Code | 5296D | ||||||||
MA number | 50/0179/20-S | ||||||||
Product Form: | tbl flm 60x80 mg/90 mg/180 mg (blis.PVC/PVDC/Al) | ||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||
Type of procedure: | Decentralised | ||||||||
MAH, country: | MEDICE Arzneimittel Pütter GmbH & Co. KG, Germany | ||||||||
Therapeutic Class: | 50 - DIURETICA | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | blister PVC/PVDC/Al | ||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 16.08.2020 |
Validity: | 16.08.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Flaverol_tbl flm_07/2020_REG.docx |
SPC: | SPC_Flaverol filmom obalené tablety_09_2023.pdf |
Safety feature | No |
Data update: | 18.08.2020 |