Product details

Commercial name Agalaxin
Authorization number 130034
Authorization status Valida
Authorization date 13-02-2013
Authorization valid date nelimitata
Active substance Mycoplasma agalactiae, tulpina S/94
Target species caprine, ovine
Therapeutical action Ovine, caprine Preventiv şi de necesitate contra agalaxiei contagioase.
Therapeutic group Produse biologice
Pharmaceutical form suspensie apoasă
Packaging flacon x 20; 50; 100 doze (20, 50, 100 ml)
Withdrawal period 0 zile.
Manufacturer ROMVAC COMPANY S.A., România
Licence owner ROMVAC COMPANY S.A., România
Romanian responsible company ROMVAC COMPANY S.A.
Link to prospectus click aici pentru a vizualiza prospectul
Link to authorization
Notes
Release Mode Cu prescripţie
Authorization variations

I. Variatii care necesita evaluare (VRA):

Variation No. Date Variation type Description
1 16-02-2022 II/B.II.d.2.c Schimbarea procedurii de testare a produsului finit.


II. Variatii care nu necesita evaluare (VNRA):

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Authorizations history
Commercial name Authorization number Authorization date Authorization valid date Authorization status
Agalaxin forte 130216 15-11-2013 15-11-2018 Expirata
Agalaxin 060736 08-11-2006 08-11-2011 Expirata