Veterinary Medicines

Telmitraxx 4 mg/ml oral solution for cats

Authorised
  • Telmisartan
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Product identification

Medicine name:
Telmitraxx 4 mg/ml oral solution for cats
Telmitraxx 4 mg/ml perorálny roztok pre mačky
Active substance:
  • Telmisartan
Target species:
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Telmisartan
    4.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC09CA07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • HDPE bottle filled with 200 ml. Each bottle is closed with an LDPE plug-in adapter and a tamper-proof polypropylene (PP) closure. Pack size of one bottle and one measuring syringe (3 ml, LDPE barrel and piston, PS plunger).
  • HDPE bottle filled with 90 ml. Each bottle is closed with an LDPE plug-in adapter and a tamper-proof polypropylene (PP) closure. Pack size of one bottle and one measuring syringe (3 ml, LDPE barrel and piston, PS plunger).
  • HDPE bottle filled with 60 ml. Each bottle is closed with an LDPE plug-in adapter and a tamper-proof polypropylene (PP) closure. Pack size of one bottle and one measuring syringe (3 ml, LDPE barrel and piston, PS plunger).
  • HDPE bottle filled with 30 ml. Each bottle is closed with an LDPE plug-in adapter and a tamper-proof polypropylene (PP) closure. Pack size of one bottle and one measuring syringe (3 ml, LDPE barrel and piston, PS plunger).

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Alfasan Nederland B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/001/DC/24-S
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0386/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

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Slovak (PDF)
Published on: 19/03/2024
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