Fortekor - Agencia Española de Medicamentos y Productos Sanitarios

Information Note
Agencia Española de Medicamentos y Productos Sanitarios
AEMPS
RECOMMENDATION REGARDING VETERINARY
MEDICINES CONTAINING BENAZEPRIL
HYDROCHLORIDE DIFFERENT FROM ‘FORTEKOR’
AND ASSOCIATED NAMES
Date of publication: 7th June 2012
Category: AEMPS, VETERINARY MEDICINES, INDUSTRY.
Reference: MVET, 05_vi /2012
On the 6th of February 2012 the European Commission adopted the
executive Decision C (2012) 772, based on the article 34 of the Directive
2001/82/CE of the European Parliament and of the Council about the
referral of veterinary medicines “FORTEKOR and associated names”,
which active ingredient is Benazepril hydrochloride.
The Decision implements the obligations of the Competent Authorities to
modify the Marketing Authorisation of these veterinary medicines based on
the scientific conclusions included on annex II, on the terms laid down on
annex III.
Based on this, the AEMPS recommends all the Marketing Authorisation
Holders of veterinary medicines containing Benazepril hydrochloride
different from ‘FORTEKOR’ and associated names, to present the
corresponding variations to adapt the Marketing Authorisation of their
veterinary medicines to what it is laid down on the Decision. The variation
that applies in accordance with the regulations in force (Guideline 2010/C
17/01) is C I.1.b, type IB.
References
• AEMPS. [Web]. 24th February 2012. Information Note Instruction about the
implementation procedure of the European Decision regarding veterinary medicines
“FORTEKOR” and associated names. Ref. MVET, 01_vi/2012. Available on:
http://www.aemps.gob.es/en/informa/notasInformativas/medicamentosVeterinarios/201
2/NI-MVET_01-2012.htm (link revised on 7th June 2012).
• AEMPS. [Web]. 7th June 2012. Information Note Amendment of instruction about the
implementation procedure of the european decision regarding veterinary medicines
‘Fortekor’ and associated names. Ref. MVET, 04_vi/2012. Available on:
http://www.aemps.gob.es/en/informa/notasInformativas/medicamentosVeterinarios/201
2/NI-MVET_04-2012.htm (link revised on 7th June 2012).
CORREO ELECTRÓNICO
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