# Jurnalul Oficial C 150/27 a

| | ISSN 1977-1029 |
| --- | --- |
| Jurnalul Oficial
  al Uniunii Europene | C 150 |
| | |
| Ediţia în limba română | Comunicări şi informări | Anul 6127 aprilie 2018 |

ISSN 1977-1029

Jurnalul Oficial

al Uniunii Europene

C 150

Ediţia în limba română

Comunicări şi informări

Anul 6127 aprilie 2018

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| Informarea nr. | Cuprins | Pagina |
| --- | --- | --- |
| | IV   Informări |
| | INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE |
| | Comisia Europeană |
| 2018/C 150/01 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 martie 2018 până la 31 martie 2018[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] | 1 |

Informarea nr.

Cuprins

Pagina

IV   Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

2018/C 150/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 martie 2018 până la 31 martie 2018[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

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| RO | |
| --- | --- |

RO

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IV Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

| 27.4.2018 | RO | Jurnalul Oficial al Uniunii Europene | C 150/1 |
| --- | --- | --- | --- |

27.4.2018

RO

Jurnalul Oficial al Uniunii Europene

C 150/1

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Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 martie 2018 până la 31 martie 2018

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]

(2018/C 150/01)

| — | Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.3.2018 | Shingrix | Vaccin herpes zoster (recombinant, cu adjuvant) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | Pulbere şi suspensie pentru suspensie injectabilă | J07BK03 | 23.3.2018 |
| 21.3.2018 | Steglatro | ertugliflozin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1267 | Comprimat filmat | A10BK04 | 23.3.2018 |
| 22.3.2018 | Lokelma | ciclosilicat de zirconiu sodic | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | Pulbere pentru suspensie orală | V03AE10 | 26.3.2018 |
| 23.3.2018 | Alofisel | Darvadstrocel | TiGenix S.A.U.
  C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España | EU/1/17/1261 | Suspension pentru injecţie | L04 | 27.3.2018 |
| 23.3.2018 | Lamzede | velmanază alfa | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1258 | Pulbere pentru soluţie perfuzabilă | A16AB | 27.3.2018 |
| 23.3.2018 | Segluromet | ertugliflozin / clorhidrat de metformin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1265 | Comprimat filmat | A10BD23 | 27.3.2018 |
| 23.3.2018 | Semglee | Insulină glargin | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1270 | Solutie pentru injecţie în stilou injector preumplut | A10AE04 | 27.3.2018 |
| 23.3.2018 | Steglujan | ertugliflozin / sitagliptin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1266 | Comprimat filmat | A10BD24 | 27.3.2018 |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

21.3.2018

Shingrix

Vaccin herpes zoster (recombinant, cu adjuvant)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

Pulbere şi suspensie pentru suspensie injectabilă

J07BK03

23.3.2018

21.3.2018

Steglatro

ertugliflozin

Merck Sharp & Dohme Limited

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

EU/1/18/1267

Comprimat filmat

A10BK04

23.3.2018

22.3.2018

Lokelma

ciclosilicat de zirconiu sodic

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

Pulbere pentru suspensie orală

V03AE10

26.3.2018

23.3.2018

Alofisel

Darvadstrocel

TiGenix S.A.U.

