Liprolog
Withdrawn
This medicine's authorisation has been withdrawn
insulin lispro
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 7 May 1997, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Liprolog, which contains insulin lispro. The pharmaceutical company responsible for this medicinal product is Eli Lilly and Company Ltd.
On 7 December 2000, the Marketing Authorisation holder notified the European Commission about the Marketing Authorisation holder's decision to withdraw the Marketing Authorisation for Liprolog.
On 19 February 2001, the European Commission has adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use, Liprolog - insulin lispro EU 1/97/038/001-003. Pursuant to this decision the European Public Assesment Report for Liprolog has been removed from this website.
For information, it should be noted that at present there is still a Marketing Authorisation valid throughout the European Union for the medicinal product Humalog, which contains insulin lispro. The pharmaceutical company responsible for this medicinal product is Eli Lilly and Company Ltd.
Following a later application by the company, the European Commission granted a marketing authorisation for the medicine.
Product information
19/02/2001
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).
Product details
- Name of medicine
- Liprolog
- Active substance
- insulin lispro
- International non-proprietary name (INN) or common name
- insulin lispro
- Therapeutic area (MeSH)
- Diabetes Mellitus
- Anatomical therapeutic chemical (ATC) code
- A10AB04
Pharmacotherapeutic group
- Drugs used in diabetes
- Insulins and analogues for injection, fast-acting
Therapeutic indication
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.
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