Buprenorphine Neuraxpharm
Authorised
This medicine is authorised for use in the European Union
buprenorphine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Buprenorphine Neuraxpharm is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine. It is used in adults and adolescents aged 15 years and above who have agreed to be treated for addiction and who are also receiving medical, social and psychological support.
Buprenorphine Neuraxpharm contains the active substance buprenorphine and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but that it is given in a different way. The reference medicine for Buprenorphine Neuraxpharm is Subutex. Buprenorphine Neuraxpharm is available as a sublingual film (a film to be placed under the tongue), whereas Subutex is available as sublingual tablets or a solution for injection.
Buprenorphine Neuraxpharm is given as a film to be placed under the tongue once a day, where it will dissolve in about 10 to 15 minutes.
Treatment should be started by and remain under the supervision of a doctor experienced in the management of opioids dependence/addiction. It is recommended that Buprenorphine Neuraxpharm is used in combination with other interventions for opioid drug dependence.
The medicine can only be obtained by ‘special’ prescription. This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
For more information about using Buprenorphine Neuraxpharm, see the package leaflet or contact your doctor or pharmacist.
The active substance in Buprenorphine Neuraxpharm, buprenorphine, is a partial opioid agonist/antagonist. This means that it acts like an opioid drug but less powerfully, and it can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Because buprenorphine is a widely used, well-known active substance, its effectiveness is well described in the medical literature. In addition, studies have shown that giving Buprenorphine Neuraxpharm produces similar levels of the active substance in the body as giving Subutex.
For the full list of side effects and restrictions with Buprenorphine Neuraxpharm, see the package leaflet.
The most common side effects with Buprenorphine Neuraxpharm (which may affect more than 1 in 10 people) include symptoms of drug withdrawal, such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Buprenorphine Neuraxpharm must not be used in patients with severe respiratory insufficiency (inability to breathe properly) or severe liver problems, and in patients who are intoxicated with alcohol or who are experiencing alcohol withdrawal symptoms.
The European Medicines Agency considered that the benefits and risks of the active substance, buprenorphine, are well known from the medical literature. Studies have shown that Buprenorphine Neuraxpharm produces sufficient levels of the active substance in people given the medicine. The Agency therefore concluded that the medicine’s benefits are greater than its risks and that 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 Buprenorphine Neuraxpharm have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Buprenorphine Neuraxpharm are continuously monitored. Suspected side effects reported with Buprenorphine Neuraxpharm are carefully evaluated and any necessary action taken to protect patients.
Buprenorphine Neuraxpharm received a marketing authorisation valid throughout the EU on
19 December 2024.
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
- Buprenorphine Neuraxpharm
- Active substance
- Buprenorphine hydrochloride
- International non-proprietary name (INN) or common name
- buprenorphine
- Therapeutic area (MeSH)
- Opioid-Related Disorders
- Anatomical therapeutic chemical (ATC) code
- N07BC01
Pharmacotherapeutic group
Other nervous system drugsTherapeutic indication
Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment.
Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.
Assessment history
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