17911 results
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015, Revision: 11, Authorised, Last updated: 26/02/2021 -
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Veterinary medicine European public assessment report (EPAR): Evalon (updated)
vaccine against coccidiosis in chickens, Chicken
Date of authorisation: 18/04/2016, Revision: 2, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 20, Authorised, Last updated: 26/02/2021 -
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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
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Human medicine European public assessment report (EPAR): Fareston (updated)
toremifene, Breast Neoplasms
Date of authorisation: 14/02/1996, Revision: 23, Authorised, Last updated: 26/02/2021 -
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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,
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, Revision: 3, Authorised, Last updated: 25/02/2021
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COVID-19: latest updates (updated)
Last updated: 25/02/2021 -
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COVID-19 vaccines: key facts (updated)
Last updated: 25/02/2021 -
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COVID-19 guidance: assessment and marketing authorisation (updated)
Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Revolade (updated)
Eltrombopag, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 11/03/2010, Revision: 26, Authorised, Last updated: 25/02/2021 -
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Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2
Last updated: 25/02/2021 -
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News: Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
CHMP, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 45, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 4, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging, Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 16, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Tesavel (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 24, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 2, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021 -
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Referral: Amfepramone-containing medicinal products (updated)
amfepramone, associated names: regenon, Regenon Retard, Tenuate, Article 31 referrals
Status: Procedure started, Last updated: 25/02/2021 -
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Minor use / minor species and limited markets (updated)
Last updated: 25/02/2021 -
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Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (updated)
Last updated: 25/02/2021 -
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Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6
Last updated: 25/02/2021 -
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Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
Last updated: 25/02/2021 -
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Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
Last updated: 25/02/2021 -
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Safety and residue data requirements for the establishment of maximum residue limits in minor species
Last updated: 25/02/2021