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559 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Summaries of opinion Remove Summaries of opinion filter Referrals Remove Referrals filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009, , Revision: 16, Authorised, Last updated: 05/03/2021
List item

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

pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016, , Revision: 6, Authorised, Last updated: 05/03/2021
List item

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: 3, Authorised, Last updated: 04/03/2021
List item

Human medicine European public assessment report (EPAR): 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, , , Authorised, Last updated: 04/03/2021
List item

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

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 9, Authorised, Last updated: 03/03/2021
List item

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

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
List item

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

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 10, Authorised, Last updated: 01/03/2021
List item

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017, , Revision: 10, Authorised, Last updated: 01/03/2021
List item

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

Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019, , Revision: 5, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012, , Revision: 11, Authorised, Last updated: 01/03/2021
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: 8, Authorised, Last updated: 01/03/2021
List item

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

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012, , Revision: 6, Authorised, Last updated: 26/02/2021
List item

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

Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014, , Revision: 21, Authorised, Last updated: 26/02/2021
List item

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

velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010, , , Revision: 14, Authorised, Last updated: 26/02/2021
List item

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

lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009, , Revision: 10, Authorised, Last updated: 26/02/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009, , Revision: 16, Authorised, Last updated: 26/02/2021
List item

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

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 23, Authorised, Last updated: 26/02/2021
List item

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

entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017, , Revision: 3, Authorised, Last updated: 25/02/2021
List item

Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)

6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, , Revision: 11, Authorised, Last updated: 25/02/2021
List item

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

pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 28/08/2015, , Revision: 9, Authorised, Last updated: 24/02/2021
List item

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

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 14, Authorised, Last updated: 24/02/2021
List item

Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)

Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011, , Revision: 17, Authorised, Last updated: 24/02/2021
List item

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

migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 11, Authorised, Last updated: 23/02/2021
List item

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

albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016, , , Revision: 9, Authorised, Last updated: 23/02/2021
List item

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)

emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017, , Revision: 7, Authorised, Last updated: 22/02/2021

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559 results

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

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

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

Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)

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

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

Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)

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

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

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)