Veterinary Medicines

Combotec 134 mg/120.6 mg Spot-on Solution for Medium Dogs

Authorised
  • Methoprene
  • Fipronil
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Product identification

Medicine name:
Combotec 134 mg/120.6 mg Spot-on Solution for Medium Dogs
Active substance:
  • Methoprene
  • Fipronil
Target species:
  • Dog
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Methoprene
    120.60
    milligram(s)
    /
    1.34
    millilitre(s)
  • Fipronil
    134.00
    milligram(s)
    /
    1.34
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AX65
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Malta
Package description:
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 3 pipettes are packed in a cardboard box.
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 2 pipettes are packed in a cardboard box.
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 1 pipette are packed in a cardboard box.
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 6 pipettes are packed in a cardboard box.
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 5 pipettes are packed in a cardboard box.
  • A blue pipette is composed of a heat-formed shell and a film. The blue pipette is enclosed in an aluminum blister. 4 pipettes are packed in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Beaphar B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Beaphar B.V.
Responsible authority:
  • Veterinary And Phytosanitary Regulation Department
Authorisation number:
  • VMA103
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0251/003
Concerned member states:
  • Czechia
  • Hungary
  • Italy
  • Malta

Documents

Combined File of all Documents

English (PDF)
Published on: 5/02/2026
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PuAR Combotec REG NL 123864 123866-9_FINAL 22Jan2024.pdf

English (PDF)
Published on: 25/01/2024
Download