RESPISURE 1 ONE, Injekční emulze
RESPISURE 1 ONE, Injekční emulze
Authorised
- Mycoplasma hyopneumoniae, Inactivated
Product identification
Medicine name:
RESPISURE 1 ONE, Injekční emulze
Active substance:
- Mycoplasma hyopneumoniae, Inactivated
Target species:
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Mycoplasma hyopneumoniae, Inactivated5.20log10 enzyme-linked immunosorbent assay unit1.00Dose
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Pig
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI09AB13
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Czechia
Available in:
-
Czechia
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:
- Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
- Laboratorios Syva S.A.U.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 97/082/03-C
Date of authorisation status change:
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: 26/10/2022
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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