Withdrawal of the marketing authorisation application
The applicant Vita (Europe) Limited submitted on 22 July 2016 an application for a marketing authorisation to the European Medicines Agency (The Agency) for HopGuard Gold, through the centralised procedure under Article 3(2)(a) of Regulation (EC) No 726/2004 (new active substance).
The eligibility to the centralised procedure was agreed upon by the CVMP on 8 November 2012 as HopGuard Gold contains a purified semi-solid extract from Humulus lupulus L. (also referred to in this report as potassium beta resin or KBR) containing approximately 48% of beta acids as potassium salts, a new active substance which was not authorised as a veterinary medicinal product in the Union on the date of entry into force of Regulation (EC) No 726/2004. An MRL for the active substance is included in Commission Regulation (EU) No 37/2010 under the name of "Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts)".
The applicant applied for the following indication: Treatment of varroosis due to Varroa destructor.
The active substance of HopGuard Gold, the potassium beta resin containing hop beta acids (as potassium salts) as the constituents with known therapeutic activity, is an antiparasitic product to be used in honey bees for treatment of varroosis. HopGuard Gold is presented as bee-hive strips for in-hive use in packs containing 12 strips or 24 strips.
The applicant (Vita (Europe) Ltd) is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.
The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC – full application.
On 12 April 2018, Vita (Europe) Ltd withdrew the application at day 203 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated the reason for the withdrawal: CVMP considered that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
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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 An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').