| Code | 2200D | ||||||||||
| MA number | EU/1/19/1376/001 | ||||||||||
| Product Form: | con inf 1x7 ml/350 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Regeneron Ireland Designated Activity Company (DAC), Ireland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.06.2019 |
| Validity: | 01.07.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Libtayo_Prirucka_pe_pacienta.pdf
|
| Dokument: |
DHPC_Libtayo_10.11.2025.pdf
|
| Dokument: |
Libtayo_Karta_pacienta_FINAL 24.2.2026.pdf
|
| Safety feature | Yes |
| Data update: | 06.06.2024 |
