Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AMBROLYTIN
Active substances:
Ambroxol
Estonian, English, Latin
ATC code: R05CB06
Dosage form: tablet
Strength: 30mg
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated March 31, 2021)
Package information leaflet (PIL): EST  (last updated March 31, 2021)
Labelling:  (last updated March 31, 2021)
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
Marketing authorization holder: Sopharma AD 
Marketing authorization number: 1025921 
Marketing authorization issued on: March 31, 2021 
Marketing authorization expires on: March 31, 2026 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1814857  AMBROLYTIN  tablet  30mg 20TK  OTC      13.06.2024     
1814868  AMBROLYTIN  tablet  30mg 30TK  OTC           
1814879  AMBROLYTIN  tablet  30mg 50TK  OTC           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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