| Code | 5216E | ||||||||||
| MA number | EU/1/23/1774/002 | ||||||||||
| Product Form: | sol ijf 1x1 ml/5 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Immedica Pharma AB, Sweden | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous and intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 15.12.2023 |
| Validity: | 15.12.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Loargys_Príručka pre pacientov a opatrovateľov.pdf
|
| Safety feature | Yes |
| Data update: | 03.01.2024 |
