Enthryv: Withdrawal of the marketing authorisation application
On 1 March 2013, the applicant Nexcyon Pharmaceuticals Ltd submitted an application for a marketing authorisation to the European Medicines Agency (The Agency) for Enthryv transdermal solution for cats, through the centralised procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 (significant therapeutic, scientific or technical innovation).The eligibility to the centralised procedure was agreed upon by the CVMP on 11 October 2012 (Article 3(2)(b) of Regulation (EC) No 726/2004) as the applicant showed that the product would constitute a significant therapeutic and technical innovation. The rapporteur appointed was D. Murphy and the co-rapporteur was F. Hasslung Wikström. The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC.Enthryv is a transdermal solution for topical application containing thiamazole as the active substance. Enthryv is presented in three strengths of single-use tubes (primary packaging) containing 0.25 ml (18.75 mg), 0.5 ml (37.5 mg) or 0.75 ml (56.25 mg thiamazole) in child-resistant blister packs (secondary packaging), with 8 tubes per outer carton box (tertiary packaging). The target species is cats. The applicant initially applied for the following indication: 'treatment of hyperthyroidism and associated clinical signs in cats'.On 30 June 2014, Nexcyon Pharmaceuticals Ltd withdrew the application at day 200 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 An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').