| Code | 46594 | ||||||||||
| MA number | 59/0397/07-S | ||||||||||
| Product Form: | sol inj 1x2 ml/300 µg (striek.inj.skl.napl.+ihla) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | CSL Behring GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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 |
