Updated on 21/03/2011 and displayed until Current
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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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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.4 (Special warnings and precautions for use); addition of the text “Skin irritation has been reported following application of Zacin”
In section 4.8 (Undesirable effects); the addition of “skin irritation” as an adverse event.
In section 5.1 (Pharmacodynamic properties); at the start the following wording has been added “Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents, ATC code: M02A B01.”
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Updated on 14/04/2010 and displayed until 21/03/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 22-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:
Section 7: Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire
Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0014 to PL 16260/0028
Section 9: Date of First Authorisation/Renewal of the Authorisation
Section 10: Date of Revision of Text
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Updated on 31/03/2010 and displayed until 14/04/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 22-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of MAH from Cephalon Limited to Cephalon UK Limited
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Updated on 11/02/2010 and displayed until 31/03/2010
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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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| Date of revision of text on the SPC: 20-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4:
The addition of a warning regarding the inhalation of vapours
Section 4.8:
Updated to add nasal and throat irritation as specific examples of mucous membrane irritation
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Updated on 13/08/2009 and displayed until 11/02/2010
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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 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 05-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 has been amended to include w/w as follows: Zacin 0.025% w/w Cream
Section 4.4 has been updated to add: ‘The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application.’
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Updated on 26/01/2009 and displayed until 13/08/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 10-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 of the SmPC that has been altered (inhalation of vapour)
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Updated on 17/10/2008 and displayed until 26/01/2009
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 02-Oct-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update MAH address from Oxford to Welwyn Garden City
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Updated on 19/06/2007 and displayed until 17/10/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Marketing Authorisation Holder
changed to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
Oxfordshire
OX4 4GA
United Kingdom
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Updated on 13/03/2006 and displayed until 19/06/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 27/09/2005 and displayed until 13/03/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/05/2004 and displayed until 27/09/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 19/11/2001 and displayed until 28/05/2004
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 19/07/2001 and displayed until 19/11/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 13/10/2000 and displayed until 19/07/2001
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Updated on 03/10/2000 and displayed until 13/10/2000
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Updated on 06/03/2000 and displayed until 03/10/2000
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Updated on 18/01/2000 and displayed until 06/03/2000
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Updated on 06/09/1999 and displayed until 18/01/2000
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