Zinc oxide
Table of contents
Overview
On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of veterinary medicinal products containing zinc oxide to be administered orally to food-producing species. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
The CVMP recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide.
Key facts
| Approved name |
Zinc oxide
|
| International non-proprietary name (INN) or common name |
zinc oxide
|
| Current status |
European Commission final decision
|
| Reference number |
EMEA/V/A/118
|
| 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. |
| Opinion date |
16/03/2017
|
| EC decision date |
26/06/2017
|
All documents
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List item
Zinc oxide Article-35 referral - Questions and answers on veterinary medicinal products containing zinc oxide to be administered orally to food-producing species (PDF/78.75 KB)
First published: 14/08/2017
Last updated: 14/09/2017
EMA/394961/2017 -
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List item
Zinc oxide Article-35 referral - Annex I,II (PDF/258.53 KB)
First published: 14/08/2017
Last updated: 14/08/2017
EMEA/V/A/118 -
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)