UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs
UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs
Authorised
- Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live
- Water for injection
Product identification
Medicine name:
UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs
UNISTRAIN PRRS λυοφιλοποιημένο υλικό και διαλύτης για ενέσιμο εναιώρημα για χοίρους
Active substance:
- Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live
- Water for injection
Target species:
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live3162.27/50% cell culture infectious dose1.00Dose
-
Water for injection1.00/other1.00Dose
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig
-
Meat and offal0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI09AD03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Cyprus
Package description:
- Solvent: Colourless Type II glass vial (50, 100 and 250 ml) or PET vials (50, 100 and 250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intradermal use: Cardboard box containing 10 vials with 20 ml of solvent.
- Solvent: Colourless Type I glass vial (10 ml), or PET vials (10 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intradermal use: Cardboard box containing 10 vials with 10 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (50, 100 and 250 ml) or PET vials (50, 100 and 250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 25 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (20 ml), or PET vials (20 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 20 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (10 ml), or PET vials (10 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 10 ml of solvent.
- Solvent: Colourless Type II glass vial (250 ml) or PET vials (250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 250 ml of solvent.
- Solvent: Colourless Type II glass vial (250 ml) or PET vials (250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 200 ml of solvent.
- Solvent: Colourless Type II glass vial (100 ml) or PET vials (100 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 100 ml of solvent.
- Solvent: Colourless Type II glass vial (50 ml) or PET vials (50 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 50 ml of solvent.
- Solvent: Colourless Type I glass vial (20 ml), or PET vials (20 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular or Intradermal use: Cardboard box containing 10 vials with 20 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular or Intradermal use: Cardboard box containing 10 vials with 125 doses of freeze-dried powder.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular or Intradermal use: Cardboard box containing 10 vials with 100 doses of freeze-dried powder.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular or Intradermal use: Cardboard box containing 10 vials with 50 doses of freeze-dried powder.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 25 doses of freeze-dried powder.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 10 vials with 10 doses of freeze-dried powder.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (250 ml) or PET vials (250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 250 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (250 ml) or PET vials (250 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 200 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (100 ml) or PET vials (100 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 100 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (50 ml) or PET vials (50 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 25 doses of freeze-dried powder and 1 vial with 50 ml of solvent.
- Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (20 ml), or PET vials (20 ml) closed with a bromobutyl rubber closure and an aluminium cap. Package sizes: Intramuscular use: Cardboard box containing 1 vial with 10 doses of freeze-dried powder and 1 vial with 20 ml of 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:
- Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- LABORATORIOS HIPRA, S.A.
Responsible authority:
- Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
- CY00401V
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0287/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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Published on: 11/08/2025