OJ:C_202403877: Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 mai 2024 până la 31 mai 2024 (Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului sau al Articolul 5 din Regulamentul (UE) 2019/6 al Parlamentului European și al Consiliului)

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

Celltrion Healthcare Hungary Kft.

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

Novo Nordisk A/S

Novo Alle 1, 2880 Bagsvaerd, Danmark

Novartis Europharm Limited

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

Outlook Therapeutics Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

BrePco Biopharma Ltd.

Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

THERAVIA

16 Rue Montrosier, 92200 Neuilly-sur-Seine, France

Celltrion Healthcare Hungary Kft.

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

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

VBI Vaccines B.V.

Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

Novartis Europharm Limited

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

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Novartis Europharm Limited

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

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Atnahs Pharma Netherlands B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark

Univar Solutions B.V.

Schouwburgplein 30, Rotterdam, 3012 CL, Nederland

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

Pfizer Europe MA EEIG

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

Bavarian Nordic A/S

Philip Heymans Allé 3, DK-2900 Hellerup, Danmark

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Bayer AG

D-51368 Leverkusen, Deutschland

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

Roche Registration GmbH

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

AstraZeneca AB

151 85 Södertälje, Sverige

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

Provepharm S.A.S.

22 rue Marc Donadille, 13013 Marseille, France

Juta Pharma GmbH

Gutenbergstr. 13, 24941, Flensburg, Deutschland

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Evolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

Pfizer Europe MA EEIG

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

Pfizer Europe MA EEIG

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

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí – Barcelona, España

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

AstraZeneca AB

151 85 Södertälje, Sverige

Taiho Pharma Netherlands B.V.

Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena, Italia

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Proveca Pharma Limited

2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

Novartis Europharm Limited

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

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

Roche Registration GmbH

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

AstraZeneca AB

151 85 Södertälje, Sverige

AstraZeneca AB

151 85 Södertälje, Sverige

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

Rayner Surgical (Ireland) Limited

The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Emdoka

John Lijsenstraat 16, 2321 Hoogstraten, België

Axience

Tour Essor, 14 Rue Scandicci, 93500 Pantin, France

Laboratorios Hipra, S.A.

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Laboratorios Hipra, S.A.

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

Laboratorios Hipra, S.A.

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

Zoetis Belgium

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

Elanco Animal Health GmbH

Alfred-Nobel-Str. 50, 40789 Monheim, Deutschland

Zoetis Belgium

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

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

CZ Vaccines S.A.U.

A Relva s/n – Torneiros 36410 O Porriño Pontevedra, España

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

Laboratorios Syva S.A

C/Marqués de la Ensenada16, 28004 Madrid, España

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

Pharmsure Veterinary Products Europe Limited

4 Fitzwilliam Terrace, Strand Road, Bray, WICKLOW A98 T6H6, Ireland

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland