Code | 0727C | ||||||||||
MA number | 41/0379/16-S | ||||||||||
Product Form: | tbl flm 98x1x5 mg (blis.OPA/Al/PVC/Al-jednotl.dáv.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 41 - CARDIACA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 04.08.2016 |
SPC: | SPC_Bixebra_tbl flm_09_2024.pdf |
PIL: | PIL_Bixebra_tbl flm_09_2024.pdf |
Safety feature | Yes |
Data update: | 10.11.2021 |