10 November 2017 EMA/CVMP/698682/2017 Committee for Medicinal Products for Veterinary Use

MRL summary opinion 1

Porcine prolactin Porcine species

On 9 November 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion 2 recommending the inclusion of porcine prolactin in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010, in accordance with the following table: Pharmaco-

Marker

Animal

logically

residue

species

Porcine

NOT

Porcine

prolactin

APPLICABLE

Target

Other

Therapeutic

tissues

provisions

classification

No MRL

NOT

For oral use in

Agents acting

required

APPLICABLE

newborn piglets

on the

at a dose of up

reproductive

to 0.2 mg

system

MRLs

active substance

/animal. For use in sows at a total dose of up to 5 mg /animal.

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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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 ...

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