Aivlosin: Withdrawal of the application to change the marketing authorisation
Table of contents
Overview
The applicant ECO Animal Health Europe Limited submitted on 31 January 2020 an application for an extension to the marketing authorisation for Aivlosin to the European Medicines Agency (The Agency) in accordance with Article 19 of Commission Regulation (EC) No 1234/2008 and Annex I thereof.
Aivlosin (active substance: tylvalosin), is a macrolide antimicrobial and was first authorised for use in pigs in the Union on 9 September 2004. The product is currently authorised for use in pigs, chickens and turkeys for various antibacterial indications, and is available as premix for medicated feed, oral powder and granules for use in drinking water.
This extension application is for a new target species, chickens, for the 42.5 mg/g premix for medicated feed presentation (currently only authorised for use in pigs). At the time of submission, the applicant applied for the following indication: “Treatment and metaphylaxis of respiratory disease associated with Mycoplasma gallisepticum in chickens.”
The dossier has been submitted in accordance with Article 19 of Commission Regulation (EC) 1234/2008 and Annex I thereof (extensions).
On 17 March 2021, ECO Animal Health withdrew the application at day 181 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated that the reason for the withdrawal was based on a commercial decision.
Key facts
| Name |
Aivlosin |
| Product number |
EMEA/V/C/000083 |
| Date of issue of market authorisation valid throughout the European Union (if applicable) |
09/09/2004 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Date of withdrawal |
17/03/2021 |
| Company making the application | |
| Withdrawal type |
Post-authorisation |
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').