Code | 3032B | ||||||||||
MA number | EU/1/14/969/001 | ||||||||||
Product Form: | imp 1x16 mg (liek.inj.skl.+implantát) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Clinuvel Europe Limited , Ireland | ||||||||||
Therapeutic Class: | 46 - DERMATOLOGICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
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: | 22.12.2014 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 13.03.2023 |