Insuman

RSS

insulin human

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 21/05/2019

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
  • A10AB01
  • A10AC01
Publication details
Marketing-authorisation holder
Sanofi-aventis Deutschland GmbH
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
21/02/1997
Contact address
D-65926 Frankfurt am Main
Germany

Product information

23/04/2019 Insuman - EMEA/H/C/000201 - IAIN/0129

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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