Dexdomitor (dexmedetomidine hydrochloride) – Conditions or restrictions regarding supply and use - QN05CM18
Updated on site: 09-Feb-2018
A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Orion Corporation Orion Pharma
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
C.STATEMENT OF THE MRLs
D.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.