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448 results
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,
, Revision: 8, Authorised, Last updated: 15/07/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
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, Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Clopidogrel TAD
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
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, , , 
, Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 11, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 1, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 25, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Ucedane
carglumic acid, Hyperammonemia; Amino Acid Metabolism, Inborn Errors
Date of authorisation: 23/06/2017,, Revision: 11, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 13, Withdrawn, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 18, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 6, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 17, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 13, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 18, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 12, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 16, Authorised, Last updated: 01/07/2022
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 14, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Memantine ratiopharm
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 8, Authorised, Last updated: 30/06/2022