EMEA-000081-PIP01-07-M11 - paediatric investigation plan
Dabigatran etexilate mesilate
PIPHuman
Key facts
Invented name
Pradaxa
Pradaxa
Active Substance
Dabigatran etexilate mesilate
Therapeutic area
Cardiovascular diseases
Haematology-Hemostaseology
Decision number
P/0399/2018
PIP number
EMEA-000081-PIP01-07-M11
Pharmaceutical form(s)
Capsule (hard)
Age-appropriate dosage form, other
Condition(s) / indication(s)
Prevention of thromboembolic events
Treatment of thromboembolic events
Route(s) of administration
Oral use
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000081-PIP01-07-M11
Compliance opinion date
Compliance outcome
Positive
Decision
P/0399/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate mesilate (Pradaxa) (EMEA-000081-PIP01-07-M11)