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 9 November 2023, 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 (powder and solvent for oral solution) and a change to an existing indication for the use of Pradaxa in children under 18 years of age. For information, the full indications for Pradaxa will be as follows:¹

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 from birththe 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.

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

---

¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Pradaxa (II-147-G)

AdoptedReference Number: EMA/CHMP/498446/2023

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:
  09/11/2023
• Status:
  Positive