European CHMP recommends paediatric license extension and paediatric formulations of dabigatran etexilate (Pradaxa)
Paediatric license extension, treatment of VTE and prevention of recurrent VTE from birth to <18 years of age, is supported by a new pharmaceutical form and strength – coated granules (20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg) and oral solution (6.25 mg/ml).
Source:
European Medicines Agency
SPS commentary:
Treatment is contraindicated in paediatric patients with eGFR <50 mL/min/1.73m2