Norsed Combi D - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Norsed Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Norsed Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in other Member States of the EU.

What is Norsed Combi D?

Norsed Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol. It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol.

Norsed Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. It is used to reduce the risk of fractures (in the hip and spine. The active substance in the tablets, risedronate sodium, is a bisphosphonate. It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.

Why was Norsed Combi D reviewed?

Sanofi-aventis S.p.A. submitted Norsed Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006. The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the 'concerned Member States').

However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.

The grounds for the referral were concerns over the evidence provided of the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Norsed Combi D outweigh its risks, and therefore the marketing authorisation for Norsed Combi D should be granted in all concerned Member States.

The European Commission issued a decision on 5 October 2010.

Questions and answers on Norsed Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules))

Reference Number: EMEA/H/A-29/1273

Key facts

About this medicine

• Approved name:
  Norsed Combi D
• International non-proprietary name (INN) or common name:
  • risedronate sodium
  • calcium carbonate
  • colecalciferol
• Associated names:
  • Actonel Combi D
  • Optinate Plus Ca&D
  • Opticalcio D3

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/001273
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  24/06/2010
• EC decision date:
  05/10/2010

All documents

Norsed Combi D - Article 29 referral - Annex I-III

Questions and answers on Norsed Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol 1000 mg/880 IU effervescent granules))

Reference Number: EMEA/H/A-29/1273

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.