| Code | 2705E | ||||||||||
| MA number | 15/0016/23-S | ||||||||||
| Product Form: | plv neo 1x1 MIU (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Inhalation use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 14.02.2023 |
| Validity: | 14.02.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Colistimethate Noridem_prášok na roztok pre rozprašovač_05_2023.pdf
|
| SPC: |
SPC_Colistimethate Noridem_prášok na roztok pre rozprašovač_05_2023.pdf
|
| Safety feature | Yes |
| Data update: | 22.02.2023 |
