Download medicine data

You can download the European Medicines Agency's (EMA) medicine-related data published on this website in Excel table format from this page. EMA updates these medicine data tables once a day.

For more information on what type of information EMA publishes on medicines, see What we publish on medicines and when.

European public assessment reports (EPAR)

European public assessment reports (EPARs) are full scientific assessment reports of medicines authorised at a European Union level. EPARs also contain a public-friendly overview in question-and-answer format and the package leaflet. You can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

Alternatively, you can search:

Pending EC decisions: summaries of opinion

When a pharmaceutical company applies for marketing authorisation through the centralised authorisation procedure, the CHMP or CVMP 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, EMA publishes a 'summary of opinion'.

This summary is replaced by a full European public assessment reports once the European Commission has decided - taking the EMA opinion into consideration - whether to grant the marketing authorisation.

EMA also publishes summaries of opinion when the CHMP or CVMP adopts scientific opinions on important changes to an existing marketing authorisation applied for by the marketing authorisation holder.

Alternatively, search for:

Withdrawn applications

At any stage during the medicine evaluation process, applicants can withdraw their application to EMA, including new marketing authorisation applications and changes to existing marketing authorisations.

When an application is withdrawn, EMA publishes the applicants' formal withdrawal letter and a summary of the evaluation of the application at the time of the withdrawal. If this is after the first stage of the assessment, EMA publishes a withdrawal assessment report.

Alternatively, you can search:

Paediatric investigation plans

A paediatric investigation plan (PIP) is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support a medicine's authorisation for use in children. The marketing authorisation applicant is responsible for submitting this plan to EMA's Paediatric Committee (PDCO), which agrees or refuses the plan and publishes an opinion on its decision.

Alternatively, you can search:

For more information, see PIPs.

Rare disease (orphan) designations

An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by EMA's Committee for Orphan Medicinal Products (COMP), which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.

Alternatively, you can search:

For more information, see Orphan designation.

Referrals

A referral is a procedure used to resolve issues such as concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. The matter is 'referred' to the European Medicines Agency, so that it can make a recommendation for a harmonised position across the European Union. The database includes ongoing and completed referral procedures.

Alternatively, you can search:

For more information, see:

Periodic safety update report single assessments

A periodic safety update report (PSUR) is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation. A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances, as included in the list of EU reference dates (EURD list).

EMA's scientific committees (PRAC and CHMP) and the CMDh together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the marketing authorisation.

EMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for active substances contained only in nationally authorised medicines, together with the outcomes of assessments that lead to a variation of marketing authorisations.

Alternatively, you can search:

The outcomes of PSUR assessments for active substances found only in centrally authorised medicines are published as part of each medicine's European public assessment report (EPAR). The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the European Commission.

For more information, see Periodic safety update reports: questions and answers.

Regulatory outcomes

When a PSUR single assessment procedure leads to a variation of marketing authorisations, marketing-authorisation holders for nationally authorised products containing the active substance(s) concerned should submit a variation to align their marketing authorisation with the single assessment outcome, even if their product was not in the direct scope of the procedure (such as a generic medicine or a medicine authorised on the basis of well established use). This is in line with Article 23 of Directive 2001/83/EC and Article 16 of regulation (EC) No 726/2004.

Documents presenting 'CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation' contain all language versions within a single PDF file if they were published before 17 October 2016.

Shortages

EMA assesses medicine shortages that affect or are likely to affect more than one EU Member State. Following its assessment, EMA publishes information on specific shortages and provided recommendations to patients and healthcare professionals across the EU. 

Alternatively, you can search:

For each shortage, additional information about the situation in a specific country may be available from the national competent authority.

For more information, see:

Herbal medicines

EMA's Committee on Herbal Medicinal Products (HMPC) compiles and assesses scientific data on herbal substances, preparations and combinations, to support the harmonisation of herbal products on the EU market.

Multiple documents may be associated with a herbal substance, depending on where it is in the assessment process. The HMPC's conclusions on a substance at the end of the assessment process are included in the final European Union herbal monographs and list entries.

Alternatively, you can search:

  • Herbal medicines (for searching substances assessed in combination, include 'combination' in the Latin name of the genus or the botanical name of the plant)

For more information, see Herbal medicinal products.

How useful was this page?

Add your rating
Average
2 ratings
2 ratings
4 ratings