Dalmazin 0,075 mg/ml Roztwór do wstrzykiwań
Dalmazin 0,075 mg/ml Roztwór do wstrzykiwań
Authorised
- D-cloprostenol
Product identification
Medicine name:
Dalmazin 0,075 mg/ml Roztwór do wstrzykiwań
Active substance:
- D-cloprostenol
Target species:
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Pig
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Cattle
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Horse
Route of administration:
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Intramuscular use
Product details
Active substance and strength:
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D-cloprostenol0.08/milligram(s)1.00millilitre(s)
Pharmaceutical form:
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Solution for injection
Withdrawal period by route of administration:
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Intramuscular use
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Pig
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Meat and offal1day
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-
Cattle
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Milk0day
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Meat and offal0day
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-
Horse
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All relevant tissuesno withdrawal periodHorses that have ever been treated with Dalmazin must not be slaughtered for human consumption. Only use on horses that have a signed declaration in their passport stating “Not intended for slaughter for human consumption in accordance with current law.”
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-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02AD90
Legal status of supply:
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Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Poland
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:
- Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
- 1445
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
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 22/10/2024
Labelling
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 22/10/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 22/10/2024
