Niapelf
Authorised
This medicine is authorised for use in the European Union
paliperidone
MedicineHumanAuthorised
Overview
Niapelf is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
Some patients whose symptoms have not yet been stabilised may still be given Niapelf if they have responded well to oral (by mouth) paliperidone or risperidone in the past, their symptoms are mild to moderate and a long-acting injectable treatment is needed.
Niapelf is a ‘generic medicine’. This means that Niapelf contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Niapelf is Xeplion. For more information on generic medicines, see the question-and-answer document here.
Niapelf contains the active substance paliperidone.
Niapelf is available as a prolonged-release suspension for injection in prefilled syringes. Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Treatment with Niapelf starts with two injections, given one week apart, followed by monthly maintenance injections. The first two injections are given into the deltoid muscle (upper part of the arm), while the maintenance doses can be given in the gluteal muscle (buttocks) or the deltoid muscle.
The medicine can only be obtained with a prescription.
For more information about using Niapelf, see the package leaflet or contact your doctor or pharmacist.
The active substance in Niapelf, paliperidone, is an active metabolite (breakdown product) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s. In the brain, paliperidone attaches to several different receptors (targets) on nerve cells. This disrupts signals transmitted between brain cells by neurotransmitters, chemicals that allow nerve cells to communicate with each other. Paliperidone acts mainly by blocking receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia. By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.
Paliperidone has been authorised in the European Union as Invega since 2007, as an oral treatment for schizophrenia. In Niapelf, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected. This allows the injection to have a long duration of action.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Xeplion, and do not need to be repeated for Niapelf.
As for every medicine, the company provided studies on the quality of Niapelf. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Niapelf is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Niapelf has been shown to have comparable quality and to be bioequivalent to Xeplion. Therefore, the Agency’s view was that, as for Xeplion, the benefits of Niapelf 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 Niapelf have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Niapelf are continuously monitored. Suspected side effects reported with Niapelf are carefully evaluated and any necessary action taken to protect patients.
Niapelf received a marketing authorisation valid throughout the EU on 21 March 2024.
This overview was last updated in 04-2024.
Product information
21/03/2024
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
- Niapelf
- Active substance
- paliperidone palmitate
- International non-proprietary name (INN) or common name
- paliperidone
- Therapeutic area (MeSH)
- Schizophrenia
- Anatomical therapeutic chemical (ATC) code
- N05AX13
Pharmacotherapeutic group
PsycholepticsTherapeutic indication
indicated for maintenance treatment of schizophrenia in adult patients stabilised withpaliperidone or risperidone.
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Niapelf may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
News on Niapelf
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