|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1841879
|
|
Name of medicinal product:
|
OGLUO
|
|
Active substances:
|
|
|
ATC code:
|
H04AA01
|
|
Dosage form:
|
solution for injection in pre-filled syringe
|
|
Route of administration:
|
intramuscular use
|
|
Strengh:
|
1mg 0.2ml
|
|
Amount in package:
|
0.2ml 1TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
Indication:
|
Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged
2 years and over with diabetes mellitus.
|
|
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:
|
Tetris Pharma B.V.
|
|
Marketing authorization number:
|
EU/1/20/1523
|
|
Marketing authorization issued on:
|
February 11, 2021
|
|
Marketing authorization expires on:
|
February 17, 2026
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Reference price:
|
|
|
Under reference price:
|
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
June 26, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere