|
Határozat időpontja
|
Gyógyszer neve
|
A forgalombahozatali engedély jogosultja
|
Gyógyszer száma a közösségi nyilvántartásban
|
Értesítés időpontja
|
|
1.8.2024.
|
Arava
|
|
Sanofi-Aventis Deutschland GmbH
|
|
D-65926 Frankfurt am Main, Deutschland
|
|
EU/1/99/118
|
6.8.2024.
|
|
1.8.2024.
|
Beyfortus
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/22/1689
|
2.8.2024.
|
|
1.8.2024.
|
Bimzelx
|
|
UCB Pharma S.A.
|
|
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
|
EU/1/21/1575
|
5.8.2024.
|
|
1.8.2024.
|
Edistride
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/15/1052
|
2.8.2024.
|
|
1.8.2024.
|
Infanrix hexa
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/00/152
|
6.8.2024.
|
|
1.8.2024.
|
Noxafil
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/05/320
|
2.8.2024.
|
|
1.8.2024.
|
Reagila
|
|
Gedeon Richter Plc.
|
|
Gyömrői út 19-21, 1103 Budapest, Magyarország
|
|
EU/1/17/1209
|
15.8.2024.
|
|
1.8.2024.
|
Rybelsus
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/20/1430
|
5.8.2024.
|
|
1.8.2024.
|
Vosevi
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/17/1223
|
6.8.2024.
|
|
5.8.2024.
|
ADVATE
|
|
Takeda Manufacturing Austria AG
|
|
Industriestraße 67, 1221 Wien, Österreich
|
|
EU/1/03/271
|
6.8.2024.
|
|
5.8.2024.
|
CAMZYOS
|
|
Bristol Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/23/1716
|
6.8.2024.
|
|
5.8.2024.
|
Dabigatran Etexilate Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/22/1665
|
12.8.2024.
|
|
5.8.2024.
|
Dapagliflozin Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/23/1721
|
6.8.2024.
|
|
5.8.2024.
|
Filsuvez
|
|
Chiesi Farmaceutici S.p.A.
|
|
Via Palermo 26/A, 43122 Parma, Italia
|
|
EU/1/22/1652
|
8.8.2024.
|
|
5.8.2024.
|
Fotivda
|
|
Recordati Netherlands B.V.
|
|
Beechavenue 54, 1119PW Schiphol-Rijk, Nederland
|
|
EU/1/17/1215
|
13.8.2024.
|
|
5.8.2024.
|
Lojuxta
|
|
Chiesi Farmaceutici S.p.A.
|
|
Via Palermo 26/A, 43122 Parma, Italia
|
|
EU/1/13/851
|
8.8.2024.
|
|
5.8.2024.
|
Pegasys
|
|
pharmaand GmbH
|
|
Taborstrasse 1, 1020 Wien, Österreich
|
|
EU/1/02/221
|
6.8.2024.
|
|
5.8.2024.
|
Skyclarys
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/23/1786
|
6.8.2024.
|
|
5.8.2024.
|
Vyndaqel
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/11/717
|
6.8.2024.
|
|
9.8.2024.
|
Actos
|
|
CHEPLAPHARM Arzneimittel GmbH
|
|
Ziegelhof 24, 17489 Greifswald, Deutschland
|
|
EU/1/00/150
|
21.8.2024.
|
|
9.8.2024.
|
Forxiga
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/12/795
|
12.8.2024.
|
|
9.8.2024.
|
Xarelto
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/08/472
|
12.8.2024.
|
|
12.8.2024.
|
Hefiya
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/18/1287
|
13.8.2024.
|
|
12.8.2024.
|
Lynparza
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/14/959
|
13.8.2024.
|
|
12.8.2024.
|
TRIXEO AEROSPHERE
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1498
|
13.8.2024.
|
|
12.8.2024.
|
Zypadhera
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/08/479
|
14.8.2024.
|
|
16.8.2024.
|
Abrysvo
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1752
|
19.8.2024.
|
|
16.8.2024.
|
Competact
|
|
CHEPLAPHARM Arzneimittel GmbH
|
|
Ziegelhof 24, 17489 Greifswald, Deutschland
|
|
EU/1/06/354
|
9.9.2024.
|
|
16.8.2024.
|
Jaypirca
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/23/1738
|
19.8.2024.
|
|
16.8.2024.
|
Ninlaro
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/16/1094
|
19.8.2024.
|
|
16.8.2024.
|
Roctavian
|
|
BioMarin International Limited
|
|
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
|
|
EU/1/22/1668
|
22.8.2024.
|
|
16.8.2024.
|
Spinraza
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/17/1188
|
19.8.2024.
|
|
16.8.2024.
|
Tepkinly
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/23/1759
|
19.8.2024.
|
|
22.8.2024.
|
Baqsimi
|
|
Amphastar France Pharmaceuticals
|
|
Usine Saint Charles, Eragny Sur Epte, 60590 France
|
|
EU/1/19/1406
|
23.8.2024.
|
|
22.8.2024.
