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620 results

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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filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Generic Remove Generic filter Exceptional circumstances Remove Exceptional circumstances filter Conditional approval Remove Conditional approval filter

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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): 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
List item

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

sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015, , , , Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Maviret (updated)

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , , Revision: 16, Authorised, Last updated: 20/06/2022
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Human medicine European public assessment report (EPAR): Carvykti (updated)

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)

dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022, , Revision: 01, Authorised, Last updated: 17/06/2022
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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: 12, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)

gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018, , Revision: 5, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 17, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , , Revision: 20, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA 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: 21/12/2020, , , , Revision: 25, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , , Revision: 21, Authorised, Last updated: 17/06/2022
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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: 23, Authorised, Last updated: 17/06/2022
List item

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

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 14, Authorised, Last updated: 17/06/2022

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620 results

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): Sildenafil ratiopharm (updated)

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)

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

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

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

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

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

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

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

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

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