Code | 8587D | ||||||||||
MA number | EU/1/21/1572/001 | ||||||||||
Product Form: | sol inj 1x0,23 ml/2,3 mg (liek.inj.skl.+ ihla s filtr.+ihla inj.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Samsung Bioepis NL B.V., Netherland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravitreal use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(4) similar biological application |
MA issued: | 18.08.2021 |
Validity: | 18.08.2026 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 22.01.2024 |