Veterinary Medicines

Ridamec 1 mg/ml oral solution for sheep

Authorised
  • Moxidectin
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Product identification

Medicine name:
Ridamec, 1 mg/mL, oralna otopina za ovce
Ridamec 1 mg/ml oral solution for sheep
Active substance:
  • Moxidectin
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Moxidectin
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        14
        day
      • Milk
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • White HDPE flexi containers containing 1L of product. The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps. The product is marketed in a cardboard outer carton.
  • White HDPE flexi containers containing 2.5 L of product. The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps. The product is marketed in a cardboard outer carton.
  • White HDPE flexi containers containing 3 L of product. The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps. The product is marketed in a cardboard outer carton.
  • White HDPE flexi containers containing 5 L of product. The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps. The product is marketed in a cardboard 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:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/17-01/254
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0403/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • France
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 15/01/2024
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