Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017
At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed two ongoing safety reviews.
More information on all safety reviews currently under evaluation is provided in the table below. The Committee did not start or conclude a referral.
The PRAC also focused on the broad range of its responsibilities which cover all aspects of the risk management of the use of medicines. Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting at the beginning of February.
|Agenda - PRAC draft agenda of meeting 9-12 January 2017|
|Article-31 referral: Factor VIII||Under evaluation||PRAC discussed a list of experts for the ad hoc expert group meeting|
|Article-31 referral: Retinoid-containing medicinal products||Under evaluation||PRAC adopted a list of questions for the targeted meeting with patients and healthcare professionals (HCP)|
|Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions||Under evaluation||PRAC continued its assessment|
|Article-31 referral: Gadolinium-containing contrast agents||Under evaluation||PRAC continued its assessment|
|Article-31 referral: Paracetamol-modified release||Under evaluation||PRAC continued its assessment|
|Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)||Under evaluation||PRAC continued its assessment|
- Factor VIII: Article 31 referrals
- Gadolinium-containing contrast agents: Article 31 referrals
- Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions: Article 31 referrals
- Paracetamol modified-release: Article 31 referrals
- Retinoid-containing medicinal products: Article 31 referrals
- SGLT2 inhibitors (previously canagliflozin): Article 20 procedures