EMEA-002120-PIP01-17 - paediatric investigation plan

Methacholine chloride

Key facts

• Invented name:
  Provocholine
• Active substance:
  Methacholine chloride
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0202/2017
• PIP number:
  EMEA-002120-PIP01-17
• Pharmaceutical form(s):
  Powder for nebuliser solution
• Condition(s) / indication(s):
  Diagnosis of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2017
• Compliance check done:
  No

Decision

P/0202/2017: EMA decision of 9 August 2017 on the refusal of a paediatric investigation plan and on the granting of waiver for methacholine chloride (EMEA-002120-PIP01-17)

Adopted Reference Number: EMA/460836/2017