| Code | 3468C | ||||||||||
| MA number | EU/1/17/1178/002 | ||||||||||
| Product Form: | tbl flm 180x5 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 22.03.2017 |
| Validity: | 24.03.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
XELJANZ Karta pre pacienta.pdf
|
| Dokument: |
XELJANZ Kontrolný zoznam k priebehu liečby.pdf
|
| Dokument: |
XELJANZ Kontrolný zoznam k začiatku liečby.pdf
|
| Dokument: |
XELJANZ Prirucka pre lekara.pdf
|
| Safety feature | Yes |
| Data update: | 10.03.2022 |
