|
Dato for afgørelser
|
Lægemidlets navn
|
Indehaver af markedsføringstilladelsen
|
Nummer i EF-registret
|
Dato for notifikation
|
|
2.7.2025
|
Imfinzi
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/18/1322
|
3.7.2025
|
|
2.7.2025
|
MenQuadfi
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/20/1483
|
3.7.2025
|
|
2.7.2025
|
Pemazyre
|
|
Incyte Biosciences Distribution B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/21/1535
|
3.7.2025
|
|
7.7.2025
|
CARVYKTI
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/22/1648
|
8.7.2025
|
|
7.7.2025
|
Humira
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/03/256
|
8.7.2025
|
|
7.7.2025
|
Ozurdex
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/10/638
|
8.7.2025
|
|
7.7.2025
|
Rydapt
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/17/1218
|
9.7.2025
|
|
7.7.2025
|
Temozolomide Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/09/606
|
8.7.2025
|
|
9.7.2025
|
AMGEVITA
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/16/1164
|
10.7.2025
|
|
9.7.2025
|
CAMZYOS
|
|
Bristol Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/23/1716
|
15.7.2025
|
|
9.7.2025
|
Dovato
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/19/1370
|
30.7.2025
|
|
9.7.2025
|
Fluad
|
|
Seqirus Netherlands B.V.
|
|
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
|
EU/1/24/1878
|
14.7.2025
|
|
9.7.2025
|
Flucelvax
|
|
Seqirus Netherlands B.V.
|
|
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
|
EU/1/24/1879
|
14.7.2025
|
|
9.7.2025
|
Fluenz
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/24/1816
|
10.7.2025
|
|
9.7.2025
|
HALAVEN
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/11/678
|
10.7.2025
|
|
9.7.2025
|
Lamivudine Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/09/566
|
10.7.2025
|
|
9.7.2025
|
Leflunomide ratiopharm
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/10/654
|
10.7.2025
|
|
9.7.2025
|
Nintedanib Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/24/1803
|
10.7.2025
|
|
9.7.2025
|
Remsima
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/13/853
|
16.7.2025
|
|
9.7.2025
|
Reyataz
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/03/267
|
15.7.2025
|
|
9.7.2025
|
Scemblix
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/22/1670
|
10.7.2025
|
|
9.7.2025
|
Sugammadex Fresenius Kabi
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/22/1663
|
10.7.2025
|
|
9.7.2025
|
Tasmar
|
|
Viatris Healthcare Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/97/044
|
10.7.2025
|
|
9.7.2025
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
|
10.7.2025
|
|
9.7.2025
|
Xtandi
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/13/846
|
10.7.2025
|
|
10.7.2025
|
Inhixa
|
|
Techdow Pharma Netherlands B.V.
|
|
Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland
|
|
EU/1/16/1132
|
16.7.2025
|
|
14.7.2025
|
Lenalidomide Krka
|
|
KRKA, d.d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/20/1519
|
25.7.2025
|
|
14.7.2025
|
Sunlenca
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/22/1671
|
15.7.2025
|
|
14.7.2025
|
Tenofovir disoproxil Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/16/1127
|
16.7.2025
|
|
17.7.2025
|
Arsenic trioxide medac
|
|
medac Gesellschaft für klinische Spezialpräparate mbH
|
|
Theaterstraße 6, 22880 Wedel, Deutschland
|
|
EU/1/20/1475
|
25.7.2025
|
|
17.7.2025
|
ASPAVELI
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/21/1595
|
7.8.2025
|
|
17.7.2025
|
Cresemba
|
|
Basilea Pharmaceutica Deutschland GmbH
|
|
Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland
|
|
EU/1/15/1036
|
29.7.2025
|
|
17.7.2025
|
Ebglyss
|
|
Almirall S.A.
