Veterinary Medicines

Vitamin AD3E pro injectione, solution for injection for horses, cattle, pigs, and dogs

Not authorised
  • Retinol palmitate
  • COLECALCIFEROL CONCENTRATE (OILY FORM)
  • DL-ALPHA TOCOPHEROL ACETATE
Download as PDF

Product identification

Medicine name:
Vitamin AD3E pro injectione, solution for injection for horses, cattle, pigs, and dogs
Belavit AD3E, raztopina za injiciranje za konje, govedo, prašiče in pse
Active substance:
  • Retinol palmitate
  • COLECALCIFEROL CONCENTRATE (OILY FORM)
  • DL-ALPHA TOCOPHEROL ACETATE
Target species:
  • Cattle
  • Dog
  • Horse
  • Pig
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Retinol palmitate
    176.46
    milligram(s)
    /
    1.00
    millilitre(s)
  • COLECALCIFEROL CONCENTRATE (OILY FORM)
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • DL-ALPHA TOCOPHEROL ACETATE
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Milk
        120
        hour
      • Meat and offal
        259
        day
    • Horse
      • Meat and offal
        250
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        194
        day
  • Intramuscular use
    • Cattle
      • Milk
        120
        hour
      • Meat and offal
        259
        day
    • Horse
      • Meat and offal
        250
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        194
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA11JA
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Slovenia
Package description:
  • (ID3): 1 unspecified outer container with 12 Bottle (Glass) with 100 millilitre(s) (1200 millilitre(s))
  • (ID2): 1 unspecified outer container with 6 Bottle (Glass) with 100 millilitre(s) (600 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Bottle (Glass) with 100 millilitre(s) (100 millilitre(s))

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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0668/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0313/001

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 14/02/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 14/02/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 14/02/2022
Download

Combined File of all Documents

English (PDF)
Published on: 15/02/2022
Download