Metaxol 20/100 mg/ml Oral solution for pigs and chickens
Metaxol 20/100 mg/ml Oral solution for pigs and chickens
Authorised
- Trimethoprim
- Sulfamethoxazole
Product identification
Medicine name:
Metaxol 20/100 mg/ml Oral solution for pigs and chickens
Active substance:
- Trimethoprim
- Sulfamethoxazole
Target species:
-
Chicken
-
Pig
Route of administration:
-
In drinking water use
Product details
Active substance and strength:
-
Trimethoprim20.00/milligram(s)1.00millilitre(s)
-
Sulfamethoxazole100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for use in drinking water
Withdrawal period by route of administration:
-
In drinking water use
-
Chicken
-
Meat and offal5day
-
-
Pig
-
Meat and offal8day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01EW11
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- HDPE bottle of 1 litre, closed with a tamper proof HDPE screw cap
- HDPE container of 5 litres, closed with tamper proof HDPE screw cap
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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera d.d.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V501173
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0198/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Estonia
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Lithuania
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
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
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Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 13/12/2023
Labelling
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