Norodine Equine Oral Paste
Norodine Equine Oral Paste
Authorised
- Trimethoprim
- Sulfadiazine
Product identification
Medicine name:
Norodine Equine Oral Paste
Active substance:
- Trimethoprim
- Sulfadiazine
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Trimethoprim5.80/gram(s)100.00gram(s)
-
Sulfadiazine28.83/gram(s)100.00gram(s)
Pharmaceutical form:
-
Oral paste
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal28day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01EW10
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Available in:
-
Ireland
Package description:
- Norodine Equine Paste is presented in a white high density polyethylene oral syringe with a high density polyethylene plungercalibrated in divisions, each equivalent to 50kg of bodyweight and a white high density polyethylene cap (push-fit). Eachsyringe contains enough for one daily dose for a 500kg horse.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Norbrook Laboratories Limited
- Norbrook Manufacturing Limited
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA22664/019/001
Date of authorisation status change:
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: 3/05/2024