SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
Not authorised
- Spiramycin
Product identification
Medicine name:
SPIROVET 600 000 IU/ML SOLUTION FOR INJECTION FOR CATTLE
Active substance:
- Spiramycin
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Spiramycin600000.00/international unit(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Milk14dayMastitis (30 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 100 kg bodyweight) twice at 24h of interval).
-
Meat and offal75dayMastitis (30 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 100 kg bodyweight) twice at 24h of interval).
-
Milkno withdrawal periodNo withdrawal period
-
Meat and offal75dayRespiratory infections (100 000 IU of spiramycin per kg bodyweight (i.e. 5 ml of product per 30 kg bodyweight) twice at 48h of interval).
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Czechia
Package description:
- Box containing 1 glass vial of 100 ml
- Box containing 1 glass vial of 250 ml
- Box containing 1 plastic vial of 50 ml
- Box containing 1 plastic vial of 100 ml
- Box containing 1 plastic vial of 250 ml
- Box containing 1 glass vial of 50 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:
- Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva Sante Animale
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/104/12-C
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0244/001
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.
Czech (PDF)
Published on: 25/10/2022
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Combined File of all Documents
English (PDF)
Download Published on: 14/03/2026
eu-puar-frv0244001-mr-rpe_77-en.pdf
English (PDF)
Download Published on: 13/03/2026
