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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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1392207
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Name of medicinal product:
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AZARGA
|
|
Active substances:
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|
|
ATC code:
|
S01ED83
|
|
Dosage form:
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eye drops, suspension
|
|
Route of administration:
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ocular use
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|
Strengh:
|
5mg+10mg 1ml
|
|
Amount in package:
|
5ml 1TK
|
|
Legal status for supply*:
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Subject to medicinal prescription
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|
Class of active substance:
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|
|
Additional information:
|
|
|
Indication:
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Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction.
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
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Last imported to Estonia:
|
May 17, 2023
|
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Marketing authorization holder:
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Novartis Europharm Limited
|
|
Marketing authorization number:
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EU/1/08/482
|
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Marketing authorization issued on:
|
November 27, 2008
|
|
Marketing authorization expires on:
|
Unlimited
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
|
100
|
01.04.2023
|
|
Yes
|
H40-H42
|
Oftalmoloog
|
Yes
|
until 4 years
|
|
|
50
|
01.04.2023
|
|
Yes
|
|
|
No
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
H40-H42
|
Oftalmoloog
|
Yes
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
Reference price:
|
8,50 EUR
|
|
Under reference price:
|
No
|
|
Reference price of daily dose:
|
0,17 EUR
|
Entry/Changing date:
May 2, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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