EMEA-002202-PIP01-17 - paediatric investigation plan

rosuvastatin

ezetimibe

Key facts

• Active substance:
  • rosuvastatin
  • ezetimibe
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0335/2017
• PIP number:
  EMEA-002202-PIP01-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of 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:
  31/10/2017
• Compliance check done:
  No

Decision

P/0335/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17)

Adopted Reference Number: EMA/666332/2017