Code | 9770C | ||||||||||
MA number | EU/1/12/782/005 | ||||||||||
Product Form: | tbl flm 28x150 mg (blis.aclar/Al) | ||||||||||
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: | 15.05.2022 |