Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Cepedex   
Auth. number : EU/2/16/200
Active substance : dexmedetomidine
ATC: Anatomical main group: QN - Nervous system
Therapeutic subgroup: QN05 - Psycholeptics
Pharmacological subgroup: QN05C - Hypnotics and sedatives
Chemical subgroup: QN05CM - Other hypnotics and sedatives
Chemical substance: QN05CM18 - Dexmedetomidine
(See WHO ATCvet Index)
Indication: Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.

Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Marketing Authorisation Holder: CP-Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/12/2016 Centralised - Authorisation EMEA/V/C/4376 (2016)8728 of 13/12/2016
04/05/2017 Centralised - Variation EMEA/V/C/4376/IAin/2