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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

Medicine type Orphan medicine Remove Orphan medicine filter Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter Generic Remove Generic filter

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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)

Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023, , Authorised, Last updated: 31/05/2023
List item

Human medicine European public assessment report (EPAR): Epysqli (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023, , , Authorised, Last updated: 31/05/2023
List item

Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021, , , Revision: 37, Authorised, Last updated: 31/05/2023
List item

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017, , Revision: 15, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)

sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022, , Revision: 2, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016, , Revision: 7, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020, , Revision: 3, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Ondexxya (updated)

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 15, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Jyseleca (updated)

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , , Revision: 9, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 11, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)

rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021, , Revision: 3, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Pombiliti (updated)

Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023, , Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Qinlock (updated)

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 3, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Procysbi (updated)

mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013, , Revision: 16, Authorised, Last updated: 26/05/2023
List item

Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 8, Authorised, Last updated: 26/05/2023
List item

Human medicine European public assessment report (EPAR): Breyanzi (updated)

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Revision: 1, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Livmarli (updated)

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Revision: 1, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Galafold (updated)

Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 16, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 33, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Nexviadyme (updated)

Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022, , Revision: 2, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)

lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016, , Revision: 16, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Epidyolex (updated)

Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019, , Revision: 14, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 19, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Alofisel (updated)

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 10, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , , Revision: 8, Authorised, Last updated: 23/05/2023

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1103 results

Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)

Human medicine European public assessment report (EPAR): Epysqli (updated)

Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

Human medicine European public assessment report (EPAR): Ondexxya (updated)

Human medicine European public assessment report (EPAR): Jyseleca (updated)

Human medicine European public assessment report (EPAR): Zolgensma (updated)

Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)

Human medicine European public assessment report (EPAR): Pombiliti (updated)

Human medicine European public assessment report (EPAR): Qinlock (updated)

Human medicine European public assessment report (EPAR): Procysbi (updated)

Human medicine European public assessment report (EPAR): Beovu (updated)

Human medicine European public assessment report (EPAR): Breyanzi (updated)

Human medicine European public assessment report (EPAR): Livmarli (updated)

Human medicine European public assessment report (EPAR): Galafold (updated)

Human medicine European public assessment report (EPAR): Evoltra (updated)

Human medicine European public assessment report (EPAR): Nexviadyme (updated)

Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)

Human medicine European public assessment report (EPAR): Epidyolex (updated)

Human medicine European public assessment report (EPAR): Kisplyx (updated)

Human medicine European public assessment report (EPAR): Alofisel (updated)

Human medicine European public assessment report (EPAR): Semglee (updated)