Code | 8199D | ||||||||||
MA number | EU/1/21/1564/001 | ||||||||||
Product Form: | sol inj 1x1 ml/10 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Rhythm Pharmaceuticals Netherlands B.V., Netherland | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 16.07.2021 |
Validity: | 16.07.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 16.10.2023 |