Résumé des décisions de l'Union européenne relatives aux autorisations de mise sur le marché des médicaments du 1 juin 2024 au 30 juin 2024 (Publié en vertu de l'article 13 ou de l'article 38 du règlement (CE) n° 726/2004 du Parlement européen et du Conseil ou de L’article 5 du règlement (UE) 2019/6 du Parlement européen et du Conseil)

AstraZeneca AB

151 85 Södertälje, Sverige

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

AstraZeneca AB

151 85 Södertälje, Sverige

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

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

PIERRE FABRE MEDICAMENT

Les Cauquillous, 81500 Lavaur, France

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

Roche Registration GmbH

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

AstraZeneca AB

151 85 Södertälje, Sverige

Navidea Biopharmaceuticals Europe Ltd.

Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

Mylan Pharmaceuticals Limited

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

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

Vifor Fresenius Medical Care Renal Pharma France

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

AMMTeK

8 rue campagne première, 75014 Paris, France

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

CSL Behring GmbH

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

Mylan Pharmaceuticals Limited

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

Mylan Pharmaceuticals Limited

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

Acorda Therapeutics Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Mylan Pharmaceuticals Limited

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

Mylan Pharmaceuticals Limited

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

AstraZeneca AB

151 85 Södertälje, Sverige

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

Mylan Pharmaceuticals Limited

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

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

Pfizer Europe MA EEIG

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

Phoenix Labs Unlimited Company

Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland

Bristol-Myers Squibb Pharma EEIG

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

Mylan Ireland Limited

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

Accord Healthcare S.L.U.

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Novartis Ireland Limited

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

Mirum Pharmaceuticals International B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland

Roche Registration GmbH

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

Mylan Pharmaceuticals Limited

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

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ViiV Healthcare BV

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

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Roche Registration GmbH

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

Accord Healthcare S.L.U.

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

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

Nova Laboratories Ireland Limited

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

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

AstraZeneca AB

151 85 Södertälje, Sverige

Accord Healthcare S.L.U.

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

Takeda France SAS

112 avenue Kléber, 75116 Paris, France

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

Roche Registration GmbH

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

Vifor Fresenius Medical Care Renal Pharma France

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

Accord Healthcare S.L.U.

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

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

Mylan IRE Healthcare Limited

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

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

AstraZeneca AB

151 85 Södertälje, Sverige

Mylan Pharmaceuticals Limited

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

Mirum Pharmaceuticals International B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

AstraZeneca AB

151 85 Södertälje, Sverige

Mylan Pharmaceuticals Limited

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

Cycle Pharmaceuticals (Europe) Ltd

70 Sir John Rogerson's Quay, Dublin 2, D02 R296, Ireland

Navidea Biopharmaceuticals Europe Ltd.

Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland

KRKA, d.d.

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

Zoetis Belgium

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