Code | 6126B | ||||||||||
MA number | EU/1/15/1015/001 | ||||||||||
Product Form: | sol inj 12x0,3 ml/12 mg (liek.inj.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Alexion Europe SAS, France | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 28.08.2015 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 03.02.2021 |