| Code | 6903D | ||||||||||
| MA number | 01/0068/21-S | ||||||||||
| Product Form: | sol inj 10x20ml/50 mg (amp.PP) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | ampoule PP |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.04.2021 |
| Validity: | 28.04.2026 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Bupivacaine Noridem 02_2022.pdf
|
| PIL: |
PIL_Bupivacaine Noridem_02_2022.pdf
|
| Safety feature | Yes |
| Data update: | 12.05.2021 |
