Notice on the beginning of dispensation of ellaOne without prescription
22.04.2015
Following to the Commission’s Decision on the reclassification status of ellaOne, we inform users of the medicine and healthcare professionals on the beginning of dispensation of ellaOne 30 mg tablets (ulipristal acetate) without prescription. This Commission’s Decision on the OTC status of ellaOne is legally binding to all EU Member States, including Croatia, and it was adopted based on the recommendation of the European Medicines Agency (EMA) in a release published by HALMED on 21 November 2014.
The marketing authorisation holder for ellaOne in the EU, Laboratoire HRA Pharma, has prepared an and produced and an OTC adapted version of the labelling, summary of product characteristics and package leaflet in Croatian. By doing this, the marketing authorisation holder has fulfilled its obligations imposed by the European Commission as a prerequisite for starting the dispensation of ellaOne without a prescription.
Since the conditions for implementation of the Commission’s decision in Croatia are fulfilled, the marketing authorisation holder’s representative for Croatia, Arenda d.o.o. has notified HALMED that OTC adapted ellaOne packaging will be available in Croatian pharmacies as of 22 April 2015. The remaining packaging intended for dispensation with medical prescription that may be still found in some Croatian pharmacies, will be dispensed solely upon prescription.
The marketing authorisation holder’s representative in Croatia has, in agreement with HALMED prepared a notice to pharmacists on the beginning of dispensation of ellaOne without a prescription that will be disseminated to pharmacies today or at delivery of new ellaOne packs.
HALMED would like to remind users that the emergency contraception by using the ellaOne method is to be used only occasionally and may not in any case replace the regular contraception methods.
Further information
EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure. EllaOne achieves its best effect if taken within 24 h. Dispensation without a prescription should facilitate access to this medicine and thus enhance its efficacy.
EllaOne has been authorised in the EU since 2009. A comprehensive number of data on its risks and benefits has been collected and reviewed by now. Based on the safety review of available data, the CHMP has concluded that ellaOne is safe and efficacious to be used without a medical prescription.
The marketing authorisation holder’s representative in Croatia has notified HALMED that in addition to the educational initiative of the Croatian Pharmaceutical Society and Croatian Society for Gynaecological Endocrinology and Human Reproduction formed through a series of workshops, pharmacists will be informed through further actions:
- wholesalers distributing ellaOne 30 mg tablets will further inform pharmacists on the change of the layout and content of the inner and outer packaging of the medicine as well as package leaflet according to implementation of the reclassification status of the medicine in the EU
- sales representatives responsible for informing on the field will further inform pharmacists on the changes regarding the new reclassification status of the medicine, by using for this purpose prepared information-educational material;
- pharmacists will be able to obtain information on all changes regarding the new reclassification status and by using the European marketing authorisation holder’s special webpages accessible in languages of all EU Member States including Croatian.
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