Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1485187
|
Name of medicinal product:
|
ALGOCALM
|
Active substances:
|
|
ATC code:
|
N02AJ06
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
30mg+500mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Medium to severe pains.
Adolescents aged 12 years to 18 years
Ultracod is indicated, due to codeine content, in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated September 27, 2022)
|
Package information leaflet (PIL):
|
EST (last updated September 27, 2022)
|
Labelling:
|
(last updated September 24, 2018)
|
Last imported to Estonia:
|
March 22, 2024
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Marketing authorization holder:
|
Zentiva k.s.
|
Marketing authorization number:
|
726010
|
Marketing authorization issued on:
|
December 20, 2010
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
Reference price:
|
3,95 EUR
|
Under reference price:
|
Yes
|
Reference price of daily dose:
|
0,79 EUR
|
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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