Code | 1318D | ||||||||||
MA number | EU/1/18/1350/001 | ||||||||||
Product Form: | sol neb 56x1,7 ml/170 mg (amp. LDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | PARI Pharma GmbH, Germany | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | ampoule LDPE | ||||||||||
Route of admin.: | Inhalation use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 18.02.2019 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 10.10.2023 |