Veterinary Medicines

Sensiblex 40 mg/ml solution for injection for cattle

Authorised
  • Denaverine hydrochloride
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Product identification

Medicine name:
Sensiblex 40 mg/ml solution for injection for cattle
Sensiblex 40 mg/ml solution for injection for cattle
Active substance:
  • Denaverine hydrochloride
Target species:
  • Cattle (dairy cow)
  • Cattle (heifer)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Denaverine hydrochloride
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (dairy cow)
      • Milk
        24
        hour
      • Meat and offal
        1
        day
    • Cattle (heifer)
      • Milk
        24
        hour
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02CX90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • (ID3) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s)
  • (ID1) 10 millilitre(s): unspecified outer container with 1 Vial (Glass) with 10 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:
  • Veyx Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Veyx Pharma GmbH
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10539/005/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0163/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 31/08/2022
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