| Code | 7410E | ||||||||||
| MA number | EU/1/24/1840/001 | ||||||||||
| Product Form: | int osd 20x0,3 ml (obal LDPE - jednodávk.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | SIFI S.p.A, Italy | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | LDPE single-dose container | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 22.08.2024 |
| Validity: | 22.08.2029 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 04.03.2025 |