| Code | 6879E | ||||||||||
| MA number | EU/1/24/1825/004 | ||||||||||
| Product Form: | con inf 4x10 ml/200 mg (liek.inj.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use | 
| Prescription Status: | Medicinal product subject to restricted medical prescription. | 
| Legal basis: | Article 10(4) similar biological application | 
| MA issued: | 20.06.2024 | 
| Validity: | 20.06.2029 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 15.10.2025 |