EMA Agenzia Europea per i Medicinali
Product Information: (Pr. In.) Summary for the Public (Su. Pu.)
Signal Assessment Report (Si. As.)
Paediatric Investigation Plan Compliance Statement (Pa. In.)
Committee for Medical Products for Human Use (Co. Me.)
All
Authorised Presentations: (A.A.P.)
Procedural Steps Taken and Scientific Information After Authorisation: (Pr. St.) Summary of Risk Management Plan (Su. Ri.) Orphan Maintenance Assessment Report (Or. Ma.)
Conditions Imposed: (Co.
In.) Risk Management Plan: (Ri. Ma.) Scientific
Conclusions and Grounds for the Variation to the Terms of the Marketing Autorisation: (Sc. Co.) Medicine
Overview: (Me. Ov.)
Post Authorisation Summary of Positive Opinion: (Po. St.)
Conclusions on the Granting of the Conditional Marketing Authorisation: (Co. Gr.)
Public Assessment Report: (Pu. As.)
Periodic Safety Updated Report Assessment (Pe. Sa.) Supply Shortage (Su. Sh.)
Amendments to relevant sections of the product information (A. R. S.)
Assessment
Report Variation: (As. Re.)