C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España

EU/1/17/1261

Suspension pentru injecţie

L04

27.3.2018

23.3.2018

Lamzede

velmanază alfa

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

Pulbere pentru soluţie perfuzabilă

A16AB

27.3.2018

23.3.2018

Segluromet

ertugliflozin / clorhidrat de metformin

Merck Sharp & Dohme Limited

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

EU/1/18/1265

Comprimat filmat

A10BD23

27.3.2018

23.3.2018

Semglee

Insulină glargin

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

Solutie pentru injecţie în stilou injector preumplut

A10AE04

27.3.2018

23.3.2018

Steglujan

ertugliflozin / sitagliptin

Merck Sharp & Dohme Limited

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

EU/1/18/1266

Comprimat filmat

A10BD24

27.3.2018

| — | Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 1.3.2018 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | EU/1/11/740 | 5.3.2018 |
| 1.3.2018 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 5.3.2018 |
| 1.3.2018 | Galvus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/414 | 5.3.2018 |
| 1.3.2018 | GONAL-f | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001 | 5.3.2018 |
| 1.3.2018 | IDELVION | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1095 | 5.3.2018 |
| 1.3.2018 | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 5.3.2018 |
| 1.3.2018 | Jalra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/485 | 5.3.2018 |
| 1.3.2018 | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 5.3.2018 |
| 1.3.2018 | Neparvis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | 5.3.2018 |
| 1.3.2018 | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 5.3.2018 |
| 1.3.2018 | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/672 | 5.3.2018 |
| 1.3.2018 | Xiliarx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/486 | 5.3.2018 |
| 5.3.2018 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 7.3.2018 |
| 5.3.2018 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 7.3.2018 |
| 5.3.2018 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 7.3.2018 |
| 5.3.2018 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 7.3.2018 |
| 5.3.2018 | Myclausen | Passauer Pharma GmbH
  Eiderstedter Weg 3, 14129 Berlin, Deutschland | EU/1/10/647 | 8.3.2018 |
| 5.3.2018 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 7.3.2018 |
| 5.3.2018 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 7.3.2018 |
| 5.3.2018 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 7.3.2018 |
| 5.3.2018 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/901 | 7.3.2018 |
| 5.3.2018 | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 7.3.2018 |
| 5.3.2018 | Viekirax | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/14/982 | 7.3.2018 |
| 5.3.2018 | Zydelig | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/14/938 | 7.3.2018 |
| 7.3.2018 | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 9.3.2018 |
| 7.3.2018 | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 9.3.2018 |
| 7.3.2018 | Kisplyx | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/16/1128 | 9.3.2018 |
| 7.3.2018 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/713 | 9.3.2018 |
| 7.3.2018 | Litak | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | EU/1/04/275 | 9.3.2018 |
| 7.3.2018 | Lonsurf | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/16/1096 | 9.3.2018 |
| 7.3.2018 | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 9.3.2018 |
| 7.3.2018 | PritorPlus | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/215 | 9.3.2018 |
| 7.3.2018 | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 9.3.2018 |
| 7.3.2018 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 9.3.2018 |
| 7.3.2018 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 9.3.2018 |
| 12.3.2018 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 14.3.2018 |
| 12.3.2018 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 14.3.2018 |
| 12.3.2018 | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | EU/1/14/913 | 14.3.2018 |
| 12.3.2018 | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/02/213 | 14.3.2018 |
| 12.3.2018 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 14.3.2018 |
| 12.3.2018 | Oprymea | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 15.3.2018 |
| 12.3.2018 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 14.3.2018 |
| 15.3.2018 | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 19.3.2018 |
| 15.3.2018 | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/848 | 19.3.2018 |
| 15.3.2018 | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 19.3.2018 |
| 15.3.2018 | NeoRecormon | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/97/031 | 19.3.2018 |
| 15.3.2018 | Pegasys | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/221 | 19.3.2018 |
| 15.3.2018 | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 19.3.2018 |
| 16.3.2018 | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1029 | 20.3.2018 |
| 16.3.2018 | Avastin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/04/300 | 20.3.2018 |
| 16.3.2018 | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 22.3.2018 |
| 16.3.2018 | Cotellic | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/15/1048 | 20.3.2018 |
| 16.3.2018 | Glyxambi | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/16/1146 | 20.3.2018 |
| 16.3.2018 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 20.3.2018 |
| 16.3.2018 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 20.3.2018 |
| 16.3.2018 | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 20.3.2018 |
| 16.3.2018 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 20.3.2018 |
| 16.3.2018 | Kadcyla | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/885 | 20.3.2018 |
| 16.3.2018 | Kinzalkomb | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214 | 20.3.2018 |
| 16.3.2018 | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 21.3.2018 |
| 16.3.2018 | Mircera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/07/400 | 20.3.2018 |
| 16.3.2018 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 21.3.2018 |
| 16.3.2018 | Vaniqa | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/01/173 | 20.3.2018 |
| 16.3.2018 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 20.3.2018 |
| 16.3.2018 | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/483 | 20.3.2018 |
| 19.3.2018 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 21.3.2018 |
| 20.3.2018 | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 22.3.2018 |
| 21.3.2018 | Aripiprazole Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | 23.3.2018 |
| 21.3.2018 | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 23.3.2018 |
| 21.3.2018 | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 23.3.2018 |
| 21.3.2018 | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 23.3.2018 |
| 21.3.2018 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 23.3.2018 |
| 21.3.2018 | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 23.3.2018 |
| 23.3.2018 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 27.3.2018 |
| 23.3.2018 | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 27.3.2018 |
| 23.3.2018 | Feraccru | Shield TX (UK) Limited
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | 27.3.2018 |
| 23.3.2018 | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 27.3.2018 |
| 23.3.2018 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 27.3.2018 |
| 23.3.2018 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 27.3.2018 |
| 23.3.2018 | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 27.3.2018 |
| 23.3.2018 | Ocrevus | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1231 | 27.3.2018 |
| 23.3.2018 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 27.3.2018 |
| 23.3.2018 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 27.3.2018 |
| 23.3.2018 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 27.3.2018 |
| 23.3.2018 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 27.3.2018 |
| 23.3.2018 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 27.3.2018 |
| 27.3.2018 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 29.3.2018 |
| 27.3.2018 | Ganfort | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 29.3.2018 |
| 27.3.2018 | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 29.3.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

