Recall of Ecalin cream, Ecalin pessaries and Ecalin cutaneous spray, solution, due to expiration of marketing authorisations
24.07.2014
Medical intertrade d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall from the market of all batches of Ecalin cream, Ecalin pessaries and Ecalin cutaneous spray, solution. These medicines are being recalled due to regulatory reasons, which means due to the expiration of the marketing authorisation granted by HALMED and under provisions laid down in the paragraph 2 of the Art. 113 of the Medicinal Products Act (Official Gazette, No 76/13) according to which a batch may remain in the distribution no longer than 18 months after the expiration of the marketing authorisation or shelf life.
Pharmacies are being advised to return the remaining stock to providing wholesalers.
For patient needs in the Republic of Croatia, there are other medicinal products from the same therapeutic group on the market.
For urgent patient needs, HALMED will, upon wholesaler’s request, approve the enter/import of those products not having marketing authorisation in the Republic of Croatia, but containing the same active substance and who have been prescribed by a medical doctor or dental medicine doctor at their own responsibility.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
