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Veterinary Medicines

MRAbit

Authorised
  • Alarelin

Product identification

Medicine name:
MRAbit
MRABIT 1,5 mg/g POLVO PARA SOLUCION VAGINAL
Active substance:
  • Alarelin
Target species:
  • Rabbit (female for reproduction)
Route of administration:
  • Vaginal use

Product details

Active substance and strength:
  • Alarelin
    1.50
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Powder for vaginal solution
Withdrawal period by route of administration:
  • Vaginal use
    • Rabbit (female for reproduction)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • cardboard box with 5 sachets of 4 g (210 doses)
  • cardboard box with 5 sachets of 12 g (630 doses)
  • cardboard box with 5 sachets of 40 g (2.100 doses)
  • cardboard box with 25 sachets of 4 g (210 doses)
  • cardboard box with 25 sachets de12 g ( 630 doses)
  • cardboard box with 25 sachets of 40 g (2.100 doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Kubus Lab S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Kubus Lab S.A.
Responsible authority:
  • (AEMPS)
Authorisation number:
  • 3946 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0286/001
Concerned member states:
  • Italy
  • Portugal

Documents

Combined File of all Documents

English (PDF)
Published on: 22/11/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
Download
Spanish (PDF)
Published on: 17/03/2023

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023

eu-PUAR-mrabit-1.5-mg-g-powder-for-vaginal-solution-en.pdf

English (PDF)
Published on: 12/04/2023
Download

es-puar-mrabit-1.5-mg-g-powder-for-vaginal-solution-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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