Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
FELINE LEUKEMIA VIRUS ENVELOPE ANTIGEN P45
Virbac S.A.
QI06AA01
FELINE LEUKEMIA VIRUS ENVELOPE ANTIGEN P45
%v/v
Suspension for Injection
POM
Feline
Feline leukaemia virus vaccine
Immunological - Inactivated vaccine
Authorised
2007-09-21
PRODUCT SPECIFIC DETAILS 1 VETERINARY PRODUCT AUTHORISATION NUMBER 10988/40/1 2 NAME OF THE VETERINARY MEDICINAL PRODUCT Leucogen 3 PRODUCT DESCRIPTION Suspension for injection. 4 QUALITATIVE AND QUANTITATIVE COMPOSITION per dose (1.0 ml) _Active Substance:_ FeLV recombinant p45 protein Minimum: 97.0 microgram Maximum: 107.0 microgram Target: 102.0 microgram _Adjuvant:_ Aluminium hydroxide gel (3%) 0.1 ml Quil A 10.0 microgram _Excipients:_ Disodium phosphate anhydrous 1.0 mg Potassium dihydrogen phosphate 0.3 mg Sodium chloride 9.0 mg Water for injection q.s. 1.0 ml HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 18/01/2017_ _CRN 7000123_ _page number: 2_ 5 NAME AND ADDRESS OF MANUFACTURER(S) _Manufacture responsible for manufacture of active substance:_ P.P. Manufacturing Corporation, Framingham, Massachusetts, USA. _Manufacturer responsible for blending, filling primary and secondary packaging:_ Virbac S.A., 1ère avenue – 2065 m-L.I.D., 06516 Carros Cedex, France. _Manufacturer responsible for batch release:_ Virbac S.A., 1ère avenue – 2065 m-L.I.D., 06516 Carros Cedex, France. 6 METHOD OF SALE OR SUPPLY POM: Prescription Only Medicine as defined in relevant national legislation. 7 SPECIAL PRODUCT LITERATURE REQUIREMENTS Product Literature for the Irish market will be updated in accordance with agreements reached on completion of the proposed MRP for Leucogen with DE acting as RMS. 8 SPECIAL CONDITIONS On completion of the proposed MRP for Leucogen with DE acting as RMS, Part II of the current licence will be updated to include the SPC agreed during the MRP. 9 ADDITIONAL INFORMATION Glass vials containing 1 ml. Each vial is closed with an elastomer closure and sealed with an aluminium cap. Cartons containin Lesen Sie das vollständige Dokument