Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
AERIUS
|
Active substances:
|
|
ATC code:
|
R06AX27
|
Dosage form:
|
film-coated tablet
|
Strength:
|
5mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
Aerius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms
associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Organon N.V.
|
Marketing authorization number:
|
EU/1/00/160
|
Marketing authorization issued on:
|
February 9, 2001
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Assessment report:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1012396
|
AERIUS
|
film-coated tablet
|
5mg 2TK
|
Prescription
|
|
|
|
|
|
1077971
|
AERIUS
|
film-coated tablet
|
5mg 10TK
|
Prescription
|
|
|
08.12.2016
|
|
|
1077982
|
AERIUS
|
film-coated tablet
|
5mg 30TK
|
Prescription
|
|
|
08.12.2016
|
|
|
1212556
|
AERIUS
|
film-coated tablet
|
5mg 1TK
|
Prescription
|
|
|
|
|
|
1212567
|
AERIUS
|
film-coated tablet
|
5mg 3TK
|
Prescription
|
|
|
|
|
|
1212578
|
AERIUS
|
film-coated tablet
|
5mg 5TK
|
Prescription
|
|
|
|
|
|
1212589
|
AERIUS
|
film-coated tablet
|
5mg 7TK
|
Prescription
|
|
|
|
|
|
1212590
|
AERIUS
|
film-coated tablet
|
5mg 14TK
|
Prescription
|
|
|
|
|
|
1212602
|
AERIUS
|
film-coated tablet
|
5mg 15TK
|
Prescription
|
|
|
|
|
|
1212613
|
AERIUS
|
film-coated tablet
|
5mg 20TK
|
Prescription
|
|
|
|
|
|
1212624
|
AERIUS
|
film-coated tablet
|
5mg 21TK
|
Prescription
|
|
|
|
|
|
1212635
|
AERIUS
|
film-coated tablet
|
5mg 50TK
|
Prescription
|
|
|
|
|
|
1212646
|
AERIUS
|
film-coated tablet
|
5mg 100TK
|
Prescription
|
|
|
|
|
|
1305021
|
AERIUS
|
film-coated tablet
|
5mg 90TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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