P/87/2010 - paediatric investigation plan

bituminosulphonate (sodium)

clindamycin phosphate

Key facts

• Active substance:
  • bituminosulphonate (sodium)
  • clindamycin phosphate
• Therapeutic area:
  Dermatology
• Decision number:
  P/87/2010
• PIP number:
  P/87/2010
• Pharmaceutical form(s):
  Solution
• Condition(s) / indication(s):
  Treatment of acne vulgaris
• Route(s) of administration:
  Cutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/06/2010
• Compliance check done:
  No

Decision

P/87/2010: European Medicines Agency decision of 1 June 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for clindamycin (phosphate) / bituminosulphonate (sodium) (EMEA-000532-PIP0...

Adopted Reference Number: EMA/335299/2010