| Code | 0657E | ||||||||||
| MA number | 87/0119/22-S | ||||||||||
| Product Form: | sol iru 3x3 ml/30 mg (striek.skl.napln.+3 ihly-multibal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.05.2022 |
| Validity: | 16.05.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Icatibant Fresenius_06.2024.pdf
|
| SPC: |
SPC_Icatibant Fresenius_06.2024.pdf
|
| Safety feature | Yes |
| Data update: | 18.05.2022 |
