| Code | 5175E | ||||||||||
| MA number | EU/1/23/1764/002 | ||||||||||
| Product Form: | sol inj 28 (4x7)x0,416 ml/16,6 mg (striek.inj.napl.skl. - viacnás.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | UCB Pharma S.A. , Belgium | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 01.12.2023 |
| Validity: | 01.12.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Zilbrysq_Karta pacienta.pdf
|
| Dokument: |
Zilbrysq_Príručka pre pacienta_opatrovateľa.pdf
|
| Dokument: |
Zilbrysq_Príručka pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 13.12.2023 |
