| Code | 1118D | ||||||||||
| MA number | 88/0098/19-S | ||||||||||
| Product Form: | sol inj 1x15 ml (liek.inj.skl.viacdávková) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Synektik S.A., , Poland | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
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| Shelf life: | 16 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: | 08.04.2019 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 21.04.2022 |