Résumé des décisions de l'Union européenne relatives aux autorisations de mise sur le marché des médicaments du 1 juillet 2025 au 31 juillet 2025 [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]

Purpose Pharma International AB

Grev Turegatan 13b 114 46 Stockholm, Sverige

Autolus GmbH

Im Schwarzenbach 4, 79576 Weil am Rhein, Deutchland

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

SpringWorks Therapeutics Ireland Limited

Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

Fresenius Kabi Deutschland GmbH

Else-Kroener-Strasse 1, 61352 Bad Homburg von der Hoehe, Deutschland

Viatris Limited

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

Roche Registration GmbH

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

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Recordati Rare Diseases

Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France

Neuraxpharm Pharmaceuticals, S.L.

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

AstraZeneca AB

151 85 Södertälje, Sverige

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

Novartis Europharm Limited

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Bristol Myers Squibb Pharma EEIG

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

ViiV Healthcare BV

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

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

AstraZeneca AB

151 85 Södertälje, Sverige

Eisai GmbH

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

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

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

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

BeOne Medicines Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

Almirall S.A.

Ronda General Mitre 151, 08022 Barcelona, España

SUBSTIPHARM

24 rue Erlanger, 75016 Paris, France

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

CSL Behring GmbH

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

GlaxoSmithKline Trading Services Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27, Ireland

Orexigen Therapeutics Ireland Limited

9-10 Fenian Street, Dublin 2, D02 RX24, Ireland

Bayer AG

D-51368 Leverkusen, Deutschland

Bristol Myers Squibb Pharma EEIG

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

Accord Healthcare S.L.U.

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

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

Accord Healthcare S.L.U.

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland

GlaxoSmithKline Trading Services Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

THERAVIA

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

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

Bayer AG

D-51368 Leverkusen, Deutschland

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

Ipsen Pharma

70 rue Balard, 75015 Paris, France

Leadiant GmbH

Liebherrstr. 22, 80538 Munich, Deutschland

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

Pacira Ireland Ltd

Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland

Takeda Pharmaceuticals International AG Ireland Branch

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

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27, Ireland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

Roche Registration GmbH

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

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

MODERNA BIOTECH SPAIN, S.L.

C/ Julián Camarillo no 31, 28037 Madrid, España

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

GlaxoSmithKline Trading Services Limited

12 River Walk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

AstraZeneca AB

151 85 Södertälje, Sverige

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

Laboratoire Aguettant

1 Rue Alexander Fleming, 69007 Lyon, France

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Roche Registration GmbH

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

Takeda Pharmaceuticals International AG Ireland Branch

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

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

Ipsen Pharma

70 rue Balard, 75015 Paris, France

Novartis Europharm Limited

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

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

Bristol-Myers Squibb Pharma EEIG

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

AstraZeneca AB

151 85 Södertälje, Sverige

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Elanco GmbH

Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Deutschland

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

FORTE Healthcare Ltd

Cougar Lane, Naul, Co. Dublin, Ireland

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

CZ Vaccines S.A.U.

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

EquiCord S.L.

103-D Loeches, Polígono Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Ecuphar NV

Legeweg 157-i, 8020 Oostkamp, België

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

AB Science S.A.

3 avenue George V, 75008 Paris, France

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

FORTE Healthcare Ltd

Cougar Lane, Naul, Co. Dublin, Ireland

Zoetis Belgium SA

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