| Code | 0258B | ||||||||||
| MA number | EU/1/14/914/001 | ||||||||||
| Product Form: | con inf 1x5 ml/5 mg (lie.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | BioMarin International Limited, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.04.2014 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 28.01.2019 |
