Sileo 0.1 mg/ml - oromucosal gel
Sileo 0.1 mg/ml - oromucosal gel
Authorised
- Dexmedetomidine hydrochloride
Product identification
Medicine name:
Sileo 0.1 mg/ml - oromucosal gel
Active substance:
- Dexmedetomidine hydrochloride
Target species:
-
Dog
Route of administration:
-
Oromucosal use
Product details
Active substance and strength:
-
Dexmedetomidine hydrochloride0.11/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oromucosal gel
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM18
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Available in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:pre-filled syringe (HDPE), Package_size:5 (5x1) pre-filled syringes (multipack), Content:3 ml
- Packaging:pre-filled syringe (HDPE), Package_size:10 (10x1) pre-filled syringes (multipack), Content:3 ml
- Packaging:pre-filled syringe (HDPE), Package_size:3 (3x1) pre-filled syringes (multipack), Content:3 ml
- Packaging:pre-filled syringe (HDPE), Package_size:20 (20x1) pre-filled syringes(multipack), Content:3 ml
- Packaging:pre-filled syringe (HDPE), Package_size:1 pre-filled syringe, Content:3 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Orion Corporation
Marketing authorisation date:
Manufacturing sites for batch release:
- Orion Oyj / Orion Corporation / Orion Pharma
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 14/04/2025
Bulgarian (PDF)
Published on: 14/04/2025
Croatian (PDF)
Published on: 14/04/2025
Czech (PDF)
Published on: 14/04/2025
Danish (PDF)
Published on: 14/04/2025
Dutch (PDF)
Published on: 14/04/2025
Estonian (PDF)
Published on: 14/04/2025
Finnish (PDF)
Published on: 14/04/2025
French (PDF)
Published on: 14/04/2025
German (PDF)
Published on: 14/04/2025
Greek (PDF)
Published on: 14/04/2025
Hungarian (PDF)
Published on: 14/04/2025
Icelandic (PDF)
Published on: 14/04/2025
Italian (PDF)
Published on: 14/04/2025
Latvian (PDF)
Published on: 14/04/2025
Lithuanian (PDF)
Published on: 14/04/2025
Maltese (PDF)
Published on: 14/04/2025
Norwegian (PDF)
Published on: 14/04/2025
Polish (PDF)
Published on: 14/04/2025
Portuguese (PDF)
Published on: 14/04/2025
Romanian (PDF)
Published on: 14/04/2025
Slovak (PDF)
Published on: 14/04/2025
Slovenian (PDF)
Published on: 14/04/2025
Spanish (PDF)
Published on: 14/04/2025
Swedish (PDF)
Published on: 14/04/2025
