Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1836378
Name of medicinal product: LYSA
Active substances:
Estonian, English, Latin
ATC code: G01AX14
Dosage form: vaginal capsule, hard
Route of administration: vaginal use
Strengh: 100000000CFU
Amount in package: 6TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Invented Name] is indicated in adult women for: - Prevention of recurrence of vaginal infections by restoring and maintaining the optimal level of vaginal lactobacilli. - Restoration of physiological vaginal flora after antibiotic treatment of bacterial vaginosis.
Safety features: No
Summary of product characteristics (SPC):  (last updated February 7, 2023)
Package information leaflet (PIL): EST  (last updated February 7, 2023)
Labelling:  (last updated February 7, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Proge Farm S.r.l. 
Marketing authorization number: 1095923 
Marketing authorization issued on: February 7, 2023 
Marketing authorization expires on: February 7, 2028 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ämmaemandal on õigus välja kirjutada
Entry/Changing date: February 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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