ghiottolux
Forumer attivo
QUESTO MI SEMBRA IMPORTANTE:
Pharmacovigilance Risk Assessment Committee (PRAC)
Agenda of meeting on 13-16 May 2013
Assessment of Periodic Safety Update Reports (PSURs)
6.1.36. Pixantrone dimaleate – PIXUVRI (CAP)
• Evaluation of a PSUR procedure
Status: for discussion and agreement of recommendation to CHMP
Regulatory details:
PRAC Rapporteur: Julia Dunne (UK)
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2013/05/WC500143300.pdf
Pharmacovigilance Risk Assessment Committee (PRAC)
Agenda of meeting on 13-16 May 2013
Assessment of Periodic Safety Update Reports (PSURs)
6.1.36. Pixantrone dimaleate – PIXUVRI (CAP)
• Evaluation of a PSUR procedure
Status: for discussion and agreement of recommendation to CHMP
Regulatory details:
PRAC Rapporteur: Julia Dunne (UK)
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2013/05/WC500143300.pdf