6 October 2017 EMA/CVMP/649207/2017 Committee for Medicinal Products for Veterinary Use
MRL summary opinion 1
Solvent naphtha, light aromatic All food producing species
On 5 October 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion 2 recommending the inclusion of solvent naphtha, light aromatic in all food producing species in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010, in accordance with the following table: Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
Therapeutic classification
Solvent naphtha, light aromatic, with cumene concentration not exceeding 2.5%, and benzene concentration not exceeding 0.0002%
NOT APPLICABLE
All food producing species
No MRL required
NOT APPLICABLE
For cutaneous use only. Only at volume not exceeding 15 μl solvent naphtha/kg bw.
NO ENTRY
1
Summaries of opinion are published without prejudice to the Commission Decision. Applicants may request re-examination of any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to request such re-examination within 15 days of receipt of the opinion 2
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Solvent naphtha, light aromatic - Summary opinion of the CVMP on the ...
Oct 6, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union. Telephone ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Solvent naphtha, light aromatic, with cumene concentration not exceeding. 2.5%, and benzene.
Oct 5, 2017 - Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Zoetis Belgium SA submitted to the. European Medicines Agency on 2 ...
On 12 April 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion2 recommending the inclusion of alarelin in all food ...
Mar 15, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Diflubenzuron Diflubenzuron. Salmonidae.
Reading summary reports and the assessment report that was prepared for the current procedure, the following can be summarised: â¢. We do not have accessible any relevant scientific information concerning the behaviour and fate of fluazuron in milk,
The CVMP has estimated the safe level based on a mathematic calculation only (even if the conclusion is that exposure does not represent a sizable part of the ...
Feb 15, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Paromomycin. Paromomycin All food produc
Apr 12, 2017 - indication application submitted in the context of regulatory procedures not ... are able to identify validation non-compliance at an early stage. 2.
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2. J3RsWG â Biennial report 2016/2017. Introduction. The Joint CHMP/CVMP Expert Group on 3Rs (JEG 3Rs) had been active since October 2010 with a mandate to provide advice and recommendations to the. CVMP and CHMP on all matters relating to the use
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