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

News 14/06/2019

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.

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 PDF iconagenda .

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 underReferral procedures.

Start of referral - Article-31 referral

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: XeljanzUnder evaluationPRAC continued its assessment

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