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PRODUCT DETAIL

Submena 400 mikrogramov sublingválne tablety

Code 9555D
MA number 65/0022/22-S
Product Form: tbl slg 10x1x400 µg (blis.PA/Al/PVC/Al/PET)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: G.L. Pharma GmbH, Austria
Therapeutic Class: 65 - ANALGETICA - ANODYNA
ATC:
N NERVOUS SYSTEM
N02 ANALGESICS
N02A OPIOIDS
N02AB Phenylpiperidine derivatives
N02AB03 Fentanyl
Shelf life: 36
Container: blister PA/Al/PVC/Al/PET
Route of admin.: Sublingual use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 10(1) generic application
MA issued: 18.02.2022
Validity: 18.02.2027
SPC: SPC_Submena_08.2024.pdf  
PIL: PIL_Submena_08.2024.pdf  
Safety feature Yes
Data update: 23.02.2022
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