| Code | 8847B | ||||||||||
| MA number | 48/0265/04-S | ||||||||||
| Product Form: | sol inj 10x10 ml (striek.inj.napln.plast.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Bayer AG, Germany | ||||||||||
| Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | pre-filled syringe | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 08.11.2004 |
| Pediatric warnings: | Yes |
| Dokument: |
DHCP Gadolinium 14mar2011.pdf
|
| PIL: |
PIL_Primovist 0,25 mmol_ml_sol inj_pfs_03.2025.pdf
|
| SPC: |
SPC_Primovist 0,25 mmol_ml_sol inj_pfs_03.2025.pdf
|
| Safety feature | No |
| Data update: | 15.03.2018 |
