| Code | 5487D | ||||||||||
| MA number | EU/1/20/1468/001 | ||||||||||
| Product Form: | tbl flm 56x75 mg/50 mg/100 mg (blis.PCTFE/PVC/papier/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 21.08.2020 |
| Validity: | 21.08.2025 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 11.01.2024 |
