Basic Information
C01CA04
dopamine
Cardiac therapy
Therapeutic indication
Treatment of hypotension in haemodynamically unstable neonates, infants and children < 18 years
Overview Summary
Neoatricon is used to treat hypotension (low blood pressure) in newborn babies, infants and children less than 18 years of age who have unstable blood pressure.
Neoatricon contains the active substance dopamine hydrochloride and is a hybrid medicine. This means that it is similar to a reference medicine containing the same active substance, but there are certain differences between the two.
Unlike the reference medicine (Sterile Dopamine Concentrate BP 40mg/mL, Ireland), Neoatricon is used in children and its strength and what it is used for are different from those of the reference medicine.
Active Substances (3)
dopamine hydrochloride
Dopamine hydrochloride
Dopamine
Documents (7)
Neoatricon : EPAR - All authorised presentations
June 19, 2024
AUTHORISED_PRESENTATIONS
Neoatricon : EPAR - Procedural steps taken and scientific information after authorisation
July 4, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Neoatricon : EPAR - Risk management plan
June 19, 2024
RISK_MANAGEMENT_PLAN_SUMMARY
Neoatricon : EPAR - Medicine overview
June 19, 2024
OVERVIEW_DOCUMENT
Neoatricon : EPAR - Public assessment report
June 19, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Neoatricon
March 22, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Neoatricon : EPAR - Product information
June 19, 2024
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
How is Neoatricon used?
Answer
Neoatricon is given as an infusion (drip into a vein) in a large vein under the supervision of a doctor. In newborns, the medicine may also be given into the umbilical cord. The amount of Neoatricon the patient receives depends on how they respond to treatment.
The medicine can only be obtained with a prescription. For more information about using Neoatricon, see the package leaflet or contact your healthcare provider.
Question
How does Neoatricon work?
Answer
Neoatricon contains the active substance dopamine hydrochloride. It works mainly by attaching to specific receptors (targets) called adrenergic receptors. Attaching to these receptors causes blood vessels to become more narrow and the heart to beat harder, thereby increasing blood pressure.
Question
What benefits of Neoatricon have been shown in studies?
Answer
The main benefits of dopamine have been shown in published studies. The studies showed that dopamine leads to an increase in arterial blood pressure, which helps to improve the blood supply to the organs of newborns, infants and children who have severe problems with their blood circulation.
Question
What are the risks associated with Neoatricon?
Answer
For the full list of side effects and restrictions with Neoatricon, see the package leaflet.
The most common side effects with Neoatricon (which may affect up to 1 in 10 people) include headache, problems with heart rhythm and electrical conduction in the heart, high blood pressure, piloerection (goosebumps), azotaemia (increased levels of nitrogen and other waste products in the blood), skin necrosis (death of skin tissue) and gangrene (decay and death of tissue)
Question
Why is Neoatricon authorised in the EU?
Answer
There is evidence from the published literature about the use of dopamine to increase blood pressure in children whose blood pressure is unstable. Important side effects include problems with the heart rhythm and reduced blood flow to tissues. The European Medicines Agency concluded that Neoatricon’s benefits are greater than its risks and that it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Neoatricon?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Neoatricon have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Neoatricon are continuously monitored. Suspected side effects reported with Neoatricon are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Neoatricon
Answer
Neoatricon received a marketing authorisation valid throughout the EU on 27 May 2024.