Product details

Commercial name FITC Anti-Rabies Monoclonal Globulin (FDI FITC Anti-rabies Monoclonal Globulin)
Authorization number 230077
Authorization status Valida
Authorization date 11-04-2023
Authorization valid date 11-04-2028
Active substance
Target species
Therapeutical action Diagnosticul histologic al rabiei pe probe de creier şi glande submaxilare prin testul de imunofluorescenţă directă.
Therapeutic group Reagenti. Seturi de diagnostic
Pharmaceutical form reagent de diagnostic
Packaging flacon x 5 ml (liofilizat)
Withdrawal period
Manufacturer FUJIREBIO DIAGNOSTICS, INC., USA
Licence owner NOVA GROUP INVESTMENT SRL, România
Romanian responsible company NOVA GROUP INVESTMENT SRL
Link to prospectus click aici pentru a vizualiza prospectul
Link to authorization
Notes
Release Mode
Authorization variations

I. Variatii care necesita evaluare (VRA):

Variation No. Date Variation type Description
1 31-10-2023 II Modificarea valabilității produsului de la 18 luni la 36 luni.


II. Variatii care nu necesita evaluare (VNRA):

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Authorizations history
Commercial name Authorization number Authorization date Authorization valid date Authorization status
FITC Anti-Rabies Monoclonal Globulin (FDI FITC Anti-rabies Monoclonal Globulin) 180091 11-06-2018 11-06-2023 Anulata