Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 January 2013

News 11/01/2013

First PRAC recommendation on safety referral

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) held its sixth meeting from 7 to 10 January 2013.

At the meeting, the PRAC assessed available data related to safety concerns over Tredaptive, Pelzont and Trevaclyn and recommended that the marketing, supply and authorisations of these medicines be suspended across the European Union (EU).

This is the first recommendation by the PRAC on a referral procedure since the pharmacovigilance legislation became operational in July 2012.

The prompt decision-making by the PRAC to recommend the suspension of Tredaptive, Pelzont and Trevaclyn underlines the fact that the new pharmacovigilance legislation provides an efficient mechanism for Member States to swiftly address safety concerns.

The PRAC recommendation will be considered by the Agency's Committee for Medicinal Products for Human Use (CHMP), which will adopt a final scientific opinion. The final opinion is expected to be adopted at the CHMP meeting of 14 to 17 January 2013.

Review of tetrazepam-containing medicines started

The PRAC also started a review of tetrazepam-containing medicines following new reports of serious skin reactions associated with these medicines. The review was initiated at the request of the French medicines agency under Article 107i of Directive 2001/83/EC.

This type of procedure is triggered when a Member State or the European Commission considers that urgent action across the EU is necessary because of a safety issue with a medicine. Situations that fall under this procedure include consideration for suspension or revocation of the marketing authorisation for a medicine, the prohibition of supply of a medicine, the refusal of a renewal of a marketing authorisation or major changes to the marketing authorisation such as restriction to the indications, reduction of the recommended dose or new contraindications.

As part of this procedure, the PRAC is inviting all stakeholders to submit data relevant to the procedure so that they can be considered during the assessment of tetrazepam-containing medicines. It is the first time that the PRAC is using this new tool, which allows the Committee to actively engage stakeholders in the evaluation process. Data can be submitted using a specific form, which is available under the data submission tab on tetrazepam-containing medicines: Article-107i procedure.

Other outcomes

In addition to the referral procedures, the PRAC also evaluated evidence for new safety signals from EU reporting systems, assessed updated risk-management plans for certain medicines and discussed a number of periodic safety update reports.

For an overview of all information available following the meeting of the PRAC, see the table below.

The minutes from the fifth PRAC meeting, which took place from 26 to 29 November 2012, will be published early during the week of 14 January 2013.


PDF icon Agenda - PRAC draft agenda of meeting 7-10 January 2013

Start of referral procedure

Tetrazepam-containing medicines

Article 107i referral: Tetrazepam-containing medicines


PDF icon Referral notification
PDF icon PRAC list of questions to be addressed by the by the marketing-authorisation holders
PDF icon PRAC list of questions to be addressed by the stakeholders
PDF icon Stakeholders' submission form
PDF icon Timetable for the procedure
PDF icon Annex I
PDF icon Rationale for triggering


Recommendation by PRAC

Tredaptive, Pelzont and Trevaclyn

Article 20 referral: Tredaptive, Pelzont and Trevaclyn


PDF icon Questions and answers

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