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PRODUCT DETAIL

Ropivacaine Readyfusor

Code 6496C
MA number 01/0416/17-S
Product Form: sol ifp 1x250 ml (fľ.HDPE+vrecko+katéter 15 cm )
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: BioQ Pharma B.V., Netherland
Therapeutic Class: 01 - ANAESTHETICA (LOKÁLNE)
ATC:
N NERVOUS SYSTEM
N01 ANESTHETICS
N01B ANESTHETICS, LOCAL
N01BB Amides
N01BB09 Ropivacaine
Shelf life: 36
Container: bottle HDPE
Route of admin.: Perineural use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 22.12.2017
Validity: 22.12.2022
MA renewed: Renewal application submitted
PIL: pil_ropivacaine readyfusor_02_2019.docx  
SPC: SPC_Ropivacaine Readyfusor_04_2019.docx  
Safety feature Yes
Data update: 24.04.2019
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