EMEA-000597-PIP02-10-M06

Key facts

Invented name
Betmiga
Active substance
Mirabegron
Therapeutic area
Uro-nephrology
Decision number
P/0350/2017
PIP number
EMEA-000597-PIP02-10-M06
Pharmaceutical form(s)
  • Polonged-release granules for oral suspension
  • Prolonged-release tablet
Condition(s) / indication(s)
Treatment of idiopathic overactive bladder
Route(s) of administration
Oral use
Contact for public enquiries
Astellas Pharma Europe B.V.
E-mail: contact@nl.astellas.com
Tel. +31 715455878
Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP

Decision

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