EMEA-001223-PIP01-11 - paediatric investigation plan

Diltiazem (hydrochloride)

Key facts

• Active substance:
  Diltiazem (hydrochloride)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0026/2012
• PIP number:
  EMEA-001223-PIP01-11
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of chronic anal fissure
• Route(s) of administration:
  • Cutaneous use
  • Epilesional use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2012
• Compliance check done:
  No

Decision

P/0026/2012: EMA decision of 27 January 2012 on the granting of a product specific waiver for diltiazem (hydrochloride), (EMEA-001223-PIP01-11)

Adopted Reference Number: EMA/54650/2012