Code | 8843B | ||||||||||
MA number | 48/0265/04-S | ||||||||||
Product Form: | sol inj 5x5 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: |
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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 |
SPC: | SPC_Primovist_pfs_11.2019.doc |
PIL: | PIL_Primovist_pfs_11.2019.doc |
Safety feature | No |
Data update: | 15.03.2018 |