Somnena: Withdrawal of the marketing authorisation application

buprenorphine

Overview

On 29 January 2016 the applicant Shernacre Enterprise Limited submitted an application for a marketing authorisation to the European Medicines Agency (EMA) for Somnena in accordance with Regulation (EC) No 726/2004.The eligibility to the centralised procedure was agreed upon by the Committee for Medicinal Products for Veterinary Use (CVMP) on 8–10 September 2015 as falling under Article 3(2)(b) of Regulation (EC) No 726/2004 as the applicant showed that the product would constitute a significant therapeutic/scientific innovation.The dossier was submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC.The applicant was registered as a micro-, small- or medium-sized enterprise (SME) pursuant to the definition set out in Commission Recommendation 2003/361/EC.Somnena is a prolonged-release solution for injection containing 3 mg/ml buprenorphine (as the hydrochloride) as the active substance. The product was to be presented in clear glass multidose vials. One vial would have been included per outer pack (cardboard box). The product was to be administered to cats by subcutaneous injection.The applicant initially applied for the following indication: 'For the control of postoperative pain in cats for 3 days.'On 14 September 2016, Shernacre Enterprise Limited withdrew the application at day 120 of the procedure. In its letter notifying the EMA of the withdrawal of the application, the applicant stated the reason for the withdrawal was based on the CVMP's consideration that a pivotal clinical study which evaluated the control of post-surgical pain did not reach a satisfactory end point.

Key facts

Name
Somnena
Product number
EMEA/V/C/004293
International non-proprietary name (INN) or common name
  • buprenorphine
Active substance
  • buprenorphine hydrochloridep
Date of withdrawal
29/01/2016
Withdrawal type
Initial 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 An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').

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