ongoing

3.2. Ongoing procedures
3.2.1. Idelalisib – ZYDELIG (CAP) - EMEA/H/A-20/1439
Applicant: Gilead Sciences International Ltd
PRAC Rapporteur: Rafe Suvarna; PRAC Co-rapporteur: Ulla Wändel Liminga
Scope: Review of the benefit-risk balance following notification by the European
Commission of a referral under Article 20 of Regulation (EC) No 726/2004 based on
pharmacovigilance data
Action: For adoption of a list of experts for the Scientific Advisory Group (SAG)
3.3. Procedures for finalisation
None
3.4. Article 5(3) of Regulation (EC) No 726/2004 as amended: PRAC
advice on CHMP request
None
3.5. Others
None
4. Signals assessment and prioritisation 1
4.1. New signals detected from EU spontaneous reporting systems
4.1.1. Anakinra – KINERET (CAP); canakinumab – ILARIS (CAP)
Applicant: Swedish Orphan Biovitrum AB (publ) (Kineret), Novartis Europharm Ltd (Ilaris)
PRAC Rapporteur: To be appointed
Scope: Signal of weight increase
Action: For adoption of PRAC recommendation
EPITT 18641 – New signal
Lead Member States: DE, DK
4.1.2. Metronidazole (NAP)
Applicant: various
PRAC Rapporteur: To be appointed
Scope: Signal of severe hepatic and neurologic toxicity in patients with Cockayne syndrome
Action: For adoption of PRAC recommendation
EPITT 18663 – New signal
1 Each signal refers to a substance or therapeutic class. The route of marketing authorisation is indicated in brackets (CAP
for Centrally Authorised Products; NAP for Nationally Authorised Products including products authorised via Mutual
Recognition Procedures and Decentralised Procedure). Product names are listed for reference Centrally Authorised Products
(CAP) only. PRAC recommendations will specify the products concerned in case of any regulatory action required
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/325452/2016 Page 12/52