Telmitraxx 4 mg/ml oral solution for cats
Telmitraxx 4 mg/ml oral solution for cats
Authorised
- Telmisartan
Product identification
Medicine name:
Telmitraxx 4 mg/ml oral solution for cats
Telmitraxx, 4mg/ml, Perorální roztok
Active substance:
- Telmisartan
Target species:
-
Cat
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Telmisartan4.00milligram(s)1.00millilitre(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:
-
Czechia
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:
- 96/052/23-C
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)
This information is not available for this product.
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 9/11/2023
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 9/11/2023
Labelling
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 9/11/2023
Combined File of all Documents
English (PDF)
Download Published on: 22/08/2023
NLV0386001DC_Telmitraxx_RMS Final PuAR.pdf
English (PDF)
Download Published on: 28/02/2024
How useful was this page?: