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
|