go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Aspen
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: +44 1748 828 798
Medical Information Direct Line: 0080000404142 - Freephone
Medical Information e-mail: aspenglobal@professionalinformation.co.uk
Summary of Product Characteristics last updated on medicines.ie: 05/05/2011
SPC Alkeran Tablets 2mg

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 05/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Change of Product ownership from GSK to Aspen, new PL numbers and date of revision of text
Updated on 09/04/2010 and displayed until 05/05/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-Feb-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


1.0       NAME OF THE MEDICINAL PRODUCT

 

Alkeran Tablets 2mg Film-coated Tablets

 

2.0       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 2mg melphalan.

For a full list of excipients, see section 6.1

 

6.5       Nature and Contents of Container

 

Alkeran Tablets are supplied in amber glass bottles of 25 or 50 tablets with a child resistant closure.

 

Not all pack sizes may be marketed

 

6.6       Instructions for Use and Handling

 

The handling of Alkeran formulations should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and or regulations (for example, Royal Pharmaceutical Society of Great Britain Working Party on the Handling of Cytotoxic Drugs)

 

 

10.              DATE OF (PARTIAL) REVISION OF THE TEXT

 

January 2007

February 2010
Updated on 30/10/2008 and displayed until 09/04/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/04/2007 and displayed until 30/10/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 25/05/2005 and displayed until 02/04/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
Updated on 05/08/2004 and displayed until 25/05/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 03/06/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 21/05/2003 and displayed until 03/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
  Melphalan