Summary of Product Characteristics
last updated on the eMC:
13/07/2007
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 13/07/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.2
An update to the information provided regarding the experience of melphalan in the elderly. Updated information under headings absorption, distribution and metabolism.
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Updated on 28/06/2007 and displayed until 13/07/2007
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1: Removal of indication: adjuvant to surgery in management of breast cancer
Section 4.4: Update leukaemogenic wording
Section 4.8: Update to add Anaemia undesirable effect & MedDRA frequencies and wording
Section 4.9: Deletion of neutropenia and addition of leucopoenia and anaemia
Section 10: 17/05/2007
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Updated on 14/03/2005 and displayed until 28/06/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 22/04/2003 and displayed until 14/03/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 19/12/2002 and displayed until 22/04/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 16/12/2002 and displayed until 19/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 12/12/2002 and displayed until 16/12/2002
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 13/07/2001 and displayed until 12/12/2002
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 12/04/2000 and displayed until 13/07/2001
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Reasons for adding or updating:
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