Code | 8422E | ||||||||||
MA number | EU/1/24/1865/002 | ||||||||||
Product Form: | sol inj 1x0,1 ml/4 mg (liek.inj.skl.+ihla s filtrom) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Samsung Bioepis NL B.V., Netherland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
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: | 13.11.2024 |
Validity: | 13.11.2029 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 17.12.2024 |