| Code | 6509E | ||||||||||
| MA number | 19/0147/24-S | ||||||||||
| Product Form: | sol inj 1x2 ml/200 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Pharmaselect International Beteiligungs GmbH, Austria | ||||||||||
| Therapeutic Class: | 19 - ANTIDOTA, DETOXICANTIA | ||||||||||
| ATC: |
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| Shelf life: | 18 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 18.07.2024 |
| Validity: | 18.07.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Areversin 100 mg_ml injekčný roztok_06 2024.pdf
|
| SPC: |
SPC_Areversin 100 mg_ml injekčný roztok_06 2024.pdf
|
| Safety feature | Yes |
| Data update: | 01.08.2024 |
