EMEA-000488-PIP02-11 - paediatric investigation plan
Rubidium (82Rb) chloride
PIPHuman
Key facts
Active Substance
Rubidium (82Rb) chloride
Therapeutic area
Diagnostic
Decision number
P/0052/2012
PIP number
EMEA-000488-PIP02-11
Pharmaceutical form(s)
Radionuclide generator
Condition(s) / indication(s)
Visualisation of myocardial perfusion for diagnostic purposes
Route(s) of administration
Intravenous use
Contact for public enquiries
Advanced Accelerator Applications
info@adacap.com Country: France Phone: +33 450993070 Fax: +33 450993071
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0052/2012: EMA decision of 23 March 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the
granting of a waiver for rubidium (82Rb) chloride (EMEA-000488-PIP02-11)