Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
1.7.2022 |
Armisarte |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjöröur, Iceland
|
EU/1/15/1063 |
6.7.2022 |
1.7.2022 |
Entecavir Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/17/1211 |
4.7.2022 |
1.7.2022 |
Hetlioz |
Vanda Pharmaceuticals Netherlands B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland
|
EU/1/15/1008 |
8.8.2022 |
1.7.2022 |
Irbesartan / Hydrochlorothiazide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/09/583 |
4.7.2022 |
1.7.2022 |
Kinzalkomb |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/02/214 |
5.7.2022 |
1.7.2022 |
Levodopa/Carbido- pa/Entacapone Orion |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/11/706 |
11.7.2022 |
1.7.2022 |
Neparvis |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/16/1103 |
7.7.2022 |
1.7.2022 |
Nuvaxovid |
Novavax CZ, a.s. Bohumil 138, 281 63 Jevany, Česká republika
|
EU/1/21/1618 |
1.7.2022 |
1.7.2022 |
Orladeyo |
Biocryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland
|
EU/1/21/1544 |
5.7.2022 |
1.7.2022 |
Paxlovid |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/22/1625 |
1.7.2022 |
1.7.2022 |
Strensiq |
Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-
Perret, France
|
EU/1/15/1015 |
4.7.2022 |
1.7.2022 |
Viramune |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/055 |
19.7.2022 |
1.7.2022 |
Zirabev |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/18/1344 |
4.7.2022 |
4.7.2022 |
Prialt |
Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |
EU/1/04/302 |
7.7.2022 |
8.7.2022 |
Amsparity |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/19/1415 |
12.7.2022 |
8.7.2022 |
AUBAGIO |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France
|
EU/1/13/838 |
11.7.2022 |
8.7.2022 |
Azacitidine Betapharm |
betapharm Arzneimittel GmbH Kobelweg 95, 86156 Augsburg, Deutschland
|
EU/1/19/1416 |
12.7.2022 |
8.7.2022 |
Azacitidine Mylan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
|
EU/1/20/1426 |
12.7.2022 |
8.7.2022 |
Calquence |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/20/1479 |
11.7.2022 |
8.7.2022 |
Dexdor |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/11/718 |
11.7.2022 |
8.7.2022 |
EDURANT |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/11/736 |
12.7.2022 |
8.7.2022 |
Efmody |
Diurnal Europe B.V. Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland
|
EU/1/21/1549 |
13.7.2022 |
8.7.2022 |
Eurartesim |
Alfasigma S.p.A. Via Ragazzi del '99, n.5, 40133 Bologna, Italia
|
EU/1/11/716 |
12.7.2022 |
8.7.2022 |
Farydak |
Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland
|
EU/1/15/1023 |
14.7.2022 |
8.7.2022 |
Fingolimod Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/20/1450 |
11.7.2022 |
8.7.2022 |
Fortacin |
Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland
|
EU/1/13/881 |
12.7.2022 |
8.7.2022 |
Giapreza |
PAION Deutschland GmbH HcussstraRc 25, 52078 Aachen, Deutschland
|
EU/1/19/1384 |
13.7.2022 |
8.7.2022 |
Grasustek |
Juta Pharma GmbH Gutenbergstr. 13, 24941, Flensburg, Deutschland |
EU/1/19/1375 |
12.7.2022 |
8.7.2022 |
Herceptin |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/00/145 |
11.7.2022 |
8.7.2022 |
Iclusig |
Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/13/839 |
15.7.2022 |
8.7.2022 |
INCRELEX |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
EU/1/07/402 |
12.7.2022 |
8.7.2022 |
Kadcyla |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/13/885 |
11.7.2022 |
8.7.2022 |
Keppra |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
EU/1/00/146 |
12.7.2022 |
8.7.2022 |
Lenalidomide My- lan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
|
EU/1/20/1490 |
11.7.2022 |
8.7.2022 |
Lutathera |
Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France
|
EU/1/17/1226 |
11.7.2022 |
8.7.2022 |
Mabthera |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/98/067 |
11.7.2022 |
8.7.2022 |
MicardisPlus |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/02/213 |
13.7.2022 |
8.7.2022 |
Minjuvi |
Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/21/1570 |
11.7.2022 |
8.7.2022 |
Mvasi |
Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
EU/1/17/1246 |
12.7.2022 |
8.7.2022 |
Orgovyx |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/22/1642 |
11.7.2022 |
8.7.2022 |
Palforzia |
Aimmune Therapeutics Ireland Limited Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland |
EU/1/20/1495 |
12.7.2022 |
8.7.2022 |
Pemetrexed Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/15/1037 |
12.7.2022 |
8.7.2022 |
Quinsair |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia
|
EU/1/14/973 |
13.7.2022 |
8.7.2022 |
Striascan |
CIS bio international RN 306 - Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France
|
EU/1/19/1372 |
11.7.2022 |
8.7.2022 |
Tepadina |
ADIENNE S.r.l.S.U. Via Galileo Galilei 19, 20867 Caponago (MB), Italia
|
EU/1/10/622 |
12.7.2022 |
8.7.2022 |
Thiotepa Riemser |
Esteve Pharmaceuticals GmbH Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |
EU/1/21/1536 |
11.7.2022 |
8.7.2022 |
Tracleer |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/02/220 |
11.7.2022 |
8.7.2022 |
Vimpat |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
EU/1/08/470 |
11.7.2022 |
8.7.2022 |
Votrient |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/10/628 |
11.7.202; |
8.7.2022 |
Xeloda |
CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland |
EU/1/00/163 |
11.7.202; |
8.7.2022 |
Xenleta |
Nabriva Therapeutics Ireland DAC Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland |
