Veterinary Medicines

Helmigal 40,0 mg/g Proszek doustny

Authorised
  • Fenbendazole
Download as PDF

Product identification

Medicine name:
Helmigal 40,0 mg/g Proszek doustny
Active substance:
  • Fenbendazole
Target species:
  • Pig
  • Wild boar
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Fenbendazole
    40.00
    milligram(s)/gram
    /
    1.00
    milligram(s)/gram
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        5
        day
    • Wild boar
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Pharmagal spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal spol. s r.o.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2856
Date of authorisation status change:

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 24/11/2025
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 24/11/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 24/11/2025
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 24/11/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."