Colesevelam hydrochloride

Key facts

Invented name
Cholestagel
Active substance
Colesevelam hydrochloride
Therapeutic area
Endocrinology, -gynacology-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
Contact for public enquiries
Applicant: Genzyme Europe B.V.
E-mail: MedInfo@genzyme.com
Country: Netherland
Phone: +31 356991499
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000543-PIP01-09
Compliance opinion date
24/07/2009
Compliance outcome
positive

Decision

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