PENETHAONE Powder and solvent for suspension for injection for cattle
PENETHAONE Powder and solvent for suspension for injection for cattle
Authorised
- Penethamate hydriodide
Product identification
Medicine name:
PENETHAONE Powder and solvent for suspension for injection for cattle
Penethaone 236,3 mg/ml прах и разтворител за инжекционна суспензия за говеда
Active substance:
- Penethamate hydriodide
Target species:
-
Cattle (lactating cow)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Penethamate hydriodide236.30milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Powder and solvent for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle (lactating cow)
-
Meat and offal4day
-
Milkno withdrawal periodMeat and offal: 4 days; Milk: 2,5 days/60 hours.
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01CE90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Bulgaria
Package description:
- box containing 10 x 10,000,000 IU powder vial and 10 x 36 ml solvent vial
- box containing 5 x 10,000,000 IU powder vial and 5 x 36 ml solvent vial
- box containing 1 x 10,000,000 IU powder vial and 1 x 36 ml solvent vial
- box containing 10 x 5,000,000 IU powder vial and 10 x 18 ml solvent vial
- box containing 5 x 5,000,000 IU powder vial and 5 x 18 ml solvent vial
- box containing 1 x 5,000,000 IU powder vial and 1 x 18 ml solvent vial
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:
- Divasa Farmavic S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Divasa Farmavic S.A.
Responsible authority:
- Bulgarian Food Safety Authority
Authorisation number:
- 0022-2554
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0226/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Czechia
-
Denmark
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Lithuania
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Sweden
-
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: 26/12/2023
Bulgarian (PDF)
Published on: 4/04/2022
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 4/04/2022
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