| Code | 00959 | ||||||||||
| MA number | 41/0773/10-S | ||||||||||
| Product Form: | sol ira 1x0,30 ml/300 µg (pero inj.napl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | ALK-Abelló A/S, Denmark | ||||||||||
| Therapeutic Class: | 41 - CARDIACA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass pre-filled pen | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 28.10.2010 |
| Pediatric posology: | Yes |
| PIL: |
PIL_Jext_sol ira_09_2023.pdf
|
| Dokument: |
Jext_Informačná karta pacienta_ver 1.pdf
|
| Dokument: |
Jext_Dotazník pre predpisujúceho lekára_ver 1.pdf
|
| SPC: |
SPC_Jext_sol ira_10_2024.pdf
|
| Safety feature | Yes |
| Data update: | 25.10.2024 |
