Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AZITHROMYCIN SANDOZ 500MG
Active substances:
Azithromycin
Estonian, English, Latin
ATC code: J01FA10
Dosage form: film-coated tablet
Strength: 500mg
Legal status for supply*: Subject to medicinal prescription
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)
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
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 
Assessment report:   
Description Additional condition
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Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1184981  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 2TK  Prescription           
1184992  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 3TK  Prescription  50% 100%  4,25  24.05.2024     
1185005  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 6TK  Prescription           
1185016  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 12TK  Prescription           
1185027  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 24TK  Prescription           
1185038  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 30TK  Prescription           
1185049  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 50TK  Prescription           
1185050  AZITHROMYCIN SANDOZ 500MG  film-coated tablet  500mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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