Colesevelam hydrochloride - paediatric investigation plan

colesevelam hydrochloride

Key facts

• Invented name:
  • Cholestagel
  • Cholestagel
• Active substance:
  colesevelam hydrochloride
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/124/2009
• PIP number:
  Colesevelam hydrochloride
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Heterozygous Familial Hypercholesterolaemia
  • Homozygous Familial Hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/06/2009
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000543-PIP01-09
• Compliance opinion date:
  24/07/2009
• Compliance outcome:
  Positive

Decision

P/124/2009: European Medicines Agency decision of 19 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for Colesevelam hydrochloride , Cholestagel (EMEA-000543-PIP01-09) in acc...

Adopted Reference Number: EMEA/363648/2009