In this dataset you can find medicines that have been evaluated by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and are currently pending a decision by the European Commission.
When a pharmaceutical company applies for marketing authorisation through the Centralised authorisation procedure, the CHMP gives a positive or negative recommendation, in the form of a scientific opinion, on whether a medicine should be authorised. Immediately after the opinion is adopted, the EMA publishes a 'summary of opinion'.
This summary is replaced by a full European Public Assessment Report (EPAR) once the European Commission has decided - taking the EMA opinion into consideration - whether to grant the marketing authorisation.
Summaries of opinion are also published when the CHMP adopts scientific opinions on important changes to an existing marketing authorisation applied for by the pharmaceutical company.
Search results can be exported in Excel format.
- Data de publicação
- Data de alteração
- Cobertura geográfica
- Roménia, Eslováquia, Eslovénia, Suécia, Malta, Países Baixos, Polónia, Portugal, Bélgica, Áustria, Chipre, Bulgária, Alemanha, Chéquia, Espanha, Dinamarca, Finlândia, Estónia, Reino Unido, França, Croácia, Grécia, Irlanda, Hungria, Lituânia, Itália, Letónia, Luxemburgo
- European Union Open Data Portal
European Medicines Agency