|
Betmiga
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/12/809
|
27.8.2024.
|
|
22.8.2024.
|
Cegfila
|
|
Mundipharma Corporation (Ireland) Limited
|
|
United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
|
|
EU/1/19/1409
|
23.8.2024.
|
|
22.8.2024.
|
Clopidogrel/Acetylsalicylic acid Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/19/1395
|
23.8.2024.
|
|
22.8.2024.
|
Copiktra
|
|
Secura Bio Limited
|
|
32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland
|
|
EU/1/21/1542
|
29.8.2024.
|
|
22.8.2024.
|
Cresemba
|
|
Basilea Pharmaceutica Deutschland GmbH
|
|
Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland
|
|
EU/1/15/1036
|
23.8.2024.
|
|
22.8.2024.
|
Evenity
|
|
UCB Pharma S.A.
|
|
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
|
EU/1/19/1411
|
26.8.2024.
|
|
22.8.2024.
|
IMBRUVICA
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/945
|
23.8.2024.
|
|
22.8.2024.
|
Instanyl
|
|
Istituto Gentili S.r.l.
|
|
Via San Giuseppe Cottolengo 15, 20143 Milano, Italia
|
|
EU/1/09/531
|
27.8.2024.
|
|
22.8.2024.
|
Jylamvo
|
|
Oresund Pharma ApS
|
|
Orient Plads 1, 2150 Nordhavn, Danmark
|
|
EU/1/17/1172
|
23.8.2024.
|
|
22.8.2024.
|
Jyseleca
|
|
Alfasigma S.p.A.
|
|
Via Ragazzi del '99, n.5, 40133 Bologna, Italia
|
|
EU/1/20/1480
|
28.8.2024.
|
|
22.8.2024.
|
Mounjaro
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/22/1685
|
26.8.2024.
|
|
22.8.2024.
|
Quofenix
|
|
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
|
|
Via Sette Santi 3, 50131 Florence, Italia
|
|
EU/1/19/1393
|
27.8.2024.
|
|
22.8.2024.
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
|
23.8.2024.
|
|
22.8.2024.
|
Savene
|
|
CNX Therapeutics Ireland Limited
|
|
5th Floor Rear, Connaught House, 1 Burlington Road, Dublin 4, Ireland
|
|
EU/1/06/350
|
23.8.2024.
|
|
22.8.2024.
|
Signifor
|
|
Recordati Rare Diseases
|
|
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
|
|
EU/1/12/753
|
26.8.2024.
|
|
22.8.2024.
|
Spravato
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/19/1410
|
23.8.2024.
|
|
22.8.2024.
|
Suliqua
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/16/1157
|
23.8.2024.
|
|
22.8.2024.
|
XALKORI
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/12/793
|
23.8.2024.
|
|
26.8.2024.
|
Arexvy
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/23/1740
|
27.8.2024.
|
|
26.8.2024.
|
Padcev
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1615
|
27.8.2024.
|
|
26.8.2024.
|
Slenyto
|
|
RAD Neurim Pharmaceuticals EEC SARL
|
|
4 rue de Marivaux, 75002 Paris, France
|
|
EU/1/18/1318
|
28.8.2024.
|
|
26.8.2024.
|
Tecentriq
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/17/1220
|
27.8.2024.
|
|
29.8.2024.
|
Abiraterone Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1512
|
30.8.2024.
|
|
29.8.2024.
|
Braftovi
|
|
Pierre Fabre Médicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/18/1314
|
3.9.2024.
|
|
29.8.2024.
|
Ilaris
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/564
|
30.8.2024.
|
|
29.8.2024.
|
KEYTRUDA
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/15/1024
|
30.8.2024.
|
|
29.8.2024.
|
Mektovi
|
|
Pierre Fabre Médicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/18/1315
|
3.9.2024.
|
|
29.8.2024.
|
Opfolda
|
|
Amicus Therapeutics Europe Limited
|
|
Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland
|
|
EU/1/23/1737
|
30.8.2024.
|
|
29.8.2024.
|
Rixathon
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/17/1185
|
30.8.2024.
|
|
29.8.2024.
|
Vyvgart
|
|
argenx BV
|
|
Industriepark-Zwijnaarde 7, 9052 Gent, België
|
|
EU/1/22/1674
|
30.8.2024.
|
|
29.8.2024.
|
Xigduo
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/13/900
|
30.8.2024.
|
|
30.8.2024.
|
ADYNOVI
|
|
Baxalta Innovations GmbH
|
|
Industriestraße 67, 1221 Wien, Österreich
|
|
EU/1/17/1247
|
3.9.2024.
|
|
30.8.2024.
|
ASPAVELI
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/21/1595
|
2.9.2024.
|
|
30.8.2024.
|
Nordimet
|
|
Nordic Group B.V.
|
|
Siriusdreef 41, 2132 WT Hoofddorp, Nederland
|
|
EU/1/16/1124
|
2.9.2024.
|
|
30.8.2024.
|
Riltrava Aerosphere
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/21/1604
|
2.9.2024.
|
