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 solution buvable pour chats
Telmitraxx 4 mg/ml orale oplossing voor katten
Telmitraxx 4 mg/ml Lösung zum Eingeben für Katzen
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
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC09CA07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V661881
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:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
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French (PDF)
Published on: 18/08/2025
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German (PDF)
Published on: 18/08/2025
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NLV0386001DC_Telmitraxx_RMS Final PuAR.pdf

English (PDF)
Published on: 28/02/2024
Updated on: 29/02/2024
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