DALMAZIN
DALMAZIN
Authorised
- Cloprostenol
Product identification
Medicine name:
DALMAZIN
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 offal1day
-
Milk1hour
-
- Pig (sow)
-
Meat and offal1day
-
- Buffalo (female)
-
Meat and offal1day
-
Milk0day
-
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 a 1 x 10 ml glass vial sealed with a rubber stopper and aluminium cap
- Cardboard box containing 60 x 2 ml glass vials sealed with a rubber stopper and aluminium cap
- Cardboard box containing 15 x 2 ml glass vials sealed with a rubber stopper and aluminium cap
- Cardboard box containing 10 x 10 ml glass vials sealed with a rubber stopper and aluminium cap
- Cardboard box containing 5 x 20 ml glass vials sealed with a rubber stopper and aluminium cap
- Cardboard box containing a 20 ml glass vial sealed with a rubber stopper and aluminium cap
- Cardboard box containing a 2 ml glass vial sealed with a rubber stopper and aluminium cap+syringe
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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in another language below.
Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 22/07/2024
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