Key facts

Invented name
Ruby-Fill (82Sr/82Rb Generator)
Active Substance
Rubidium (82Rb) chloride
Therapeutic area
Diagnostic
Decision number
P/0356/2021
PIP number
EMEA-000882-PIP03-11-M05
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

Jubilant DraxImage Inc., dba Jubilant Radiopharma

E-mail: Ra@jdi.jubl.com
Tel: 1-514-694-8220, ext.7045

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0356/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rubidium (82Rb) chloride (Ruby-Fill (82Sr/82Rb Generator)), (EMEA-000882-PIP03-11-M05)

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