|
Data wydania decyzji
|
Nazwa produktu leczniczego
|
Posiadacz pozwolenia na dopuszczenie do obrotu
|
Numer pozycji w rejestrze wspólnotowym
|
Data notyfikacji
|
|
1.9.2022
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
1.9.2022
|
|
1.9.2022
|
Spikevax
|
|
MODERNA BIOTECH SPAIN, S.L.
|
|
Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España
|
|
EU/1/20/1507
|
1.9.2022
|
|
2.9.2022
|
Aprovel
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/97/046
|
5.9.2022
|
|
2.9.2022
|
CoAprovel
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/98/086
|
5.9.2022
|
|
2.9.2022
|
Copalia HCT
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/575
|
5.9.2022
|
|
2.9.2022
|
Dafiro HCT
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/574
|
5.9.2022
|
|
2.9.2022
|
Dupixent
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/17/1229
|
5.9.2022
|
|
2.9.2022
|
Imcivree
|
|
Rhythm Pharmaceuticals Netherlands B.V.
|
|
Radarweg 29, 1043 NX Amsterdam, Nederland
|
|
EU/1/21/1564
|
5.9.2022
|
|
2.9.2022
|
Januvia
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/07/383
|
7.9.2022
|
|
2.9.2022
|
Retsevmo
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/20/1527
|
5.9.2022
|
|
2.9.2022
|
Tecartus
|
|
Kite Pharma EU B.V.
|
|
Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
|
EU/1/20/1492
|
5.9.2022
|
|
2.9.2022
|
Zolgensma
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1443
|
12.9.2022
|
|
6.9.2022
|
Nuvaxovid
|
|
Novavax CZ, a.s.
|
|
Bohumil 138, 281 63 Jevany, Česká republika
|
|
EU/1/21/1618
|
7.9.2022
|
|
09.9.2022
|
Ceplene
|
|
Laboratoires Delbert
|
|
49 rue Rouelle, 75015 Paris, FRANCE
|
|
EU/1/08/477
|
12.9.2022
|
|
12.9.2022
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
12.9.2022
|
|
13.9.2022
|
Buvidal
|
|
Camurus AB
|
|
Ideon Science Park, 223 70 Lund, Sverige
|
|
EU/1/18/1336
|
14.9.2022
|
|
13.9.2022
|
Exforge HCT
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/569
|
14.9.2022
|
|
13.9.2022
|
GAVRETO
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/21/1555
|
15.9.2022
|
|
13.9.2022
|
Izba
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/13/905
|
14.9.2022
|
|
13.9.2022
|
JEMPERLI
|
|
GlaxoSmithKline (Ireland) Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/21/1538
|
14.9.2022
|
|
13.9.2022
|
Karvea
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/97/049
|
14.9.2022
|
|
13.9.2022
|
Karvezide
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/98/085
|
14.9.2022
|
|
13.9.2022
|
Ninlaro
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/16/1094
|
19.9.2022
|
|
13.9.2022
|
Oncaspar
|
|
Les Laboratoires Servier
|
|
50 rue Carnot, 92284 Suresnes Cedex, France
|
|
EU/1/15/1070
|
14.9.2022
|
|
13.9.2022
|
Temozolomide HEXAL
|
|
Hexal AG
|
|
Industriestraße 25, 83607 Holzkirchen, Deutschland
|
|
EU/1/10/616
|
19.9.2022
|
|
13.9.2022
|
Temozolomide Sandoz
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/10/617
|
16.9.2022
|
|
13.9.2022
|
Tigecycline Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/19/1394
|
14.9.2022
|
|
13.9.2022
|
Xeljanz
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/17/1178
|
14.9.2022
|
|
15.9.2022
|
Corlentor
|
|
Les Laboratoires Servier
|
|
50 rue Carnot, 92284 Suresnes CEDEX, France
|
|
EU/1/05/317
|
19.9.2022
|
|
15.9.2022
|
Fasenra
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/17/1252
|
16.9.2022
|
|
15.9.2022
|
Hemlibra
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/18/1271
|
16.9.2022
|
|
15.9.2022
|
Intrarosa
|
|
Endoceutics S.A.
