Summary of Product Characteristics
last updated on the eMC:
25/09/2007
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 25/09/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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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: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1. Change "Andropatch 2.5 mg" to "Andropatch 2.5 mg / 24 hours Transdermal Patch"
section 2. Add the following as a separate paragraph underneath the existing paragraph: "For full list of excipients, see section 6.1."
Section 3. Add the word "beige" in the first paragraph after the words "consisting of a ..." and before "... self-adhesive patch ..."
Section 6.1: Add "(E422)" after "Glycerol".
Section 6.3: Change from "24 months." to read "2 years."
Section 6.4: Delete the final sentence "Do not store outside the pouch provided." and replace with "Store in the original package."
Secton 6.5: Add an asterisk ("*") directly after "... and supplied in cartons of" in the first paragraph. Underneath that paragraph add a separate paragraph "*Not all pack sizes may be marketed."
Section 10: To change the date from "29 August 2006" to "12 September 2007"
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Updated on 29/08/2006 and displayed until 25/09/2007
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Correction of spelling/typing errors
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 22/09/2004 and displayed until 29/08/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 10/03/2003 and displayed until 22/09/2004
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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 17/09/2002 and displayed until 10/03/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 09/09/2002 and displayed until 17/09/2002
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 26/07/2002 and displayed until 09/09/2002
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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 17/04/2002 and displayed until 26/07/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 05/02/2002 and displayed until 17/04/2002
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 18/01/2002 and displayed until 05/02/2002
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 20/08/2001 and displayed until 18/01/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 20/08/2001
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Reasons for adding or updating:
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