| Code | 4353E | ||||||||||
| MA number | 88/0196/23-S | ||||||||||
| Product Form: | gen rnk 1x16 GBq (kontajner prepravný) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | CIS bio international, France | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
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| Shelf life: | 21 dní |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 01.11.2023 |
| Validity: | 01.11.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Tekcis 2-50 GBq rádionuklidový generátor_12.2024.pdf
|
| SPC: |
SPC_Tekcis 2-50 GBq rádionuklidový generátor_12.2024.pdf
|
| Safety feature | No |
| Data update: | 10.11.2023 |
