Pradaxa - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

dabigatran etexilate

Opinion

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Pradaxa. The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.

The CHMP adopted the removal of a pharmaceutical form, coated granules, and a change to an existing indication for the use of Pradaxa in children: 

Treatment of VTE and prevention of recurrent VTE in paediatric patients aged 8 from the time the child is able to swallow soft food to less than 18 years of age.

For age appropriate dose forms, see section 4.2.

For information, the full indications for Pradaxa will be as follows:

Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Treatment of VTE and prevention of recurrent VTE in paediatric patients aged 8 to less than 18 years of age.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Pradaxa (VR-0000347421)

Adopted Reference Number: EMADOC-1700519818-3452883

Key facts

• Name of medicine:
  Pradaxa
• EMA product number:
  EMEA/H/C/000829
• Active substance:
  dabigatran etexilate mesilate
• International non-proprietary name (INN) or common name:
  dabigatran etexilate
• Therapeutic area (MeSH):
  • Arthroplasty, Replacement
  • Venous Thromboembolism
• Anatomical therapeutical chemical (ATC) code:
  B01AE07
• Marketing authorisation holder:
  Boehringer Ingelheim International GmbH
• Date of opinion:
  17/09/2026
• Status:
  Positive