EMEA-000081-PIP01-07-M11

Table of contents

Key facts

Invented name
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
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

Decision

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