Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1305144
|
Name of medicinal product:
|
AERIUS
|
Active substances:
|
|
ATC code:
|
R06AX27
|
Dosage form:
|
orodispersible tablet
|
Route of administration:
|
oral use
|
Strengh:
|
2,5mg
|
Amount in package:
|
15TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Aerius is indicated in adults, adolescents aged 12 years and older and children aged 6 11 years old
for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Organon N.V.
|
Marketing authorization number:
|
EU/1/00/160
|
Marketing authorization issued on:
|
April 23, 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Entry/Changing date:
May 20, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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