# C_2018390EN.01000101.xml

| 26.10.2018 | EN | Official Journal of the European Union | C 390/1 |
| --- | --- | --- | --- |

26.10.2018

EN

Official Journal of the European Union

C 390/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2018 to 30 September 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 390/01)

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

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Issuing of a marketing 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.9.2018 | Hulio | adalimumab | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1319 | Solution for injection | L04AB04 | 19.9.2018 |
| 17.9.2018 | Ilumetri | tildrakizumab | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/18/1323 | Solution for injection | L04AC17 | 19.9.2018 |
| 20.9.2018 | Braftovi | encorafenib | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1314 | Capsule, hard | Pending | 24.9.2018 |
| 20.9.2018 | Deferiprone Lipomed | Deferiprone | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | EU/1/18/1310 | Film-coated tablet | V03AC02 | 24.9.2018 |
| 20.9.2018 | Kigabeq | vigabatrin | ORPHELIA Pharma SAS
  85 boulevard Saint-Michel, 75005 Paris, France | EU/1/18/1302 | Soluble tablet | N03AG04 | 24.9.2018 |
| 20.9.2018 | Lenalidomide Accord | lenalidomide | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/18/1316 | Capsule, hard | L04AX04 | 24.9.2018 |
| 20.9.2018 | Mektovi | binimetinib | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1315 | Film-coated tablet | L01XE41 | 24.9.2018 |
| 20.9.2018 | Slenyto | melatonin | RAD Neurim Pharmaceuticals EEC Limited
  5th Floor, Thames Tower, Station Road, Reading, Berkshire RG1 1LX, United Kingdom | EU/1/18/1318 | Prolonged-release tablet | N05CH01 | 25.9.2018 |
| 20.9.2018 | Xerava | Eravacycline | Tetraphase Pharmaceuticals Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | EU/1/18/1312 | Powder for concentrate for solution for infusion | J01AA13 | 24.9.2018 |
| 21.9.2018 | Imfinzi | durvalumab | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1322 | Concentrate for solution for infusion | L01XC | 25.9.2018 |
| 21.9.2018 | Pelgraz | pegfilgrastim | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/18/1313 | Solution for injection in a pre-filled syringe | L03AA13 | 25.9.2018 |
| 21.9.2018 | Udenyca | pegfilgrastim | ERA Consulting GmbH
  Lange Straße 70, 29664 Walsrode, Deutschland | EU/1/18/1303 | Solution for injection | L03AA13 | 25.9.2018 |
| 27.9.2018 | Gefitinib Mylan | gefitinib | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1321 | Film-coated tablet | L01XE02 | 1.10.2018 |
| 27.9.2018 | Verzenios | abemaciclib | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/18/1307 | Film-coated tablet | L01XE50 | 1.10.2018 |

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

17.9.2018

Hulio

adalimumab

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1319

Solution for injection

L04AB04

19.9.2018

17.9.2018

Ilumetri

tildrakizumab

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/18/1323

Solution for injection

L04AC17

19.9.2018

20.9.2018

Braftovi

encorafenib

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1314

Capsule, hard

Pending

24.9.2018

20.9.2018

Deferiprone Lipomed

Deferiprone

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

Film-coated tablet

V03AC02

24.9.2018

20.9.2018

Kigabeq

vigabatrin

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/18/1302

Soluble tablet

N03AG04

24.9.2018

20.9.2018

Lenalidomide Accord

lenalidomide

Accord Healthcare Limited

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

EU/1/18/1316

Capsule, hard

L04AX04

24.9.2018

20.9.2018

Mektovi

binimetinib

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1315

Film-coated tablet

L01XE41

24.9.2018

20.9.2018

Slenyto

melatonin

RAD Neurim Pharmaceuticals EEC Limited

5th Floor, Thames Tower, Station Road, Reading, Berkshire RG1 1LX, United Kingdom

