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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021, , Revision: 2, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)

tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014, , Revision: 14, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Memantine ratiopharm (updated)

memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013, , Revision: 8, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): HyQvia (updated)

Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013, , Revision: 18, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 13, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Keytruda (updated)

Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, , Revision: 46, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan (updated)

ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019, , Revision: 3, Authorised, Last updated: 29/06/2022
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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: 24, Authorised, Last updated: 29/06/2022
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Human medicine European public assessment report (EPAR): Prasugrel Mylan (updated)

prasugrel besilate, Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
Date of authorisation: 15/05/2018, , Revision: 8, Authorised, Last updated: 28/06/2022
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)

sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009, , Revision: 15, Authorised, Last updated: 28/06/2022
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)

Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020, , , Revision: 4, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Vocabria (updated)

Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020, , Revision: 5, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Ozempic (updated)

semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018, , Revision: 8, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 25, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)

azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020, , Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 17, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma (updated)

Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022, , Revision: 1, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)

desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012, , Revision: 12, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)

zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012, , Revision: 13, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Libmeldy (updated)

atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020, , , Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm (updated)

sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009, , Revision: 19, Authorised, Last updated: 24/06/2022
List item

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

imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013, , Revision: 23, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Erleada (updated)

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 7, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Myfenax (updated)

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 26, Authorised, Last updated: 23/06/2022

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995 results

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

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

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

Human medicine European public assessment report (EPAR): Memantine ratiopharm (updated)

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)

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

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

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

Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)

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

Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

Human medicine European public assessment report (EPAR): Sapropterin Dipharma (updated)

Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)

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

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

Human medicine European public assessment report (EPAR): Sildenafil ratiopharm (updated)

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

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

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