Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1039250
|
Name of medicinal product:
|
ACC LONG
|
Active substances:
|
|
ATC code:
|
R05CB01
|
Dosage form:
|
effervescent tablet
|
Route of administration:
|
oral use
|
Strengh:
|
600mg
|
Amount in package:
|
10TK
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Mucolytic.
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
(last updated July 27, 2023)
|
Package information leaflet (PIL):
|
EST (last updated July 27, 2023)
|
Translation of package information leaflet into Russian:
|
RUS (last updated May 13, 2023)
|
Translation of package information leaflet into English:
|
ENG (last updated May 13, 2023)
|
Labelling:
|
(last updated July 27, 2023)
|
Last imported to Estonia:
|
November 22, 2023
|
Marketing authorization holder:
|
Sandoz Pharmaceuticals d.d.
|
Marketing authorization number:
|
273199
|
Marketing authorization issued on:
|
August 27, 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
24.10.2023
|
|
Yes
|
E84-E84
|
Pediaater, Pulmonoloog
|
Yes
|
until 4 years
|
|
100
|
24.10.2023
|
|
Yes
|
J84-J84
|
|
No
|
until 4 years
|
|
100
|
24.10.2023
|
|
Yes
|
E84-E84
|
Pediaater, Pulmonoloog
|
Yes
|
|
|
50
|
24.10.2023
|
|
Yes
|
J84-J84
|
|
No
|
|
|
Reference price:
|
6,00 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,02 EUR
|
Entry/Changing date:
July 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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