1.3.2018

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

5.3.2018

1.3.2018

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

5.3.2018

1.3.2018

Galvus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/414

5.3.2018

1.3.2018

GONAL-f

Merck Serono Europe Limited

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

EU/1/95/001

5.3.2018

1.3.2018

IDELVION

CSL Behring GmbH

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

EU/1/16/1095

5.3.2018

1.3.2018

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

5.3.2018

1.3.2018

Jalra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/485

5.3.2018

1.3.2018

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

5.3.2018

1.3.2018

Neparvis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

5.3.2018

1.3.2018

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

5.3.2018

1.3.2018

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

5.3.2018

1.3.2018

Xiliarx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/486

5.3.2018

5.3.2018

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

7.3.2018

5.3.2018

CellCept

Roche Registration Limited

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

EU/1/96/005

7.3.2018

5.3.2018

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

7.3.2018

5.3.2018

Hizentra

CSL Behring GmbH

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

EU/1/11/687

7.3.2018

5.3.2018

Myclausen

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

8.3.2018

5.3.2018

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

7.3.2018

5.3.2018

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

7.3.2018

5.3.2018

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

7.3.2018

5.3.2018

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

7.3.2018

5.3.2018

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

7.3.2018

5.3.2018

Viekirax

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/14/982

7.3.2018

5.3.2018

Zydelig

Gilead Sciences International Limited

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

EU/1/14/938

7.3.2018

7.3.2018

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

9.3.2018

7.3.2018

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

9.3.2018

7.3.2018

Kisplyx

Eisai Europe Limited

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

EU/1/16/1128

9.3.2018

7.3.2018

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

9.3.2018

7.3.2018

Litak

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/04/275

9.3.2018

7.3.2018

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

9.3.2018

7.3.2018

Pregabalin Pfizer

Pfizer Limited

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

EU/1/14/916

9.3.2018

7.3.2018

PritorPlus

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

9.3.2018

7.3.2018

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland

EU/1/14/985

9.3.2018

7.3.2018

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

9.3.2018

7.3.2018

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

9.3.2018

12.3.2018

CellCept

Roche Registration Limited

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

EU/1/96/005

14.3.2018

12.3.2018

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

14.3.2018

12.3.2018

Latuda

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

14.3.2018

12.3.2018

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213

14.3.2018

12.3.2018

Neuraceq

Piramal Imaging Limited

Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom

EU/1/13/906

14.3.2018

12.3.2018

Oprymea

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

15.3.2018

12.3.2018

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

14.3.2018

15.3.2018

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

19.3.2018

15.3.2018

Erivedge

Roche Registration GmbH

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

EU/1/13/848

19.3.2018

15.3.2018

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

19.3.2018

15.3.2018

NeoRecormon

Roche Registration GmbH

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

EU/1/97/031

19.3.2018

15.3.2018

Pegasys

Roche Registration GmbH

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

EU/1/02/221

19.3.2018

15.3.2018

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

19.3.2018

16.3.2018

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

20.3.2018

16.3.2018

Avastin

Roche Registration GmbH

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

EU/1/04/300

20.3.2018

16.3.2018

Cetrotide

Merck Serono Europe Limited

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

EU/1/99/100

22.3.2018

16.3.2018

Cotellic

Roche Registration GmbH

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

EU/1/15/1048

20.3.2018

16.3.2018

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

20.3.2018

16.3.2018

Herceptin

Roche Registration GmbH

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

EU/1/00/145

20.3.2018

16.3.2018

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

20.3.2018

16.3.2018

Integrilin

Glaxo Group Ltd

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

EU/1/99/109

20.3.2018

16.3.2018

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

20.3.2018

16.3.2018

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

20.3.2018

16.3.2018

Kinzalkomb

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

20.3.2018

16.3.2018

Mabthera

Roche Registration GmbH

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

EU/1/98/067

21.3.2018

16.3.2018

Mircera

Roche Registration GmbH

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

EU/1/07/400

20.3.2018

16.3.2018

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

21.3.2018

16.3.2018

Vaniqa

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173

20.3.2018

16.3.2018

Xeloda

Roche Registration GmbH

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

EU/1/00/163

20.3.2018

16.3.2018

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/483

20.3.2018

19.3.2018

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

21.3.2018

20.3.2018

Invirase

Roche Registration Limited

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

EU/1/96/026

22.3.2018

21.3.2018

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

23.3.2018

21.3.2018

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

23.3.2018

21.3.2018

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

23.3.2018

21.3.2018

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

23.3.2018

