| Code | 2825F | ||||||||||
| MA number | EU/1/25/1956/011 | ||||||||||
| Product Form: | tbl plg 84x48 mg (blis.PVC/PCTFE/PVC/Al ) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | TEVA GmbH, Germany | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PCTFE/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 08.01.2026 |
| Validity: | 08.01.2031 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 24.02.2026 |
