Lasofoxifene tartrate - paediatric investigation plan

Lasofoxifene tartrate

Key facts

• Active substance:
  Lasofoxifene tartrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/1/2008
• PIP number:
  Lasofoxifene tartrate
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of osteoporosis in postmenopausal women at increased risk of fracture
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/01/2008
• Compliance check done:
  No

Decision

P/1/2008: European medicines agency decision of 7 January 2008 on the application for product-specific waiver for Lasofoxifene tartrate EMEA-000039-PIP01-2007 in accordance with Regulation (EC) No 1901/2006 of the Europe...

Adopted Reference Number: EMEA/602212/2007