# Úradný vestník C 150/27.

| | ISSN 1977-1037 |
| --- | --- |
| Úradný vestník
  Európskej únie | C 150 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Ročník 6127. apríla 2018 |

ISSN 1977-1037

Úradný vestník

Európskej únie

C 150

Slovenské vydanie

Informácie a oznámenia

Ročník 6127. apríla 2018

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| Číslo oznamu | Obsah | Strana |
| --- | --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| | Európska komisia |
| 2018/C 150/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. marca 2018 do 31. marca 2018(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004) | 1 |

Číslo oznamu

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

2018/C 150/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. marca 2018 do 31. marca 2018(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004)

(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004)

1

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| SK | |
| --- | --- |

SK

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IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

| 27.4.2018 | SK | Úradný vestník Európskej únie | C 150/1 |
| --- | --- | --- | --- |

27.4.2018

SK

Úradný vestník Európskej únie

C 150/1

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Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. marca 2018 do 31. marca 2018

(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004 (1))

(2018/C 150/01)

| — | Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté |
| --- | --- |

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Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.3.2018 | Shingrix | Očkovacia látka proti pásovému oparu (rekombinantná, s adjuvantom) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | Prášok a suspenzia na injekčnú suspenziu | J07BK03 | 23.3.2018 |
| 21.3.2018 | Steglatro | ertugliflozín | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1267 | Filmom obalená tableta | A10BK04 | 23.3.2018 |
| 22.3.2018 | Lokelma | hydrát sodno-zirkoničitej soli kyseliny kremičitej | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | Prášok na perorálnu suspenziu | 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 | Injekčná suspenzia | L04 | 27.3.2018 |
| 23.3.2018 | Lamzede | velmanáza alfa | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1258 | Prášok na infúzny roztok | A16AB | 27.3.2018 |
| 23.3.2018 | Segluromet | ertugliflozín / metformíniumchlorid | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1265 | Filmom obalená tableta | A10BD23 | 27.3.2018 |
| 23.3.2018 | Semglee | Inzulín glargín | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1270 | Injekčný roztok v naplnenom pere | A10AE04 | 27.3.2018 |
| 23.3.2018 | Steglujan | ertugliflozín / sitagliptín | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1266 | Filmom obalená tableta | A10BD24 | 27.3.2018 |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

21.3.2018

Shingrix

Očkovacia látka proti pásovému oparu (rekombinantná, s adjuvantom)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

Prášok a suspenzia na injekčnú suspenziu

J07BK03

23.3.2018

21.3.2018

Steglatro

ertugliflozín

Merck Sharp & Dohme Limited

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

EU/1/18/1267

Filmom obalená tableta

A10BK04

23.3.2018

22.3.2018

Lokelma

hydrát sodno-zirkoničitej soli kyseliny kremičitej

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

Prášok na perorálnu suspenziu

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

Injekčná suspenzia

L04

27.3.2018

23.3.2018

Lamzede

velmanáza alfa

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

Prášok na infúzny roztok

A16AB

27.3.2018

23.3.2018

Segluromet

ertugliflozín / metformíniumchlorid

Merck Sharp & Dohme Limited

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

EU/1/18/1265

Filmom obalená tableta

A10BD23

27.3.2018

23.3.2018

Semglee

Inzulín glargín

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

Injekčný roztok v naplnenom pere

A10AE04

27.3.2018

23.3.2018

Steglujan

ertugliflozín / sitagliptín

Merck Sharp & Dohme Limited

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

EU/1/18/1266

Filmom obalená tableta

A10BD24

27.3.2018

| — | Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté |
| --- | --- |

—

Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 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 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

| — | Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004) |
| --- | --- |

—

Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 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 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

| — | Pozastavenie platnosti povolenia na uvedenie na trh (článok 20 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004) |
| --- | --- |

—

Pozastavenie platnosti povolenia na uvedenie na trh (článok 20 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 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 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

| — | Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté |
| --- | --- |

—

Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 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 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

Ak sa chcete oboznámiť s verejnou hodnotiacou správou o príslušných liekoch a s ňou súvisiacimi rozhodnutiami, môžete kontaktovať:

| 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)  Ú. v. EÚ L 136, 30.4.2004, s. 1.

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