Salmoporc, lyophilisate and solvent for suspension for injection / lyophilisate for use in drinking water
Salmoporc, lyophilisate and solvent for suspension for injection / lyophilisate for use in drinking water
Authorised
- Salmonella enterica, subsp. enterica, serovar Typhimurium, histidine-adenine auxotrophic, Live
Product identification
Medicine name:
SALMOPORC LIOFILIZADO Y DISOLVENTE PARA SUSPENSION INYECTABLE / LIOFILIZADO PARA ADMINISTRACION EN AGUA DE BEBIDA
Salmoporc, lyophilisate and solvent for suspension for injection / lyophilisate for use in drinking water
Active substance:
- Salmonella enterica, subsp. enterica, serovar Typhimurium, histidine-adenine auxotrophic, Live
Target species:
-
Pig
-
Pig (sow for reproduction)
-
Pig (sucking piglet)
Route of administration:
-
Subcutaneous use
-
Oral use
Product details
Active substance and strength:
-
Salmonella enterica, subsp. enterica, serovar Typhimurium, histidine-adenine auxotrophic, Live5000.00million colony forming units1.00Dose
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Pig
-
Meat and offal6week
-
- Pig (sow for reproduction)
-
Meat and offal6week
-
-
Oral use
- Pig (sucking piglet)
-
Meat and offal6week
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI09AE02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Package description:
- Cardboard box containing 1 vial with 200 doses
- Cardboard box containing 1 vial with 20 doses lyophilised vaccine and 1 vial with 20 ml solvent
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:
- Ceva Salud Animal S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
- IDT Biologika GmbH
Responsible authority:
- The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
- 4027 ESP
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0290/001
Concerned member states:
-
France
-
Spain
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.
Spanish (PDF)
Published on: 16/02/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2024
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2024
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