Veterinary Medicines

PROMILEX 21,94 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA

Authorised
  • Bromhexine hydrochloride
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Product identification

Medicine name:
PROMILEX 21,94 mg/ml SOLUCION PARA ADMINISTRACION EN AGUA DE BEBIDA
Active substance:
  • Bromhexine hydrochloride
Target species:
  • Cattle
  • Pig
Route of administration:
  • In drinking water/milk use

Product details

Active substance and strength:
  • Bromhexine hydrochloride
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for use in drinking water
Withdrawal period by route of administration:
  • In drinking water/milk use
    • Cattle
      • Meat and offal
        3
        day
      • Milk
        no withdrawal period
    • Pig
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QR05CB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
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:
  • Super's Diana S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Super's Diana S.L.
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 634 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 14/08/2025
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Package Leaflet

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Spanish (PDF)
Published on: 14/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 14/08/2025
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