Calcichew D3 - referral

Current status

European Commission final decision

Overview

Cholecalciferol (vit D3), undergoes a biotransformation into 1,25 dihydroxycholecalciferol, a main active metabolite of vitamine D, which is necessary to promote the intestinal absorption of calcium. Calcium is essential for a number of physiological functions and particularly bone mineralization.

Medicinal products containing cholecalciferol and/or carbonate calcium have been nationally authorised in EU Member States, resulting in different Summaries of Product Characteristics based on individual national decisions.

Nycomed Pharma AS presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national SPCs of the medicinal product Calcichew-D3 and associated names and additionally to harmonise the pharmaceutical documentation. A dossier in CTD format and a proposal for a harmonised SPC were submitted by the MAH on 20 September 2002. The referral procedure started on 27 September 2002.

The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, and scientific discussion within the Committee was of the opinion that the benefit/risk ratio of calcium carbonate is considered to be favourable. The CPMP issued a positive opinion, on 26 June 2003, recommending the harmonisation of the SPC for Calcichew-D3 and associated names for the following agreed therapeutic indications: prevention and treatment of vitamine D and calcium deficiency; vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.

An overall summary of the scientific evaluation is provided in Annex II together with the amended summary of product characteristics in Annex III.

A Decision was issued by the European Commission on 1 December 2003.

Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Calcichew-D3 and associated names International Non-Proprietary Name (INN): Calcium 500mg / choleca...

Adopted Reference Number: EMEA/CPMP/3257/03/en/Final

Key facts

About this medicine

• Approved name:
  Calcichew D3
• International non-proprietary name (INN) or common name:
  • colecalciferol
  • calcium

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/3257/03
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  26/06/2003
• EC decision date:
  01/12/2003

All documents

Calcichew D3 - Article 30 referral - Annex I, II, III

Adopted

Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Calcichew-D3 and associated names International Non-Proprietary Name (INN): Calcium 500mg / choleca...

Adopted Reference Number: EMEA/CPMP/3257/03/en/Final

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.