Veterinary Medicines

NOROVIT

Authorised
  • Colecalciferol
  • Dexpanthenol
  • Nicotinamide
  • Pyridoxine hydrochloride
  • RIBOFLAVIN SODIUM PHOSPHATE
  • Thiamine hydrochloride
  • TOCOPHERYL ACETATE
  • Colecalciferol
  • Retinol palmitate
Download as PDF

Product identification

Medicine name:
НОРОВИТ
NOROVIT
Active substance:
  • Colecalciferol
  • Dexpanthenol
  • Nicotinamide
  • Pyridoxine hydrochloride
  • RIBOFLAVIN SODIUM PHOSPHATE
  • Thiamine hydrochloride
  • TOCOPHERYL ACETATE
  • Colecalciferol
  • Retinol palmitate
Target species:
  • Horse
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Colecalciferol
    25.00
    microgram(s)
    /
    1.00
    millilitre(s)
  • Dexpanthenol
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Nicotinamide
    35.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Pyridoxine hydrochloride
    3.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • RIBOFLAVIN SODIUM PHOSPHATE
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Thiamine hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • TOCOPHERYL ACETATE
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Colecalciferol
    25.00
    microgram(s)
    /
    1.00
    millilitre(s)
  • Retinol palmitate
    15000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
    • Cattle
    • Sheep
    • Pig
  • Subcutaneous use
    • Horse
    • Cattle
    • Pig
    • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA11A
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Asklep-Pharma OOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2463
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 12/06/2022
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 12/06/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."