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:
- D-CLOPROSTENOL SODIUM SALT
Target species:
-
Cattle (cow)
-
Pig (female)
-
Horse (mare)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
D-CLOPROSTENOL SODIUM SALT0.08milligram(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
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)
Manufacturing sites for batch release:
- Fatro S.p.A.
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)
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