Code | 8857E | ||||||||||
MA number | 59/0017/25-S | ||||||||||
Product Form: | sus iru 10x0,5 ml (striek.inj.napl.skl. + 10 x inj.ihla) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Sanofi Winthrop Industrie, 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: | 11.02.2025 |
Validity: | 11.02.2030 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 11.02.2025 |