Ralcam, 100+0,05mg/ml, Solution for injection
Ralcam, 100+0,05mg/ml, Solution for injection
Authorised
- Cyanocobalamin
- Butafosfan
Product identification
Medicine name:
Ralcam, 100+0,05mg/ml, Solution for injection
Ralcam, 100+0,05mg/ml, Injekční roztok
Active substance:
- Cyanocobalamin
- Butafosfan
Target species:
-
Cattle
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Cyanocobalamin0.05/milligram(s)1.00millilitre(s)
-
Butafosfan100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Cattle
-
Milk0hour
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA12CX99
Legal status of supply:
This information is not available for this product.
Authorisation status:
-
Valid
Authorised in:
-
Czechia
Package description:
- Glass Vial 1 x 250.0 millilitre(s)
- Glass Vial 1 x 100.0 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:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- Tad Pharma GmbH
- Krka d.d. Novo Mesto
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/063/19-C
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0160/001
Concerned member states:
-
Germany
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: 24/05/2022
Czech (PDF)
Published on: 24/05/2022
eu-puar-czv0160001-mr-ralcam-en.pdf
English (PDF)
Download Published on: 16/11/2023
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