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: |
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Safety feature | Yes |
Data update: | 26.10.2021 |