| Code | 8987E | ||||||||||
| MA number | EU/1/22/1683/002 | ||||||||||
| Product Form: | sol inj 1x0,175 ml/21 mg (striek.inj.napl.skl. + inj.ihla) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Roche Registration GmbH, Germany | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravitreal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 15.09.2022 |
| Validity: | 15.09.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC_Vabysmo_15.10.2024.pdf
|
| Dokument: |
Vabysmo_Príručka pre pacienta a opatrovateľa.pdf
|
| Safety feature | Yes |
| Data update: | 11.02.2025 |
