Ketarenil filmom obložene tablete
| Name | Ketarenil filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-240366619 |
| Active Substance | ketoizoleucinkalcij ketoleucinkalcij ketofenilalaninkalcij ketovalinkalcij hidroksimetioninkalcij lizinacetat treonin triptofan histidin tirozin |
| Composition | 1 filmom obložena tableta sadrži: D,L-alfa-keto-izoleucinkalcij 67 mg, alfa-keto-leucinkalcij 101 mg, alfa-keto-fenilalaninkalcij 68 mg, alfa-keto-valinkalcij 86 mg D,L-alfa-hidroksimetioninkalcij 59 mg L-lizinacetat što odgovara 75 mg L-lizina 105 mg L-treonin 53 mg L-triptofan 23 mg L-histidin 38 mg L-tirozin 30 mg Ukupan sadržaj dušika po tableti 36 mg Sadržaj kalcija po tableti 1,25 mmol = 50 mg |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Labesfal - Laboratorios Almiro S.A., Santiago de Besteiros, Portugal |
| Marketing Authorisation Holder | Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 11.08.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/25-02/65 |
| Registration Number | 381-12-01/70-25-04 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | V06DD |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
