238 results
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Nulojix
belatacept, Graft Rejection; Kidney Transplantation
Date of authorisation: 17/06/2011, Revision: 20, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Sirturo (updated)
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,
, 
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, Revision: 21, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Emtriva
emtricitabine, HIV Infections
Date of authorisation: 24/10/2003, Revision: 33, Authorised, Last updated: 18/04/2023 -
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Human medicine European public assessment report (EPAR): Rapamune
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022 -
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National expert: Ewa Marta Smidova Molska, Danish Medicines Agency (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 24.98 KB | PDF
Jérôme O Rouvière, Guifen Wu, Carina Demel, Björn Schwalb, Manfred … -
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Opzelura
ruxolitinib phosphate, Vitiligo
Date of authorisation: 19/04/2023, Authorised, Last updated: 20/04/2023 -
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Human medicine European public assessment report (EPAR): Celsentri
maraviroc, HIV Infections
Date of authorisation: 18/09/2007, Revision: 28, Authorised, Last updated: 22/08/2022 -
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,
, Revision: 42, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Ximluci
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, 
, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 30, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Combivir
lamivudine, zidovudine, HIV Infections
Date of authorisation: 18/03/1998, Revision: 37, Authorised, Last updated: 29/08/2022 -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Cancidas (previously Caspofungin MSD)
caspofungin (as acetate), Candidiasis; Aspergillosis
Date of authorisation: 23/10/2001, Revision: 30, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Crixivan
indinavir sulfate ethanolate, HIV Infections
Date of authorisation: 04/10/1996, Revision: 39, Withdrawn, Last updated: 12/07/2022 -
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Human medicine European public assessment report (EPAR): Viramune
nevirapine, HIV Infections
Date of authorisation: 04/02/1998, Revision: 44, Authorised, Last updated: 21/04/2023 -
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National expert: Gergana Kirkova, Bulgarian Agency For Food Safety (updated)
- Declaration of interests - 39.32 KB | PDF
- Curriculum Vitae - 24.73 KB | PDF
medicine, infection diseases, pet caring, pharmacy, vital monitoring … -
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Human medicine European public assessment report (EPAR): Lydisilka
estetrol monohydrate, drospirenone, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 3, Authorised, Last updated: 31/03/2023 -
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Human medicine European public assessment report (EPAR): Drovelis
drospirenone, estetrol monohydrate, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 4, Authorised, Last updated: 31/03/2023 -
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Human medicine European public assessment report (EPAR): Ziagen
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 46, Authorised, Last updated: 29/08/2022 -
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Human medicine European public assessment report (EPAR): Epivir
lamivudine, HIV Infections
Date of authorisation: 08/08/1996, Revision: 50, Authorised, Last updated: 29/08/2022 -
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Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 68, Authorised, Last updated: 18/10/2022 -
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Human medicine European public assessment report (EPAR): Rukobia
fostemsavir trometamol, HIV Infections
Date of authorisation: 04/02/2021,, Revision: 3, Authorised, Last updated: 22/08/2022