Product details
Commercial name | Pestiholvac forte |
Authorization number | 110088 |
Authorization status | Valida |
Authorization date | 27-05-2011 |
Authorization valid date | nelimitata |
Active substance | Pasteurella multocida CU,Ar,Mh,Or, VND-tulpina La Sota |
Target species | păsări |
Therapeutical action | Gaini, curci, fazani, bibilici Imunoprofilaxia bolii de Newcastle si holerei. |
Therapeutic group | Produse biologice |
Pharmaceutical form | emulsie injectabilă |
Packaging | flacon x 50; 100; 200; 500; 1000 doze |
Withdrawal period | Carne: 0 zile. Oua: 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): |
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Variation No. | Date | Variation type | Description |
2 | 14-04-2025 | G.I.18 | Alinierea informatiilor despre produs cu versiunea QRD 9.0, adica actualizarea majora a formatelor QRD, conform Regulamentului (UE) 2019/6, pentru produse medicinale veterinare introduse pe piata in conformitate cu Directiva 2001/82/CE, Directiva 2001/82/CE sau Regulamentul (CE) nr. 726 / 2004. |
1 | 14-02-2018 | II/B.II.a.3.b.3 | Schimbări ale compoziției (excipienților) produsului finit. |
Authorizations history | ||||
Commercial name | Authorization number | Authorization date | Authorization valid date | Authorization status |
Pestiholvac forte | 050678 | 25-10-2005 | 25-10-2010 | Expirata |