# Úradný vestník C 188/1. j

| | ISSN 1977-1037 |
| --- | --- |
| Úradný vestník
  Európskej únie | C 188 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Ročník 611. júna 2018 |

ISSN 1977-1037

Úradný vestník

Európskej únie

C 188

Slovenské vydanie

Informácie a oznámenia

Ročník 611. júna 2018

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| Obsah | Strana |
| --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| | Európska komisia |
| 2018/C 188/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. apríla 2018 do 30. apríla 2018(Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004) | 1 |

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

2018/C 188/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. apríla 2018 do 30. apríla 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 | |
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SK

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IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

| 1.6.2018 | SK | Úradný vestník Európskej únie | C 188/1 |
| --- | --- | --- | --- |

1.6.2018

SK

Úradný vestník Európskej únie

C 188/1

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Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. apríla 2018 do 30. apríla 2018

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

(2018/C 188/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018 | Alpivab | peramivir | BioCryst UK Ltd.
  c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom | EU/1/18/1269 | Koncentrát na infúzny roztok | J05AH03 | 17.4.2018 |
| 19.4.2018 | Mylotarg | gemtuzumab ozogamicín | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1277 | Prášok na prípravu infúzneho koncentrátu | L01XC05 | 23.4.2018 |
| 23.4.2018 | Riarify | beklometazón/formoterol/glykopyróniumbromid | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1275 | inhalačný roztok v tlakovom obale | R03AL | 26.4.2018 |
| 26.4.2018 | Trydonis | beklometazón/formoterol/glykopyróniumbromid | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1274 | inhalačný roztok v tlakovom obale | R03AL | 2.5.2018 |

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

13.4.2018

Alpivab

peramivir

BioCryst UK Ltd.

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

EU/1/18/1269

Koncentrát na infúzny roztok

J05AH03

17.4.2018

19.4.2018

Mylotarg

gemtuzumab ozogamicín

Pfizer Limited

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

EU/1/18/1277

Prášok na prípravu infúzneho koncentrátu

L01XC05

23.4.2018

23.4.2018

Riarify

beklometazón/formoterol/glykopyróniumbromid

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

inhalačný roztok v tlakovom obale

R03AL

26.4.2018

26.4.2018

Trydonis

beklometazón/formoterol/glykopyróniumbromid

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

inhalačný roztok v tlakovom obale

R03AL

2.5.2018

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

—

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

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 6.4.2018 | EnCyzix | Renable Pharma Limited
  20-22 Bedford Row, London WC1R 4JS, United Kingdom | — | 23.4.2018 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

6.4.2018

EnCyzix

Renable Pharma Limited

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

—

23.4.2018

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

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

4.4.2018

Bondronat

Atnahs Pharma UK Limited

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

EU/1/96/012

6.4.2018

4.4.2018

Bonviva

Atnahs Pharma UK Limited

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

EU/1/03/265

6.4.2018

4.4.2018

Esbriet

Roche Registration GmbH

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

EU/1/11/667

6.4.2018

4.4.2018

Kinzalmono

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

6.4.2018

4.4.2018

Lacosamide Accord

Accord Healthcare Limited

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

EU/1/17/1230

6.4.2018

4.4.2018

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

6.4.2018

4.4.2018

Marixino

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/820

6.4.2018

4.4.2018

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

6.4.2018

4.4.2018

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

6.4.2018

6.4.2018

Fuzeon

Roche Registration GmbH

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

EU/1/03/252

10.4.2018

6.4.2018

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

10.4.2018

6.4.2018

Herceptin

Roche Registration GmbH

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

EU/1/00/145

10.4.2018

6.4.2018

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

10.4.2018

6.4.2018

Revolade

Novartis Europharm Limited

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

EU/1/10/612

10.4.2018

6.4.2018

RoActemra

Roche Registration GmbH

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

EU/1/08/492

10.4.2018

6.4.2018

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

10.4.2018

6.4.2018

Tarceva

Roche Registration GmbH

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

EU/1/05/311

10.4.2018

6.4.2018

Zelboraf

Roche Registration GmbH

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

EU/1/12/751

10.4.2018

12.4.2018

Actraphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/229

16.4.2018

12.4.2018

Actrapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/230

16.4.2018

12.4.2018

Azopt

Novartis Europharm Limited

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

EU/1/00/129

16.4.2018

12.4.2018

Extavia

Novartis Europharm Limited

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

EU/1/08/454

16.4.2018

12.4.2018

Farydak

Novartis Europharm Limited

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

EU/1/15/1023

16.4.2018

12.4.2018

Ferriprox

Apotex Europe B.V.

