marlanki schreef op 12 juni 2018 15:06:
[...]
5.1. Medicines in the pre-authorisation phase
5.1.4. Lanadelumab - EMEA/H/C/004806, Orphan
Applicant: Shire Pharmaceuticals Ireland Limited
Scope (accelerated assessment): Routine prevention of angioedema attacks and control of symptoms of hereditary angioedema (HAE) in patients aged 12 years and older
Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP
7.2. Protocols of PASS non-imposed in the marketing authorisation(s)17
7.2.5. Conestat alfa - RUCONEST (CAP) - EMEA/H/C/001223/MEA 019.2
Applicant: Pharming Group N.V
PRAC Rapporteur: Julie Williams
Scope: MAH’s response to MEA 019.1 [revised protocol for a survey to measure the
effectiveness of risk minimisation materials distributed to treatment centres/prescribing physicians] as per the request for supplementary information (RSI) adopted in January 2018
Action: For adoption of advice to CHMP
Hoe krijgt Shire toch steeds weer een versnelling bij FDA en EMA voor elkaar?