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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