European Medicines Agency - EMEA (EU)
09/18/2020 08:39
Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b.
Search Results
European Medicines Agency - EMEA (EU)
09/18/2020 08:30
Minutes of the CVMP meeting of 14-16 July 2020 meeting.
European Medicines Agency - EMEA (EU)
09/18/2020 06:55
Summary of opinion: Yervoy,ipilimumab, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Tecentriq,atezolizumab, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Supemtek,quadrivalent influenza vaccine (recombinant, prepared in cell culture), 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Fycompa,perampanel, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Olumiant,baricitinib, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
EMA has recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria in adult patients. This rare...
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Flucelvax Tetra,influenza vaccine surface antigen inactivated prepared in cell cultures, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Kalydeco,ivacaftor, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Nyvepria,pegfilgrastim, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Orfadin,nitisinone, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Zejula,niraparib, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Scientific advice and protocol assistance adopted during the CHMP meeting 14-17 September 2020.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Withdrawn application: Upkanz, deferiprone, Date of withdrawal: 10/08/2020, Initial authorisation.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Deltyba,delamanid, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Symkevi,tezacaftor / ivacaftor, 17/09/2020, Negative.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Opdivo,nivolumab, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
Summary of opinion: Phelinun,melphalan, 17/09/2020, Positive.
European Medicines Agency - EMEA (EU)
09/18/2020 06:00
EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in...
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