Information about shortage of medicines with combination of active substances cilazapril and hydrochlorothiazide (Co-Cazaprol and Cilazil Plus)
19.05.2014
Krka-farma d.o.o., the marketing authorisation holder for Co-Cazaprol 5 mg/12.5 mg film-coated tablets and Pliva Hrvatska d.o.o., the marketinga authorisation holder for Lilazil Plus 5 mg + 12.5 mg film coated tablets, have notified the Agency for Medicinal Products and Medical devices (HALMED) on shortage of these medicinal products on the Croatian market. The shortage is due to supply problem of the active substance cilazapril, manufactured by Ranbaxy Laboratories in India, whose export has temporary been cancelled due to GMP compliance problems.
The normalisation of the Croatian market with Co-Cazaprol is expected by the end of June 2014, and normalisation of the market with Cilazil Plus is expected by the end of July 2014.
There are other authorisd medicinal products on the Croatian market from the same therapeutic group with other active substances and all patients who run out of the medicine should ask their doctors for advice about the treatment continuation.
In the case where the treatment with alternative medicines from the same therapeutic group is not acceptable, for urgent cases of individual treatment, HALMED will at wholesalers request approve the import/enter of medicines not authorised in Croatia, containing the same active substance combination as medicines affected by shortage.
