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
|
| Compliance procedure number |
EMEA-C-000172-PIP01-07-M03
|
| Compliance opinion date |
20/05/2022
|
| Compliance outcome |
positive
|