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

Updated on site: 21-Sep-2017

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

A.MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers of the biological active substance

Fermion Oy Oulu Plant

Orion Corporation Fermion

Fermion Oy Oulu Plant

Lääketehtaantie 2

Sanginsuu

90650 Oulu

Finland

Orion Corporation Fermion

Espoo Plant, Koivu-Mankkaan tie 6 02200 Espoo

Finland

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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