Code | 6906D | ||||||||||
MA number | 01/0068/21-S | ||||||||||
Product Form: | sol inj 10x5ml/12,5 mg (amp.PP v blistri) | ||||||||||
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 |