EU/1/20/1457 |
13.7.202; |
8.7.2022 |
Yondelis |
Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España
|
EU/1/07/417 |
12.7.202; |
11.7.2022 |
Enhertu |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland
|
EU/1/20/1508 |
13.7.202; |
15.7.2022 |
Alecensa |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/16/1169 |
19.7.202; |
15.7.2022 |
AYVAKYT |
Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland
|
EU/1/20/1473 |
18.7.202; |
15.7.2022 |
Edistride |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/15/1052 |
19.7.202; |
15.7.2022 |
Elebrato Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1237 |
19.7.202; |
15.7.2022 |
Emgality |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/18/1330 |
19.7.202; |
15.7.2022 |
Forxiga |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/12/795 |
19.7.202; |
15.7.2022 |
Fotivda |
EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland
|
EU/1/17/1215 |
10.8.202; |
15.7.2022 |
Galvus |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/07/414 |
18.7.202; |
15.7.2022 |
Idefirix |
Hansa Biopharma AB P.O. Box 785, 220 07 Lund, Sverige
|
EU/1/20/1471 |
19.7.202; |
15.7.2022 |
Jalra |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/08/485 |
18.7.202; |
15.7.2022 |
Nitisinone MDK |
MendeliKABS Europe Limited Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23
AT2P, Ireland
|
EU/1/17/1217 |
19.7.202; |
15.7.2022 |
PecFent |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
EU/1/10/644 |
20.7.2022 |
15.7.2022 |
Posaconazole AHCL |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/19/1380 |
3.8.2022 |
15.7.2022 |
Raxone |
Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Straße 8, 79539 Lörrach, Deutschland |
EU/1/15/1020 |
2.8.2022 |
15.7.2022 |
Remsima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
EU/1/13/853 |
18.7.2022 |
15.7.2022 |
Trelegy Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1236 |
19.7.2022 |
15.7.2022 |
Tremfya |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1234 |
19.7.2022 |
15.7.2022 |
Xiliarx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/08/486 |
18.7.2022 |
18.7.2022 |
Accofil |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/14/946 |
8.8.2022 |
18.7.2022 |
Bortezomib Fresenius Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
EU/1/19/1397 |
20.7.2022 |
18.7.2022 |
Cyramza |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/14/957 |
22.7.2022 |
18.7.2022 |
Darunavir Krka d.d. |
KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/17/1248 |
20.7.2022 |
18.7.2022 |
Irbesartan Zentiva |
Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika
|
EU/1/06/376 |
19.7.2022 |
18.7.2022 |
Lenalidomide Krka |
KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/20/1519 |
22.7.2022 |
18.7.2022 |
Mayzent |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/19/1414 |
19.7.2022 |
18.7.2022 |
Suboxone |
Indivior Europe Limited 27 Windsor Place, Dublin 2, D02 DK44, Ireland
|
EU/1/06/359 |
22.7.2022 |
18.7.2022 |
Zejula |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin
24, Ireland
|
EU/1/17/1235 |
20.7.2022 |
19.7.2022 |
Veklury |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/20/1459 |
19.7.2022 |
22.7.2022 |
Fluad Tetra |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
EU/1/20/1433 |
28.7.2022 |
22.7.2022 |
Imvanex |
Bavarian Nordic A/S Philip Heymans Allé 3, DK-2900 Hellerup, Danmark
|
EU/1/13/855 |
25.7.2022 |
22.7.2022 |
Kirsty |
Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
|
EU/1/20/1506 |
26.7.2022 |
22.7.2022 |
Lonquex |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/13/856 |
2.8.2022 |
22.7.2022 |
Miglustat Dipharma |
Dipharma B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland
|
EU/1/18/1346 |
26.7.2022 |
22.7.2022 |
Onureg |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/21/1556 |
27.7.2022 |
22.7.2022 |
Rinvoq |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/19/1404 |
25.7.2022 |
22.7.2022 |
Ryeqo |
Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország
|
EU/1/21/1565 |
27.7.2022 |
22.7.2022 |
Xevudy |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/21/1562 |
22.7.2022 |
22.7.2022 |
Zavesca |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/02/238 |
26.7.2022 |
25.7.2022 |
Braftovi |
Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France
|
EU/1/18/1314 |
26.7.2022 |
25.7.2022 |
CRYSVITA |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
EU/1/17/1262 |
28.7.2022 |
25.7.2022 |
Cyramza |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/14/957 |
27.7.2022 |
25.7.2022 |
Zerbaxa |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/15/1032 |
26.7.2022 |
27.7.2022 |
BroPair Spiromax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/21/1534 |
2.8.2022 |
27.7.2022 |
Flucelvax Tetra |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
EU/1/18/1326 |
29.7.2022 |
27.7.2022 |
Fluenz Tetra |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/13/887 |
28.7.2022 |
27.7.2022 |
Phesgo |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/20/1497 |
29.7.2022 |
27.7.2022 |
Rinvoq |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/19/1404 |
28.7.2022 |
27.7.2022 |
Seffalair Spiromax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/21/1533 |
2.8.2022 |
27.7.2022 |
Zubsolv |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/17/1233 |
8.8.2022 |
28.7.2022 |
COVID-19 Vaccine (inactivated, adju- vanted) Valneva |
Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich
|
EU/1/21/1624 |
29.7.2022 |