| Code | 6529C | ||||||||||
| MA number | 48/0418/17-S | ||||||||||
| Product Form: | sol iru 1x10 mmol/20 ml (20 ml striek.inj.napl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | GE Healthcare AS, Norway | ||||||||||
| Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | pre-filled syringe | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 21.12.2017 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Clariscan 0,5 mmol ml injekčný roztok_07.2022.pdf
|
| PIL: |
PIL_Clariscan_08.2022.pdf
|
| Safety feature | No |
| Data update: | 17.05.2022 |
