| 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: |
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| Safety feature | Yes |
| Data update: | 02.06.2021 |