Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

  • Email
  • Help



Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

PRAC concludes review of safety signal for Uptravi

At its April meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) completed the safety review of Uptravi (selexipag), which is used to treat pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs. The review was initiated following the deaths of five patients in France. The PRAC concluded that the data examined do not suggest an increase in mortality with Uptravi and the medicine can continue to be used by both new and existing patients according to the current prescribing information.

More information is available below.


Agenda - PRAC draft agenda of meeting 3-6 April 2017


Safety signal evaluation

Uptravi (selexipag)
Summary of PRAC recommendation


Ongoing referrals

Article 31 referral: Gadolinium-containing contrast agentsPRAC recommendation issued in March 2017Following the PRAC’s March 2017 recommendation, some of the marketing authorisation holders concerned by this referral procedure have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude in July 2017.
 Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC continued its assessment
 Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactionsUnder evaluationPRAC continued its assessment
 Article-31 referral: Factor VIIIUnder evaluationPRAC continued its assessment
 Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibioticsUnder evaluationPRAC continued its assessment


How useful is this page?

Average rating:

 Based on 2 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
2 ratings

Related content

Related documents

Contact point:

Tel. +44 (0)20 3660 8427
Follow us on Twitter @EMA_News