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ACC
General data
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
PƤritolumaa
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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