Veterinary Medicines

Helminthex, 425mg/g, Oral paste

Authorised
  • Pyrantel embonate
Download as PDF

Product identification

Medicine name:
Helminthex, 425mg/g, Oral paste
Helminthex 425 mg/g pasta orale per cavalli
Active substance:
  • Pyrantel embonate
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pyrantel embonate
    425.45
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Milk
        no withdrawal period
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AF02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Plastic Applicator 20 x 32.08 gram(s)
  • Plastic Applicator 20 x 27.5 gram(s)
  • Plastic Applicator 10 x 32.08 gram(s)
  • Plastic Applicator 10 x 27.5 gram(s)
  • Plastic Applicator 1 x 32.08 gram(s)
  • Plastic Applicator 1 x 27.5 gram(s)

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:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma Production B.V.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105223
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0146/001
Concerned member states:
  • Austria
  • France
  • Italy
  • Latvia
  • Poland
  • Portugal

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 8/11/2024
Download