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 |
|
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
|