Code | 7538E | ||||||||||
MA number | 87/0340/17-S | ||||||||||
Product Form: | sol inf 4x100 ml/5 mg (liek.inj.skl. - borosilikát.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 20.11.2017 |
SPC: | SPC_Kys zoledronova Stada_november_2017.doc |
PIL: | PIL_Kyselina zoledrónová STADA 5 mg_100 ml infúzny roztok_09.2022.pdf |
Safety feature | Yes |
Data update: | 16.09.2024 |