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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.

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can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved.

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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.

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Withdrawn applications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When an application is withdrawn, EMA publishes the applicants' formal withdrawal letter and a summary of the evaluation of the application?at the time of the withdrawal.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.

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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.

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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.

XLS icon Download table of all orphan designations

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.

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For more information, see:

Periodic safety update report single assessments (PSUSAs)

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.

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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.?

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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.

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