Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs
Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs
Authorised
- Cloprostenol
Product identification
Medicine name:
Dalmazin, 75 micrograms/ml, solution for injection for cattle, buffaloes and pigs
Dalmazin 75 µg/ml Oplossing voor injectie
Dalmazin 75 µg/ml Solution injectable
Dalmazin 75 µg/ml Injektionslösung
Active substance:
- Cloprostenol
Target species:
-
Cattle (cow)
-
Pig (sow)
-
Buffalo (female)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Cloprostenol75.00/microgram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle (cow)
-
Meat and offal0day
-
Milk0hour
-
-
Pig (sow)
-
Meat and offal1day
-
-
Buffalo (female)
-
Meat and offal1day
-
Milk0hour
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02AD90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box containing 1 x 10 ml type II glass vial sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box containing 4 blister of 15 x 2 ml type I glass vials (60 vials) sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box containing 1 blister of 15 x 2 ml type I glass vials (15 vials) sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box containing 10 x 10 ml type II glass vials sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box containing 5 x 20 ml type II glass vials sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box containing a 20 ml type II glass vial sealed with a chlorobutyl type I rubber stopper and aluminium overseal
- Cardboard box with 1 type II glass vial of 50 ml with a chlorobutyl type I rubber stopper and an aluminium overseal
- Cardboard box with 1 HDPE multidose container of 100 ml with a chlorobutyl type I rubber stopper and an aluminium overseal
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Fatro S.p.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
-
Italy
Procedure number:
- IT/V/0105/001
Concerned member states:
-
Austria
-
Belgium
-
France
-
Germany
-
Ireland
-
Luxembourg
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 6/08/2025
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