| Code | 53113 | ||||||||||
| MA number | 88/0521/08-S | ||||||||||
| Product Form: | sol inj 1x0,2 ml-10 ml/36 MBq-14300 MBq (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | BIONT, a.s., Slovakia | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
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| Shelf life: | 10 hodín | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 06.10.2008 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_biontFDG_sol inj_maj2016.docx
|
| SPC: |
SPC_biontFDG_sol inj_maj2016.doc
|
| Safety feature | No |
| Data update: | 28.12.2018 |
