Adempas

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Riociguat 2.5 mg
Available from:
Bayer New Zealand Limited
INN (International Name):
Riociguat 2.5 mg
Dosage:
2.5 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Riociguat 2.5 mg Excipient: Crospovidone Hyprolose Hypromellose   Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propylene glycol Purified water Sodium laurilsulfate Titanium dioxide
Prescription type:
Prescription
Manufactured by:
Bayer AG
Therapeutic indications:
Pulmonary arterial hypertension Adempas, as monotherapy or in combination with approved PAH treatments (endothelin receptor agonists or inhaled or subcutaneous prostanoids ), is indicated for the treatment of: - idiopathic pulmonary arterial hypertension - heritable pulmonary arterial hypertension - pulmonary arterial hypertension associated with connective tissue diseases - pulmonary arterial hypertension associated with congenital heart disease in adult patients with WHO functional Class II, III or IV symptoms.
Product summary:
Package - Contents - Shelf Life: Blister pack, PP/Al - 42 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PP/Al - 84 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-9584c
Authorization date:
2014-06-25

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