EMEA-000430-PIP01-08-M11
Key facts
Invented name |
Xarelto
|
Active substance |
rivaroxaban
|
Therapeutic area |
Cardiovascular diseases
|
Decision number |
P/0126/2019
|
PIP number |
EMEA-000430-PIP01-08-M11
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Bayer Pharma AG
Tel. +49 3046 815333 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000430-PIP01-08-M11
|
Compliance opinion date |
20/09/2019
|
Compliance outcome |
positive
|