Code | 3830E | ||||||||||
MA number | 59/0291/16-S | ||||||||||
Product Form: | sus iru 10x0,5 ml (striek.inj.napl.s ochran.viečko + 10 samostat.ihiel) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Sanofi Pasteur , France | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | 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: | 27.06.2016 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_TETRAXIM_05.2024.pdf |
PIL: | PIL_TETRAXIM_05.2024.pdf |
Safety feature | Yes |
Data update: | 09.05.2024 |