Calcichew D3 mite

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

Key facts

Approved name
Calcichew D3 mite
International non-proprietary name (INN) or common name

Calcium 500 mg / cholecalciferol 5 µg

Reference number
CPMP/3258/03
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.

Status
European Commission final decision
Opinion date
26/06/2003
EC decision date
01/12/2003

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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