| Code | 07294 | ||||||||||
| MA number | 13/0294/11-S | ||||||||||
| Product Form: | plc ifo 1x2500 mg (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Orpha-Devel Handels und Vertriebs GmbH, Austria | ||||||||||
| Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 29.04.2011 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_ESMOCARD LYO_05.2018.doc
|
| PIL: |
PIL_ESMOCARD LYO 2500 mg_plc ifo_09_2021.pdf
|
| Safety feature | Yes |
| Data update: | 26.03.2019 |