Darwinweg 20, 2333 CR Leiden, Nederland

EU/1/99/108

16.4.2018

12.4.2018

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/16/1160

16.4.2018

12.4.2018

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

16.4.2018

12.4.2018

Galafold

Amicus Therapeutics UK Ltd

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

EU/1/15/1082

16.4.2018

12.4.2018

Icandra

Novartis Europharm Limited

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

EU/1/08/484

16.4.2018

12.4.2018

Kinzalkomb

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

16.4.2018

12.4.2018

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

16.4.2018

12.4.2018

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

16.4.2018

12.4.2018

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

16.4.2018

12.4.2018

Neparvis

Novartis Europharm Limited

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

EU/1/16/1103

16.4.2018

12.4.2018

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

16.4.2018

12.4.2018

Ravicti

Horizon Pharma Ireland Limited

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

EU/1/15/1062

16.4.2018

12.4.2018

RoActemra

Roche Registration GmbH

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

EU/1/08/492

16.4.2018

12.4.2018

Sebivo

Novartis Europharm Limited

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

EU/1/07/388

16.4.2018

12.4.2018

Sialanar

Proveca Limited

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

EU/1/16/1135

17.4.2018

12.4.2018

Signifor

Novartis Europharm Limited

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

EU/1/12/753

16.4.2018

12.4.2018

Simulect

Novartis Europharm Limited

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

EU/1/98/084

16.4.2018

12.4.2018

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/928

16.4.2018

12.4.2018

Tadalafil Mylan

Generics [UK] Limited

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

EU/1/14/961

16.4.2018

12.4.2018

Vidaza

Celgene Europe Limited

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

EU/1/08/488

16.4.2018

12.4.2018

Zomarist

Novartis Europharm Limited

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

EU/1/08/483

16.4.2018

13.4.2018

Bretaris Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/781

17.4.2018

13.4.2018

Eklira Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/778

17.4.2018

13.4.2018

Memantine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/13/836

17.4.2018

13.4.2018

Pritor

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/089

17.4.2018

13.4.2018

PritorPlus

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

17.4.2018

13.4.2018

Sialanar

Proveca Limited

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

EU/1/16/1135

17.4.2018

13.4.2018

Travatan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/199

17.4.2018

19.4.2018

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

23.4.2018

19.4.2018

Azarga

Novartis Europharm Limited

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

EU/1/08/482

23.4.2018

19.4.2018

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

23.4.2018

19.4.2018

Comtan

Novartis Europharm Limited

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

EU/1/98/081

23.4.2018

19.4.2018

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

23.4.2018

19.4.2018

Descovy

Gilead Sciences International Limited

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

EU/1/16/1099

23.4.2018

19.4.2018

Exjade

Novartis Europharm Limited

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

EU/1/06/356

23.4.2018

19.4.2018

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

23.4.2018

19.4.2018

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/13/876

23.4.2018

19.4.2018

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

23.4.2018

19.4.2018

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

23.4.2018

19.4.2018

Natpar

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1078

23.4.2018

19.4.2018

Opatanol

Novartis Europharm Limited

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

EU/1/02/217

23.4.2018

19.4.2018

Peyona

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

23.4.2018

19.4.2018

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

23.4.2018

19.4.2018

Simbrinza

Novartis Europharm Limited

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

EU/1/14/933

23.4.2018

19.4.2018

Stribild

Gilead Sciences International Limited

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

EU/1/13/830

23.4.2018

19.4.2018

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

23.4.2018

19.4.2018

Sutent

Pfizer Limited

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

EU/1/06/347

23.4.2018

19.4.2018

Volibris

Glaxo Group Ltd

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

EU/1/08/451

23.4.2018

19.4.2018

Xadago

Zambon S.p.A.

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

EU/1/14/984

23.4.2018

19.4.2018

Yargesa

JensonR+ Limited

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

EU/1/17/1176

23.4.2018

23.4.2018

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

25.4.2018

23.4.2018

Bosulif

Pfizer Limited

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

EU/1/13/818

25.4.2018

23.4.2018

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

25.4.2018

23.4.2018

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

25.4.2018

23.4.2018

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

25.4.2018

23.4.2018

Emadine

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/095

25.4.2018

23.4.2018

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

25.4.2018

23.4.2018

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

25.4.2018

23.4.2018

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/066

25.4.2018

23.4.2018

Fycompa

Eisai Europe Limited

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

EU/1/12/776

25.4.2018

23.4.2018

GILENYA

Novartis Europharm Limited

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

EU/1/11/677

25.4.2018

23.4.2018

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

25.4.2018

23.4.2018

Hycamtin

Novartis Europharm Limited

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

EU/1/96/027

25.4.2018

23.4.2018

Imnovid

Celgene Europe Limited

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

EU/1/13/850

25.4.2018

23.4.2018

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

25.4.2018

23.4.2018

Lojuxta

Aegerion Pharmaceuticals Limited

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

EU/1/13/851

25.4.2018

23.4.2018

NeuroBloc

Eisai Limited

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

EU/1/00/166

25.4.2018

23.4.2018

Nevanac

Novartis Europharm Limited

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

EU/1/07/433

25.4.2018

23.4.2018

Onbrez Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/593

25.4.2018

23.4.2018

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

25.4.2018

23.4.2018

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

25.4.2018

23.4.2018

Spedra

Menarini International Operations Luxembourg S.A.

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

EU/1/13/841

25.4.2018

23.4.2018

TOBI Podhaler

Novartis Europharm Limited

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

EU/1/10/652

25.4.2018

23.4.2018

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200

25.4.2018

23.4.2018

Zydelig

Gilead Sciences International Limited

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

EU/1/14/938

25.4.2018

23.4.2018

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

25.4.2018

26.4.2018

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

30.4.2018

26.4.2018

Avonex

Biogen Idec Limited

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

EU/1/97/033

30.4.2018

26.4.2018

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

30.4.2018

26.4.2018

Elonva

Merck Sharp & Dohme Limited

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

EU/1/09/609

30.4.2018

26.4.2018

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, 10117 Berlin, Deutschland

EU/1/08/461

30.4.2018

26.4.2018

Galvus

Novartis Europharm Limited

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

EU/1/07/414

30.4.2018

26.4.2018

Jalra

Novartis Europharm Limited

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

EU/1/08/485

30.4.2018

26.4.2018

Lucentis

Novartis Europharm Limited

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

EU/1/06/374

30.4.2018

26.4.2018

Maviret

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/17/1213

30.4.2018

26.4.2018

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

30.4.2018

26.4.2018

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

2.5.2018

26.4.2018

Voncento

CSL Behring GmbH

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

EU/1/13/857

30.4.2018

26.4.2018

Xiliarx

Novartis Europharm Limited

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

EU/1/08/486

30.4.2018

26.4.2018

Xolair

Novartis Europharm Limited

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

EU/1/05/319

30.4.2018

26.4.2018

Zometa

Novartis Europharm Limited

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

EU/1/01/176

30.4.2018

30.4.2018

Avamys

Glaxo Group Ltd

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

EU/1/07/434

3.5.2018

30.4.2018

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

3.5.2018

30.4.2018

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

3.5.2018

30.4.2018

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

3.5.2018

30.4.2018

Perjeta

Roche Registration GmbH

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

EU/1/13/813

3.5.2018

30.4.2018

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

3.5.2018

30.4.2018

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

3.5.2018

30.4.2018

Rydapt

Novartis Europharm Limited

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

EU/1/17/1218

3.5.2018

| — | Udelenie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté |
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Udelenie povolenia na uvedenie na trh (článok 38 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018 | Clevor | Ropinirol | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/17/222 | Očná roztoková instilácia | QN04BC04 | 17.4.2018 |

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

13.4.2018

Clevor

Ropinirol

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

Očná roztoková instilácia

QN04BC04

17.4.2018

| — | Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004): Prijaté |
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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 |
| --- | --- | --- | --- | --- |
| 4.4.2018 | Convenia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/059 | 6.4.2018 |
| 4.4.2018 | Stronghold | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/99/014 | 6.4.2018 |
| 4.4.2018 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 6.4.2018 |
| 4.4.2018 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 6.4.2018 |
| 4.4.2018 | Zulvac 8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/105 | 6.4.2018 |
| 6.4.2018 | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 10.4.2018 |
| 6.4.2018 | Stronghold Plus | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/16/204 | 10.4.2018 |
| 11.4.2018 | Zulvac 8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/104 | 13.4.2018 |
| 13.4.2018 | Equip WNV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/086 | 17.4.2018 |
| 13.4.2018 | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 17.4.2018 |
| 16.4.2018 | BTVPUR | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/113 | 18.4.2018 |
| 16.4.2018 | Equilis West Nile | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/151 | 18.4.2018 |
| 20.4.2018 | Meloxidolor | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/13/148 | 24.4.2018 |
| 26.4.2018 | Naxcel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 30.4.2018 |
| 26.4.2018 | Onsior | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/08/089 | 30.4.2018 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

4.4.2018

Convenia

Zoetis Belgium S.A.

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

EU/2/06/059

6.4.2018

4.4.2018

Stronghold

Zoetis Belgium S.A.

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

EU/2/99/014

6.4.2018

4.4.2018

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

6.4.2018

4.4.2018

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

6.4.2018

4.4.2018

Zulvac 8 Bovis

Zoetis Belgium S.A.

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

EU/2/09/105

6.4.2018

6.4.2018

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

10.4.2018

6.4.2018

Stronghold Plus

Zoetis Belgium S.A.

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

EU/2/16/204

10.4.2018

11.4.2018

Zulvac 8 Ovis

Zoetis Belgium S.A.

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

EU/2/09/104

13.4.2018

13.4.2018

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

17.4.2018

13.4.2018

ProZinc

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

17.4.2018

16.4.2018

BTVPUR

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/113

18.4.2018

16.4.2018

Equilis West Nile

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/151

18.4.2018

20.4.2018

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

24.4.2018

26.4.2018

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

30.4.2018

26.4.2018

Onsior

Elanco Europe Ltd.

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

EU/2/08/089

30.4.2018

| — | Odňatie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (Es) č. 726/2004) |
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Odňatie povolenia na uvedenie na trh (článok 38 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 |
| --- | --- | --- | --- | --- |
| 26.4.2018 | CERTIFECT | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/11/125 | 30.4.2018 |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

26.4.2018

CERTIFECT

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/11/125

30.4.2018

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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