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PRODUCT DETAIL

Bupensanduo 2 mg/0,5 mg sublingválne tablety

Code 8380C
MA number 19/0212/18-S
Product Form: tbl slg 7x2 mg/0,5 mg (blis.OPA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
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(1) generic application
MA issued: 11.07.2018
Validity: 11.07.2023
MA renewed: Renewal application submitted
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Bupensanduo sublingvalne tablety_august2021.pdf  
SPC: SPC_Bupensanduou sublingvalne tablety_august2021.pdf  
Safety feature Yes
Data update: 23.01.2020
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