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 |