Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1027820
Name of medicinal product: AMBROLAN
Active substances:
Ambroxol
Estonian, English, Latin
ATC code: R05CB06
Dosage form: tablet
Route of administration: oral use
Strengh: 30mg
Amount in package: 20TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Mucolytic therapy of productive cough associated with acute or chronic bronchopulmonary diseases.
Safety features: No
Summary of product characteristics (SPC):  (last updated June 21, 2016)
Package information leaflet (PIL): EST  (last updated June 21, 2016)
Translation of package information leaflet into Russian: RUS  (last updated June 21, 2016)
Translation of package information leaflet into English: ENG  (last updated June 21, 2016)
Labelling:  (last updated November 4, 2011)
Last imported to Estonia: June 4, 2024
Marketing authorization holder: G.L. Pharma GmbH 
Marketing authorization number: 273899 
Marketing authorization issued on: August 27, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 5, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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