Code | 7321B | ||||||||||
MA number | EU/1/15/1062/001 | ||||||||||
Product Form: | liq por 1x25 ml/27,5 g (fľ.skl.+adaptér) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Immedica Pharma AB, Sweden | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass bottle | ||||||||||
Route of admin.: | Oral or gastrointestinal use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 27.11.2015 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 29.05.2022 |