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408 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter

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Human medicine European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya) (updated)

clopidogrel (as hydrochloride),
Date of authorisation: 20/09/2009, , Revision: 12, Authorised, Last updated: 30/07/2021
List item

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

sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016, , Revision: 4, Authorised, Last updated: 30/07/2021
List item

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

azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020, , Revision: 2, Authorised, Last updated: 29/07/2021
List item

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

levetiracetam, Epilepsy
Date of authorisation: 03/10/2011, , Revision: 23, Authorised, Last updated: 29/07/2021
List item

Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) (updated)

pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 24/04/2017, , Revision: 7, Withdrawn, Last updated: 29/07/2021
List item

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

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Orphacol (updated)

cholic acid, Digestive System Diseases, Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , , Revision: 10, Authorised, Last updated: 28/07/2021
List item

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

pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018, , , Revision: 7, Authorised, Last updated: 26/07/2021
List item

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

lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020, , Revision: 2, Authorised, Last updated: 26/07/2021
List item

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

tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014, , Revision: 12, Authorised, Last updated: 26/07/2021
List item

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

rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016, , Revision: 4, Authorised, Last updated: 23/07/2021
List item

Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019, , , Revision: 5, Authorised, Last updated: 22/07/2021
List item

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

filgrastim, Neutropenia
Date of authorisation: 17/09/2014, , Revision: 12, Authorised, Last updated: 22/07/2021
List item

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)

tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016, , Revision: 10, Authorised, Last updated: 22/07/2021
List item

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

emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016, , Revision: 6, Authorised, Last updated: 21/07/2021
List item

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

Apixaban, Venous Thromboembolism, Stroke, Arthroplasty
Date of authorisation: 23/07/2020, , Revision: 1, Authorised, Last updated: 21/07/2021
List item

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

lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011, , Revision: 13, Authorised, Last updated: 20/07/2021
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: 27, Authorised, Last updated: 20/07/2021
List item

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

miglustat, Gaucher Disease
Date of authorisation: 18/02/2019, , Revision: 3, Authorised, Last updated: 20/07/2021
List item

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

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 2, Authorised, Last updated: 20/07/2021
List item

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

ioflupane (123l), Radionuclide Imaging, Dementia, Movement Disorders
Date of authorisation: 25/06/2019, , Revision: 1, Authorised, Last updated: 16/07/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel TAD (updated)

clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009, , Revision: 13, Authorised, Last updated: 16/07/2021
List item

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

levetiracetam, Epilepsy
Date of authorisation: 07/01/2014, , Revision: 18, Authorised, Last updated: 16/07/2021
List item

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

pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 14/09/2015, , Revision: 6, Authorised, Last updated: 14/07/2021
List item

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

adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 17/09/2018, , , Revision: 7, Authorised, Last updated: 13/07/2021

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408 results

Human medicine European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya) (updated)

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

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

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

Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) (updated)

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)

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

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Clopidogrel TAD (updated)

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

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

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