|
—
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Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt
|
Dato for afgørelser
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Lægemidlets navn
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Indehaver af markedsføringstilladelsen
|
Nummer i EF-registret
|
Dato for notifikation
|
|
2.9.2025
|
Bronchitol
|
|
Pharmaxis Europe Limited
|
|
108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
|
|
EU/1/12/760
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4.9.2025
|
|
2.9.2025
|
Edarbi
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/11/734
|
3.9.2025
|
|
2.9.2025
|
Qoyvolma
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/25/1925
|
10.9.2025
|
|
2.9.2025
|
Steglujan
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/18/1266
|
3.9.2025
|
|
2.9.2025
|
Tevagrastim
|
|
Teva GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/08/445
|
5.9.2025
|
|
2.9.2025
|
Yuflyma
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/20/1513
|
3.9.2025
|
|
8.9.2025
|
Bexsero
|
|
GlaxoSmithKline Vaccines S.r.l.
|
|
Via Fiorentina, 1, 53100 Siena, Italia
|
|
EU/1/12/812
|
9.9.2025
|
|
8.9.2025
|
Dectova
|
|
GlaxoSmithKline Trading Services Limited
|
|
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland
|
|
EU/1/18/1349
|
10.9.2025
|
|
8.9.2025
|
ELREXFIO
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1770
|
10.9.2025
|
|
8.9.2025
|
Helicobacter Test INFAI
|
|
INFAI GmbH
|
|
An der Kohlenbahn 39, D-58135 Hagen, Deutschland
|
|
EU/1/97/045
|
16.9.2025
|
|
8.9.2025
|
Jaypirca
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/23/1738
|
12.9.2025
|
|
8.9.2025
|
Ninlaro
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/16/1094
|
9.9.2025
|
|
8.9.2025
|
Otulfi
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/24/1863
|
10.9.2025
|
|
8.9.2025
|
Rapamune
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/01/171
|
10.9.2025
|
|
8.9.2025
|
Rukobia
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/20/1518
|
9.9.2025
|
|
8.9.2025
|
Vumerity
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/21/1585
|
10.9.2025
|
|
11.9.2025
|
Azacitidine Kabi
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/23/1777
|
15.9.2025
|
|
11.9.2025
|
EVUSHELD
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/22/1651
|
12.9.2025
|
|
11.9.2025
|
Imatinib Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/13/845
|
16.9.2025
|
|
11.9.2025
|
Imraldi
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/17/1216
|
15.9.2025
|
|
11.9.2025
|
Omlyclo
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/24/1817
|
16.9.2025
|
|
11.9.2025
|
Pioglitazone Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/11/722
|
16.9.2025
|
|
11.9.2025
|
Pregabalin Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/15/1027
|
16.9.2025
|
|
11.9.2025
|
Rivastigmine Actavis
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/11/693
|
12.9.2025
|
|
11.9.2025
|
Segluromet
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/18/1265
|
12.9.2025
|
|
11.9.2025
|
Steglatro
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/18/1267
|
17.9.2025
|
|
11.9.2025
|
Steqeyma
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/24/1844
|
12.9.2025
|
|
12.9.2025
|
IXCHIQ
|
|
Valneva Austria GmbH
|
|
Campus Vienna Biocenter 3, 1030 Wien, Österreich
|
|
EU/1/24/1828
|
15.9.2025
|
|
15.9.2025
|
Apexelsin
|
|
WhiteOak Pharmaceutical B.V.
|
|
Teleportboulevard 130, Amsterdam, 1043 EJ, Nederland
|
|
EU/1/24/1835
|
18.9.2025
|
|
15.9.2025
|
AUBAGIO
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/13/838
|
16.9.2025
|
|
15.9.2025
|
JEMPERLI
|
|
GlaxoSmithKline Trading Services Limited
|
|
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
|
|
EU/1/21/1538
|
16.9.2025
|
|
15.9.2025
|
mRESVIA
|
|
MODERNA BIOTECH SPAIN, S.L.
|
|
C/ Julián Camarillo no 31, 28037 Madrid, España
|
|
EU/1/24/1849
|
16.9.2025
|
|
15.9.2025
|
Ogluo
|
|
Strongbridge Dublin Limited
|
|
25 North Wall Quay, Dublin 1, Co. Dublin, D01 H104, Ireland
|
|
EU/1/20/1523
|
17.9.2025
|
|
15.9.2025
|
Ratiograstim
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/08/444
|
16.9.2025
|
|
15.9.2025
|
Rybelsus
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/20/1430
|
16.9.2025
|
|
15.9.2025
|
Skyclarys
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/23/1786
|
16.9.2025
|
|
15.9.2025
|
Tecfidera
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/13/837
|
16.9.2025
|
|
15.9.2025
|
Zoely
|
|
Theramex Ireland Limited
|
|
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland
|
|
EU/1/11/690
|
18.9.2025
|
|
15.9.2025
|
Zyprexa
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/96/022
|
17.9.2025
|
|
17.9.2025
|
Azacitidine Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/19/1413
|
18.9.2025
|
|
17.9.2025
|
Cejemly
|
|
CStone Pharmaceuticals Ireland Limited
|
|
117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland
|
|
EU/1/24/1833
|
18.9.2025
|
|
17.9.2025
|
Efmody
|
|
Neurocrine Netherlands B.V.
