EMEA-000172-PIP01-07-M03

Key facts

Invented name
Mircera
Active substance
Methoxy polyethylene glycol-epoetin beta
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0317/2017
PIP number
EMEA-000172-PIP01-07-M03
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of symptomatic anaemia associated with chronic kidney disease
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Roche Registration Limited
Tel. +41 616879411
E-mail: info.paediatrics@roche.com
Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP

Decision

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