Code | 5515D | ||||||||
MA number | EU/1/20/1470/001 | ||||||||
Product Form: | tbl plg 8x25 mg (blis.PA/Al/PVC/Al) | ||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||
Type of procedure: | EU | ||||||||
MAH, country: | Cosmo Technologies Ltd, Ireland | ||||||||
Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | blister PA/Al/PVC/Al | ||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 19.08.2020 |
Validity: | 19.08.2025 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 02.06.2021 |