TRIVACTON 6

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Kupi sada

Svojstava lijeka Svojstava lijeka (SPC)
12-06-2017

Aktivni sastojci:

Inactivated bovine coronavirus strain f15, Inactivated bovine rotavirus strain ro1, Inactivated e.coli k99 strain serotype o101, Inactivated e.coli y strain serotype o117, Inactivated e.coli f41 strain serotype o101, Inactivated e. coli 31a strain serotype O78

Dostupno od:

Merial Animal Health Limited

ATC koda:

QI02AL01

INN (International ime):

Inactivated bovine coronavirus strain f15, Inactivated bovine rotavirus strain ro1, Inactivated e.coli k99 strain serotype o101,

Doziranje:

1.9/3.0/0.6/0.9/0.7/1.6 Seroagglutinating antibody titre

Farmaceutski oblik:

Suspension for injection

Tip recepta:

LM: Licensed Merchant as defined in relevant national legislation

Terapijska grupa:

Cattle

Područje terapije:

bovine rotavirus + bovine coronavirus + escherichia

Terapijske indikacije:

Immunological - Inactivated Vaccine

Status autorizacije:

Authorised

Datum autorizacije:

2003-08-06

Svojstava lijeka

                                IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10857/032/001
Case No: 7004880
The Irish Medicines Board in exercise of the powers conferred on it by
Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE
,
SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW
,
ESSEX CM19 5TG
,
UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations
and the general conditions of the attached authorisation, in respect
of the
Veterinary Medicinal Product:
TRIVACTON 6
The particulars of which are set out in Part 1 and Part 2 of the said
Schedule. The authorisation is also subject to any special conditions
as may
be specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from
30/01/2009
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in
respect of this product which is now null and void.)
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TRIVACTON 6.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* 1SA.U = q.s. to obtain to obtain a seroagglutinating antibody titre
of 1 log
10
in mice a
                                
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