Seroquel XR - referral

Current status

European Commission final decision

Overview

Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended.

The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that Seroquel XR can be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.

What is Seroquel XR?

Seroquel XR is an antipsychotic medicine that contains the active substance quetiapine. It is used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). It is also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.

The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin. As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this disrupts signals transmitted between brain cells. Since these neurotransmitters are involved in schizophrenia and bipolar disorder, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

Seroquel XR is available as prolonged-release tablets. Prolonged-release means that the active substance is released slowly from the tablet over a few hours. Seroquel XR is also marketed under other trade names: Seroquel Depot, Seroquel Prolong, and Seroquel SR. The company that markets these medicines is Astra Zeneca.

Why was Seroquel XR reviewed?

Seroquel XR is authorised in Austria, Belgium, Cyprus, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, and Sweden under a mutual recognition procedure on the basis of the initial authorisation granted by the 'reference Member State', the Netherlands, in August 2007.

On 15 May 2009, the Netherlands and all the other concerned Member States rejected a change (variation) to the marketing authorisation to add as a new indication the treatment of recurrent depressive episodes in patients with major depressive disorder (MDD). The indication excluded the use of Seroquel XR as initial treatment, and restricted its use only to patients who cannot be appropriately managed on alternative antidepressant treatment.

The variation to the marketing authorisation was rejected because the Member States concluded that the benefit-risk balance of the medicine was unfavourable. Not enough data had been submitted to support the restriction to patients not responsive to standard antidepressants. In addition, evidence in support of the proposed dose was insufficient.

However, Astra Zeneca was not in agreement with the grounds for refusal and, on 22 May 2009, it referred the matter to the CHMP for arbitration.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that a new indication for Seroquel XR can be granted. The Committee recommended that the medicine be used as add-on to ongoing treatment for major depressive episodes in MDD patients who have had sub-optimal response to monotherapy with another antidepressant.

The European Commission issued a decision on 26 August 2010.

Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)

Adopted

Key facts

About this medicine

• Approved name:
  Seroquel XR
• International non-proprietary name (INN) or common name:
  quetiapine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/6(13)/001188
• Type:
  Article 6(13) referrals (prior to January 2010)

  This type of referral was triggered by the marketing-authorisation holder for a medicine that had been authorised by mutual recognition or via the decentralised procedure when Member States could not accept the variation (type II).

Key dates and outcomes

• CHMP opinion date:
  22/04/2010
• EC decision date:
  26/08/2010

All documents

Seroquel XR - Article 6(13) referral - Annex I, II, III, IV

Adopted

Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)

Adopted

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.