Fampridin Teva 10 mg tablete s produljenim oslobađanjem
Name | Fampridin Teva 10 mg tablete s produljenim oslobađanjem |
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Marketing Authorisation Number | HR-H-936907434 |
Active Substance | fampridin |
Composition | jedna tableta s produljenim oslobađanjem sadrži 10 mg fampridina |
Pharmaceutical Form | Tableta s produljenim oslobađanjem |
Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Str. 3, Ulm, Njemačka |
Marketing Authorisation Date | 02.09.2021 |
MA Period of Validity | 02.09.2026 |
Classification Number | UP/I-530-09/20-01/45 |
Registration Number | 381-12-01/154-21-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N07XX07 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |