Overview
Ogluo is a medicine for treating severe hypoglycaemia (very low levels of glucose in the blood) in patients with diabetes who are at least 2 years old.
Hypoglycaemia can occur when diabetes medicines to reduce blood glucose cause glucose levels to fall too low. In severe cases, patients can faint or become unconscious and they must be treated urgently to raise glucose levels.
Ogluo contains the active substance glucagon.
Ogluo is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance. However, Ogluo is available as a solution for injection while the reference medicine is available as a powder that needs to be dissolved to make up the injection. The reference medicine for Ogluo is GlucaGen.
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Ogluo : EPAR - Medicine overview (PDF/131.91 KB)
First published: 26/02/2021
EMA/36/2021 -
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Ogluo : EPAR - Risk-management-plan summary (PDF/5.42 MB)
First published: 26/02/2021
Last updated: 26/05/2023
Authorisation details
Product details | |
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Name |
Ogluo
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Agency product number |
EMEA/H/C/005391
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Active substance |
Glucagon
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International non-proprietary name (INN) or common name |
glucagon
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Therapeutic area (MeSH) |
Diabetes Mellitus
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Anatomical therapeutic chemical (ATC) code |
H04AA01
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Publication details | |
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Marketing-authorisation holder |
Tetris Pharma B.V
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
11/02/2021
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Contact address |
Element Offices |
Product information
01/02/2023 Ogluo - EMEA/H/C/005391 - IB/0009
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Pancreatic hormones
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Glycogenolytic hormones
Therapeutic indication
Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.