EMEA-001495-PIP01-13-M01 - paediatric investigation plan

drospirenone

Key facts

• Active substance:
  drospirenone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0136/2016
• PIP number:
  EMEA-001495-PIP01-13-M01
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of pregnancy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/05/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001495-PIP01-13-M01
• Compliance opinion date:
  23/03/2018
• Compliance outcome:
  Positive

Decision

P/0136/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for drospirenone (EMEA-001495-PIP01-13-M01)

Adopted Reference Number: EMA/265305/2016