| Code | 1849F | ||||||||||
| MA number | 41/0387/25-S | ||||||||||
| Product Form: | sol por 1x60 ml/3 mg (fľ.skl. jantárová) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | ENEO Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 41 - CARDIACA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 05.12.2025 |
| Validity: | 05.12.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Digoxin ENEO 0,05 mg_ml perorálny roztok_11.2025.pdf
|
| SPC: |
SPC_Digoxin ENEO 0,05 mg_ml perorálny roztok_11.2025.pdf
|
| Safety feature | Yes |
| Data update: | 08.12.2025 |
