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A.Menarini Pharma U.K. S.R.L.
Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Telephone: +44 (0) 1628 856400
Fax: +44 (0) 1628 856402
Medical Information Direct Line: 0800 085 8678
Medical Information e-mail: menarini@medinformation.co.uk
Out of Hours contact: menarini@medinformation.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 11/05/2010
SPC Calfovit D3

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 11/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Sep-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following sections have been updated:

  • 1. Product name: add ‘1200 mg/800 I.U.’ to the product name
  • 2. Composition: add details of excipients - also contains 2 mg sunset yellow FCF (E110) and not more than 8.8 mg sucrose per dose.
  • 4.8. Side-effects: Section rewritten and undesirable effects listed according to MedRA System Organ Class.
  • 4.9. Overdose: More detailed information added
  • 6.6. Instructions for use: Add details of appearance of the product once reconstituted (smooth orange opaque suspension with visible white granules)
  • 9. Date of renewal:  Renewal date added.
  • 10. Date of revision of the test:  Date updated.
Updated on 25/09/2008 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 Add a new pack size - 2 sachets
Updated on 18/01/2007 and displayed until 25/09/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  colecalciferol
  calcium phosphate