On the first day after the expiration of the patent, JGL launched the first, and currently the only generic parallel of an originator product. Magnolicomb HCT has been authorised as part of the European decentralised procedure (DCP), which makes it the first prescription drug from JGL to be authorised in such a way in Croatia.
The drug represents a triple combination for treating arterial hypertension: amlodipine/valsartan/hydrochlorothiazide.
Magnolicomb HCT 5 mg/160 mg/12.5 mg film-coated tablets
Magnolicomb HCT 10 mg/160 mg/12.5 mg film-coated tablets
Magnolicomb HCT 5 mg/160 mg/25 mg film-coated tablets
Magnolicomb HCT is indicated for treating arterial hypertension as a replacement therapy in adults whose blood pressure is adequately controlled through a combination of amlodipine, valsartan and hydrochlorothiazide (HCT) taken in the form of three single-component formulations or as one two-component and one single-component formulation.
This is a prescription drug. Magnolicomb HCT is included on the Supplemental List of Drugs by the Croatian Institute for Health Insurance (CIHI).
Marketing authorisation numbers: Magnolicomb HCT 5 mg/160 mg/12.5 mg film-coated tablets: HR-H-398492130, Magnolicomb HCT 10 mg/160 mg/12.5 mg film-coated tablets: HR-H-690890278, Magnolicomb HCT 5 mg/160 mg/25 mg film-coated tablets HR-H-095154612. Marketing authorisation holder: JADRAN-GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka, Croatia. For a complete overview of the drug information, see the approved summary of product characteristics (SmPC) and patient information leaflet (PIL), available on the Croatian Agency for Medicinal Products and Medical Devices’ website (www.halmed.hr/Lijekovi/Baza-lijekova/).