EMEA-000081-PIP01-07-M09

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Overview

Product details for Pradaxa
Invented namePradaxa
Active substance

Dabigatran etexilate

Decision numberP/0282/2016
PIP numberEMEA-000081-PIP01-07-M09
Pharmaceutical form(s)Capsule, hard; Age-appropriate formulation
Condition(s)/indication(s)

Treatment of thromboembolic events

Prevention of thromboembolic events

Route(s) of administrationOral use
PIP applicant

Boehringer Ingelheim International GmbH
Germany
Tel. +49 6132778271
Fax +49 6132776601
E-mail: paediatrics@boehringer-ingelheim.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision

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