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Bristol-Myers Squibb Holdings Limited
Swords, Co.Dublin, Ireland
Fax: +44 (0)208 754 3677
Medical Information Direct Line: +1 800 749 749
Medical Information e-mail: medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 21/02/2012
SPC Megace 160mg Tablets

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 21/02/2012 and displayed until Current
Reasons for adding or updating:
  • Addition of legal category
Date of revision of text on the SPC:   20-Feb-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Legal Catergory

POM

has been added.
Updated on 20/04/2011 and displayed until 21/02/2012
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Apr-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.9 - Overdose
Following added in line with Company Core Data Sheet:

Reports of overdose have been received in the postmarketing setting. Signs and symptoms reported in the context of overdose included diarrhoea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megace. In case of overdose, appropriate supportive measures should be taken.
Updated on 13/05/2010 and displayed until 20/04/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.1 - Removal of the endometrial cancer indication.
Section 4.2 - Removal of the reference to the posology for the endometrial cancer indication.
Updated on 02/02/2010 and displayed until 13/05/2010
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 6.2 - Incompatibilities
  • 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:   18-Nov-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 1: Strength moved before the pharmaceutical form
Section 2: Lactose content added
Section 3: Information about breakline included
Section 6.1: 'Colloidal silicone dioxide' replaced by 'Colloidal anhydrous silica'
Section 6.2: 'None stated' replaced by 'Not applicable'
Section 6.4: 'Store in the original container in order to protect from moisture' included
Section 6.6: 'None' replaced by 'No special requirements'
Section 9: Date of renewal changed
Updated on 20/08/2007 and displayed until 02/02/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  megestrol acetate