| Code | 5546E | ||||||||||
| MA number | EU/1/12/782/008 | ||||||||||
| Product Form: | gra sac 28(4x7)x59,5 mg (vre.BOPET/PE/fólia/PE - multibal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Vertex Pharmaceuticals (Ireland) Limited, Ireland | ||||||||||
| 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: | 23.07.2012 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 28.02.2024 |
