Mefeda 54 mg tablete s produljenim oslobađanjem
| Name | Mefeda 54 mg tablete s produljenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-141356167 |
| Active Substance | metilfenidatklorid |
| Composition | jedna tableta s produljenim oslobađanjem sadrži 54 mg metilfenidatklorida |
| Pharmaceutical Form | Tableta s produljenim oslobađanjem |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
| Marketing Authorisation Date | 07.12.2021 |
| MA Period of Validity | 07.12.2026 |
| Classification Number | UP/I-530-09/20-01/68 |
| Registration Number | 381-12-01/154-21-08 |
| 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 | N06BA04 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Kontrolni popis prije propisivanja metilfenidata, verzija 1 Obrazac za kontinuirano praćenje liječenja metilfenidatom, verzija 1 |