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Bristol-Myers Squibb Holdings Limited

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: 20/02/2012
SPC Megace 40 mg/ml Oral Suspension

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 20/02/2012 and displayed until Current
Reasons for adding or updating:
  • Addition of legal category
Date of revision of text on the SPC:   16-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 Category

POM

added
Updated on 20/04/2011 and displayed until 20/02/2012
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 22/12/2010 and displayed until 20/04/2011
Reasons for adding or updating:
  • 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:   16-Dec-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.2:  Information regarding Elderly included.
Updated on 02/02/2010 and displayed until 22/12/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • 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:   01-Dec-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 1 - name revised to include the strength
Section 2 - Sucrose content included
Section 6.1 - citric acid anhydrous and Macrogol changed to polyethylene glycol
Section 9 - renewal date revised
 
Updated on 03/04/2008 and displayed until 02/02/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2006 and displayed until 03/04/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   09/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The trade name has changed to MEGACE 40 mg / ml ORAL SUSPENSION
 
Section 4.4 had been changed to   

Megace should be used with caution in patients with a history of thrombophlebitis.

Megace Oral Suspension contains sucrose which may be harmful to the teeth.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Updated on 30/05/2003 and displayed until 24/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   megestrol acetate

Versions

 
20/02/2012 to Current
20/04/2011 to 20/02/2012
22/12/2010 to 20/04/2011
02/02/2010 to 22/12/2010
03/04/2008 to 02/02/2010
24/08/2006 to 03/04/2008
30/05/2003 to 24/08/2006
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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