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  1. Home
  2. Medicines
  3. Invega - withdrawal of application for variation to marketing authorisation

Invega - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

paliperidone
Post-authorisationHuman

Page contents

  • Overview
  • Key facts
  • Documents
  • Related information on withdrawals
  • News on Invega
  • More information on Invega

Overview

On 15 December 2008, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Invega, to add the treatment of acute manic episodes associated with bipolar I disorder.

Invega is a medicine containing the active substance paliperidone. It is available as prolonged-release tablets (tablets that release paliperidone slowly from the tablet over a few hours).

Invega is already used to treat schizophrenia, a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).

Invega was also expected to be used in adults with bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal or depressed mood. Invega was expected to be used to treat acute (sudden) manic episodes.

The active substance in Invega, paliperidone, is an antipsychotic medicine. It is known as an 'atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s and in the treatment of bipolar I disorder since the early 2000s.

In the brain, paliperidone attaches to several different receptors on the surface of 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 the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in bipolar I disorder. By blocking these receptors, paliperidone is expected to help normalise the activity of the brain and reduce the symptoms of acute manic episodes.

The company presented the results of three main studies involving a total of 1,262 adults with bipolar I disorder who were having an acute manic episode.Two of the studies compared Invega taken alone with placebo (a dummy treatment), one in 469 patients over three weeks and another in 493 patients over 12 weeks. The 12-week study also included a group of patients treated with quetiapine taken alone (another treatment for bipolar I disorder).

The third study compared the effects of Invega and placebo when they were taken together with either lithium or sodium valproate (other treatments for bipolar I disorder). The study involved 300 patients and lasted six weeks.
In all three studies, the main measure of effectiveness was the change in the severity of acute manic episodes, as measured using a standard symptom scale.

The application was at day 85 when the company withdrew. The CHMP was evaluating the initial documentation provided by the company.

The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation. Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.

The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.

The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.

The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Invega for bipolar I disorder or any other disease. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

There are no consequences on the use of Invega in its authorised indication, for which the balance of benefits and risks remains unchanged.

Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Invega

Reference Number: EMEA/2672/2009

English (EN) (39.82 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Other languages (21)

български (BG) (147.14 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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español (ES) (41.85 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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čeština (CS) (123.8 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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dansk (DA) (41.84 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Deutsch (DE) (42.71 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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eesti keel (ET) (41.1 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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ελληνικά (EL) (146.63 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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français (FR) (42.3 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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italiano (IT) (41.6 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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latviešu valoda (LV) (124.85 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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lietuvių kalba (LT) (121.98 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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magyar (HU) (118.01 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Malti (MT) (125.99 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Nederlands (NL) (41.55 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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polski (PL) (127.14 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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português (PT) (41.61 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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română (RO) (119.05 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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slovenčina (SK) (122.67 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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slovenščina (SL) (116.21 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Suomi (FI) (41.63 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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svenska (SV) (41.43 KB - PDF)

First published: 22/01/2009Last updated: 22/01/2009
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Key facts

Name of medicine
Invega
EMA product number
EMEA/H/C/000746
Active substance
paliperidone
International non-proprietary name (INN) or common name
paliperidone
Therapeutic area (MeSH)
  • Schizophrenia
  • Psychotic Disorders
Anatomical therapeutical chemical (ATC) code
N05AX13
Marketing authorisation holder
Janssen-Cilag International NV
Date of issue of marketing authorisation valid throughout the European Union
24/06/2007
Date of withdrawal
15/12/2008

Documents

Withdrawal letter : Invega

English (EN) (26.24 KB - PDF)

First published: 15/12/2008Last updated: 15/12/2008
View

Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone)

Reference Number: 17 December 2008

English (EN) (24.94 KB - PDF)

First published: 17/12/2008Last updated: 17/12/2008
View

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

News on Invega

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
24/04/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2014
25/04/2014
Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone)
17/12/2008

More information on Invega

  • Invega
This page was last updated on 17/12/2008

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