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431 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter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

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

etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016, , , Revision: 12, Authorised, Last updated: 30/11/2020
List item

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

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 2, Authorised, Last updated: 30/11/2020
List item

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

pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/05/2018, , Revision: 3, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)

emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016, , Revision: 7, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma) (updated)

clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009, , Revision: 19, Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Retacrit (updated)

epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer
Date of authorisation: 18/12/2007, , Revision: 27, Authorised, Last updated: 26/11/2020
List item

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

sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016, , Revision: 4, Authorised, Last updated: 26/11/2020
List item

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

etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 2, Authorised, Last updated: 26/11/2020
List item

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

efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018, , Revision: 5, Authorised, Last updated: 26/11/2020
List item

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

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 13, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Zercepac (updated)

trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020, , , Revision: 1, Authorised, Last updated: 26/11/2020
List item

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

bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019, , , Revision: 6, Authorised, Last updated: 26/11/2020
List item

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

lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011, , Revision: 11, Authorised, Last updated: 25/11/2020
List item

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

epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic
Date of authorisation: 18/12/2007, , Revision: 17, Authorised, Last updated: 25/11/2020
List item

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

posaconazole, Mycoses
Date of authorisation: 25/07/2019, , Revision: 1, Authorised, Last updated: 24/11/2020
List item

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

docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/01/2010, , Revision: 18, Authorised, Last updated: 23/11/2020
List item

Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 11, Authorised, Last updated: 23/11/2020
List item

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

Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009, , Revision: 14, Authorised, Last updated: 23/11/2020
List item

Human medicine European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers) (updated)

Ribavirin, Hepatitis C, Chronic
Date of authorisation: 10/06/2010, , Revision: 10, Withdrawn, Last updated: 23/11/2020
List item

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

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 24/08/2017, , , Revision: 13, Authorised, Last updated: 20/11/2020
List item

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

zoledronic acid monohydrate, Fractures, Bone, Cancer
Date of authorisation: 03/08/2012, , Revision: 13, Authorised, Last updated: 20/11/2020
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: 6, Authorised, Last updated: 20/11/2020
List item

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

lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016, , Revision: 10, Authorised, Last updated: 20/11/2020
List item

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

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 1, Authorised, Last updated: 19/11/2020
List item

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

infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 26, Authorised, Last updated: 18/11/2020

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431 results

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

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

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

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

Human medicine European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma) (updated)

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

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

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

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

Human medicine European public assessment report (EPAR): Ribavirin Mylan (previously Ribavirin Three Rivers) (updated)

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

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

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

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

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

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