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ACC
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1639762
Name of medicinal product:
ACC
Active substances:
Acetylcysteine
Estonian
,
English
,
Latin
ATC code:
R05CB01
Dosage form:
powder for oral solution
Route of administration:
oral use
Strengh:
600mg
Amount in package:
30TK
Legal status for supply*:
Not subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Secretolytic therapy in acute and chronic bronchopulmonary diseases accompanied by impaired formation and transport of mucus in adults and adolescents from 14 years of age.
Safety features:
No
Summary of product characteristics (SPC):
(last updated July 6, 2023)
Package information leaflet (PIL):
EST
(last updated July 6, 2023)
Labelling:
(last updated April 29, 2020)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
838214
Marketing authorization issued on:
February 28, 2014
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: October 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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