Code | 39108 | ||||||||||
MA number | 13/0079/07-S | ||||||||||
Product Form: | sol inj 5x10 ml/100 mg (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Orpha-Devel Handels und Vertriebs GmbH, Austria | ||||||||||
Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
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: | 19.04.2007 |
SPC: | SPC_ESMOCARD 100 mg/10 ml injekčný roztok_11_2020.doc |
PIL: | PIL_ESMOCARD 100 mg_10 ml injekčný roztok_09_2021.pdf |
Safety feature | Yes |
Data update: | 26.03.2019 |