EU/1/18/1318

Prolonged-release tablet

N05CH01

25.9.2018

20.9.2018

Xerava

Eravacycline

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/18/1312

Powder for concentrate for solution for infusion

J01AA13

24.9.2018

21.9.2018

Imfinzi

durvalumab

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

Concentrate for solution for infusion

L01XC

25.9.2018

21.9.2018

Pelgraz

pegfilgrastim

Accord Healthcare Limited

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

EU/1/18/1313

Solution for injection in a pre-filled syringe

L03AA13

25.9.2018

21.9.2018

Udenyca

pegfilgrastim

ERA Consulting GmbH

Lange Straße 70, 29664 Walsrode, Deutschland

EU/1/18/1303

Solution for injection

L03AA13

25.9.2018

27.9.2018

Gefitinib Mylan

gefitinib

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1321

Film-coated tablet

L01XE02

1.10.2018

27.9.2018

Verzenios

abemaciclib

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1307

Film-coated tablet

L01XE50

1.10.2018

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

—

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.9.2018 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/884 | 6.9.2018 |
| 4.9.2018 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 6.9.2018 |
| 4.9.2018 | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 7.9.2018 |
| 6.9.2018 | Akynzeo | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | 10.9.2018 |
| 6.9.2018 | Alkindi | Diurnal Europe B.V.
  Jachthavenweg 109 H, 1081 KM Amsterdam, Nederland | EU/1/17/1260 | 10.9.2018 |
| 6.9.2018 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/431 | 10.9.2018 |
| 6.9.2018 | Silapo | STADA Arzneimittel AG
  Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | EU/1/07/432 | 10.9.2018 |
| 6.9.2018 | Venclyxto | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | 10.9.2018 |
| 10.9.2018 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 12.9.2018 |
| 10.9.2018 | Memantine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/13/827 | 19.9.2018 |
| 10.9.2018 | Pregabalin Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/997 | 19.9.2018 |
| 12.9.2018 | Tegsedi | Akcea Therapeutics UK Ltd
  Office 32, 19-21 Crawford Street, London, W1H 1PJ, United Kingdom | EU/1/18/1296 | 14.9.2018 |
| 17.9.2018 | CRYSVITA | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/17/1262 | 19.9.2018 |
| 17.9.2018 | Fortacin | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/13/881 | 19.9.2018 |
| 17.9.2018 | Inhixa | Techdow Europe AB
  Kåbovägen 32, 75236 Uppsala, Sverige | EU/1/16/1132 | 24.9.2018 |
| 17.9.2018 | Kadcyla | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/885 | 19.9.2018 |
| 17.9.2018 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 19.9.2018 |
| 17.9.2018 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 19.9.2018 |
| 17.9.2018 | Pregabalin Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/998 | 19.9.2018 |
| 17.9.2018 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 19.9.2018 |
| 17.9.2018 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 19.9.2018 |
| 17.9.2018 | Targretin | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/01/178 | 19.9.2018 |
| 20.9.2018 | Atazanavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1091 | 24.9.2018 |
| 20.9.2018 | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1205 | 24.9.2018 |
| 20.9.2018 | Cinqaero | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/16/1125 | 24.9.2018 |
| 20.9.2018 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 24.9.2018 |
| 20.9.2018 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 24.9.2018 |
| 20.9.2018 | Diacomit | Biocodex
  7 avenue Gallieni, 94250 Gentilly, France | EU/1/06/367 | 24.9.2018 |
| 20.9.2018 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 24.9.2018 |
| 20.9.2018 | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 24.9.2018 |
| 20.9.2018 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/07/402 | 24.9.2018 |
| 20.9.2018 | Kanuma | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1033 | 24.9.2018 |
| 20.9.2018 | Karvezide | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/085 | 24.9.2018 |
| 20.9.2018 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 24.9.2018 |
| 20.9.2018 | Neofordex | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/15/1053 | 24.9.2018 |
| 20.9.2018 | NeuroBloc | Sloan Pharma S.a.r.l.
  33 Rue de Puits Romain, 8070 Bertrange, Luxembourg | EU/1/00/166 | 24.9.2018 |
| 20.9.2018 | Nitisinone MDK | MendeliKABS Europe Limited
  The Light Box, 111 Power Rd, Unit G. 07, Chiswick, London, W4 5PY, United Kingdom | EU/1/17/1217 | 24.9.2018 |
| 20.9.2018 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 24.9.2018 |
| 20.9.2018 | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/165 | 24.9.2018 |
| 20.9.2018 | Rasilez | Noden Pharma DAC
  D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland | EU/1/07/405 | 24.9.2018 |
| 20.9.2018 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/09/521 | 24.9.2018 |
| 20.9.2018 | Rixathon | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1185 | 24.9.2018 |
