19790 results
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Reporting safety information on clinical trials (updated)
Last updated: 29/03/2025 -
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Assessment templates and guidance (veterinary medicines) (new)
Last updated: 10/03/2025 -
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Crisis preparedness and management (updated)
Last updated: 13/02/2025 -
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Medicines Shortages Single Point of Contact (SPOC) Working Party (new)
Last updated: 26/09/2024 -
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Human medicine European public assessment report (EPAR): Abiraterone Krka (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,
, Revision: 1, Authorised, Last updated: 06/07/2022
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COVID-19: latest updates (updated)
Last updated: 06/07/2022 -
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Human medicine European public assessment report (EPAR): Harvoni (updated)
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): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 22, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Sovaldi (updated)
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): Paxlovid (updated)
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 2, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Epclusa (updated)
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): Gardasil 9 (updated)
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata; Papillomavirus Infections; Immunization; Uterine Cervical Dysplasia
Date of authorisation: 10/06/2015, Revision: 18, Authorised, Last updated: 06/07/2022 -
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EMA workshop on thrombosis with thrombocytopenia syndrome (new)
Online, 27/06/2022, Last updated: 06/07/2022 -
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Human medicine European public assessment report (EPAR): Gardasil (updated)
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
Date of authorisation: 20/09/2006, Revision: 47, Authorised, Last updated: 06/07/2022 -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)
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 (updated)
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): Dificlir (updated)
fidaxomicin, Clostridium Infections
Date of authorisation: 05/12/2011, Revision: 16, Authorised, Last updated: 06/07/2022 -
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Human medicine European public assessment report (EPAR): Alymsys (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, 
, Revision: 3, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Ucedane (updated)
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): Sogroya (updated)
Somapacitan, Growth
Date of authorisation: 31/03/2021,, 
, Revision: 1, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Vectibix (updated)
panitumumab, Colorectal Neoplasms
Date of authorisation: 03/12/2007, Revision: 34, Authorised, Last updated: 06/07/2022 -
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Digital application dataset integration (DADI) Q&A webinar - variations form for human medicinal products (new)
Online, 11:00 - 12:30 Amsterdam time (CEST), 12/07/2022, Last updated: 06/07/2022 -
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Human medicine European public assessment report (EPAR): Iressa (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 15, Authorised, Last updated: 05/07/2022 -
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Human medicine European public assessment report (EPAR): Lyrica (updated)
pregabalin, Epilepsy; Anxiety Disorders; Neuralgia
Date of authorisation: 05/07/2004, Revision: 57, Authorised, Last updated: 05/07/2022 -
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Human medicine European public assessment report (EPAR): Nerlynx (updated)
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 11, Authorised, Last updated: 05/07/2022