Find the following types of information on medicines in the table below:
- Approved medicines
- Withdrawn applications for new marketing authorisations
- Status of opinions
As of 14 August 2024, you can find a table that includes information on authorised medicines, withdrawn applications, and pending opinions in the 'Medicines' section. A table with information on post-authorisation procedures is available in the 'Post-authorisation procedures for medicines' section.
You can download data related to medicines published on EMA's website in table format. The website automatically updates these data tables overnight.
To stay up-to-date with new and updated information on this website, see:
Find the following types of information on medicines in the table below:
All relevant information and documents on medicines authorised at a European Union (EU) level are available on medicine pages. This includes:
These pages also contain information on medicines for which the European Commission has refused a marketing authorisation, or has suspended or withdrawn the marketing authorisation after approval.
For more information, see:
Find information on opinions on post-authorisation procedures and withdrawn applications in the table below.
Download post-authorisation procedures for medicines data tableDuring the post-authorisation stage of a medicine life-cycle, marketing authorisation holders can submit an application to change the terms of marketing authorisation. This is known as a variation.
At any stage of the assessment process, applicants can withdraw the application to EMA.
Information on approved post-authorisation procedures is available on medicine pages.
For more information, see:
Find information on all ongoing and completed referrals in the table below.
Download referrals data tableFor more information, see:
Find information on decisions related to paediatric investigation plans following evaluation from the Paediatric Committee (PDCO) in the table below.
Download paediatric investigation plans data tableFor more information, see:
Find information on the status of orphan designations following assessment from the Committee for Orphan Medicinal Products (COMP) in the table below.
Download orphan designations data tableFor more information, see:
Find information on the regulatory outcomes of periodic safety update report single assessments (PSUSAs) in the table below.
Download period safety update report single assessments data tableMarketing authorisation holders periodically submit PSURs following a medicine's authorisation. EMA and national competent authorities carry out a single joint assessment of all medicines containing the same active substance or combination of active substances to determine if there is a need to update marketing authorisations.
For more information, see:
Find information on direct healthcare professional communication (DHPCs) for human and veterinary medicines in the table below. These contain important new safety information about a medicine, including recommended actions that healthcare professionals should take.
Download direct healthcare professional communications data tableFind information that EMA publishes on medicines shortages in the table below. EMA expects to provide a daily updated table in the coming months.
EMA publishes information on specific shortages and provides recommendations to patients and healthcare professionals across the EU following its own assessment
For each type of shortage, additional information about the situation in a specific country may be available from its national competent authority.
For more information, see:
Find information on the status and outcomes of assessments from EMA's Committee on Herbal Medicinal Products (HMPC) in the table below.
Download herbal medicines data tableFor more information, see:
Find information on the status of EMA's scientific opinions on high priority medicines for use outside of the EU in the table below.
Download medicines for use outside EU data tableFor more information, see: