EMEA-001591-PIP01-14 - paediatric investigation plan

glycopyrronium bromide

Key facts

• Active substance:
  glycopyrronium bromide
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0343/2014
• PIP number:
  EMEA-001591-PIP01-14
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of sialorrhoea
• Route(s) of administration:
  Oral use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  22/12/2014
• Compliance check done:
  No

Decision

P/0343/2014: EMA decision of 22 December 2014 on the refusal of a paediatric investigation plan and on the refusal of a waiver for glycopyrronium bromide (EMEA-001591-PIP01-14)

Adopted Reference Number: EMA/624773/2014