21.3.2018

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

23.3.2018

21.3.2018

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

23.3.2018

23.3.2018

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

27.3.2018

23.3.2018

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

27.3.2018

23.3.2018

Feraccru

Shield TX (UK) Limited

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

27.3.2018

23.3.2018

Invirase

Roche Registration Limited

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

EU/1/96/026

27.3.2018

23.3.2018

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

27.3.2018

23.3.2018

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

27.3.2018

23.3.2018

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

27.3.2018

23.3.2018

Ocrevus

Roche Registration GmbH

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

EU/1/17/1231

27.3.2018

23.3.2018

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

27.3.2018

23.3.2018

Perjeta

Roche Registration GmbH

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

EU/1/13/813

27.3.2018

23.3.2018

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

27.3.2018

23.3.2018

Torisel

Pfizer Limited

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

EU/1/07/424

27.3.2018

23.3.2018

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

27.3.2018

27.3.2018

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

29.3.2018

27.3.2018

Ganfort

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

29.3.2018

27.3.2018

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

29.3.2018

| — | Retragerea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului) |
| --- | --- |

—

Retragerea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului)

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 5.3.2018 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 7.3.2018 |
| 19.3.2018 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 21.3.2018 |
| 23.3.2018 | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 27.3.2018 |
| 27.3.2018 | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 29.3.2018 |
| 27.3.2018 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 29.3.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

5.3.2018

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

7.3.2018

19.3.2018

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

21.3.2018

23.3.2018

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

27.3.2018

27.3.2018

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland

EU/1/14/985

29.3.2018

27.3.2018

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

29.3.2018

| — | Suspendarea unei autorizații de introducere pe piață [articolul 20 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] |
| --- | --- |

—

Suspendarea unei autorizații de introducere pe piață [articolul 20 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 8.3.2018 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 12.3.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

8.3.2018

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

12.3.2018

| — | Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
| --- | --- |

—

Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 19.3.2018 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/158 | 21.3.2018 |
| 19.3.2018 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 21.3.2018 |
| 19.3.2018 | Porcilis PCV ID | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/187 | 21.3.2018 |
| 20.3.2018 | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 22.3.2018 |
| 20.3.2018 | Oncept IL-2 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/150 | 22.3.2018 |
| 20.3.2018 | Panacur AquaSol | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/135 | 22.3.2018 |
| 22.3.2018 | Draxxin | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 26.3.2018 |
| 22.3.2018 | ERAVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/199 | 26.3.2018 |
| 22.3.2018 | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 26.3.2018 |
| 22.3.2018 | Suvaxyn CSF Marker | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/179 | 26.3.2018 |
| 22.3.2018 | Suvaxyn PCV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 26.3.2018 |
| 27.3.2018 | Versican Plus DHPPi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 29.3.2018 |
| 27.3.2018 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 29.3.2018 |
| 27.3.2018 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 29.3.2018 |
| 27.3.2018 | Zulvac 1+8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 29.3.2018 |
| 27.3.2018 | Zulvac 1+8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 29.3.2018 |
| 27.3.2018 | Zulvac SBV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/178 | 29.3.2018 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

19.3.2018

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

21.3.2018

19.3.2018

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

21.3.2018

19.3.2018

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

21.3.2018

20.3.2018

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/13/149

22.3.2018

20.3.2018

Oncept IL-2

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/150

22.3.2018

20.3.2018

Panacur AquaSol

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/135

22.3.2018

22.3.2018

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

26.3.2018

22.3.2018

ERAVAC

Laboratorios Hipra, S.A.

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

EU/2/16/199

26.3.2018

22.3.2018

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

26.3.2018

22.3.2018

Suvaxyn CSF Marker

Zoetis Belgium S.A.

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

EU/2/14/179

26.3.2018

22.3.2018

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

26.3.2018

27.3.2018

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

29.3.2018

27.3.2018

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

29.3.2018

27.3.2018

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

29.3.2018

27.3.2018

Zulvac 1+8 Bovis

Zoetis Belgium S.A.

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

EU/2/12/139

29.3.2018

27.3.2018

Zulvac 1+8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

29.3.2018

27.3.2018

Zulvac SBV

Zoetis Belgium S.A.

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

EU/2/14/178

29.3.2018

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

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

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