Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BRONTEX SIIRUP
Active substances:
Ambroxol
Estonian, English, Latin
ATC code: R05CB06
Dosage form: syrup
Strength: 3mg 1ml
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated May 26, 2022)
Package information leaflet (PIL): EST  (last updated May 26, 2022)
Translation of package information leaflet into Russian: RUS  (last updated May 26, 2022)
Translation of package information leaflet into English: ENG  (last updated May 26, 2022)
Labelling:  (last updated May 26, 2022)
Indication: Mucolytic therapy of productive cough associated with acute or chronic bronchopulmonary diseases.
Marketing authorization holder: Ratiopharm GmbH 
Marketing authorization number: 057294 
Marketing authorization issued on: December 17, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1008931  BRONTEX SIIRUP  syrup  3mg 1ml 100ml 1TK  OTC      15.02.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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