LEUCOGEN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-01-2017
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Active ingredient:
FELINE LEUKEMIA VIRUS ENVELOPE ANTIGEN P45
Available from:
Virbac S.A.
ATC code:
QI06AA01
INN (International Name):
FELINE LEUKEMIA VIRUS ENVELOPE ANTIGEN P45
Dosage:
%v/v
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Feline
Therapeutic area:
Feline leukaemia virus vaccine
Therapeutic indications:
Immunological - Inactivated vaccine
Authorization status:
Authorised
Authorization date:
2007-09-21
Summary of Product characteristics
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
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