Selehold 360 mg spot-on solution for dogs 40.1�60.0 kg
Selehold 360 mg spot-on solution for dogs 40.1�60.0 kg
Authorised
- Selamectin
Product identification
Medicine name:
Selehold 360 mg spot-on solution for dogs 40.1�60.0 kg
SELEHOLD 360 mg soluție spot-on pentru câini 40,1 - 60,0 kg
Active substance:
- Selamectin
Target species:
-
Dog
Route of administration:
-
Spot-on use
Product details
Active substance and strength:
-
Selamectin360.00milligram(s)1.00Pipette
Pharmaceutical form:
-
Spot-on solution
Withdrawal period by route of administration:
-
Spot-on use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA05
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 1 pipette.
- Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 3 pipettes.
- Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 6 pipettes.
- Translucent polypropylene unit-dose pipette with polyethylene or polyoxymethylene or polypropylene closure with spike packaged into a laminated triplex bag composed of polyester, aluminium and polyethylene. 6 ml pipette containing 3.0 ml of solution. Cardboard box containing 15 pipettes.
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:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- Krka d.d. Novo Mesto
- Tad Pharma GmbH
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 230164
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0395/005
Concerned member states:
-
Belgium
-
Bulgaria
-
Croatia
-
Czechia
-
Estonia
-
France
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 11/02/2022
Romanian (PDF)
Published on: 5/12/2023
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