Fiasp
insulin aspart
Table of contents
Overview
Fiasp is a medicine that is used to treat children from one year of age and adults with diabetes. It contains the active substance insulin aspart, a rapid-acting insulin.
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List item
Fiasp : EPAR - Medicine overview (PDF/110.22 KB)
First published: 03/02/2017
Last updated: 26/08/2019
EMA/467722/2019 -
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List item
Fiasp : EPAR - Risk-management-plan summary (PDF/69.78 KB)
First published: 26/08/2019
Last updated: 15/06/2020
Authorisation details
Product details | |
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Name |
Fiasp
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Agency product number |
EMEA/H/C/004046
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Active substance |
insulin aspart
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International non-proprietary name (INN) or common name |
insulin aspart
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Therapeutic area (MeSH) |
Diabetes Mellitus
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Anatomical therapeutic chemical (ATC) code |
A10AB05
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Publication details | |
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Marketing-authorisation holder |
Novo Nordisk A/S
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Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
09/01/2017
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Contact address |
Novo Alle
2880 Bagsvaerd Denmark |
Product information
18/08/2021 Fiasp - EMEA/H/C/004046 - R/0028
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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Drugs used in diabetes
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Insulins and analogues for injection, fast-acting
Therapeutic indication
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Assessment history
News
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28/06/2019
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23/03/2018
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23/03/2018
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 201611/11/2016