Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1035379
Name of medicinal product: ACC 100 MG/ML
Active substances:
Acetylcysteine
Estonian, English, Latin
ATC code: R05CB01
Dosage form: solution for injection
Route of administration: intravenous use; intramuscular use
Strengh: 100mg 1ml
Amount in package: 3ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication:
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 27, 2021)
Package information leaflet (PIL): EST  (last updated February 1, 2022)
Labelling:  (last updated January 2, 2019)
Last imported to Estonia: April 6, 2020
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 368101 
Marketing authorization issued on: December 7, 2001 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
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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