Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
Authorised
- Tulathromycin
Product identification
Medicine name:
Tulieve 100 mg/ml solution for injection for cattle, pigs and sheep
Tulieve 100 mg/ml Injektionslösung für Rinder, Schweine und Schafe
Active substance:
- Tulathromycin
Target species:
-
Cattle
-
Sheep
-
Pig
Route of administration:
-
Subcutaneous use
-
Intramuscular use
Product details
Active substance and strength:
-
Tulathromycin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Cattle
-
Meat and offal22day
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
-
-
-
Intramuscular use
-
Sheep
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
-
Meat and offal16day
-
-
Pig
-
Meat and offal13day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Germany
Package description:
- (ID9) 500 millilitre(s): Box (board) with 1 Vial (clear glass) with 500 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID8) 250 millilitre(s): Box (board) with 1 Vial (clear glass) with 250 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID7) 100 millilitre(s): Box (board) with 1 Vial (clear glass) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID6) 50 millilitre(s): Box (board) with 1 Vial (clear glass) with 50 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID5) 1 litre(s): Box (board) with 1 Vial (high-density polyethylene) with 1 litre(s), closed with Stopfen (bromobutyl rubber)
- (ID4) 500 millilitre(s): Box (board) with 1 Vial (high-density polyethylene) with 500 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID3) 250 millilitre(s): Box (board) with 1 Vial (high-density polyethylene) with 250 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID2) 100 millilitre(s): Box (board) with 1 Vial (high-density polyethylene) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber)
- (ID1) 50 millilitre(s): Box (board) with 1 Vial (high-density polyethylene) with 50 millilitre(s), closed with Stopfen (bromobutyl rubber)
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:
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Laboratories (Ireland) Limited
Responsible authority:
- Federal Office Of Consumer Protection And Food Safety
Authorisation number:
- 402669.00.00
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0322/001
Concerned member states:
-
Belgium
-
Estonia
-
France
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
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Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
