EMEA-001528-PIP01-13 - paediatric investigation plan

Solifenacin (succinate)

Mirabegron

Key facts

• Active Substance:
  • Solifenacin (succinate)
  • Mirabegron
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0319/2013
• PIP number:
  EMEA-001528-PIP01-13
• Pharmaceutical form(s):
  Modified-release film-coated tablet
• Condition(s) / indication(s):
  Treatment of myoneurogenic bladder disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Astellas Pharma Europe B.V.

  The Netherlands ; E-mail: [e-mail] ; Tel. [phone] ; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2013

Decision

P/0319/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for solifenacin (succinate) / mirabegron (EMEA-001528-PIP01-13)

AdoptedReference Number: EMA/693823/2013