|
|
Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België
|
|
EU/1/17/1255
|
18.9.2022
|
|
15.9.2022
|
Kinpeygo
|
|
STADA Arzneimittel AG
|
|
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland
|
|
EU/1/22/1657
|
19.9.2022
|
|
15.9.2022
|
Nyxoid
|
|
Mundipharma Corporation (Ireland) Limited
|
|
Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland
|
|
EU/1/17/1238
|
16.9.2022
|
|
15.9.2022
|
Oxlumo
|
|
Alnylam Netherlands B.V.
|
|
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
|
EU/1/20/1496
|
16.9.2022
|
|
15.9.2022
|
PREZISTA
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/06/380
|
16.9.2022
|
|
15.9.2022
|
Procoralan
|
|
Les Laboratoires Servier
|
|
50 rue Carnot, 92284 Suresnes CEDEX, France
|
|
EU/1/05/316
|
19.9.2022
|
|
15.9.2022
|
Stribild
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/13/830
|
19.9.2022
|
|
16.9.2022
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
19.9.2022
|
|
16.9.2022
|
EVUSHELD
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/22/1651
|
16.9.2022
|
|
16.9.2022
|
Spikevax
|
|
MODERNA BIOTECH SPAIN, S.L.
|
|
Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España
|
|
EU/1/20/1507
|
19.9.2022
|
|
16.9.2022
|
Veklury
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/20/1459
|
19.9.2022
|
|
19.9.2022
|
Miglustat Gen.Orph
|
|
Gen.Orph
|
|
185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France
|
|
EU/1/17/1232
|
21.9.2022
|
|
19.9.2022
|
Reblozyl
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/20/1452
|
23.9.2022
|
|
19.9.2022
|
SomaKit TOC
|
|
Advanced Accelerator Applications
|
|
20 rue Diesel, 01630 Saint-Genis-Pouilly, France
|
|
EU/1/16/1141
|
21.9.2022
|
|
19.9.2022
|
TAGRISSO
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/16/1086
|
20.9.2022
|
|
19.9.2022
|
Tarceva
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/05/311
|
21.9.2022
|
|
21.9.2022
|
Betmiga
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/12/809
|
26.9.2022
|
|
21.9.2022
|
Cervarix
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/07/419
|
26.9.2022
|
|
21.9.2022
|
Dafiro
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/06/371
|
23.9.2022
|
|
21.9.2022
|
Daxas
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/10/636
|
23.9.2022
|
|
21.9.2022
|
Efficib
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/457
|
26.9.2022
|
|
21.9.2022
|
Evrysdi
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/21/1531
|
23.9.2022
|
|
21.9.2022
|
InductOs
|
|
Medtronic BioPharma B.V.
|
|
Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland
|
|
EU/1/02/226
|
23.9.2022
|
|
21.9.2022
|
Inlyta
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/12/777
|
26.9.2022
|
|
21.9.2022
|
Lyrica
|
|
Upjohn EESV
|
|
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland
|
|
EU/1/04/279
|
27.9.2022
|
|
21.9.2022
|
Mvasi
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/17/1246
|
26.9.2022
|
|
21.9.2022
|
Ocrevus
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/17/1231
|
23.9.2022
|
|
21.9.2022
|
Ozempic
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/17/1251
|
23.9.2022
|
|
21.9.2022
|
Rubraca
|
|
Clovis Oncology Ireland Limited
|
|
Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland
|
|
EU/1/17/1250
|
23.9.2022
|
|
21.9.2022
|
Tegsedi
|
|
Akcea Therapeutics Ireland Ltd
|
|
Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland
|
|
EU/1/18/1296
|
23.9.2022
|
|
21.9.2022
|
Tesavel
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/07/435
|
26.9.2022
|
|
21.9.2022
|
Travatan
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/01/199
|
26.9.2022
|
|
21.9.2022
|
Tybost
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/13/872
|
28.9.2022
|
|
21.9.2022
|
Ultomiris
|
|
Alexion Europe SAS
|
|
103-105 Rue Anatole France, 92300 Levallois-Perret, France
|
|
EU/1/19/1371
|
23.9.2022
|
|
21.9.2022
|
Verkazia
