NovoRapid

insulin aspart

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This is a summary of the European public assessment report (EPAR) for NovoRapid. 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 NovoRapid.

What is NovoRapid?

NovoRapid is a solution for injection that contains the active substance insulin aspart. It is available in vials, cartridges (PenFill and PumpCart) and pre-filled pens (FlexPen, FlexTouch and InnoLet).

What is NovoRapid used for?

NovoRapid is used to treat adults, adolescents and children over the age of two years who have diabetes.

The medicine can only be obtained with a prescription.

How is NovoRapid used?

NovoRapid is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock. The injection site should be changed for each injection. NovoRapid is a rapid-acting insulin. It is usually given immediately before a meal, although it may be given after a meal if necessary. 

NovoRapid is normally used in combination with an intermediate- or long-acting insulin given at least once a day. The patient’s blood glucose (sugar) should be tested regularly to find the lowest effective dose.

The usual dose is between 0.5 and 1.0 units per kilogram body weight per day. When it is used with meals, 50 to 70% of the insulin requirement may be provided by NovoRapid and the remainder by an intermediate or long-acting insulin. NovoRapid can be used in pregnant women.

NovoRapid can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be given into a vein but only by a doctor or a nurse.

How does NovoRapid work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. NovoRapid is a replacement insulin that is very similar to the insulin made by the body.

The active substance in NovoRapid, insulin aspart, is produced by a method known as ‘recombinant DNA technology’: it is made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce insulin aspart.

Insulin aspart is very slightly different from human insulin. The change means that it is absorbed faster by the body, and can therefore act faster than human insulin. The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has NovoRapid been studied?

NovoRapid has been studied in two studies involving 1,954 patients with type 1 diabetes (when the pancreas cannot produce insulin) and in one study involving 182 patients with type 2 diabetes (when the body is unable to use insulin effectively). The studies compared NovoRapid with human insulin by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. The safety of NovoRapid has also been compared with that of human insulin in two studies involving 349 pregnancies in women with type 1 or gestational diabetes (diabetes caused by pregnancy). NovoRapid has not been studied in children below two years of age.

What benefit has NovoRapid shown during the studies?

NovoRapid gave almost identical results to human insulin. In the two studies in type 1 diabetes, NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months. NovoRapid had the same safety profile as human insulin when used during pregnancy.

What is the risk associated with NovoRapid?

The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with NovoRapid, see the package leaflet. 

For the full list of restrictions, see the package leaflet.

Why has NovoRapid been approved?

The CHMP decided that NovoRapid’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about NovoRapid

The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid on 7 September 1999.

For more information about treatment with NovoRapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
NovoRapid : EPAR - Summary for the public BG = bălgarski 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public ES = español 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public CS = čeština 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public DA = dansk 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public DE = Deutsch 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public ET = eesti keel 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public EL = elliniká 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public EN = English 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public FR = français 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public IT = italiano 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public LV = latviešu valoda 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public LT = lietuvių kalba 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public HU = magyar 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public MT = Malti 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public NL = Nederlands 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public PL = polski 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public PT = português 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public RO = română 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public SK = slovenčina 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public SL = slovenščina 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public FI = suomi 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public SV = svenska 06/08/2009 27/03/2014
NovoRapid : EPAR - Summary for the public HR = Hrvatski 06/08/2009 27/03/2014

This EPAR was last updated on 27/03/2014 .

Authorisation details

Product details

Product details for NovoRapid
NameNovoRapid
Agency product numberEMEA/H/C/000258
Active substance

insulin aspart

International non-proprietary name (INN) or common name

insulin aspart

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AB05

Publication details

Publication details for NovoRapid
Marketing-authorisation holder

Novo Nordisk A/S

Revision19
Date of issue of marketing authorisation valid throughout the European Union07/09/1999

Contact address:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

Product information

10/01/2014  NovoRapid -EMEA/H/C/000258 -II/0092

Name Language First published Last updated
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014
NovoRapid : EPAR - Product Information HR = Hrvatski 17/12/2009 27/03/2014

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.


Name Language First published Last updated
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014
NovoRapid : EPAR - All Authorised presentations HR = Hrvatski 19/06/2009 27/03/2014

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
NovoRapid : EPAR - Procedural steps taken before authorisation HR = Hrvatski 19/06/2009  
NovoRapid : EPAR - Scientific Discussion HR = Hrvatski 19/06/2009  

Authorised

This medicine is approved for use in the European Union