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

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Solvent naphtha, light aromatic - Summary opinion of the CVMP on the ...

Oct 6, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ 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.

89KB Sizes 0 Downloads 156 Views

Recommend Documents

CVMP opinion for solvent naphtha, light aromatic - European ...
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 ...

Alarelin - Summary opinion of the CVMP on the establishment of ...
On 12 April 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion2 recommending the inclusion of alarelin in all food ...

Diflubenzuron - Summary opinion of the CVMP on the establishment ...
Mar 15, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Diflubenzuron Diflubenzuron. Salmonidae.

Divergent position on a CVMP opinion on the establishment of ...
Reading summary reports and the assessment report that was prepared for the current procedure, the following can be summarised: •. We do not have accessible any relevant scientific information concerning the behaviour and fate of fluazuron in milk,

Divergent position on a CVMP opinion on the establishment of ...
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 ...

CVMP opinion on fluazuron - European Medicines Agency - Europa EU
Oct 5, 2017 - Veterinary Use on the establishment of maximum residue limits. Procedure no: EMEA/V/MRL/003471/EXTN/0002. Name of the substance: ...

Paromomycin summary opinion - European Medicines Agency
Feb 15, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Paromomycin. Paromomycin All food produc

Eprinomectin summary opinion - European Medicines Agency
Nov 9, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European ...

Porcine prolactin summary opinion - European Medicines Agency
Nov 9, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © European ...

Summary of changes to the 'External guidance on the implementation ...
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.

Implementation of CVMP guideline on environmental impact ...
18 Jan 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © Europ

opinion on privatization of slaughterhouse.pdf
trade or business establishment[s] as legitimate exercise of their corporate. and/or proprietary power[s]. I. FACTUAL BACKGROUND. The City Government of ...

Substituent and solvent e˛ ects on photoexcited states of ... - CiteSeerX
which has a strong electron-donating group, shows a prominent solvent polarity e†ect on the ..... With an external heavy-atom e†ect in a mixed solvent of toluene ...

Summary of the EMA public hearing on quinolone and ...
Jun 13, 2018 - Page 2/7. Background. On 13 June 2018, the European Medicines Agency ... Page 3/7 and active pursuits or even carry out daily tasks such as ...

pdf-1830\a-commentary-on-the-executive-summary-of-mission ...
... the apps below to open or edit this item. pdf-1830\a-commentary-on-the-executive-summary-of-mi ... ciation-of-academic-health-centers-by-geoffrey-v.pdf.

Aromatic Thiol pKa Effects on the Folding Rate of a ...
The folding pathways of a number of disulfide containing proteins have ... Telephone: 305-348-3993. ...... We thank Dr. Michael Sponsler and Dr. Roger C. Hahn.

A New Theory on the Behaviour of Light
et al. (1976) sent electromagnetic signals between standard clock stations on Earth and showed that these signals ..... the water by precisely the required amount. This requirement ...... and controller of theory and opinion”. It is interesting to 

9th-Circuit-s-opinion-on-the-muslim-ban.pdf
MINNESOTA, ... Before: William C. Canby, Richard R. Clifton, and. Michelle T. Friedland .... Main menu. Displaying 9th-Circuit-s-opinion-on-the-muslim-ban.pdf.

A versatile, solvent-free methodology for the functionalisation of ...
(flow rate 10 mL/min) applying a constant ramping rate of 10 K/min in a temperature range between 50 and 850ºC. The grafting ratio Δ, i.e. the weight of.

LGBTTTI Coalition. Press Release and Summary. Advisory Opinion ...
TRANSGENDER PEOPLE AND THE RIGHTS OF SAME SEX COUPLES .... 2017, published on January 9, 2018, available (only in Spanish, at the moment) at: http://www.corteidh.or.cr/docs/opiniones/seriea_24_esp.pdf. ... January 2018.pdf.

Biennial report of the joint CVMP/CHMP working group on the ...
2. J3RsWG — 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

Opinion of the HMPC on a European Union herbal monograph on ...
Send a question via our website www.ema.europa.eu/contact ... The HMPC, in accordance with Article 16h(3) of Directive 2001/83/EC, as amended, and as set ...

Aromatic Thiol pKa Effects on the Folding Rate of a ...
University, University Park Campus, 11200 SW 8th Street, Miami, FL. 33199. Telephone: .... plot was fit using least squares to % refolded ) A(1 - e-kt), where A is ...

Opinion of the HMPC on a European Union herbal monograph on ...
An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/ ...