|
|
Santen Oy
|
|
Niittyhaankatu 20, 33720 Tampere, Suomi
|
|
EU/1/17/1219
|
26.9.2022
|
|
21.9.2022
|
Zabdeno
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/20/1444
|
27.9.2022
|
|
26.9.2022
|
Cometriq
|
|
Ipsen Pharma
|
|
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
|
EU/1/13/890
|
27.9.2022
|
|
26.9.2022
|
Gencebok
|
|
Gennisium Pharma
|
|
Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France
|
|
EU/1/20/1465
|
28.9.2022
|
|
26.9.2022
|
Lamivudine / Zidovudine Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/10/663
|
27.9.2022
|
|
26.9.2022
|
Lutathera
|
|
Advanced Accelerator Applications
|
|
20 rue Diesel, 01630 Saint-Genis-Pouilly, France
|
|
EU/1/17/1226
|
28.9.2022
|
|
26.9.2022
|
Pirfenidone axunio
|
|
axunio Pharma GmbH
|
|
Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland
|
|
EU/1/22/1655
|
27.9.2022
|
|
26.9.2022
|
Pregabalin Pfizer
|
|
Upjohn EESV
|
|
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland
|
|
EU/1/14/916
|
27.10.2022
|
|
26.9.2022
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
|
27.9.2022
|
|
26.9.2022
|
TOOKAD
|
|
Steba Biotech S.A
|
|
7 Place du Théâtre, 2613 Luxembourg, Luxembourg
|
|
EU/1/17/1228
|
6.10.2022
|
|
27.9.2022
|
COVID-19 Vaccine (inactivated, adjuvanted) Valneva
|
|
Valneva Austria GmbH
|
|
Campus Vienna Biocenter 3, 1030 Wien, Österreich
|
|
EU/1/21/1624
|
29.9.2022
|
|
27.9.2022
|
Jorveza
|
|
Dr Falk Pharma GmbH
|
|
Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland
|
|
EU/1/17/1254
|
28.9.2022
|
|
29.9.2022
|
ABILIFY MAINTENA
|
|
Otsuka Pharmaceutical Netherlands B.V.
|
|
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
|
EU/1/13/882
|
3.10.2022
|
|
29.9.2022
|
Byooviz
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/21/1572
|
4.10.2022
|
|
29.9.2022
|
CABOMETYX
|
|
Ipsen Pharma
|
|
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
|
EU/1/16/1136
|
30.9.2022
|
|
29.9.2022
|
Copalia
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/06/372
|
30.9.2022
|
|
29.9.2022
|
Dupixent
|
|
Sanofi-Aventis groupe
|
|
54 rue La Boétie, 75008 Paris, France
|
|
EU/1/17/1229
|
30.9.2022
|
|
29.9.2022
|
Efient
|
|
SUBSTIPHARM
|
|
24 rue Erlanger, 75016 Paris, France
|
|
EU/1/08/503
|
30.9.2022
|
|
29.9.2022
|
Entresto
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/15/1058
|
3.10.2022
|
|
29.9.2022
|
Exforge
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/06/370
|
30.9.2022
|
|
29.9.2022
|
IVEMEND
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/07/437
|
3.10.2022
|
|
29.9.2022
|
Janumet
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/455
|
29.9.2022
|
|
29.9.2022
|
Lydisilka
|
|
Estetra SRL
|
|
Rue Saint Georges 5-7, 4000 Liège, Belgique
|
|
EU/1/21/1548
|
3.10.2022
|
|
29.9.2022
|
Paxlovid
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/22/1625
|
30.9.2022
|
|
29.9.2022
|
PHELINUN
|
|
ADIENNE S.r.l.S.U.
|
|
Via Galileo Galilei 19, 20867 Caponago (MB), Italia
|
|
EU/1/20/1487
|
30.9.2022
|
|
29.9.2022
|
Ristaben
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/10/621
|
30.9.2022
|
|
29.9.2022
|
Ristfor
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/10/620
|
29.9.2022
|
|
29.9.2022
|
Simbrinza
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/14/933
|
3.10.2022
|
|
29.9.2022
|
TAKHZYRO
|
|
Takeda Pharmaceuticals International AG Ireland Branch
|
|
Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
|
|
EU/1/18/1340
|
3.10.2022
|
|
29.9.2022
|
Vaniqa
|
|
Almirall, S.A.
|
|
Ronda General Mitre, 151, 08022 Barcelona, España
|
|
EU/1/01/173
|
3.10.2022
|
|
29.9.2022
|
Velmetia
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/456
|
30.9.2022
|
|
30.9.2022
|
Evrenzo
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1574
|
3.10.2022
|
|
30.9.2022
|
Lamivudine Teva Pharma B.V.
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/09/596
|
3.10.2022
|
