Revised SPC: Adempas (riociguat) 0.5 mg film-coated tablets
SPC has been updated with license extension to include treatment of pulmonary arterial hypertension in paediatric patients aged <18 years and body weight ≥ 50 kg with WHO Functional Class II to III in combination with endothelin receptor antagonists.
Source:
electronic Medicines compendium
SPS commentary:
It is also now contraindicated for use in children aged 6 to < 12 years with systolic blood pressure < 90 mmHg, and in patients ≥ 12 years with systolic blood pressure < 95 mmHg.