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HIDRASEC
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1520536
Name of medicinal product:
HIDRASEC
Active substances:
Racecadotril
Estonian
,
English
,
Latin
ATC code:
A07XA04
Dosage form:
granules for oral suspension
Route of administration:
oral use
Strengh:
10mg
Amount in package:
10TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible. If causal treatment is possible, racecadotril can be administered as a complementary treatment.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated September 7, 2017)
Package information leaflet (PIL):
EST
(last updated March 29, 2023)
Labelling:
(last updated February 22, 2019)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Bioprojet Europe Limited
Marketing authorization number:
758111
Marketing authorization issued on:
September 26, 2011
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: March 30, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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