Veterinary Medicines

ALFABEDYL 2 mg/ml solución inyectable

Authorised
  • Alfaprostol
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Product identification

Medicine name:
ALFABEDYL 2 mg/ml solución inyectable
Active substance:
  • Alfaprostol
Target species:
  • Pig (sow)
  • Horse (mare)
  • Cattle (cow)
  • Cattle (heifer)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Alfaprostol
    2.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (sow)
      • Meat and offal
        1
        day
    • Horse (mare)
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Cattle (cow)
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Cattle (heifer)
      • Meat and offal
        1
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

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:
  • Ceva Salud Animal S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetem SPA
  • CEVA SANTE ANIMALE - LIBOURNE
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 987 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 20/05/2024
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Package Leaflet

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Spanish (PDF)
Published on: 20/05/2024
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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: 20/05/2024
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