Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1586538
Name of medicinal product: AMBROLYTIN
Active substances:
Ambroxol
Estonian, English, Latin
ATC code: R05CB06
Dosage form: syrup
Route of administration: oral use
Strengh: 3mg 1ml
Amount in package: 100ml 1TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication:
Safety features: No
Summary of product characteristics (SPC):  (last updated November 3, 2020)
Package information leaflet (PIL): EST  (last updated November 3, 2020)
Translation of package information leaflet into Russian: RUS  (last updated January 2, 2019)
Translation of package information leaflet into English: ENG  (last updated January 2, 2019)
Labelling:  (last updated November 3, 2020)
Last imported to Estonia: September 28, 2023
Marketing authorization holder: Sopharma AD 
Marketing authorization number: 891515 
Marketing authorization issued on: November 11, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 12, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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