WC500169468

3.5.5. Tigecycline – TYGACIL (CAP)
Evaluation of interim PASS results
Regulatory details:
PRAC Rapporteur: Miguel-Angel Macia (ES)
Administrative details:
Procedure number(s): EMEA/H/C/000644/ANX 058.4
Procedure scope: Interim results of PASS aimed to evaluate Tygacil prescription patterns and monitor
superinfections and treatment outcomes
MAH(s): Pfizer Limited
4. ANNEX I Renewals of the Marketing Authorisation,
Conditional Renewals and Annual Reassessments
Based on the review of the available pharmacovigilance data for the medicines listed below and the
CHMP Rapporteur’s assessment report, the PRAC considered that the renewal of the marketing
authorisation procedure could be concluded, and supported the renewal of their marketing
authorisations for an unlimited or additional period, as applicable. As per agreed criteria, the
procedures were finalised at the PRAC level without further plenary discussion.
4.1.1. Amifampridine – FIRDAPSE (CAP)
PRAC consultation on an annual reassessment of the marketing authorisation
Regulatory details:
PRAC Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number(s): EMEA/H/C/001032/S/0027, Orphan (without RMP)
MAH(s): BioMarin Europe Ltd
ANNEX II – List of participants:
Including any restrictions with respect to involvement of members / alternates / experts following
evaluation of declared interests for the 5 - 8 May 2014 meeting.
PRAC member
PRAC alternate
Country
Outcome
restriction
following
evaluation of
e-DoI for the
meeting
Topics on the current Committee
Agenda for which restriction applies
Product/
substance
Harald Herkner Austria Full involvement
Jean-Michel Dogné Belgium Cannot act as
Rapporteur or Peer
reviewer for:
Veerle Verlinden Belgium Full involvement
paracetamol, aflibercept, iloprost,
regorafenib
Yuliyan Eftimov Bulgaria Full involvement
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 69/73