Code | 4504D | ||||||||||
MA number | 59/0114/20-S | ||||||||||
Product Form: | sus iru 1x0,7 ml (striek.inj.skl.napl. bez ihly) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Sanofi Pasteur , France | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 12 | ||||||||||
Route of admin.: | Intramuscular and subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 22.05.2020 |
Validity: | 22.05.2025 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Efluelda Tetra_04.2024.pdf |
PIL: | PIL_Efluelda Tetra_04.2024.pdf |
Safety feature | Yes |
Data update: | 08.04.2024 |