Notice on cessation of production of Vagifem 25 microgram vaginal tablets (estradiol) and kliogest 2 mg/1 mg film-coated tablets (estradiol, norethisterone) for the Croatian market.
11.09.2014
Novo Nordisk Croatia d.o.o., the marketing authorisation holder for Vagifem 25 microgram vaginal tablets and Kliogest 2 mg/1 mg film-coated tablets has notified the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to cease permanently the production of these medicines for the Croatian market. This decision has been taken due to commercial reasons and it is not associated with quality, efficacy or safe use of these medicines.
The batches of these medicines currently on the Croatian market, remain in the supply chain until they have been out of stock or they shelf live has expired.
There are other medicinal products containing the same active substances on the Croatian market, intended for hormone replacement therapy, with different strengths, though. Therefore, all patients using these medicines should consult their doctor about a change of medication.
We remind marketing authorisation holders that they are obliged to notify HALMED at least two months before a temporary or permanent cessation of supply chain with their medicine, by completing the cover letter and table with information on medicines concerned and forwarding it to the e-mail: ukidanje@halmed.hr.
