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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,
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, 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
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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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Human medicine European public assessment report (EPAR): Lunsumio (updated)
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
, , Revision: 2, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Givlaari (updated)
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 4, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 17, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Ryeqo (updated)
relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,, Revision: 3, Authorised, Last updated: 22/06/2022
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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: 1, Authorised, Last updated: 21/06/2022