EMEA-000998-PIP01-10 - paediatric investigation plan

bazedoxifene

conjugated estrogens

Key facts

• Active substance:
  • bazedoxifene
  • conjugated estrogens
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/155/2010
• PIP number:
  EMEA-000998-PIP01-10
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Postmenopausal osteoporosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/09/2010
• Compliance check done:
  No

Decision

P/155/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for bazedoxifene / conjugated estrogens, (EMEA-000998-PIP01-10)

Adopted Reference Number: EMA/477259/2010