More specifically, doxycycline stops bacteria from producing certain proteins that are essential for their growth and development. How Doxycycline Worksĭoxycycline works by killing or slowing down the growth of certain types of bacteria, including the types of bacteria responsible for acne and other diseases and conditions. Millions of people use doxycycline in the U.S. It’s sold as a tablet, capsule and liquid solution, and is prescribed to treat a diverse range of bacterial infections and conditions caused by bacteria.ĭoxycycline is also sometimes prescribed as a traveler’s medication to prevent diseases such as malaria.ĭue to its diverse range of applications, doxycycline is a very common medication. List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g.Doxycycline is a type of prescription antibiotic referred to as a tetracycline.List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s).Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion.List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified.Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure.Overview - lay-language summary of the stage of the procedure.Please note that some of the listed documents apply only to certain procedures. The final opinion was converted into a Decision by the European Commission on 14 June 2010. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III. The list of product names concerned is given in Annex I. Therefore the Committee, adopted on 11 February 2010, an opinion recommending variations of the marketing authorisations for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water in order to amend the SPC, labelling and package leaflet to include appropriate standard prudent use statements in line with recommendations of the CVMP revised guideline on the SPC for antimicrobial products and to include additional information regarding the correct administration of the concerned products.
However, due to the known prevalence of resistance to this antimicrobial, changes to the product literature of the relevant products were recommended to reflect the principles for prudent use. Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.ĭuring its 13-15 October 2009 meeting, the Committee agreed on a request from one marketing authorisation holder to provide an oral explanation to the CVMP which was subsequently withdrawn by the marketing authorisation holder.īased on the rapporteurs' assessment of the currently available data, the CVMP did not identify emerging risks to human or animal health arising as a result of differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union and did not therefore recommend changes to these aspects of the summary of the product characteristics (SPC), labelling and package leaflet. The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. The referral procedure started on 11 February 2009. The water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water, are used for treatment of respiratory and gastrointestinal infections caused by different bacterial pathogens susceptible to doxycycline.ĭue to concerns that the differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 11 February 2009, under Article 35 of Directive 2001/82/EC. Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics.
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