EMEA-000081-PIP01-07-M11
Key facts
Invented name |
Pradaxa
|
Active substance |
Dabigatran etexilate mesilate
|
Therapeutic area |
|
Decision number |
P/0399/2018
|
PIP number |
EMEA-000081-PIP01-07-M11
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000081-PIP01-07-M11
|
Compliance opinion date |
23/08/2019
|
Compliance outcome |
positive
|