| Code | 8883D | ||||||||||
| MA number | EU/1/15/1049/002 | ||||||||||
| Product Form: | int opo 4 (4x1) + 4 (4x1)x5 ml/19 mg (liek.skl.+kvapk.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Recordati Rare Diseases, France | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
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| Shelf life: | 6 | ||||||||||
| Container: | glass 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: | 19.01.2017 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 26.10.2021 |
