| Code | 9805E | ||||||||||
| MA number | 59/0169/25-S | ||||||||||
| Product Form: | sus iru 10x1 ml/1440 E.U. (striek.inj.skl.napln.bez ihiel) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | GlaxoSmithKline Biologicals S.A., Belgium | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 31.10.1996 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Havrix 1440 sus iru_05.2025.pdf
|
| SPC: |
SPC_Havrix 720_ Havrix 1440_05.2025.pdf
|
| Safety feature | Yes |
| Data update: | 04.06.2025 |
