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Wednesday, April 18, 2018 4:05:36 AM
EMA/216799/2018
Information Management Division
Applications for new human medicines under evaluation
by the Committee for Medicinal Products for Human Use
April 2018
This document lists information on applications for centralised marketing authorisation for human
medicines that the European Medicines Agency has received for evaluation. It includes the international
non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation
by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines,
it includes the INN (active moiety only, with no information on salt, ester or derivative) and
therapeutic area.
This list only includes information for medicines whose applications have been validated at the time the
report was compiled. The information in this report was compiled on 5 April 2018.
Information on designated orphan medicines that are being assessed for marketing authorisation is
also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
Information in bold corresponds to new entries in the monthly list.
Entries are removed from this list once the medicine has received a positive or negative opinion from
the CHMP or when the applicant has withdrawn the application. The Agency publishes information on
these opinions and withdrawn applications on its website.
Information on CHMP opinions is also published in the monthly CHMP highlights.
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