| 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 |
