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—
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Modificarea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat
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Data deciziei
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Denumirea medicamentului
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Titularul autorizației de introducere pe piață
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Numărul de înregistrare în Registrul comunitar
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Data notificării
|
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4.2.2026
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Actelsar HCT
|
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Íceland
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EU/1/13/817
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6.2.2026
|
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4.2.2026
|
Lytenava
|
Outlook Therapeutics NL B.V.
Strawinskylaan 569, 1077XX Amsterdam, Nederland
|
EU/1/24/1798
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5.2.2026
|
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4.2.2026
|
Nucala
|
GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland
|
EU/1/15/1043
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5.2.2026
|
|
10.2.2026
|
Carbaglu
|
Recordati Rare Diseases
Tour Hekla, 52 Avenue Du General De Gaulle, 92800 Puteaux, France
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EU/1/02/246
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16.2.2026
|
|
10.2.2026
|
Casgevy
|
Vertex Pharmaceuticals (Ireland) Limited
Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland
|
EU/1/23/1787
|
12.2.2026
|
|
10.2.2026
|
Emadine
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Immedica Pharma AB
SE-113 63, Stockholm, Sverige
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EU/1/98/095
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11.2.2026
|
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10.2.2026
|
Enspryng
|
Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/21/1559
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11.2.2026
|
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10.2.2026
|
JEMPERLI
|
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
|
EU/1/21/1538
|
13.2.2026
|
|
10.2.2026
|
Kengrexal
|
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
|
EU/1/15/994
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17.2.2026
|
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10.2.2026
|
Myalepta
|
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
|
EU/1/18/1276
|
11.2.2026
|
|
10.2.2026
|
Relistor
|
Bausch Health Ireland Limited
3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
|
EU/1/08/463
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13.2.2026
|
|
10.2.2026
|
Retsevmo
|
Eli Lilly Nederland B.V.
Orteliuslaan 1000, 3528 BD, Nederland
|
EU/1/20/1527
|
11.2.2026
|
|
10.2.2026
|
Uplizna
|
Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland
|
EU/1/21/1602
|
11.2.2026
|
|
10.2.2026
|
Vfend
|
Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/02/212
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11.2.2026
|
|
12.2.2026
|
Akynzeo
|
Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland
|
EU/1/15/1001
|
13.2.2026
|
|
12.2.2026
|
Aptivus
|
Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
EU/1/05/315
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15.2.2026
|
|
12.2.2026
|
Bronchitol
|
Pharmaxis Europe Limited
108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
|
EU/1/12/760
|
16.2.2026
|
|
12.2.2026
|
Emblaveo
|
Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/24/1808
|
13.2.2026
|
|
12.2.2026
|
EndolucinBeta
|
ITM Medical Isotopes GmbH
Lichtenbergstraße 1, 85748 Garching/München, Deutschland
|
EU/1/16/1105
|
13.2.2026
|
|
12.2.2026
|
Klisyri
|
Almirall, S.A.
Ronda General Mitre, 151, 08022 Barcelona, España
|
EU/1/21/1558
|
13.2.2026
|
|
12.2.2026
|
Mvabea
|
Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
|
EU/1/20/1445
|
13.2.2026
|
|
12.2.2026
|
Orladeyo
|
Biocryst Ireland Limited
Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland
|
EU/1/21/1544
|
13.2.2026
|
|
12.2.2026
|
Pemazyre
|
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/21/1535
|
13.2.2026
|
|
12.2.2026
|
Ponvory
|
LABORATOIRES JUVISE PHARMACEUTICALS
149 Boulevard Bataille de Stalingrad, 69100 Villeurbanne, France
|
EU/1/21/1550
|
18.2.2026
|
|
12.2.2026
|
Skyrizi
|
AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
EU/1/19/1361
|
13.2.2026
|
|
12.2.2026
|
Veoza
|
Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland
|
EU/1/23/1771
|
17.2.2026
|
|
12.2.2026
|
Yondelis
|
Pharma Mar S.A.
Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España
|
EU/1/07/417
|
18.2.2026
|
|
12.2.2026
|
Zynlonta
|
Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige
|
EU/1/22/1695
|
13.2.2026
|
|
16.2.2026
|
Abraxane
|
Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
EU/1/07/428
|
17.2.2026
|
|
16.2.2026
|
SIMBRINZA
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/14/933
|
17.2.2026
|
|
16.2.2026
|
Strensiq
|
Alexion Europe SAS
103-105 rue Anatole France, 92300 Levallois-Perret, France
|
EU/1/15/1015
|
18.2.2026
|
|
16.2.2026
|
Wegovy
|
Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/21/1608
|
17.2.2026
|
|
16.2.2026
|
Zabdeno
|
Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
|
EU/1/20/1444
|
17.2.2026
|
|
18.2.2026
|
Busulfan Fresenius Kabi
|
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
EU/1/14/951
|
19.2.2026
|
|
18.2.2026
|
Dimethyl fumarate Neuraxpharm
|
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
EU/1/24/1810
|
23.2.2026
|
|
18.2.2026
|
Irbesartan Zentiva
|
Zentiva k.s.
U kabelovny 130, 102 37 Praha 10, Česká republika
|
EU/1/06/376
|
23.2.2026
|
|
18.2.2026
|
Jylamvo
|
Oresund Pharma ApS
Orient Plads 1, 2150 Nordhavn, Danmark
|
EU/1/17/1172
|
20.2.2026
|
|
18.2.2026
|
Kinzalmono
|
Bayer AG
D-51368 Leverkusen, Deutschland
|
EU/1/98/091
|
19.2.2026
|
|
18.2.2026
|
Livmarli
|
Mirum Pharmaceuticals International B.V.
Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland
|
EU/1/22/1704
|
19.2.2026
|
|
18.2.2026
|
Micardis
|
Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
EU/1/98/090
|
19.2.2026
|
|
18.2.2026
|
Natpar
|
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
EU/1/15/1078
|
20.2.2026
|
|
18.2.2026
|
Pritor
|
Bayer AG
D-51368 Leverkusen, Deutschland
|
EU/1/98/089
|
19.2.2026
|
|
18.2.2026
|
Xevudy
|
GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland
|
EU/1/21/1562
|
19.2.2026
|
|
20.2.2026
|
Rybrevant
|
Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
|
EU/1/21/1594
|
23.2.2026
|
|
23.2.2026
|
Afinitor
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/538
|
24.2.2026
|
|
23.2.2026
|
Atazanavir Krka
|
KRKA d d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/19/1353
|
25.2.2026
|
|
23.2.2026
|
Balversa
|
Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
|
EU/1/24/1841
|
24.2.2026
|
|
23.2.2026
|
Copalia
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/372
|
24.2.2026
|
|
23.2.2026
|
Dafiro
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/371
|
24.2.2026
|
|
23.2.2026
|
Evkeeza
|
Ultragenyx Germany GmbH
Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland
|
EU/1/21/1551
|
24.2.2026
|
|
23.2.2026
|
Kadcyla
|
Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
EU/1/13/885
|
24.2.2026
|
|
23.2.2026
|
Obgemsa
|
PIERRE FABRE MEDICAMENT
Les Cauquillous, 81500 Lavaur, France
|
EU/1/24/1822
|
2.3.2026
|
|
23.2.2026
|
Ravicti
|
Immedica Pharma AB
SE-113 63, Stockholm, Sverige
|
EU/1/15/1062
|
2.3.2026
|
|
23.2.2026
|
Sitagliptin Accord
|
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/22/1633
|
25.2.2026
|
|
23.2.2026
|
Tabrecta
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/22/1650
|
24.2.2026
|
|
23.2.2026
|
TAKHZYRO
|
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
EU/1/18/1340
|
24.2.2026
|
|
23.2.2026
|
Telmisartan Actavis
|
Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
EU/1/10/639
|
25.2.2026
|
|
23.2.2026
|
Trazimera
|
Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/18/1295
|
24.2.2026
|
|
23.2.2026
|
Vectibix
|
Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland
|
EU/1/07/423
|
24.2.2026
|
|
23.2.2026
|
Viagra
|
Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland
|
EU/1/98/077
|
10.3.2026
|
|
23.2.2026
|
Vokanamet
|
Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
|
EU/1/14/918
|
24.2.2026
|
|
23.2.2026
|
Wilzin
|
Recordati Rare Diseases
Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France
|
EU/1/04/286
|
24.2.2026
|
|
25.2.2026
|
Bimzelx
|
UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
EU/1/21/1575
|
2.3.2026
|
|
25.2.2026
|
Bortezomib Fresenius Kabi
|
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
EU/1/19/1397
|
26.2.2026
|
|
25.2.2026
|
Exforge HCT
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/569
|
26.2.2026
|
|
25.2.2026
|
Neoatricon
|
BrePco Biopharma Ltd.
Suite One, The Avenue, Beacon Court, Sandyford, Dublin D18HX31, Ireland
|
EU/1/24/1804
|
27.2.2026
|
|
25.2.2026
|
Nexium Control
|
Haleon Ireland Dungarvan Limited
Knockbrack,Dungarvan, Co. Waterford, Ireland
|
EU/1/13/860
|
3.3.2026
|
|
25.2.2026
|
Nimenrix
|
Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/12/767
|
26.2.2026
|
|
25.2.2026
|
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
|
26.2.2026
|
|
25.2.2026
|
Oslif Breezhaler
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/586
|
26.2.2026
|
|
25.2.2026
|
Strimvelis
|
Fondazione Telethon ETS
Via Varese 16/B, 00185 Roma, Italia
|
EU/1/16/1097
|
26.2.2026
|
|
25.2.2026
|
Suliqua
|
Sanofi Winthrop Industrie
82 avenue Raspail, 94250 Gentilly, France
|
EU/1/16/1157
|
26.2.2026
|
|
25.2.2026
|
Ultibro Breezhaler
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/13/862
|
26.2.2026
|
|
26.2.2026
|
Copalia HCT
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/575
|
27.2.2026
|
|
26.2.2026
|
Dafiro HCT
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/574
|
27.2.2026
|
|
26.2.2026
|
Exforge
|
Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/370
|
27.2.2026
|
|
26.2.2026
|
Incellipan
|
Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
EU/1/24/1807
|
2.3.2026
|
|
26.2.2026
|
Pepaxti
|
Oncopeptides AB (publ)
Luntmakargatan 46, 111 37 Stockholm, Sverige
|
EU/1/22/1669
|
3.3.2026
|
|
26.2.2026
|
Thiotepa Riemser
|
Esteve Pharmaceuticals GmbH
Hohenzollerndamm 150-151, 14199 Berlin, Deutschland
|
EU/1/21/1536
|
27.2.2026
|
|
