Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1184992
Name of medicinal product: AZITHROMYCIN SANDOZ 500MG
Active substances:
Azithromycin
Estonian, English, Latin
ATC code: J01FA10
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 500mg
Amount in package: 3TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Nationally completed name] can be applied in situations where micro-organisms sensitive to azithromycin have caused (see section 5.1): upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis acute otitis media lower respiratory tract infections: acute bronchitis and mild to moderately severe community acquired pneumonia skin and soft tissue infections uncomplicated Chlamydia trachomatis urethritis and cervicitis Considerations should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 6, 2021)
Package information leaflet (PIL): EST  (last updated October 6, 2021)
Labelling:  (last updated October 14, 2021)
Last imported to Estonia: May 24, 2024
Marketing authorization holder: Sandoz GmbH 
Marketing authorization number: 495105 
Marketing authorization issued on: September 30, 2005 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
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  Pulmonoloog, Pediaater  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: May 24, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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