| 20.9.2018 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/12/806 | 24.9.2018 |
| 20.9.2018 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/952 | 24.9.2018 |
| 20.9.2018 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 24.9.2018 |
| 20.9.2018 | Topotecan Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/10/633 | 24.9.2018 |
| 20.9.2018 | Tresiba | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/12/807 | 24.9.2018 |
| 20.9.2018 | Zoledronic acid Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/800 | 24.9.2018 |
| 21.9.2018 | Brilique | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/10/655 | 25.9.2018 |
| 21.9.2018 | Fycompa | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/12/776 | 25.9.2018 |
| 21.9.2018 | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/06/378 | 25.9.2018 |
| 21.9.2018 | Opsumit | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/893 | 25.9.2018 |
| 21.9.2018 | Tivicay | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/13/892 | 25.9.2018 |
| 21.9.2018 | Voriconazole Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 25.9.2018 |
| 21.9.2018 | Zonegran | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/04/307 | 25.9.2018 |
| 27.9.2018 | BeneFIX | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/97/047 | 1.10.2018 |
| 27.9.2018 | Ecalta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/416 | 1.10.2018 |
| 27.9.2018 | Prevenar 13 | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/09/590 | 1.10.2018 |
| 27.9.2018 | Trumenba | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1187 | 1.10.2018 |
| 27.9.2018 | Vimizim | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/14/914 | 1.10.2018 |
| 28.9.2018 | Celsentri | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/07/418 | 2.10.2018 |
| 28.9.2018 | CoAprovel | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/98/086 | 2.10.2018 |
| 28.9.2018 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/611 | 2.10.2018 |
| 28.9.2018 | Dynastat | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/02/209 | 2.10.2018 |
| 28.9.2018 | HALAVEN | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/11/678 | 2.10.2018 |
| 28.9.2018 | Imnovid | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/13/850 | 2.10.2018 |
| 28.9.2018 | Imraldi | Samsung Bioepis UK Limited
  5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom | EU/1/17/1216 | 2.10.2018 |
| 28.9.2018 | IntronA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/127 | 2.10.2018 |
| 28.9.2018 | Intuniv | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND | EU/1/15/1040 | 2.10.2018 |
| 28.9.2018 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 2.10.2018 |
| 28.9.2018 | Metalyse | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/00/169 | 2.10.2018 |
| 28.9.2018 | Nexium Control | Pfizer Healthcare Ireland
  9 Riverwalk National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20, Ireland | EU/1/13/860 | 2.10.2018 |
| 28.9.2018 | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | EU/1/12/803 | 2.10.2018 |
| 28.9.2018 | PegIntron | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/131 | 2.10.2018 |
| 28.9.2018 | Pemetrexed Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1183 | 2.10.2018 |
| 28.9.2018 | Rebetol | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/107 | 2.10.2018 |
| 28.9.2018 | Retacrit | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/07/431 | 2.10.2018 |
| 28.9.2018 | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1207 | 2.10.2018 |
| 28.9.2018 | Telzir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/04/282 | 2.10.2018 |
| 28.9.2018 | Trizivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/00/156 | 2.10.2018 |
| 28.9.2018 | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/15/1083 | 2.10.2018 |
| 28.9.2018 | Vfend | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/02/212 | 2.10.2018 |
| 28.9.2018 | Vimizim | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/14/914 | 2.10.2018 |
| 28.9.2018 | ViraferonPeg | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/132 | 2.10.2018 |
| 28.9.2018 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 2.10.2018 |
| 28.9.2018 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 2.10.2018 |
| 28.9.2018 | Zavesca | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/02/238 | 2.10.2018 |
| 28.9.2018 | Zoledronic acid Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/759 | 2.10.2018 |
| 28.9.2018 | Zoledronic acid Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/12/786 | 2.10.2018 |
| 28.9.2018 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/771 | 2.10.2018 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.9.2018

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

6.9.2018

4.9.2018

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

6.9.2018

4.9.2018

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

7.9.2018

6.9.2018

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

10.9.2018

6.9.2018

Alkindi

Diurnal Europe B.V.

Jachthavenweg 109 H, 1081 KM Amsterdam, Nederland

EU/1/17/1260

10.9.2018

6.9.2018

Retacrit

Pfizer Europe MA EEIG

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

EU/1/07/431

10.9.2018

6.9.2018

Silapo

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432

10.9.2018

6.9.2018

Venclyxto

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

10.9.2018

10.9.2018

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

12.9.2018

10.9.2018

Memantine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/13/827

19.9.2018

10.9.2018

Pregabalin Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/997

19.9.2018

12.9.2018

Tegsedi

Akcea Therapeutics UK Ltd

Office 32, 19-21 Crawford Street, London, W1H 1PJ, United Kingdom

EU/1/18/1296

14.9.2018

17.9.2018

CRYSVITA

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

19.9.2018

17.9.2018

Fortacin

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

19.9.2018

17.9.2018

Inhixa

Techdow Europe AB

Kåbovägen 32, 75236 Uppsala, Sverige

EU/1/16/1132

24.9.2018

17.9.2018

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

19.9.2018

17.9.2018

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

19.9.2018

17.9.2018

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

19.9.2018

17.9.2018

Pregabalin Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/998

19.9.2018

17.9.2018

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

19.9.2018

17.9.2018

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

19.9.2018

17.9.2018

Targretin

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/01/178

19.9.2018

20.9.2018

Atazanavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1091

24.9.2018

20.9.2018

Blitzima

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

24.9.2018

20.9.2018

Cinqaero

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1125

24.9.2018

20.9.2018

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

24.9.2018

20.9.2018

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

24.9.2018

20.9.2018

Diacomit

Biocodex

7 avenue Gallieni, 94250 Gentilly, France

EU/1/06/367

24.9.2018

20.9.2018

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

24.9.2018

20.9.2018

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

24.9.2018

20.9.2018

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402

24.9.2018

20.9.2018

Kanuma

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1033

24.9.2018

20.9.2018

Karvezide

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/085

24.9.2018

20.9.2018

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

24.9.2018

20.9.2018

Neofordex

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/15/1053

24.9.2018

20.9.2018

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

24.9.2018

20.9.2018

Nitisinone MDK

MendeliKABS Europe Limited

The Light Box, 111 Power Rd, Unit G. 07, Chiswick, London, W4 5PY, United Kingdom

