Veterinary Medicines

Regumate Equine 2.2 mg/ml oral solution for horses

Authorised
  • Altrenogest
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Product identification

Medicine name:
Regumate Equine 2.2 mg/ml oral solution for horses
Regumate Equini 2,2 mg/ml soluzione orale per cavalli
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:
  • Italy
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
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103722
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: 11/02/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 6/04/2022
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