EMEA-000597-PIP02-10-M06

  • Email
  • Help

Overview

Product details for Betmiga
Invented nameBetmiga
Active substance

Mirabegron

Decision numberP/0350/2017
PIP numberEMEA-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 administrationOral use
PIP applicant

Astellas Pharma Europe B.V.
E-mail: contact@nl.astellas.com
Tel. +31 715455878

Decision typeRPM: decision refers to a refusal on the application for modifiction of an agreed PIP

Decision