Zubsolv

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On 14 September 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zubsolv, intended for the treatment of opioid dependence. The applicant for this medicinal product is Mundipharma Corporation Limited.

Zubsolv contains the active substances buprenorphine and naloxone and will be available as tablets for sublingual use (0.7 mg / 0.18 mg, 1.4 mg / 0.36 mg, 2.9 mg / 0.71 mg, 5.7 mg / 1.4 mg, 8.6 mg / 2.1 mg and 11.4 mg / 2.9 mg). Buprenorphine and naloxone are used in addictive disorders (ATC code: N07BC51) and act as opioid agonist and opioid receptor antagonist, respectively.

The benefit of Zubsolv is substitution of opioids during addiction treatment.The most common side effects are constipation, nausea, insomnia and headache.

The full indication is: "Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction."

It is proposed that Zubsolv be prescribed by physicians experienced in the treatment of opioid dependence.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Zubsolv (English only) 2017-09-15  

Key facts

Product details for Zubsolv
NameZubsolv
INN or common namebuprenorphine / naloxone
Therapeutic area Opioid-Related Disorders
Active substance

buprenorphine hydrochloride, naloxone hydrochloride dihydrate

Date opinion adopted14/09/2017
Company name

Mundipharma Corporation Limited

StatusPositive
Application typeInitial authorisation