Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1614439
Name of medicinal product: AZITHROMYCIN KRKA
Active substances:
Azithromycin
Estonian, English, Latin
ATC code: J01FA10
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 250mg
Amount in package: 6TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: is indicated for the following bacterial infections induced by micro-organisms susceptible to azithromycin (see sections 4.4 and 5.1): - acute bacterial sinusitis (adequately diagnosed) - acute bacterial otitis media (adequately diagnosed) - pharyngitis, tonsillitis - acute exacerbation of chronic bronchitis (adequately diagnosed) - mild to moderately severe community acquired pneumonia - infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas - uncomplicated Chlamydia trachomatis urethritis and cervicitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated January 30, 2023)
Package information leaflet (PIL): EST  (last updated January 30, 2023)
Labelling:  (last updated January 30, 2023)
Last imported to Estonia: November 6, 2023
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 843414 
Marketing authorization issued on: April 29, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  E84-E84  Pulmonoloog, Pediaater  Yes  until 4 years   
100  05.04.2024     Yes      No  until 4 years   
50  05.04.2024     Yes      No      
100  05.04.2024     Yes  E84-E84  Pediaater, Pulmonoloog  Yes      
Reference price: 4,25 EUR 
Under reference price: No 
Reference price of daily dose: 0,85 EUR 
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: October 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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