EMEA-001366-PIP01-12-M02 - paediatric investigation plan

glycopyrronium bromide

Key facts

• Invented name:
  Sialanar
• Active substance:
  glycopyrronium bromide
• Therapeutic area:
  Neurology
• Decision number:
  P/0240/2014
• PIP number:
  EMEA-001366-PIP01-12-M02
• Pharmaceutical form(s):
  Oral liquid
• Condition(s) / indication(s):
  Treatment of sialorrhoea
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  26/09/2014
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001366-PIP01-12-M02
• Compliance opinion date:
  14/11/2014
• Compliance outcome:
  Positive

Decision

P/0240/2014: EMA decision of 26 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for glycopyrronium (bromide) (EMEA-001366-PIP01-12-M02)

Adopted Reference Number: EMA/573797/2014