ROTAGAL emulsion for injection
ROTAGAL emulsion for injection
Authorised
- Bovine rotavirus, strain TM-91, Inactivated
- Bovine coronavirus, strain C-197, Inactivated
- Escherichia coli, fimbrial adhesin F5
Product identification
Medicine name:
ROTAGAL injekčná emulzia
ROTAGAL emulsion for injection
Active substance:
- Bovine rotavirus, strain TM-91, Inactivated
- Bovine coronavirus, strain C-197, Inactivated
- Escherichia coli, fimbrial adhesin F5
Target species:
-
Cattle (pregnant cow)
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bovine rotavirus, strain TM-91, Inactivated32.10enzyme-linked immunosorbent assay unit3.00millilitre(s)
-
Bovine coronavirus, strain C-197, Inactivated44.80enzyme-linked immunosorbent assay unit3.00millilitre(s)
-
Escherichia coli, fimbrial adhesin F539.70enzyme-linked immunosorbent assay unit3.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle (pregnant cow)
-
All relevant tissues0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AL01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovakia
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Pharmagal Bio spol. s r.o.
Marketing authorisation date:
This information is not available for this product.
Manufacturing sites for batch release:
- Pharmagal Bio spol. s r.o.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 97/072/07-S
Date of authorisation status change:
Reference member state:
-
Slovakia
Procedure number:
- SK/V/0105/001
Concerned member states:
-
Czechia
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 24/01/2022
Slovak (PDF)
Published on: 24/01/2022
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