Product details
| Commercial name | Carboromvac |
| Authorization number | 150001 |
| Authorization status | Valida |
| Authorization date | 08-01-2015 |
| Authorization valid date | nelimitata |
| Active substance | Bacillus anthracis – tulpina 1190 R Stamatin |
| Target species | bovine, cabaline, caprine, ovine, porcine |
| Therapeutical action | Bovine, ovine, caprine, suine, cabaline Imunoprofilaxia antraxului. |
| Therapeutic group | Produse biologice |
| Pharmaceutical form | suspensie injectabilă |
| Packaging | flacoane x 10, 20, 50, 100 ml |
| Withdrawal period | Carne: 0 zile. Lapte: 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 | |||
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I. Variatii care necesita evaluare (VRA): |
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| Variation No. | Date | Variation type | Description |
| 2 | 22-03-2024 | 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 | 14-09-2016 | IB/B.II.f.1.b.1 | Modificarea perioadei de valabilitate a produsului finit de la 24 luni la 36 luni. |
| Authorizations history | ||||
| Commercial name | Authorization number | Authorization date | Authorization valid date | Authorization status |
| Carboromvac | 090180 | 22-12-2009 | 22-12-2014 | Expirata |
