Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019

14 June 2019

PRAC starts review of leuprorelin medicines

EMA’s safety committee (PRAC) has started a review of leuprorelin medicines after reports indicated that handling errors during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment.

The PRAC will now evaluate all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately.

While the review is ongoing, healthcare professionals should carefully follow the handling instructions for leuprorelin medicines. Patients prescribed these medicines who have any concerns should discuss them with their doctor.

More information is available below.

Agenda

Agenda - PRAC draft agenda of meeting 11-14 June 2019

Draft Reference Number: EMA/PRAC/325596/2019

PRAC statistics: June 2019

PRAC statistics: June 2019

The infographic below presents the total number of procedures discussed during the PRAC meeting in June 2019, as captured and detailed in the meeting Agenda - PRAC draft agenda of meeting 11-14 June 2019.

PRAC statistics: June 2019

The PRAC’s broad range of responsibilities cover all aspects of the risk management of medicines throughout their lifecycle and include assessment of signals, periodic safety update reports, risk management plans, post-authorisation safety studies and referrals. These terms are explained below: 

• Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ' Signal management'.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by marketing authorisation holders to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under ' Periodic safety update reports (PSURs)'.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under ' Risk-management plans'.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses both the protocols (aspects related to the design and conduct of a study) and the results of PASSs. More information can be found under ' Post-authorisation safety studies (PASS)'.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures.

Start of referral - Article-31 referral

Leuprorelin-containing depot medicinal products

Leuprorelin-containing depot medicines Article-31 referral - Notification

Leuprorelin-containing depot medicines Article-31 referral - Timetable for the procedure

Reference Number: EMA/PRAC/317693/2019 Rev 2

Leuprorelin-containing depot medicines Article-31 referral - List of questions

Reference Number: EMA/PRAC/317692/2019 Summary:

PRAC List of questions to be addressed by the marketing authorisation holder(s) for leuprorelin-containing depot medicinal products

Leuprorelin-containing depot medicines Article-31 referral - Annex I

Leuprorelin-containing depot medicines Article-31 referral - Review of handling errors with depot formulations of leuprorelin medicines started

Reference Number: EMA/316598/2019 Summary:

EMA has started a review of leuprorelin medicines after reports indicated that handling errors with the products during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment.

Ongoing referrals

Procedure	Status	Update
Article-31 procedure: Estradiol-containing (0.01% w/w) medicinal products for topical use	Under evaluation	PRAC continued its assessment
Article-31 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products	Under evaluation	PRAC continued its assessment
Article-20 procedure: Lemtrada	Under evaluation	PRAC continued its assessment
Article-31 procedure: Methotrexate containing medicinal products	Under evaluation	PRAC continued its assessment
Article-20 procedure: Xeljanz	Under evaluation	PRAC continued its assessment