Product details
Commercial name | Iron (fier) dextran plus 200 mg/ml + 1000 mcg/ml |
Authorization number | 110311 |
Authorization status | Valida |
Authorization date | 17-11-2011 |
Authorization valid date | nelimitata |
Active substance | complex fier (III) – dextran, vitamina B12 |
Target species | bovine, porcine |
Therapeutical action | Bovine (vitei) si suine (purcei) Produsul se recomanda pentru prevenirea si tratamentul anemiilor determinate de deficienta in fier. |
Therapeutic group | Alte medicamente |
Pharmaceutical form | soluţie injectabilă |
Packaging | flacon x 100 ml |
Withdrawal period | 0 zile. |
Manufacturer | DUTCH FARM INTERNATIONAL, Olanda |
Licence owner | DUTCH FARM INTERNATIONAL, Olanda |
Romanian responsible company | _N/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 | 04-07-2025 | 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 | 04-07-2025 | A.2 | Schimbarea denumirii produsului din IRON (FIER) DEXTRAN 20% PLUS în IRON (FIER) DEXTRAN PLUS 200 mg/ml + 1000 mcg/ml. |
Authorizations history | ||||
Commercial name | Authorization number | Authorization date | Authorization valid date | Authorization status |
Iron (fier) dextran 20% plus | 060003 | 20-01-2006 | 20-01-2011 | Expirata |