| Code | 0342F | ||||||||||
| MA number | 88/0227/25-S | ||||||||||
| Product Form: | kit 10x300µl (téglik s blis.PVC/papier) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Cyclomedica Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | jar | ||||||||||
| Route of admin.: | Inhalation use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 08.08.2025 |
| Validity: | 08.08.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Carbotech_07_2025_REG.pdf
|
| SPC: |
SPC_Carbotech_07_2025_REG.pdf
|
| Safety feature | No |
| Data update: | 19.08.2025 |
