Code | 4681C | ||||||||||
MA number | EU/1/17/1192/001 | ||||||||||
Product Form: | sol inf 2x5 ml/150 mg+1x5 ml prepl.roztok (liek.inj.skl.) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | BioMarin International Limited, Ireland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intracerebroventricular use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.05.2017 |
Validity: | 01.06.2027 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 28.07.2022 |