Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1584312
Name of medicinal product: ACC
Active substances:
Acetylcysteine
Estonian, English, Latin
ATC code: R05CB01
Dosage form: oral solution
Route of administration: oral use
Strengh: 20mg 1ml
Amount in package: 200ml 1TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: To liquefy the mucus and ease expectoration in cold-induced bronchitis in children from 2 years, adolescents and adults.
Safety features: No
Summary of product characteristics (SPC):  (last updated April 29, 2020)
Package information leaflet (PIL): EST  (last updated April 29, 2020)
Translation of package information leaflet into Russian: RUS  (last updated April 29, 2020)
Translation of package information leaflet into English: ENG  (last updated April 29, 2020)
Labelling:  (last updated April 29, 2020)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 836414 
Marketing authorization issued on: January 27, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 19, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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