Veterinary Medicines

Zantoral 30mg/ml oral solution for dogs

Authorised
  • Ranitidine
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Product identification

Medicine name:
Zantoral 30mg/ml oral solution for dogs
Active substance:
  • Ranitidine
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ranitidine
    30.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA02BA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Available in:
  • Italy
Package description:
  • High density polyethylene bottle 48 ml with high density polyethylene stoppers and a low density polyethylene plug. 3 ml polypropylene/silicone syringe, graduated every 0.1 ml to 3 ml.
  • High density polyethylene bottle 24 ml with high density polyethylene stoppers and a low density polyethylene plug. 3 ml polypropylene/silicone syringe, graduated every 0.1 ml to 3 ml.
  • High density polyethylene bottle 12 ml with high density polyethylene stoppers and a low density polyethylene plug. 3 ml polypropylene/silicone syringe, graduated every 0.1 ml to 3 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:
  • Emdoka
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105328
Date of authorisation status change:
Reference member state:
  • Italy
Procedure number:
  • IT/V/0141/001
Concerned member states:
  • Austria
  • Belgium
  • Germany
  • Luxembourg
  • Netherlands

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 10/10/2024
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