Sensiblex 40 mg/ml solution for injection for cattle
Sensiblex 40 mg/ml solution for injection for cattle
Authorised
- Denaverine hydrochloride
Product identification
Medicine name:
Sensiblex 40 mg/ml solution for injection for cattle
Sensiblex 40 mg/ml injekčný roztok pre hovädzí dobytok
Active substance:
- Denaverine hydrochloride
Target species:
-
Cattle (dairy cow)
-
Cattle (heifer)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Denaverine hydrochloride40.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle (dairy cow)
-
Milk24hour
-
Meat and offal1day
-
- Cattle (heifer)
-
Milk24hour
-
Meat and offal1day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02CX90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovakia
Available in:
-
Slovakia
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:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/034/DC/17-S
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 31/08/2022
Combined File of all Documents
This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 12/04/2023
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