Dexdomitor (dexmedetomidine hydrochloride) – Conditions or restrictions regarding supply and use - QN05CM18

Updated on site: 09-Feb-2018

Medication name: Dexdomitor
ATC: QN05CM18
Substance: dexmedetomidine hydrochloride
Manufacturer: Orion Corporation

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

Not applicable.

D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Pharmacovigilance system

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.

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