EMEA-000395-PIP01-08 - paediatric investigation plan

Midazolam Hydrochloride

Key facts

• Invented name:
  Buccolam
• Active substance:
  Midazolam Hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/155/2009
• PIP number:
  EMEA-000395-PIP01-08
• Pharmaceutical form(s):
  Oromucosal solution
• Condition(s) / indication(s):
  Epileptic seizures
• Route(s) of administration:
  Oromucosal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2009
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000395-PIP01-08
• Compliance opinion date:
  06/08/2010
• Compliance outcome:
  Positive

Decision

P/155/2009: European Medicines Agency decision of 11 August 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for midazolam hydrochloride (EMEA-000395-PIP01-08 in accordance with Re...

Adopted Reference Number: EMEA/494800/2009