| Code | 7424D | ||||||||||
| MA number | 01/0119/21-S | ||||||||||
| Product Form: | sol inj 10x10x1,8 ml (náplň skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Pierrel S.p.A, Italy | ||||||||||
| Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | glass cartrige | ||||||||||
| Route of admin.: | Dental use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.05.2021 |
| Validity: | 16.05.2026 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Orabloc_02_2023.pdf
|
| SPC: |
SPC_Orabloc_02_2023.pdf
|
| Safety feature | Unknown |
| Data update: | 17.05.2021 |
