Calcium Sandoz

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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.

Key facts

Approved name
Calcium Sandoz
International non-proprietary name (INN) or common name

Calcium lactate gluconate, Calcium carbonate

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.

Status
European Commission final decision
Opinion date
21/04/2005
EC decision date
09/08/2005

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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