Code | 0376B | ||||||||||
MA number | 59/0397/07-S | ||||||||||
Product Form: | sol inj 5x2 ml/300 µg (striek.inj.skl.napl.+ihla) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass pre-filled syringe | ||||||||||
Route of admin.: | Intramuscular or intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 19.11.2007 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: | SPC_Rhophylac_09.2019.doc |
PIL: | PIL Rhophylac_09.2019.doc |
Safety feature | Yes |
Data update: | 07.03.2019 |