Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Authorised
- R-Cloprostenol sodium
Product identification
Medicine name:
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmazin SYNCH 0,075 mg/ml injekčný roztok pre hovädzí dobytok, ošípané a kone
Active substance:
- R-Cloprostenol sodium
Target species:
-
Cattle (cow)
-
Pig (female)
-
Horse (mare)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
R-Cloprostenol sodium0.08milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle (cow)
-
Meat and offalno withdrawal periodwithdrawal period is 0 days
-
Milkno withdrawal periodwithdrawal period is 0 hours
-
-
Pig (female)
-
Meat and offal1day
-
-
Horse (mare)
-
Meat and offal2day
-
Milkno withdrawal periodwithdrawal period is 0 hours
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02AD90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovakia
Available in:
-
Slovakia
Package description:
- box containing 15 vials of 2 ml
- box containing 60 vials of 2 ml
- box containing 1 vial of 10 ml
- box containing 1 vial of 20 ml
- box containing 1 HDPE container of 100 ml
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:
- Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Fatro S.p.A.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/041/DC/19-S
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0305/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
This document does not exist in this language (English). You can find it
in another language below.
Slovak (PDF)
Published on: 23/05/2022
Summary of Product Characteristics
English (PDF)
Download Published on: 12/04/2023
Package Leaflet
English (PDF)
Download Published on: 12/04/2023
Labelling
English (PDF)
Download Published on: 12/04/2023
eu-PUAR-dalmaprost-0.075-mg-ml-solution-for-injection-for-cattle--pigs-and-horses-en.pdf
English (PDF)
Download Published on: 24/03/2023
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