| Code | 8442E | ||||||||||
| MA number | 59/0018/22-S | ||||||||||
| Product Form: | sol icu 10x5 ml/1 g (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Instituto Grifols, S.A., Spain | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 27.04.2022 |
| Validity: | 27.04.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Xembify 200 mg_ml roztok na subkutánnu injekciu_12.2024.pdf
|
| PIL: |
PIL_Xembify 200 mg_ml roztok na subkutánnu injekciu_12. 2024.pdf
|
| Safety feature | Yes |
| Data update: | 19.12.2024 |
