Product details
| Commercial name | Isathal 10 mg/g |
| Authorization number | 250098 |
| Authorization status | Valida |
| Authorization date | 04-07-2025 |
| Authorization valid date | nelimitata |
| Active substance | acid fusidic |
| Target species | câini |
| Therapeutical action | Câini Pentru tratamentul infecțiilor oculare necomplicate la câini cauzate de bacteriile gram-pozitive sensibile la acid fusidic. |
| Therapeutic group | Alte medicamente |
| Pharmaceutical form | picături oftalmice, suspensie |
| Packaging | tub x 3 g, 5 g |
| Withdrawal period | Nu este cazul. |
| Manufacturer | LEO Laboratories Limited, Irlanda |
| Licence owner | DECHRA VETERINARY PRODUCTS A/S, Danemarca |
| Romanian responsible company | _N/A |
| Link to prospectus | click aici pentru a vizualiza prospectul |
| Link to authorization | |
| Notes | Autorizat prin MRP. |
| 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 |
| 1 | 04-02-2026 | 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. |
| Authorizations history | ||||
| Commercial name | Authorization number | Authorization date | Authorization valid date | Authorization status |
| Isathal 10 mg/g | 200076 | 07-07-2020 | 07-07-2025 | Expirata |
