SPIR INYECTABLE
SPIR INYECTABLE
Authorised
- SPIRAMYCIN ADIPATE
Product identification
Medicine name:
SPIR INYECTABLE
Active substance:
- SPIRAMYCIN ADIPATE
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
SPIRAMYCIN ADIPATE540000.00/international unit(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal75day
-
Milkno withdrawal periodLeche: Para Mastitis 13,5 días/ En caso de tratamiento en la dosis necesaria para infecciones respiratorias el medicamento no está autorizado para uso en animales que producen leche para consumo humano.
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Laboratorios Maymo S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Maymo S.A.
Responsible authority:
- Spanish Agency For Medicines And Health Products
Authorisation number:
- 265 ESP
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.
Spanish (PDF)
Published on: 8/04/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 8/04/2024
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