Product class: Authorized package
Medicinal product class: For human use
Package code: 1814879
Name of medicinal product: AMBROLYTIN
Active substances:
Ambroxol
Estonian, English, Latin
ATC code: R05CB06
Dosage form: tablet
Route of administration: oral use
Strengh: 30mg
Amount in package: 50TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Ambrolytin is indicated for secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. Ambrolytin is intended for use in children over 6 years of age, adolescents and adults.
Safety features: No
Summary of product characteristics (SPC):  (last updated 31 March 2021)
Package information leaflet (PIL): EST  (last updated 31 March 2021)
Labelling:  (last updated 31 March 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sopharma AD 
Marketing authorization number: 1025921 
Marketing authorization issued on: 31 March 2021 
Marketing authorization expires on: 31 March 2026 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 05 March 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription