Calcium Sandoz - referral

Current status

European Commission final decision

Overview

Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.

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

Novartis Consumer Health SA 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 Calcium Sandoz Effervescent tablets, 500/1000 mg 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 22 September 2004. The referral procedure started on 21 October 2004

The CHMP 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 Sandoz Effervescent tablets, 500/1000 mg and associated names is considered to be favourable. The CHMP issued a positive opinion, on 21 April 2005, recommending the harmonisation of the SPC for Calcium Sandoz Effervescent tablets, 500/1000 mg and associated names for the following agreed therapeutic indications:

• Prevention and treatment of calcium deficiency
• Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis
• Rickets and osteomalacia, in addition to vitamin D3 therapy

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

A Decision was issued by the European Commission on 9 August 2005.

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

Adopted Reference Number: EMEA/CHMP/289490/2005

Key facts

About this medicine

• Approved name:
  Calcium Sandoz
• International non-proprietary name (INN) or common name:
  • calcium lactate gluconate
  • calcium carbonate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/289490/05
• 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:
  21/04/2005
• EC decision date:
  09/08/2005

All documents

Calcium Sandoz - 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 Calcium Sandoz and associated names International Non-Proprietary Name (INN): Calcium lactate gluco...

Adopted Reference Number: EMEA/CHMP/289490/2005

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.