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PRODUCT DETAIL

Defumoxan

Code 5744D
MA number 87/0236/20-S
Product Form: tbl 100x1,5 mg (blis.PVC/PCTFE/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 87 - VARIA I
ATC:
N NERVOUS SYSTEM
N07 OTHER NERVOUS SYSTEM DRUGS
N07B DRUGS USED IN ADDICTIVE DISORDERS
N07BA Drugs used in nicotine dependence
N07BA04 Cytisinicline (Cytisine)
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 26.11.2020
SPC: SPC_Defumoxan_10.2023.pdf  
PIL: PIL_Defumoxan_10_2023.pdf  
Safety feature Yes
Data update: 11.04.2024
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