Code | 7555B | ||||||||||
MA number | 05/0379/13-S | ||||||||||
Product Form: | emu iis 6x20 ml (striek.inj.napl.cykloolefín.kopolymér) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Fresenius Kabi Deutschland GmbH, Germany | ||||||||||
Therapeutic Class: | 05 - ANAESTHETICA (CELKOVÉ) | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | pre-filled syringe | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 27.11.2013 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Propofol MCT_10 mg_ml_emu iis_03_2022.pdf |
PIL: | PIL_Propofol MCT_10 mg_ml_emu iis_11_2023.pdf |
Safety feature | Yes |
Data update: | 17.04.2018 |