Baklofen Sintetica Intratekalni 0,5 mg/ml otopina za infuziju
| Name | Baklofen Sintetica Intratekalni 0,5 mg/ml otopina za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-358356156 |
| Active Substance | baklofen |
| Composition | 1 ml otopine za infuziju sadržava 0,5 mg (500 mikrograma) baklofena, 3,5 mg natrija 1 ampula (20 ml) sadržava 10 mg (10 000 mikrograma) baklofena, 70 mg natrija |
| Pharmaceutical Form | otopina za infuziju |
| Manufacturer | Sirton Pharmaceuticals S.p.A., Villa Guardia (CO), Italija
Laboratoire Aguettant, Lyon, Francuska L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A., Scandicci, Firenza, Italija Sintetica GmbH, Münster, Njemačka |
| Marketing Authorisation Holder | Sintetica GmbH, Albersloher Weg 11, Münster, Njemačka |
| Marketing Authorisation Date | 26.11.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/199 |
| Registration Number | 381-12-01/38-20-02 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | M03BX01 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
