Insuman
insulin human
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Insuman. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Insuman.
Authorisation details
Product details | |
---|---|
Name |
Insuman
|
Agency product number |
EMEA/H/C/000201
|
Active substance |
insulin human
|
International non-proprietary name (INN) or common name |
insulin human
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
|
Publication details | |
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Marketing-authorisation holder |
Sanofi-aventis Deutschland GmbH
|
Revision |
30
|
Date of issue of marketing authorisation valid throughout the European Union |
21/02/1997
|
Contact address |
D-65926 Frankfurt am Main
Germany |
Product information
21/10/2020 Insuman - EMEA/H/C/000201 - N/0135
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.