Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1713079
Name of medicinal product: DONAXYL
Active substances:
Estonian, English, Latin
ATC code: G01AC05
Dosage form: vaginal tablet
Route of administration: vaginal use
Strengh: 10mg
Amount in package: 6TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Fluomizin 10 mg vaginal tablets are indicated for the treatment of Bacterial vaginosis (see section 4.4) Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 3, 2021)
Package information leaflet (PIL): EST  (last updated March 3, 2021)
Labelling:  (last updated November 8, 2016)
Last imported to Estonia: May 13, 2024
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: 921916 
Marketing authorization issued on: November 8, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ämmaemandal on õigus välja kirjutada
Entry/Changing date: November 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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