Committee for Medicinal Products for Veterinary Use
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چکیده
2. The Committee for Medicinal Products for Veterinary Use (CVMP) previously considered triclabendazole and agreed a toxicological ADI of 0.0015 mg/kg bw (i.e. 0.09 mg/person) based on the basis of the increased postpartum mortality of the F2 generation in the two-generation rat reproduction study (NOEL equal to 0.15 mg/kg bw/day) using a safety factor of 100. A validated analytical method based on HPLC with UV detection was available and had been validated for edible tissues of sheep and cattle. The CVMP recommended the following final MRLs based on data available as laid down in Council Regulation (EEC) No. 2377/90:
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Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
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 © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 20 November 2014 EMA/CHMP/ CVMP/ SWP/169430/2012 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterina...
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Committee for Veterinary Medicinal Products
Article 4 of Council Directive 81/851/EEC requires that a Member State shall not authorise the placing on the market of a veterinary medicinal product intended for administration to food producing animals [...] unless the active substance [...] contained in the product: a) were authorised for use in other veterinary medicinal products in the Member State concerned on the day of entry into force...
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Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 27 February 2014 EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterina...
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