EMEA-001268-PIP01-12-M05

Key facts

Invented name
Repatha
Active substance
Evolocumab
Therapeutic area
Cardiovascular diseases
Decision number
P/0104/2018
PIP number
EMEA-001268-PIP01-12-M05
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Amgen Europe B.V
Tel. +44 (0)1223 420305
E-mail: medinfointernational@amgen.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-001268-PIP01-12-M05
Compliance opinion date
24/06/2022
Compliance outcome
positive

Decision

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