EMEA-000573-PIP02-13-M03

Key facts

Invented name
Vesicare and associated names
Active substance
Solifenacin (succinate)
Therapeutic area
Uro-nephrology
Decision number
P/0115/2015
PIP number
EMEA-000573-PIP02-13-M03
Pharmaceutical form(s)
  • Oral suspension
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of neurogenic detrusor overactivity
Route(s) of administration
Oral use
Contact for public enquiries
Astellas Pharma Europe B.V.
The Netherlands
E-mail: contact@nl.astellas.com
Tel. +31 715455878
Fax +31 715455224
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000573-PIP02-13-M03
Compliance opinion date
16/12/2016
Compliance outcome
positive

Decision

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