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PRODUCT DETAIL

Bupensanduo 4 mg/1 mg sublingválne tablety

Code 8389C
MA number 19/0213/18-S
Product Form: tbl slg 28x4 mg/1 mg (blis.OPA/Al/PVC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
Therapeutic Class: 19 - ANTIDOTA, DETOXICANTIA
ATC:
N NERVOUS SYSTEM
N07 OTHER NERVOUS SYSTEM DRUGS
N07B DRUGS USED IN ADDICTIVE DISORDERS
N07BC Drugs used in opioid dependence
N07BC51 Buprenorphine, combinations
Shelf life: 36
Container: blister OPA/Al/PVC/Al
Route of admin.: Sublingual use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 10(3) hybrid application
MA issued: 11.07.2018
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Bupensanduo sublingválne tablety_04_2023.pdf  
SPC: SPC_Bupensanduo sublingválne tablety_04_2023.pdf  
Safety feature Yes
Data update: 02.05.2023
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