Code | 2614E | ||||||||||
MA number | EU/1/22/1662/004 | ||||||||||
Product Form: | tbl flm 56x20 mg (blis.PVC/PCTFE/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
|
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Shelf life: | 24 | ||||||||||
Container: | blister PVC/PCTFE/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 09.11.2022 |
Validity: | 09.11.2027 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 21.12.2022 |