| Code | 5859D | ||||||||||
| MA number | 88/0246/20-S | ||||||||||
| Product Form: | sol inj 1x0,2-10 ml/176-60 000 MBq (liek.inj.skl.-viacdáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | BIONT, a.s., Slovakia | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
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| Shelf life: | 12 hodín | ||||||||||
| Container: | multidose 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: | 23.11.2020 |
| Validity: | 23.11.2025 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Fluorocholine Biont_02.2022.pdf
|
| SPC: |
SPC_Fluorocholine Biont_02.2022.pdf
|
| Safety feature | No |
| Data update: | 14.02.2022 |
