Humalog

RSS

insulin lispro

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

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 15/03/2018

Authorisation details

Product details
Name
Humalog
Agency product number
EMEA/H/C/000088
Active substance
insulin lispro
International non-proprietary name (INN) or common name
insulin lispro
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AC04
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
30/04/1996
Contact address
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

01/02/2018 Humalog - EMEA/H/C/000088 - WS/1314

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

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

Assessment history

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