| Code | 8474C | ||||||||||
| MA number | EU/1/17/1219/002 | ||||||||||
| Product Form: | int ope 60x0,3 ml/0,3 mg (obal LDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Santen Oy, Finland | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | LDPE single-dose container | ||||||||||
| Route of admin.: | Ocular use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 06.07.2018 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 11.04.2023 |
