|
Dato for afgørelser
|
Lægemidlets navn
|
Indehaver af markedsføringstilladelsen
|
Nummer i EF-registret
|
Dato for notifikation
|
|
6.6.2024
|
Alecensa
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/16/1169
|
7.6.2024
|
|
6.6.2024
|
Cinqaero
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/16/1125
|
11.6.2024
|
|
6.6.2024
|
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/17/1263
|
17.6.2024
|
|
6.6.2024
|
Fasenra
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/17/1252
|
7.6.2024
|
|
6.6.2024
|
Lymphoseek
|
|
Navidea Biopharmaceuticals Europe Ltd.
|
|
Kilminion South, Ballinroad, Dungarvan, Co. Waterford, X35 WP70, Ireland
|
|
EU/1/14/955
|
7.6.2024
|
|
6.6.2024
|
Pedmarqsi
|
|
Norgine B.V.
|
|
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
|
EU/1/23/1734
|
7.6.2024
|
|
6.6.2024
|
Ritonavir Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/17/1242
|
7.6.2024
|
|
6.6.2024
|
Suliqua
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/16/1157
|
7.6.2024
|
|
6.6.2024
|
Sunlenca
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/22/1671
|
7.6.2024
|
|
6.6.2024
|
Synflorix
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/09/508
|
10.6.2024
|
|
6.6.2024
|
Tepmetko
|
|
Merck Europe B.V.
|
|
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
|
EU/1/21/1596
|
10.6.2024
|
|
6.6.2024
|
Twynsta
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/10/648
|
17.6.2024
|
|
6.6.2024
|
Veltassa
|
|
Vifor Fresenius Medical Care Renal Pharma France
|
|
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
|
|
EU/1/17/1179
|
7.6.2024
|
|
10.6.2024
|
AMGLIDIA
|
|
AMMTeK
|
|
8 rue campagne première, 75014 Paris, France
|
|
EU/1/18/1279
|
12.6.2024
|
|
10.6.2024
|
Ozempic
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/17/1251
|
11.6.2024
|
|
10.6.2024
|
Respreeza
|
|
CSL Behring GmbH
|
|
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland
|
|
EU/1/15/1006
|
26.6.2024
|
|
10.6.2024
|
Wegovy
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/21/1608
|
11.6.2024
|
|
13.6.2024
|
Atazanavir Viatris
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1091
|
14.6.2024
|
|
13.6.2024
|
Darunavir Viatris
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1140
|
14.6.2024
|
|
13.6.2024
|
Inbrija
|
|
Acorda Therapeutics Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/19/1390
|
14.6.2024
|
|
13.6.2024
|
Lopinavir/Ritonavir Viatris
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/15/1067
|
14.6.2024
|
|
13.6.2024
|
Ritonavir Viatris
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/17/1242
|
14.6.2024
|
|
13.6.2024
|
TALVEY
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/23/1748
|
14.6.2024
|
|
13.6.2024
|
TECVAYLI
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/22/1675
|
14.6.2024
|
|
13.6.2024
|
Telmisartan Actavis
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/10/639
|
14.6.2024
|
|
17.6.2024
|
Eviplera
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/11/737
|
18.6.2024
|
|
17.6.2024
|
Forxiga
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/12/795
|
18.6.2024
|
|
17.6.2024
|
Galafold
|
|
Amicus Therapeutics Europe Limited
|
|
Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland
|
|
EU/1/15/1082
|
19.6.2024
|
|
17.6.2024
|
Giotrif
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/13/879
|
18.6.2024
|
|
17.6.2024
|
Givlaari
|
|
Alnylam Netherlands B.V.
|
|
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
|
EU/1/20/1428
|
18.6.2024
|
|
17.6.2024
|
Kinpeygo
|
|
STADA Arzneimittel AG
|
|
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland
|
|
EU/1/22/1657
|
20.6.2024
|
|
17.6.2024
|
Mektovi
|
|
Pierre Fabre Médicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/18/1315
|
18.6.2024
|
|
17.6.2024
|
Pioglitazon Actavis
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/12/755
|
18.6.2024
|
|
17.6.2024
|
Rasagiline Viatris
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1090
|
18.6.2024
|
|
17.6.2024
|
Renagel
|
|
Sanofi B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/99/123
|
19.6.2024
|
|
17.6.2024
|
Verzenios
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/18/1307
|
18.6.2024
|
|
17.6.2024
|
Vfend
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/02/212
|
18.6.2024
|
|
17.6.2024
|
Xultophy
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/14/947
|
19.6.2024
|
|
17.6.2024
|
Yentreve
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/04/280
|
18.6.2024
|
|
17.6.2024
|
Zometa
|
|
Phoenix Labs Unlimited Company
|
|
Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland
|
|
EU/1/01/176
|
18.6.2024
|
|
20.6.2024
|
Abecma
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/21/1539
|
26.6.2024
|
|
20.6.2024
|
Abiraterone Mylan
|
|
Mylan Ireland Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
|
|
EU/1/21/1571
|
21.6.2024
|
|
20.6.2024
|
Bridion
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/466
|
24.6.2024
|
|
20.6.2024
|
Cinacalcet Accordpharma
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1429
|
21.6.2024
|
|
20.6.2024
|
CONTROLOC Control
|
|
Takeda GmbH
|
|
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland
|
|
EU/1/09/515
|
25.6.2024
|
|
20.6.2024
|
Cymbalta
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/04/296
|
25.6.2024
|
|
20.6.2024
|
Duloxetin Lilly
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/14/972
|
24.6.2024
|
|
20.6.2024
|
Ifirmacombi
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/11/673
|
26.6.2024
|
|
20.6.2024
|
Kesimpta
|
|
Novartis Ireland Limited
|
|
Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland
|
|
EU/1/21/1532
|
21.6.2024
|
|
20.6.2024
|
Livmarli
|
|
Mirum Pharmaceuticals International B.V.
