Key facts

Active Substance
Rubidium (82Rb)
Therapeutic area
Diagnostic
Decision number
P/91/2009
PIP number
EMEA-000488-PIP01-08
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
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Decision date

Decision

P/91/2009: European medicines agency decision of 18 May 2009 on the refusal of a product specific waiver for rubidium-82 (EMEA-000488-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliament a...

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