Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Monotard
Auth. number : EU/1/02/235
Active substance : Insulin human (rDNA)
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10A - Insulins and analogues
Chemical subgroup: A10AC - Insulins and analogues for injection, intermediate-acting
Chemical substance: A10AC01 - insulin (human)
(See WHO ATC Index)
Indication: Treatment of diabetes mellitus
Marketing Authorisation Holder: Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
09/10/2002 Centralised - Authorisation EMEA/H/C/440 (2002)3795 of 07/10/2002
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/440/II/2
01/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/440/II/1
16/11/2006 Centralised - Withdrawal (2006)5547 of 14/11/2006