Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1558177
Name of medicinal product: DIFLUCAN 150MG
Active substances:
Fluconazole
Estonian, English, Latin
ATC code: J02AC01
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 150mg
Amount in package: 7TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Diflucan is indicated in the following fungal infections (see section 5.1). Diflucan is indicated in adults for the treatment of: • Cryptococcal meningitis (see section 4.4). • Coccidioidomycosis (see section 4.4). • Invasive candidiasis. • Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis. • Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient. • Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate. • Candidal balanitis when local therapy is not appropriate. • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated. • Tinea unguinium (onychomycosis) when other agents are not considered appropriate. Diflucan is indicated in adults for the prophylaxis of: • Relapse of cryptococcal meningitis in patients with high risk of recurrence. • Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse. • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year). • Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)). Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old: Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4). Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti infective therapy should be adjusted accordingly. Consideration should be given to official guidance on the appropriate use of antifungals.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 24, 2022)
Package information leaflet (PIL): EST  (last updated October 24, 2022)
Labelling:  (last updated October 27, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Pfizer Europe MA EEIG 
Marketing authorization number: 104595 
Marketing authorization issued on: May 2, 1995 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Ämmaemandal on õigus välja kirjutada
Entry/Changing date: January 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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