Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
1.10.2021 |
COVID-19 Vaccine Janssen
|
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgie |
EU/1/20/1525 |
1.10.2021 |
4.10.2021 |
Docetaxel Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/12/769 |
5.10.2021 |
4.10.2021 |
Docetaxel Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-StraEe 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
EU/1/12/770 |
6.10.2021 |
4.10.2021 |
Posaconazole Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/19/1379 |
5.10.2021 |
4.10.2021 |
Spikevax |
MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España
|
EU/1/20/1507 |
4.10.2021 |
5.10.2021 |
Comirnaty |
BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland
|
EU/1/20/1528 |
5.10.2021 |
5.10.2021 |
Spikevax |
MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España
|
EU/1/20/1507 |
5.10.2021 |
11.10.2021 |
Copalia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/372 |
12.10.2021 |
11.10.2021 |
COVID-19 Vaccine Janssen
|
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgie |
EU/1/20/1525 |
11.10.2021 |
11.10.2021 |
Dafiro |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/371 |
12.10.2021 |
11.10.2021 |
Entecavir Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/17/1227 |
12.10.2021 |
11.10.2021 |
Equidacent |
Centus Biotherapeutics Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland |
EU/1/20/1472 |
8.11.2021 |
11.10.2021 |
Exforge |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/370 |
12.10.2021 |
11.10.2021 |
Onpattro |
Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
EU/1/18/1320 |
13.10.2021 |
11.10.2021 |
Ovitrelle |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
EU/1/00/165 |
12.10.2021 |
11.10.2021 |
ReFacto AF |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/99/103 |
12.10.2021 |
11.10.2021 |
Sifrol |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/050 |
14.10.2021 |
11.10.2021 |
Vargatef |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/954 |
27.10.2021 |
11.10.2021 |
Vyndaqel |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/11/717 |
12.10.2021 |
15.10.2021 |
Vaxzevria |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/21/1529 |
15.10.2021 |
19.10.2021 |
Ammonaps |
Immedica Pharma AB SE-113 29 Stockholm, Sverige
|
EU/1/99/120 |
20.10.2021 |
19.10.2021 |
Busilvex |
Pierre Fabre Médicament 45 place Abel Gance, 92654 Boulogne-Billancourt CEDEX, France
|
EU/1/03/254 |
20.10.2021 |
19.10.2021 |
Ceprotin |
Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich |
EU/1/01/190 |
20.10.2021 |
Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
19.10.2021 |
Clopidogrel/Acetyl- salicylic acid Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/19/1395 |
20.10.2021 |
19.10.2021 |
Duloxetine Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/15/1010 |
21.10.2021 |
19.10.2021 |
Ecalta |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/07/416 |
20.10.2021 |
19.10.2021 |
Erelzi |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/17/1195 |
20.10.2021 |
19.10.2021 |
Firmagon |
Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark
|
EU/1/08/504 |
25.10.2021 |
19.10.2021 |
Forsteo |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/03/247 |
25.10.2021 |
19.10.2021 |
Gazyvaro |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/14/937 |
20.10.2021 |
19.10.2021 |
Gefitinib Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/18/1321 |
20.10.2021 |
19.10.2021 |
Hefiya |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/18/1287 |
20.10.2021 |
19.10.2021 |
Imfinzi |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/18/1322 |
21.10.2021 |
19.10.2021 |
Inrebic |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/20/1514 |
21.10.2021 |
19.10.2021 |
Integrilin |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin
24, Ireland
|
EU/1/99/109 |
20.10.2021 |
19.10.2021 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/15/1024 |
21.10.2021 |
19.10.2021 |
Lopinavir/Ritonavir Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/15/1067 |
21.10.2021 |
19.10.2021 |
Memantine LEK |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
|
EU/1/13/826 |
21.10.2021 |
19.10.2021 |
Memantine Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/13/827 |
20.10.2021 |
19.10.2021 |
Mirapexin |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/051 |
21.10.2021 |
19.10.2021 |
Myozyme |
Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/06/333 |
25.10.2021 |
19.10.2021 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/13/888 |
21.10.2021 |
19.10.2021 |
NovoMix |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/00/142 |
21.10.2021 |
19.10.2021 |
Noxafil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/05/320 |
21.10.2021 |
19.10.2021 |
OPDIVO |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/15/1014 |
