 | 4.7.2018 |
| 2.7.2018 | Zolvix | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/09/101 | 4.7.2018 |
| 5.7.2018 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 9.7.2018 |
| 9.7.2018 | Coliprotec F4/F18 | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | 11.7.2018 |
| 9.7.2018 | Credelio | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/17/206 | 11.7.2018 |
| 9.7.2018 | ERYSENG | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/166 | 11.7.2018 |
| 9.7.2018 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/114 | 11.7.2018 |
| 9.7.2018 | Trocoxil | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/084 | 11.7.2018 |
| 10.7.2018 | Econor | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/010 | 12.7.2018 |
| 12.7.2018 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 16.7.2018 |
| 13.7.2018 | Reconcile | Nexcyon Pharmaceuticals Ltd
  First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom | EU/2/08/080 | 16.7.2018 |
| 23.7.2018 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/143 | 25.7.2018 |
| 23.7.2018 | Respiporc Flu3 | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/09/103 | 25.7.2018 |
| 26.7.2018 | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 30.7.2018 |

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

2.7.2018

ERYSENG PARVO

Laboratorios Hipra, S.A.

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

EU/2/14/167

4.7.2018

2.7.2018

Zolvix

Elanco Europe Ltd

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

EU/2/09/101

4.7.2018

5.7.2018

Pexion

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/147

9.7.2018

9.7.2018

Coliprotec F4/F18

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

11.7.2018

9.7.2018

Credelio

Elanco Europe Ltd

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

EU/2/17/206

11.7.2018

9.7.2018

ERYSENG

Laboratorios Hipra, S.A.

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

EU/2/14/166

11.7.2018

9.7.2018

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

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

EU/2/10/114

11.7.2018

9.7.2018

Trocoxil

Zoetis Belgium S.A.

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

EU/2/08/084

11.7.2018

10.7.2018

Econor

Elanco Europe Ltd

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

EU/2/98/010

12.7.2018

12.7.2018

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

16.7.2018

13.7.2018

Reconcile

Nexcyon Pharmaceuticals Ltd

First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom

EU/2/08/080

16.7.2018

23.7.2018

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

25.7.2018

23.7.2018

Respiporc Flu3

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/09/103

25.7.2018

26.7.2018

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

30.7.2018

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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