Veterinary Medicines

OPTICORTENOL-S 2.5 mg/ml + 7.5 mg/ml, sospensione iniettabile per equidi non destinati alla produzione di alimenti per il consumo umano e per cani e gatti

Authorised
  • Prednisolone
  • Dexamethasone pivalate
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Product identification

Medicine name:
OPTICORTENOL-S 2.5 mg/ml + 7.5 mg/ml, sospensione iniettabile per equidi non destinati alla produzione di alimenti per il consumo umano e per cani e gatti
Active substance:
  • Prednisolone
  • Dexamethasone pivalate
Target species:
  • Dog
  • Cat
  • Horse (non food-producing)
Route of administration:
  • Intraperitoneal use
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use
  • Intraarticular use

Product details

Active substance and strength:
  • Prednisolone
    7.50
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexamethasone pivalate
    2.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Dog
    • Cat
    • Horse (non food-producing)
  • Intramuscular use
    • Dog
    • Cat
    • Horse (non food-producing)
  • Intravenous use
    • Cat
    • Horse (non food-producing)
    • Dog
  • Subcutaneous use
    • Dog
    • Cat
    • Horse (non food-producing)
  • Intraarticular use
    • Dog
    • Cat
    • Horse (non food-producing)
      • Unspecified
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB56
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Acme S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 101134
Date of authorisation status change:

Documents

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Italian (PDF)
Published on: 7/06/2023
Updated on: 8/06/2023
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