Veterinary Medicine Information website

BISEPTYL

Authorised
  • Spectinomycin sulfate
  • Lincomycin hydrochloride
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Product identification

Medicine name:
BISEPTYL
Active substance:
  • Spectinomycin sulfate
  • Lincomycin hydrochloride
Target species:
  • Cattle
  • Pig
  • Dog
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Spectinomycin sulfate
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Lincomycin hydrochloride
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        14
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        14
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1197 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 13/09/2024
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Package Leaflet

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Spanish (PDF)
Published on: 13/09/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 13/09/2024
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