Dazparda
Authorised
This medicine is authorised for use in the European Union
insulin aspart
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Dazparda is a medicine used to control blood glucose (sugar) levels in patients from one year of age with diabetes.
Dazparda contains the active substance insulin aspart and is a biological medicine. It is a ‘biosimilar medicine’; this means that Dazparda is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Dazparda is NovoRapid. For more information on biosimilar medicines, see here.
Dazparda can only be obtained with a prescription. It is given as an injection under the skin of the upper arm, thigh, buttock or abdomen (belly). Patients can inject themselves under the skin with Dazparda if they have been trained appropriately.
Because Dazparda is a fast-acting insulin, it is usually given just before a meal or, if more appropriate, soon after a meal. The dose of Dazparda is worked out for each patient and depends on the patient’s blood glucose level.
For more information about using Dazparda, see the package leaflet or contact your doctor or pharmacist.
In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin, or the body is unable to use insulin effectively.
Dazparda is a replacement insulin that is very similar to the insulin made by the body.
The active substance in Dazparda, insulin aspart, is a form of insulin that acts faster than naturally produced human insulin because it is absorbed more quickly by the body. It helps control blood glucose levels, thereby improving symptoms and reducing the risk of complications of diabetes.
Laboratory studies comparing Dazparda with NovoRapid have shown that the active substance in Dazparda is highly similar to that in NovoRapid in terms of structure, purity and biological activity. Studies have also shown that giving Dazparda produces similar levels of the active substance in the body to those seen with NovoRapid.
Based on the data accumulated on biosimilars of insulin medicines, studies on the effectiveness of insulin aspart carried out with NovoRapid do not need to be repeated for Dazparda.
Studies carried out with Dazparda are described in more detail in the medicine’s assessment report.
The safety of Dazparda has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of NovoRapid.
For the full list of side effects and restrictions of Dazparda, see the package leaflet.
The most common side effect with Dazparda (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Dazparda has a highly similar structure, purity and biological activity to NovoRapid and is distributed in the body in the same way.
Based on these data, and those accumulated on insulin biosimilars, Dazparda is expected to have the same effects as NovoRapid in its authorised uses.
Therefore, the Agency’s view was that, as for NovoRapid, the benefits of Dazparda outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dazparda have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dazparda are continuously monitored. Side effects reported with Dazparda are carefully evaluated and any necessary action taken to protect patients.
Dazparda received a marketing authorisation valid throughout the EU on 27 April 2026.
Product information
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
- Dazparda
- Active substance
- insulin aspart
- International non-proprietary name (INN) or common name
- insulin aspart
- Therapeutic area (MeSH)
- Diabetes Mellitus
- Anatomical therapeutic chemical (ATC) code
- A10AB05
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
News on Dazparda
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