9.11.2021 |
19.10.2021 |
Prasugrel Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/18/1273 |
20.10.2021 |
19.10.2021 |
Rasagiline Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/16/1090 |
20.10.2021 |
19.10.2021 |
REKAMBYS |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgie |
EU/1/20/1482 |
20.10.2021 |
19.10.2021 |
Repaglinide Krka |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/09/579 |
21.10.2021 |
19.10.2021 |
Semglee |
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
EU/1/18/1270 |
20.10.2021 |
19.10.2021 |
Spedra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg
|
EU/1/13/841 |
21.10.2021 |
19.10.2021 |
Sunosi |
Jazz Pharmaceuticals Ireland Ltd 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland
|
EU/1/19/1408 |
21.10.2021 |
19.10.2021 |
Tasmar |
Meda AB Pipers vag 2A, 170 09 Solna, Sverige
|
EU/1/97/044 |
21.10.2021 |
19.10.2021 |
Tenofovir disopro- xil Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/16/1129 |
20.10.2021 |
19.10.2021 |
Torisel |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/07/424 |
20.10.2021 |
19.10.2021 |
Vaborem |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Luxembourg
|
EU/1/18/1334 |
20.10.2021 |
19.10.2021 |
Vfend |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/02/212 |
21.10.2021 |
19.10.2021 |
Vocabria |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/20/1481 |
20.10.2021 |
19.10.2021 |
Xydalba |
Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland |
EU/1/14/986 |
20.10.2021 |
19.10.2021 |
Zessly |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/18/1280 |
20.10.2021 |
22.10.2021 |
Adempas |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/13/907 |
5.11.2021 |
22.10.2021 |
Alofisel |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/17/1261 |
28.10.2021 |
22.10.2021 |
Betaferon |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/95/003 |
5.11.2021 |
22.10.2021 |
Biktarvy |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/18/1289 |
27.10.2021 |
22.10.2021 |
Clopidogrel ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/14/975 |
26.10.2021 |
22.10.2021 |
Hyrimoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/18/1286 |
25.10.2021 |
22.10.2021 |
Idacio |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
EU/1/19/1356 |
25.10.2021 |
22.10.2021 |
Imcivree |
Rhythm Pharmaceuticals Netherlands B.V. Herengracht 280, 1016 BX Amsterdam, Nederland |
EU/1/21/1564 |
26.10.2021 |
22.10.2021 |
Inflectra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/13/854 |
25.10.2021 |
22.10.2021 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
25.10.2021 |
22.10.2021 |
Retacrit |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/07/431 |
25.10.2021 |
22.10.2021 |
Steglatro |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/18/1267 |
25.10.2021 |
22.10.2021 |
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 |
9.11.2021 |
22.10.2021 |
Zepatier |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/16/1119 |
25.10.2021 |
25.10.2021 |
Clopidogrel Taw Pharma |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France
|
EU/1/09/559 |
26.10.2021 |
25.10.2021 |
Clopidogrel Viatris |
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
EU/1/09/568 |
1.11.2021 |
25.10.2021 |
Firazyr |
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza, 50 - 58 Baggot Street
Lower, Dublin 2, Ireland
|
EU/1/08/461 |
27.10.2021 |
25.10.2021 |
Forxiga |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/12/795 |
26.11.2021 |
25.10.2021 |
Latuda |
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia 70, 00181 Roma, Italia
|
EU/1/14/913 |
26.10.2021 |
25.10.2021 |
Nerlynx |
Pierre Fabre Médicament 45, place Abel Gance, 92100 Boulogne-Billancourt, France
|
EU/1/18/1311 |
10.11.2021 |
25.10.2021 |
Segluromet |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/18/1265 |
28.10.2021 |
25.10.2021 |
Zyllt |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/09/553 |
27.10.2021 |
28.10.2021 |
Clopidogrel Krka |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/09/556 |
2.11.2021 |
28.10.2021 |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-StraEe 5, 27472 Cuxhaven, Deutschland
|
EU/1/09/555 |
3.11.2021 |
28.10.2021 |
Darunavir Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/16/1140 |
5.11.2021 |
28.10.2021 |
Mysildecard |
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
EU/1/16/1134 |
29.10.2021 |
28.10.2021 |
Ontozry |
Angelini Pharma S.p.A Viale Amelia 70, 00181 Rome, Italia
|
EU/1/21/1530 |
29.10.2021 |
28.10.2021 |
Tyverb |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/07/440 |
29.10.2021 |
28.10.2021 |
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 |
29.10.2021 |
29.10.2021 |
Spikevax |
MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España
|
EU/1/20/1507 |
29.10.2021 |