• Procedure started
  • Under evaluation
  • CVMP opinion
  • European Commission final decision

Overview

Doxycycline is a tetracycline derivative with uses similar to those of tetracycline antibiotics. 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.

Due 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. The referral procedure started on 11 February 2009. The rapporteur and co-rapporteur appointed were: Dr Cornelia Ibrahim and Prof. Christian Friis, respectively. Written explanations were provided by the applicants/marketing authorisation holders on 21 April 2009 and 16 September 2009.

During 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on a request from one marketing authorisation holder to provide an oral explanation to the CVMP which was subsequently withdrawn by the marketing authorisation holder.

Based 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. 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. 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.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III.

The final opinion was converted into a Decision by the European Commission on 14 June 2010.

Opinion following an Article 35 referral 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

български (BG) (82.64 KB - PDF)
español (ES) (112.07 KB - PDF)
čeština (CS) (135.19 KB - PDF)
dansk (DA) (51.32 KB - PDF)
Deutsch (DE) (50.95 KB - PDF)
eesti keel (ET) (49.91 KB - PDF)
ελληνικά (EL) (145.74 KB - PDF)
français (FR) (51.39 KB - PDF)
italiano (IT) (51.93 KB - PDF)
latviešu valoda (LV) (76.21 KB - PDF)
lietuvių kalba (LT) (135.26 KB - PDF)
magyar (HU) (71.1 KB - PDF)
Malti (MT) (73.22 KB - PDF)
Nederlands (NL) (51.28 KB - PDF)
polski (PL) (74.23 KB - PDF)
português (PT) (111.74 KB - PDF)
română (RO) (72.6 KB - PDF)
slovenčina (SK) (134.27 KB - PDF)
slovenščina (SL) (71.29 KB - PDF)
Suomi (FI) (51.24 KB - PDF)
svenska (SV) (110.63 KB - PDF)

Key facts

About this medicine

Approved name
Doxycycline hyclate
International non-proprietary name (INN) or common name
doxycycline hyclate

About this procedure

Current status
European Commission final decision
Reference number
EMA/190025/2010
Type
Article 35

Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

Opinion date
11/02/2010
EC decision date
14/06/2010

All documents

Doxycycline hyclate - Article 35 referral - Annexes I, II, III

български (BG) (952.18 KB - PDF)
español (ES) (531.06 KB - PDF)
čeština (CS) (801.13 KB - PDF)
dansk (DA) (297.98 KB - PDF)
Deutsch (DE) (665.11 KB - PDF)
eesti keel (ET) (645.72 KB - PDF)
ελληνικά (EL) (922.83 KB - PDF)
français (FR) (540.75 KB - PDF)
italiano (IT) (666.73 KB - PDF)
latviešu valoda (LV) (777.3 KB - PDF)
lietuvių kalba (LT) (691.66 KB - PDF)
magyar (HU) (699.9 KB - PDF)
Malti (MT) (777.13 KB - PDF)
Nederlands (NL) (596.72 KB - PDF)
polski (PL) (631.96 KB - PDF)
português (PT) (650.92 KB - PDF)
română (RO) (706.88 KB - PDF)
slovenčina (SK) (621.38 KB - PDF)
slovenščina (SL) (672.13 KB - PDF)
Suomi (FI) (583.82 KB - PDF)
svenska (SV) (652.72 KB - PDF)

Opinion following an Article 35 referral 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

български (BG) (82.64 KB - PDF)
español (ES) (112.07 KB - PDF)
čeština (CS) (135.19 KB - PDF)
dansk (DA) (51.32 KB - PDF)
Deutsch (DE) (50.95 KB - PDF)
eesti keel (ET) (49.91 KB - PDF)
ελληνικά (EL) (145.74 KB - PDF)
français (FR) (51.39 KB - PDF)
italiano (IT) (51.93 KB - PDF)
latviešu valoda (LV) (76.21 KB - PDF)
lietuvių kalba (LT) (135.26 KB - PDF)
magyar (HU) (71.1 KB - PDF)
Malti (MT) (73.22 KB - PDF)
Nederlands (NL) (51.28 KB - PDF)
polski (PL) (74.23 KB - PDF)
português (PT) (111.74 KB - PDF)
română (RO) (72.6 KB - PDF)
slovenčina (SK) (134.27 KB - PDF)
slovenščina (SL) (71.29 KB - PDF)
Suomi (FI) (51.24 KB - PDF)
svenska (SV) (110.63 KB - PDF)

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. veterinary healthcare professionals, farmers, academia) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of CVMP
  • Divergent positions – divergent positions of the CVMP members (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)

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