Register of Medicinal Products

ACC

Product class:	Medicinal product with marketing authorization
Medicinal product class:	Human medicine
Name of medicinal product:	ACC
Active substances:	Acetylcysteine Estonian, English, Latin
ATC code:	R05CB01
Dosage form:	powder for oral solution
Strength:	600mg
Legal status for supply*:	Not subject to medicinal prescription
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)
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

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
Assessment report:	(last updated March 14, 2014)

Packages approved by this marketing authorization

Package code	Name of medicinal product	Dosage form	Package	Legal status	Reimbursements	Reference price	Last imported	PĆ¤ritolumaa	Additional information
1584277	ACC	powder for oral solution	600mg 6TK	OTC
1584288	ACC	powder for oral solution	600mg 10TK	OTC
1584299	ACC	powder for oral solution	600mg 20TK	OTC
1639762	ACC	powder for oral solution	600mg 30TK	OTC
1639773	ACC	powder for oral solution	600mg 60TK	OTC
1712203	ACC	powder for oral solution	600mg 90TK	OTC

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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