| Code | 0504C | ||||||||||
| MA number | 59/0352/16-S | ||||||||||
| Product Form: | sus iru 1x0,5 ml (striek.inj.napl.+2 ihly) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sanofi Winthrop Industrie, France | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | glass pre-filled syringe | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 22.07.2016 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_ADACEL_02.2025.pdf
|
| PIL: |
PIL_ADACEL_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 23.06.2022 |