|
|
Ronda General Mitre 151, 08022 Barcelona, España
|
|
EU/1/23/1765
|
18.7.2025
|
|
17.7.2025
|
Efient
|
|
SUBSTIPHARM
|
|
24 rue Erlanger, 75016 Paris, France
|
|
EU/1/08/503
|
18.7.2025
|
|
17.7.2025
|
Emtricitabine/Tenofovir disoproxil Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/16/1148
|
18.7.2025
|
|
17.7.2025
|
Hizentra
|
|
CSL Behring GmbH
|
|
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland
|
|
EU/1/11/687
|
7.8.2025
|
|
17.7.2025
|
Incruse Ellipta
|
|
GlaxoSmithKline Trading Services Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
|
|
EU/1/14/922
|
18.7.2025
|
|
17.7.2025
|
Jubbonti
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/24/1813
|
21.7.2025
|
|
17.7.2025
|
Kaftrio
|
|
Vertex Pharmaceuticals (Ireland) Limited
|
|
Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland
|
|
EU/1/20/1468
|
18.7.2025
|
|
17.7.2025
|
LIBTAYO
|
|
Regeneron Ireland Designated Activity Company (DAC)
|
|
One Warrington Place, Dublin 2, D02 HH27, Ireland
|
|
EU/1/19/1376
|
18.7.2025
|
|
17.7.2025
|
Mysimba
|
|
Orexigen Therapeutics Ireland Limited
|
|
9-10 Fenian Street, Dublin 2, D02 RX24, Ireland
|
|
EU/1/14/988
|
21.7.2025
|
|
17.7.2025
|
NUBEQA
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/20/1432
|
25.7.2025
|
|
17.7.2025
|
Opdualag
|
|
Bristol Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/22/1679
|
22.7.2025
|
|
17.7.2025
|
Pramipexole Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/08/490
|
21.7.2025
|
|
17.7.2025
|
Prolia
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/10/618
|
18.7.2025
|
|
17.7.2025
|
Tepkinly
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/23/1759
|
18.7.2025
|
|
17.7.2025
|
Verzenios
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/18/1307
|
18.7.2025
|
|
17.7.2025
|
Voriconazole Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/13/835
|
18.7.2025
|
|
17.7.2025
|
Yescarta
|
|
Kite Pharma EU B.V.
|
|
Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
|
EU/1/18/1299
|
19.7.2025
|
|
18.7.2025
|
Aclasta
|
|
Sandoz Pharmaceuticals d.d.
|
|
Verovškova ulica 57, 1000 Ljubljana, Slovenija
|
|
EU/1/05/308
|
24.7.2025
|
|
18.7.2025
|
Apixaban Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1458
|
24.7.2025
|
|
18.7.2025
|
Benlysta
|
|
GlaxoSmithKline (Ireland) Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/11/700
|
23.7.2025
|
|
18.7.2025
|
Darzalex
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/16/1101
|
23.7.2025
|
|
18.7.2025
|
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/17/1210
|
22.7.2025
|
|
18.7.2025
|
IMBRUVICA
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/945
|
23.7.2025
|
|
18.7.2025
|
JERAYGO
|
|
Idorsia Pharmaceuticals Deutschland GmbH
|
|
Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland
|
|
EU/1/24/1818
|
22.7.2025
|
|
18.7.2025
|
Laventair Ellipta
|
|
GlaxoSmithKline Trading Services Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
|
|
EU/1/14/899
|
25.7.2025
|
|
18.7.2025
|
Multaq
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/09/591
|
24.7.2025
|
|
18.7.2025
|
Rezolsta
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/967
|
23.7.2025
|
|
18.7.2025
|
Sarclisa
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/20/1435
|
22.7.2025
|
|
18.7.2025
|
Siklos
|
|
THERAVIA
|
|
16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
|
|
EU/1/07/397
|
22.7.2025
|
|
18.7.2025
|
Supemtek Tetra
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/20/1484
|
24.7.2025
|
|
18.7.2025
|
VEYVONDI
|
|
Baxalta Innovations GmbH
|
|
Industriestraße 67, 1221 Wien, Österreich
|
|
EU/1/18/1298
|
28.7.2025
|
|
18.7.2025
|
VITRAKVI
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/19/1385
|
22.7.2025
|
|
18.7.2025
|
Wezenla
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/24/1823
|
30.7.2025
|
|
23.7.2025
|
CABOMETYX
|
|
Ipsen Pharma
|
|
70 rue Balard, 75015 Paris, France
|
|
EU/1/16/1136
|
24.7.2025
|
|
23.7.2025
|
Chenodeoxycholic acid Leadiant
|
|
Leadiant GmbH
|
|
Liebherrstr. 22, 80538 Munich, Deutschland
|
|
EU/1/16/1110
|
24.7.2025
|
|
23.7.2025
|
Elocta
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/15/1046
|
25.7.2025
|
|
23.7.2025
|
EXPAREL liposomal
|
|
Pacira Ireland Ltd
|
|
Unit 13, Classon House, Dundrum Business Park, Dundrum, Dublin 14, D14W9Y3, Ireland
|
|
EU/1/20/1489
|
28.7.2025
|
|
23.7.2025
|
FRUZAQLA
|
|
Takeda Pharmaceuticals International AG Ireland Branch
|
|
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
|
EU/1/24/1827
|
24.7.2025
|
|
23.7.2025
|
Ordspono
|
|
Regeneron Ireland Designated Activity Company (DAC)
|
|
One Warrington Place, Dublin 2, D02 HH27, Ireland
|
|
EU/1/24/1843
|
25.7.2025
|
|
23.7.2025
|
Repatha
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1016
|
24.7.2025
|
|
23.7.2025
|
Trulicity
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/14/956
|
24.7.2025
|
|
23.7.2025
|
Xofluza
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/20/1500
|
24.7.2025
|
|
23.7.2025
|
Zynlonta
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/22/1695
|
24.7.2025
|
|
25.7.2025
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
29.7.2025
|
|
25.7.2025
|
Spikevax
|
|
MODERNA BIOTECH SPAIN, S.L.
