Résumé des décisions de l'Union européenne relatives aux autorisations de mise sur le marché des médicaments du 1 mai 2026 au 31 mai 2026 [Publié en vertu de l'article 13 ou de l'article 38 du règlement (CE) no 726/2004 du Parlement européen et du Conseil ou de L’article 5 du règlement (UE) 2019/6 du Parlement européen et du Conseil]

Gan & Lee Pharmaceuticals Europe GmbH

Prinzenallee 11a, 40549 Düsseldorf, Deutschland

Pharming Technologies B.V.

Darwinweg 24, 2333 CR Leiden, Nederland

Ferring Pharmaceuticals A/S

Amager Strandvej 405, 2770 Kastrup, Danmark

Proveca Pharma Limited

2 Dublin Landings, North Wall Quay, Dublin 1, D01 V4A3, Ireland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

Mylan Pharmaceuticals Limited

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

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

Viatris Limited

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

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

AstraZeneca AB

151 85 Södertälje, Sverige

Eisai GmbH

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

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

Bayer AG

D-51368 Leverkusen, Deutschland

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

Prestige Biopharma Belgium BVBA

Terhulpensesteenweg 449, 3090 Overijse, België

Pfizer Europe MA EEIG

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

Accord Healthcare S.L.U.

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

Pfizer Europe MA EEIG

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

Novartis Europharm Limited

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

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

Immedica Pharma AB

SE-113 63, Stockholm, Sverige

Midas Pharma GmbH

Rheinstraße 49, D-55218 Ingelheim, Deutschland

Pfizer Europe MA EEIG

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

Eisai GmbH

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

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Roche Registration GmbH

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

Novartis Europharm Limited

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

Pfizer Europe MA EEIG

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

Novartis Europharm Limited

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

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Laboratoires Thea

12 Rue Louis Bleriot, 63100 Clermont-Ferrand, France

AstraZeneca AB

151 85 Södertälje, Sverige

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Geron Netherlands B.V.

La Guardiaweg 58, 1043 DJ Amsterdam, Nederland

CHEPLAPHARM Registration GmbH

Weiler Straße 5e, 79540 Lörrach, Deutschland

PTC Therapeutics International Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

Esteve Pharmaceuticals S.A.

Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

Italfarmaco S.p.A.

Viale F. Testi, 330, 20126 Milano, Italia

Accord Healthcare S.L.U.

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

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

Mylan Pharmaceuticals Limited

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

Eisai GmbH

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

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

Pfizer Europe MA EEIG

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Roche Registration GmbH

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

Taiho Pharma Netherlands B.V.

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

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland

Accord Healthcare S.L.U.

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

Pfizer Europe MA EEIG

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

Agios Netherlands B.V.

Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland

Pfizer Europe MA EEIG

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

Pfizer Europe MA EEIG

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

Viatris Limited

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

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

AstraZeneca AB

151 85 Södertälje, Sverige

Ipsen Pharma

70 rue Balard, 75015 Paris, France

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

Novartis Europharm Limited

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

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

Novartis Europharm Limited

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

Immunocore Ireland Limited

Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland

Roche Registration GmbH

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

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

CSL Behring GmbH

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

Takeda Pharmaceuticals International AG

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Co. Dublin, D02 HW68, Ireland

Accord Healthcare S.L.U.

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

Celltrion Healthcare Hungary Kft.

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

Novartis Europharm Limited

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

Galderma International

La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France

Bristol-Myers Squibb Pharma EEIG

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

Corza Medical GmbH

Speditionstraße 21, 40221 Düsseldorf, Deutschland

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

Viatris Limited

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

Novartis Europharm Limited

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

SIGA Technologies Netherlands B.V.

Prinsenhil 29, Breda 4825 AX, Nederland

Bayer AG

D-51368 Leverkusen, Deutschland

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

Pfizer Europe MA EEIG

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

Laboratorios Hipra, S.A.

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Ceva Santé Animale

8 rue de Logrono, 33500 Libourne, France