XYLASED BIO 20 mg/mL, otopina za injekciju, za konje, goveda, pse i mačke
XYLASED BIO 20 mg/mL, otopina za injekciju, za konje, goveda, pse i mačke
Authorised
- Xylazine hydrochloride
Product identification
Medicine name:
XYLASED BIO 20 mg/mL, otopina za injekciju, za konje, goveda, pse i mačke
Active substance:
- Xylazine hydrochloride
Target species:
-
Horse
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Xylazine hydrochloride20.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Horse
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM92
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Croatia
Package description:
- Available only in Croatian
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:
- Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
- Bioveta a.s.
Responsible authority:
- Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
- UP/I-322-05/21-01/754
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Croatian (PDF)
Published on: 16/10/2023
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