|
|
Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland
|
|
EU/1/21/1549
|
29.9.2025
|
|
17.9.2025
|
Epidyolex
|
|
Jazz Pharmaceuticals Ireland Ltd
|
|
5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland
|
|
EU/1/19/1389
|
22.9.2025
|
|
17.9.2025
|
Ervebo
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/19/1392
|
18.9.2025
|
|
17.9.2025
|
Evrenzo
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1574
|
3.10.2025
|
|
17.9.2025
|
Idacio
|
|
Fresenius Kabi Deutschland GmbH
|
|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
|
|
EU/1/19/1356
|
18.9.2025
|
|
17.9.2025
|
Jayempi
|
|
Lipomed GmbH
|
|
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
|
|
EU/1/21/1557
|
18.9.2025
|
|
17.9.2025
|
Kentera
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/03/270
|
18.9.2025
|
|
17.9.2025
|
Klisyri
|
|
Almirall, S.A.
|
|
Ronda General Mitre, 151, 08022 Barcelona, España
|
|
EU/1/21/1558
|
22.9.2025
|
|
17.9.2025
|
Lenalidomide Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/18/1316
|
18.9.2025
|
|
17.9.2025
|
Loargys
|
|
Immedica Pharma AB
|
|
SE-113 63, Stockholm, Sverige
|
|
EU/1/23/1774
|
18.9.2025
|
|
17.9.2025
|
Minjuvi
|
|
Incyte Biosciences Distribution B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/21/1570
|
18.9.2025
|
|
17.9.2025
|
Orkambi
|
|
Vertex Pharmaceuticals (Ireland) Limited
|
|
Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland
|
|
EU/1/15/1059
|
18.9.2025
|
|
17.9.2025
|
Ozempic
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/17/1251
|
18.9.2025
|
|
17.9.2025
|
Padcev
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1615
|
18.9.2025
|
|
17.9.2025
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
|
18.9.2025
|
|
17.9.2025
|
TUKYSA
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/20/1526
|
18.9.2025
|
|
19.9.2025
|
BIMERVAX
|
|
Hipra Human Health, S.L.U.
|
|
Avda. la Selva, 135, 17170 Amer (Girona), España
|
|
EU/1/22/1709
|
22.9.2025
|
|
22.9.2025
|
Hepcludex
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/20/1446
|
23.9.2025
|
|
22.9.2025
|
Kinzalkomb
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/02/214
|
24.9.2025
|
|
22.9.2025
|
Phesgo
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/20/1497
|
23.9.2025
|
|
24.9.2025
|
Biktarvy
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/18/1289
|
25.9.2025
|
|
24.9.2025
|
Dovprela
|
|
Mylan IRE Healthcare Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
|
|
EU/1/20/1437
|
29.9.2025
|
|
24.9.2025
|
Gliolan
|
|
photonamic GmbH & Co. KG
|
|
Eggerstedter Weg 12, 25421 Pinneberg, Deutschland
|
|
EU/1/07/413
|
25.9.2025
|
|
24.9.2025
|
Ilaris
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/564
|
25.9.2025
|
|
24.9.2025
|
Imatinib Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/12/808
|
25.9.2025
|
|
24.9.2025
|
Lytenava
|
|
Outlook Therapeutics Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/24/1798
|
25.9.2025
|
|
24.9.2025
|
Onivyde pegylated liposomal
|
|
Les Laboratoires Servier
|
|
50 rue Carnot, 92284 Suresnes Cedex, France
|
|
EU/1/16/1130
|
29.9.2025
|
|
24.9.2025
|
Opfolda
|
|
Amicus Therapeutics Europe Limited
|
|
Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland
|
|
EU/1/23/1737
|
26.9.2025
|
|
24.9.2025
|
PritorPlus
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/02/215
|
2.10.2025
|
|
24.9.2025
|
Spikevax
|
|
MODERNA BIOTECH SPAIN, S.L.
|
|
C/ Julián Camarillo no 31, 28037 Madrid, España
|
|
EU/1/20/1507
|
25.9.2025
|
|
24.9.2025
|
Vyndaqel
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/11/717
|
26.9.2025
|
|
29.9.2025
|
Orphacol
|
|
THERAVIA
|
|
16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
|
|
EU/1/13/870
|
16.10.2025
|
|
29.9.2025
|
Stayveer
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/13/832
|
30.9.2025
|
|
29.9.2025
|
Striascan
|
|
CIS bio international
|
|
RN 306 – Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France
|
|
EU/1/19/1372
|
1.10.2025
|
|
29.9.2025
|
Tracleer
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/02/220
|
30.9.2025
|
|
30.9.2025
|
LEQEMBI
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/24/1891
|
30.9.2025
|
|
