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PRODUCT DETAIL

SANERGY SPINAL 5 mg/ml injekčný roztok

Code 7046C
MA number 01/0057/18-S
Product Form: sol inj 5x4 ml (amp.skl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 01 - ANAESTHETICA (LOKÁLNE)
ATC:
N NERVOUS SYSTEM
N01 ANESTHETICS
N01B ANESTHETICS, LOCAL
N01BB Amides
N01BB01 Bupivacaine
Shelf life: 60
Container: glass ampoule
Route of admin.: Intrathecal use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 26.02.2018
Validity: 26.02.2023
MA renewed: Renewal application submitted
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Sanergy Spinal_02_2021.doc  
PIL: PIL_Sanergy Spinal_02_2021.doc  
Safety feature Yes
Data update: 11.07.2018
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