Dimetilfumarat Teva GmbH 120 mg tvrde želučanootporne kapsule
Name | Dimetilfumarat Teva GmbH 120 mg tvrde želučanootporne kapsule |
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Marketing Authorisation Number | HR-H-392405045 |
Active Substance | dimetilfumarat |
Composition | jedna tvrda želučanootporna kapsula sadrži 120 mg dimetilfumarata |
Pharmaceutical Form | Želučanootporna kapsula, tvrda |
Manufacturer | Pharmadox Healthcare Limited, Paola, Malta AdAlvo Limited, San Gwann, Malta Kevaro Group Ltd, Sofia, Bugarska |
Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Str. 3, Ulm, Njemačka |
Marketing Authorisation Date | 02.05.2023 |
MA Period of Validity | 02.05.2028 |
Classification Number | UP/I-530-09/22-01/148 |
Registration Number | 381-12-01/154-23-12 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L04AX07 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |