Veterinary Medicines

Rumenil 34 mg/ml oral suspension for cattle

Authorised
  • Oxyclozanide
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Product identification

Medicine name:
Rumenil 34 mg/ml oral suspension for cattle
RUMENIL 34 mg/ml SUSPENSION ORAL PARA BOVINO
Active substance:
  • Oxyclozanide
Target species:
  • Cattle
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Oxyclozanide
    34.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Cattle
      • Meat and offal
        13
        day
      • Milk
        108
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AG05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • 1L: White High Density Polyethylene HDPE flexi containers with a Polypropylene cap and a PVDC sealThe product can be marketed with or without an outer carton.
  • 2.5L: White High Density Polyethylene HDPE flexi containers with a Polypropylene cap and a PVDC sealThe product can be marketed with or without an outer carton.
  • 5L: White High Density Polyethylene HDPE flexi containers with a Polypropylene cap and a PVDC sealThe product can be marketed with or without an outer carton.
  • 10 L: High Density Polyethylene (HDPE) container with a HDPE cap and an aluminium foil seal.The product can be marketed with or without an outer carton.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3465 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0369/001
Concerned member states:
  • Bulgaria
  • Hungary
  • Italy
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 4/05/2025
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Spanish (PDF)
Published on: 28/05/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/05/2025
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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: 28/05/2025
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Combined File of all Documents

English (PDF)
Published on: 4/05/2025
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