|
|
C/ Julián Camarillo no 31, 28037 Madrid, España
|
|
EU/1/20/1507
|
29.7.2025
|
|
28.7.2025
|
Actraphane
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/02/229
|
30.7.2025
|
|
28.7.2025
|
Adcirca
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/08/476
|
6.8.2025
|
|
28.7.2025
|
Aerius
|
|
N.V. Organon
|
|
Kloosterstraat 6, 5349 AB Oss, Nederland
|
|
EU/1/00/160
|
29.7.2025
|
|
28.7.2025
|
Anoro Ellipta
|
|
GlaxoSmithKline Trading Services Limited
|
|
12 River Walk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
|
|
EU/1/14/898
|
30.7.2025
|
|
28.7.2025
|
Aranesp
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/01/185
|
30.7.2025
|
|
28.7.2025
|
AYVAKYT
|
|
Blueprint Medicines (Netherlands) B.V.
|
|
Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland
|
|
EU/1/20/1473
|
29.7.2025
|
|
28.7.2025
|
Azomyr
|
|
N.V. Organon
|
|
Kloosterstraat 6, 5349 AB Oss, Nederland
|
|
EU/1/00/157
|
29.7.2025
|
|
28.7.2025
|
Calquence
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1479
|
29.7.2025
|
|
28.7.2025
|
Cinryze
|
|
Takeda Manufacturing Austria AG
|
|
Industriestraße 67, 1221 Wien, Österreich
|
|
EU/1/11/688
|
30.7.2025
|
|
28.7.2025
|
Dzuveo
|
|
Laboratoire Aguettant
|
|
1 Rue Alexander Fleming, 69007 Lyon, France
|
|
EU/1/18/1284
|
29.7.2025
|
|
28.7.2025
|
Gardasil 9
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/15/1007
|
29.7.2025
|
|
28.7.2025
|
Javlor
|
|
PIERRE FABRE MEDICAMENT
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/09/550
|
29.7.2025
|
|
28.7.2025
|
Oprymea
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KRKA d d., Novo mesto
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Šmarješka cesta 6, 8501 Novo mesto, Slovenija
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EU/1/08/469
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1.8.2025
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|
28.7.2025
|
Phesgo
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Roche Registration GmbH
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Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/20/1497
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30.7.2025
|
|
28.7.2025
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Qalsody
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Biogen Netherlands B.V.
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Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
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EU/1/23/1783
|
30.7.2025
|
|
28.7.2025
|
Revestive
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Takeda Pharmaceuticals International AG Ireland Branch
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|
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
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EU/1/12/787
|
29.7.2025
|
|
28.7.2025
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Spinraza
|
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Biogen Netherlands B.V.
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Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/17/1188
|
29.7.2025
|
|
28.7.2025
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Vyxeos liposomal
|
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Jazz Pharmaceuticals Ireland Ltd
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|
5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland
|
|
EU/1/18/1308
|
29.7.2025
|
|
30.7.2025
|
ABILIFY MAINTENA
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Otsuka Pharmaceutical Netherlands B.V.
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|
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
|
EU/1/13/882
|
6.8.2025
|
|
30.7.2025
|
BiResp Spiromax
|
|
Teva Pharma B.V.
|
|
Swensweg 5, 2031GA Haarlem, Nederland
|
|
EU/1/14/921
|
7.8.2025
|
|
30.7.2025
|
DuoResp Spiromax
|
|
Teva Pharma B.V.
|
|
Swensweg 5, 2031GA Haarlem, Nederland
|
|
EU/1/14/920
|
7.8.2025
|
|
30.7.2025
|
Iqirvo
|
|
Ipsen Pharma
|
|
70 rue Balard, 75015 Paris, France
|
|
EU/1/24/1855
|
31.7.2025
|
|
30.7.2025
|
Leqvio
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1494
|
31.7.2025
|
|
30.7.2025
|
Neoclarityn
|
|
N.V. Organon
|
|
Kloosterstraat 6, 5349 AB Oss, Nederland
|
|
EU/1/00/161
|
31.7.2025
|
|
30.7.2025
|
Neulasta
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/02/227
|
8.8.2025
|
|
30.7.2025
|
Orencia
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/07/389
|
31.7.2025
|
|
30.7.2025
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
|
31.7.2025
|
|
30.7.2025
|
Wegovy
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/21/1608
|
31.7.2025
|
