| Code | 2539F | ||||||||||
| MA number | EU/1/25/2001/002 | ||||||||||
| Product Form: | sol inj 3x0,8 ml/80 mg (pero napl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Otsuka Pharmaceutical Netherlands B.V., Netherland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | pre-filled pen | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 19.01.2026 |
| Validity: | 19.01.2031 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 04.02.2026 |
