Veterinary Medicines

Regumate Equine 2.2 mg/ml oral solution for horses

Authorised
  • Altrenogest
Download as PDF

Product identification

Medicine name:
Regumate Equine 2.2 mg/ml oral solution for horses
Regumate Equine 2,2 mg/ml mikstur, oppløsning til hest
Active substance:
  • Altrenogest
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Altrenogest
    2.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        9
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG03DX90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • The product is packaged in brown opaque 150 ml polyethylene bottles sealed by an aluminium protective cap and closed by a plastic screwed-on stopper. The 150 ml is provided with a luer lock cap which, when screwed on the bottle neck, allows the user to safely and accurately withdraw the product with a syringe that can directly adjust on the luer lock cap.
  • The product is packaged in brown opaque 250 ml polyethylene bottles sealed by an aluminium protective cap and closed by a plastic screwed-on stopper.The 250 ml bottle is equipped with a 12.5 measuring compartment.
  • The product is packaged in a brown opaque 300 ml polyethylene bottle sealed by an aluminium protective cap and closed by a plastic screwed-on stopper.The 300 ml bottle is provided with a luer lock cap which, when screwed on the bottle neck, allows the user to safely and accurately withdraw the product with a syringe that can directly adjust on the luer lock cap.
  • The product is packaged in a brown opaque 1000 ml polyethylene bottle sealed by an aluminium protective cap and closed by a plastic screwed-on stopper.The 1000 ml bottle is provided with a luer lock cap which, when screwed on the bottle neck, allows the user to safely and accurately withdraw the product with a syringe that can directly adjust on the luer lock cap.

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:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet Productions S.A.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 04-2810
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0155/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/11/2024
Download
Norwegian (PDF)
Published on: 26/01/2022
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."