Code | 5844D | ||||||||||
MA number | EU/1/20/1469/001 | ||||||||||
Product Form: | dis neb 28x590 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Insmed Netherlands B.V., Netherland | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Inhalation use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 27.10.2020 |
Validity: | 27.10.2025 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 04.11.2020 |