Eprotirome - paediatric investigation plan

Eprotirome

Key facts

• Active substance:
  Eprotirome
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/128/2008
• PIP number:
  Eprotirome
• Pharmaceutical form(s):
  Gastro-resistant tablet
• Condition(s) / indication(s):
  Primary hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/12/2008
• Compliance check done:
  No

Decision

P/128/2008: European Medicines Agency decision of 23 December 2008 on the application for product specific waiver for eprotirome (EMEA-000255-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parl...

Adopted Reference Number: EMEA/671590/2008