Product details
Commercial name | Tralieve 50 mg/ml |
Authorization number | 230007 |
Authorization status | Valida |
Authorization date | 27-01-2023 |
Authorization valid date | nelimitata |
Active substance | tramadol clorhidrat |
Target species | câini |
Therapeutical action | Câini Pentru reducerea dureriii post-operatorii ușoare. |
Therapeutic group | Alte medicamente |
Pharmaceutical form | soluţie injectabilă |
Packaging | flacon x 10 ml, 20 ml, 50 ml |
Withdrawal period | Nu este cazul. |
Manufacturer | PRODULAB PHARMA B.V., Țările de Jos |
Licence owner | LE VET BEHEER B.V., Țările de Jos |
Romanian responsible company | _N/A |
Link to prospectus | click aici pentru a vizualiza prospectul |
Link to authorization | |
Notes | Autorizat prin DCP. |
Release Mode | Cu prescripţie |
Authorization variations | |||
I. Variatii care necesita evaluare (VRA): |
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Variation No. | Date | Variation type | Description |
1 | 30-10-2024 | 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. |
Authorizations history | ||||
Commercial name | Authorization number | Authorization date | Authorization valid date | Authorization status |
Tralieve 50 mg/ml | 180008 | 29-01-2018 | 29-01-2023 | Expirata |