Authorised

Product identification

Medicine name:
ZANTEL
ZANTEL
Active substance:
  • Praziquantel
  • Fenbendazole
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Praziquantel
    50.00
    milligram(s)
    /
    1.00
    Tablet
  • Fenbendazole
    500.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AA51
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 96 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 2 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 3 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 4 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 6 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 8 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 10 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 12 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 20 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 24 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 30 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 48 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 50 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 60 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 100 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 120 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 200 tablets
  • 1. White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Foil strips and blisters: 400 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 200 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 120 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 100 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 60 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 50 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 30 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 24 tablets
  • White high density polyethylene (HDPE) containers with a white polypropylene child resistant tamper evident cap. 2. Foil strips (LDPE/aluminium). 3. Foil blisters (aluminium/aluminium) Pack sizes: Containers: 20 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b 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:
  • HPRA
Authorisation number:
  • VPA10987/060/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0152/001
Concerned member states:
  • Belgium
  • Czechia
  • Greece
  • Italy
  • Norway
  • Slovakia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
Download
Source URL: https://medicines.health.europa.eu/veterinary/600000047946