Code | 1145F | ||||||||||
MA number | 01/0297/25-S | ||||||||||
Product Form: | sol inj 10x20 ml/400 mg (amp. PP) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | ampoule PP |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 30.09.2025 |
Validity: | 30.09.2030 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 01.10.2025 |