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15/02/2019 Referral: Diotop capsules , diclofenac/omeprazole , Article 29(4) referrals, European Commission final decision, 15/11/2018, 31/01/2019, 15/02/2019 (updated)
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast, PM: decision on the application for modification of an agreed PIP, P/0398/2018 (updated)
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0353/2018 (updated)
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera), Ceftobiprole medocaril (sodium), PM: decision on the application for modification of an agreed PIP, P/0406/2018 (updated)
15/02/2019 Referral: Fenspiride containing medicinal products , fenspiride , Article 107i procedures, Procedure started
15/02/2019 News and press releases: Suspension of fenspiride medicines due to potential risk of heart rhythm problems
15/02/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
15/02/2019 Big data
15/02/2019 Other: HMA/EMA Joint Task Force on big data – Survey for national competent authorities
15/02/2019 Other: HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry