| Code | 7011D | ||||||||||
| MA number | 56/0083/21-S | ||||||||||
| Product Form: | sol inj 20x1 ml (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 56 - HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass ampoule |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.04.2021 |
| Validity: | 28.04.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dexamethasone Noridem_07_2022.pdf
|
| PIL: |
PIL_Dexamethasone Noridem_07_2022.pdf
|
| Safety feature | Yes |
| Data update: | 12.05.2021 |
