Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Authorised
- Florfenicol
Product identification
Medicine name:
Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Norfenicol 300 mg/ml injektionsvæske, opløsning
Active substance:
- Florfenicol
Target species:
-
Cattle
-
Pig
Route of administration:
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Florfenicol300.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal39day
-
- Pig
-
Meat and offal22day
-
-
Subcutaneous use
- Cattle
-
Meat and offal44day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01BA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Package description:
- 500 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
- 250 ml clear type I glass vial with bromobutyl rubber bung and aluminium presented in a cardboard box or a protective sleeve.
- 100 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
- 50 ml clear type I glass vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
- 50 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box.
- 100 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
- 250 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
- 500 ml HDPE plastic vial with bromobutyl rubber bung and aluminium seal presented in a cardboard box or a protective sleeve.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
This information is not available for this product.
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Manufacturing Limited
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 48668
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0282/001
Concerned member states:
-
Belgium
-
Czechia
-
Denmark
-
Germany
-
Greece
-
Hungary
-
Italy
-
Luxembourg
-
Netherlands
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Danish (PDF)
Published on: 26/09/2023
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