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Aspen

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 Leukeran 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

Product ownership transfered from GSK to Aspen
Updated on 25/05/2010 and displayed until 05/05/2011
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   30-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



 2        qualitative and QUantitative composition

Each tablet contains 2mg of the active ingredient chlorambucil.

Each tablet also contains 67.65mg of lactose.

For a full list of excipients, see 6.1.

 

3   pharmaceutical form

Film-coated tablet (Tablet)

Brown, film-coated, round, biconvex tablets engraved ‘GX EG3’ on one side and ‘L’ on the other.

………………………

4.3     Contraindications

Use in the management of patients with non-malignant disease.

Hypersensitivity to chlorambucil or to any of the excipients.

……………………………

6.5.    Nature and Contents of Container

Leukeran tablets are supplied in amber (Type III) glass bottles with a child resistant polypropylene/ HDPE closure containing 25 or 50 tablets.

Not all pack sizes may be marketed

6.6.    Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Updated on 04/04/2008 and displayed until 25/05/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

4.4        Special Warnings and Special Precautions for Use

5.1       Pharmacodynamic Properties

Updated on 29/01/2007 and displayed until 04/04/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Blood and Lymphatic system disorders:

Very common: leucopenia, neutropenia, thrombocytopenia, panyctopenia

Common: anaemia

Updated on 02/06/2006 and displayed until 29/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 05/01/2005 and displayed until 02/06/2006
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Updated on 06/08/2004 and displayed until 05/01/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Updated on 29/01/2004 and displayed until 06/08/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 04/06/2003 and displayed until 29/01/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Chlorambucil

Versions

 
05/05/2011 to Current
25/05/2010 to 05/05/2011
04/04/2008 to 25/05/2010
29/01/2007 to 04/04/2008
02/06/2006 to 29/01/2007
05/01/2005 to 02/06/2006
06/08/2004 to 05/01/2005
29/01/2004 to 06/08/2004
04/06/2003 to 29/01/2004
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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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