Cholib
fenofibrate
simvastatin
Dyslipidemias
Date of authorisation:
Revision: 17
Last updated:
MedicineHumanAuthorised
Simvastatin Vale - referral
simvastatin
Article 29(4) referrals
Associated names:
Simvastatin Vale pharmaceuticals
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralHuman
EMEA-000006-PIP03-12 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/0141/2012
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000006-PIP02-10 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/95/2011
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000631-PIP01-09 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/235/2009
Route(s) of administration: Oral use
Pharmaceutical form(s):
Capsule (hard)
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Simvastatin / sitagliptin phosphate monohydrate - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/170/2009
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Sitagliptin phosphate monohydrate / simvastatin - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: P/171/2009
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman