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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|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|
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.
|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|