16 March 2018 EMA/CVMP/141912/2018 Committee for Medicinal Products for Veterinary Use

MRL summary opinion 1

Isoflurane Porcine species

On 15 March 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion 2 recommending the establishment of MRLs for isoflurane in porcine species and amending the existing entry for Equidae with regard to the ‘Other provisions’ in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009, in accordance with the following table: Pharmaco

Marker

Animal

-logically

residue

species

NOT

Equidae

Target

Other

Therapeutic

tissues

provisions

classification

No MRL

NOT

For use by

General

required

APPLICABLE

inhalation

anaesthetics

No MRL

NOT

For use by

required

APPLICABLE

inhalation in

MRLs

active substance Isoflurane

APPLICABLE Porcine

piglets up to 7 days of age.

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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Isoflurane summary opinion - European Medicines Agency - Europa EU

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. Isoflurane. NOT. APPLICABLE. Equidae. No MRL required. NOT. APPLICABLE. For use by inhalation.

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