| Code | 0934F | ||||||||||
| MA number | 88/0288/25-S | ||||||||||
| Product Form: | sol inj 1x0,2-10 ml/176-70 000 MBq (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | BIONT, a.s., Slovakia | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 12 hodín | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 17.09.2025 |
| Validity: | 17.09.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Fluorodopa (18F) Biont_09_2025.pdf
|
| PIL: |
PIL_Fluorodopa (18F) Biont_09_2025.pdf
|
| Safety feature | No |
| Data update: | 23.09.2025 |
