🇪🇺 Drug: Apixaban sprinkle capsules in European Union

EMA authorised Drug: Apixaban sprinkle capsules on 18 May 2011

Marketing authorisation

EMA — authorised 18 May 2011

  • Application: EMEA/H/C/002148
  • Marketing authorisation holder: Bristol-Myers Squibb / Pfizer EEIG
  • Local brand name: Eliquis
  • Indication: Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or 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 ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DV
  • Status: approved

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Drug: Apixaban sprinkle capsules in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Drug: Apixaban sprinkle capsules approved in European Union?

Yes. EMA authorised it on 18 May 2011.

Who is the marketing authorisation holder for Drug: Apixaban sprinkle capsules in European Union?

Bristol-Myers Squibb / Pfizer EEIG holds the EU marketing authorisation.