EU/1/17/1217

24.9.2018

20.9.2018

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

24.9.2018

20.9.2018

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

24.9.2018

20.9.2018

Rasilez

Noden Pharma DAC

D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland

EU/1/07/405

24.9.2018

20.9.2018

Renvela

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/09/521

24.9.2018

20.9.2018

Rixathon

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

24.9.2018

20.9.2018

Ryzodeg

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/806

24.9.2018

20.9.2018

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/952

24.9.2018

20.9.2018

Tecfidera

Biogen Idec Limited

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

EU/1/13/837

24.9.2018

20.9.2018

Topotecan Hospira

Pfizer Europe MA EEIG

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

EU/1/10/633

24.9.2018

20.9.2018

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

24.9.2018

20.9.2018

Zoledronic acid Hospira

Pfizer Europe MA EEIG

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

EU/1/12/800

24.9.2018

21.9.2018

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

25.9.2018

21.9.2018

Fycompa

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/12/776

25.9.2018

21.9.2018

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/06/378

25.9.2018

21.9.2018

Opsumit

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/893

25.9.2018

21.9.2018

Tivicay

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/13/892

25.9.2018

21.9.2018

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

25.9.2018

21.9.2018

Zonegran

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/04/307

25.9.2018

27.9.2018

BeneFIX

Pfizer Europe MA EEIG

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

EU/1/97/047

1.10.2018

27.9.2018

Ecalta

Pfizer Europe MA EEIG

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

EU/1/07/416

1.10.2018

27.9.2018

Prevenar 13

Pfizer Europe MA EEIG

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

EU/1/09/590

1.10.2018

27.9.2018

Trumenba

Pfizer Europe MA EEIG

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

EU/1/17/1187

1.10.2018

27.9.2018

Vimizim

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/14/914

1.10.2018

28.9.2018

Celsentri

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/07/418

2.10.2018

28.9.2018

CoAprovel

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

2.10.2018

28.9.2018

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

2.10.2018

28.9.2018

Dynastat

Pfizer Europe MA EEIG

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

EU/1/02/209

2.10.2018

28.9.2018

HALAVEN

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/11/678

2.10.2018

28.9.2018

Imnovid

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/13/850

2.10.2018

28.9.2018

Imraldi

Samsung Bioepis UK Limited

5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom

EU/1/17/1216

2.10.2018

28.9.2018

IntronA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/127

2.10.2018

28.9.2018

Intuniv

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND

EU/1/15/1040

2.10.2018

28.9.2018

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

2.10.2018

28.9.2018

Metalyse

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/00/169

2.10.2018

28.9.2018

Nexium Control

Pfizer Healthcare Ireland

9 Riverwalk National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20, Ireland

EU/1/13/860

2.10.2018

28.9.2018

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

EU/1/12/803

2.10.2018

28.9.2018

PegIntron

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/131

2.10.2018

28.9.2018

Pemetrexed Pfizer

Pfizer Europe MA EEIG

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

EU/1/17/1183

2.10.2018

28.9.2018

Rebetol

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/107

2.10.2018

28.9.2018

Retacrit

Pfizer Europe MA EEIG

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

EU/1/07/431

2.10.2018

28.9.2018

Ritemvia

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1207

2.10.2018

28.9.2018

Telzir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/04/282

2.10.2018

28.9.2018

Trizivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/00/156

2.10.2018

28.9.2018

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

2.10.2018

28.9.2018

Vfend

Pfizer Europe MA EEIG

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

EU/1/02/212

2.10.2018

28.9.2018

Vimizim

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/14/914

2.10.2018

28.9.2018

ViraferonPeg

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/132

2.10.2018

28.9.2018

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

2.10.2018

28.9.2018

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

2.10.2018

28.9.2018

Zavesca

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/238

2.10.2018

28.9.2018

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/759

2.10.2018

28.9.2018

Zoledronic acid Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/12/786

2.10.2018

28.9.2018

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

2.10.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 27.9.2018 | IONSYS | Incline Therapeutics Europe Ltd
  21 St Thomas Street, Bristol BS1 6JS, United Kingdom | EU/1/15/1050 | 1.10.2018 |

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

27.9.2018

IONSYS

Incline Therapeutics Europe Ltd

21 St Thomas Street, Bristol BS1 6JS, United Kingdom

EU/1/15/1050

1.10.2018

| — | 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 |
| --- | --- | --- | --- | --- |
| 24.9.2018 | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/157 | 26.9.2018 |
| 24.9.2018 | Comfortis | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/10/115 | 26.9.2018 |
| 24.9.2018 | FORTEKOR PLUS | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/15/185 | 26.9.2018 |
| 24.9.2018 | Kexxtone | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/12/145 | 26.9.2018 |
| 24.9.2018 | Sileo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/15/181 | 26.9.2018 |
| 27.9.2018 | Credelio | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/17/206 | 1.10.2018 |
| 27.9.2018 | Ingelvac PCV FLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/17/208 | 1.10.2018 |
| 27.9.2018 | MS-H vaccine | Pharmsure Veterinary Products Europe Ltd
  4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland | EU/2/11/126 | 1.10.2018 |

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

24.9.2018

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/157

26.9.2018

24.9.2018

Comfortis

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

26.9.2018

24.9.2018

FORTEKOR PLUS

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/185

26.9.2018

24.9.2018

Kexxtone

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/12/145

26.9.2018

24.9.2018

Sileo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/15/181

26.9.2018

27.9.2018

Credelio

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

1.10.2018

27.9.2018

Ingelvac PCV FLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/17/208

1.10.2018

27.9.2018

MS-H vaccine

Pharmsure Veterinary Products Europe Ltd

4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland

EU/2/11/126

1.10.2018

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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