|
|
Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland
|
|
EU/1/22/1704
|
21.6.2024
|
|
20.6.2024
|
Ocrevus
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/17/1231
|
21.6.2024
|
|
20.6.2024
|
PANTOZOL Control
|
|
Takeda GmbH
|
|
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland
|
|
EU/1/09/517
|
25.6.2024
|
|
20.6.2024
|
SOMAC Control
|
|
Takeda GmbH
|
|
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland
|
|
EU/1/09/516
|
25.6.2024
|
|
20.6.2024
|
Spravato
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/19/1410
|
24.6.2024
|
|
20.6.2024
|
Tivicay
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/13/892
|
21.6.2024
|
|
20.6.2024
|
TOBI Podhaler
|
|
Viatris Healthcare Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/10/652
|
21.6.2024
|
|
20.6.2024
|
Vabysmo
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/22/1683
|
21.6.2024
|
|
20.6.2024
|
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
|
21.6.2024
|
|
20.6.2024
|
Voriconazole Hikma
|
|
Hikma Farmacêutica (Portugal), S.A.
|
|
Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal
|
|
EU/1/15/1004
|
28.6.2024
|
|
20.6.2024
|
Voxzogo
|
|
BioMarin International Limited
|
|
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
|
|
EU/1/21/1577
|
24.6.2024
|
|
20.6.2024
|
Xaluprine
|
|
Nova Laboratories Ireland Limited
|
|
3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland
|
|
EU/1/11/727
|
21.6.2024
|
|
20.6.2024
|
Xerava
|
|
PAION Deutschland GmbH
|
|
Heussstraße 25, 52078 Aachen, Deutschland
|
|
EU/1/18/1312
|
24.6.2024
|
|
20.6.2024
|
Xtandi
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/13/846
|
21.6.2024
|
|
20.6.2024
|
Zabdeno
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/20/1444
|
21.6.2024
|
|
20.6.2024
|
Zyclara
|
|
Viatris Healthcare Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/12/783
|
24.6.2024
|
|
20.6.2024
|
Zydelig
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/14/938
|
21.6.2024
|
|
20.6.2024
|
Оlanzapin Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/08/475
|
21.6.2024
|
|
27.6.2024
|
Byetta
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/06/362
|
28.6.2024
|
|
27.6.2024
|
Levetiracetam Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/11/712
|
28.6.2024
|
|
27.6.2024
|
Mepact
|
|
Takeda France SAS
|
|
112 avenue Kléber, 75116 Paris, France
|
|
EU/1/08/502
|
2.7.2024
|
|
27.6.2024
|
Nucala
|
|
GlaxoSmithKline Trading Services Limited
|
|
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/15/1043
|
1.7.2024
|
|
27.6.2024
|
Rozlytrek
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/20/1460
|
28.6.2024
|
|
27.6.2024
|
Stribild
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/13/830
|
28.6.2024
|
|
27.6.2024
|
Tavneos
|
|
Vifor Fresenius Medical Care Renal Pharma France
|
|
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
|
|
EU/1/21/1605
|
28.6.2024
|
|
27.6.2024
|
Vokanamet
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/918
|
28.6.2024
|
|
27.6.2024
|
Xospata
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/19/1399
|
28.6.2024
|
|
27.6.2024
|
Zoledronsyre medac
|
|
medac Gesellschaft für klinische Spezialpräparate mbH
|
|
Theaterstraße 6, 22880 Wedel, Deutschland
|
|
EU/1/12/779
|
28.6.2024
|
|
28.6.2024
|
Cabazitaxel Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1448
|
1.7.2024
|
|
28.6.2024
|
CRYSVITA
|
|
Kyowa Kirin Holdings B.V.
|
|
Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
|
EU/1/17/1262
|
2.7.2024
|
|
28.6.2024
|
Dovprela
|
|
Mylan IRE Healthcare Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
|
|
EU/1/20/1437
|
1.7.2024
|
|
28.6.2024
|
Dupixent
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/17/1229
|
1.7.2024
|
|
28.6.2024
|
Edistride
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/15/1052
|
1.7.2024
|
|
28.6.2024
|
Emtricitabine/Tenofovir disoproxil Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1133
|
1.7.2024
|
|
28.6.2024
|
Invokana
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/13/884
|
1.7.2024
|
|
28.6.2024
|
Isturisa
|
|
Recordati Rare Diseases
|
|
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
|
|
EU/1/19/1407
|
1.7.2024
|
|
28.6.2024
|
Kineret
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/02/203
|
9.7.2024
|
|
28.6.2024
|
Livmarli
|
|
Mirum Pharmaceuticals International B.V.
|
|
Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland
|
|
EU/1/22/1704
|
1.7.2024
|
|
28.6.2024
|
Matever
|
|
Pharmathen S.A.
|
|
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
|
|
EU/1/11/711
|
3.7.2024
|
|
28.6.2024
|
Relvar Ellipta
|
|
GlaxoSmithKline (Ireland) Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/13/886
|
1.7.2024
|
|
28.6.2024
|
Revinty Ellipta
|
|
GlaxoSmithKline (Ireland) Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/14/929
|
1.7.2024
|
|
28.6.2024
|
Rotarix
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/05/330
|
2.7.2024
|
|
28.6.2024
|
Supemtek
|
|
Sanofi Pasteur
|
|
14 Espace Henry Vallée, 69007 Lyon, France
|
|
EU/1/20/1484
|
1.7.2024
|
|
28.6.2024
|
TAGRISSO
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/16/1086
|
1.7.2024
|
|
28.6.2024
|
Zonisamide Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1093
|
1.7.2024
|
