EMEA-000365-PIP01-08-M12
Key facts
Invented name |
Tamiflu
|
Active substance |
Oseltamivir (phosphate)
|
Therapeutic area |
Infectious diseases
|
Decision number |
P/0241/2021
|
PIP number |
EMEA-000365-PIP01-08-M12
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment and prevention of influenza
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Roche Registration GmbH
E-mail: info.paediatrics@roche.com |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000365-PIP01-08-M12
|
Compliance opinion date |
15/10/2021
|
Compliance outcome |
positive
|