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Bristol-Myers Squibb Pharmaceutical Limited
South Country Business Park, Leopardstown, Dublin 18,
Telephone: +353 1 291 3800
Fax: +353 1 291 3899
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Medical Information Facsimile: +44(0)20 8754 3677
Summary of Product Characteristics last updated on medicines.ie: 04/03/2010
SPC Hydrea 500 mg Hard Capsules

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

Updated on 04/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Feb-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


Sections 1, 2, 3, 6.1, 6.4, 6.6 - revised in line with SPC QRD Template

 Section 6.3 - Reduction of shelf life from 5 to 2 years. 

Sections 9 and 10 - Dates of renewal and revision
Updated on 02/02/2010 and displayed until 04/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Oct-2008
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Lactose statement included

Section 4.8 - Side effects in MEDRA terminology

Section 5.1 - ATC Code included
Updated on 07/02/2006 and displayed until 02/02/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 24/12/2004 and displayed until 07/02/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change from the BAN of the active substance to the rINN
Updated on 29/05/2003 and displayed until 24/12/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydroxycarbamide