Tapista 200 mg tablete s produljenim oslobađanjem
| Name | Tapista 200 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-494641412 |
| Active Substance | tapentadolfosfat |
| Composition | jedna tableta s produljenim oslobađanjem sadrži tapentadolfosfat, što odgovara 200 mg tapentadola |
| Pharmaceutical Form | Tableta s produljenim oslobađanjem |
| Manufacturer | Develco Pharma GmbH, Schopfheim, Njemačka STADA Arzneimittel AG, Bad Vilbel, Njemačka |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 17.10.2022 |
| MA Period of Validity | 17.10.2027 |
| Classification Number | UP/I-530-09/21-01/42 |
| Registration Number | 381-12-01/38-22-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | poseban recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N02AX06 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
