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Cephalon (UK) Limited
Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
Telephone: +44 (0) 207 5407117
Fax: +44 (0) 207 4507349
WWW: http://www.tevauk.com
Medical Information Direct Line: +44 (0) 207 5407117
Medical Information e-mail: medinfo@tevauk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 21/03/2011
SPC Axsain

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 21/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
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


Section 1 (Name of the medicinal product); the words “0.075% w/w” have been added after the name.

In section 4.4 (Special Warnings and Precautions for Use); the addition of the text “Skin irritation has been reported following application of Axsain”

In section 4.8  (Undesirable Effects); the addition of “skin irritation” as an adverse event.

 

In section 5.1: (Pharmacodynamic Properties); at the start of this section the following wording has been added “Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents, ATC code: M02A B01.”

 
Updated on 09/12/2010 and displayed until 21/03/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   29-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 (Nature and Contents of Container) now reads:

    Aluminium tubes with epoxyphenolic lining and polypropylene spiked cap containing 45g Axsain Cream.

Reference to the 7.5gm professional sample pack has been removed.
Updated on 14/04/2010 and displayed until 09/12/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
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


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 21799/0002 to PL 16260/0016

Section 9: Date of First Authorisation/Renewal of the Authorisation

Section 10:  Date of Revision of Text
Updated on 01/04/2010 and displayed until 14/04/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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
Change of MAH from Cephalon Limited to Cephalon UK Limited
Updated on 05/02/2010 and displayed until 01/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
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


Section 4.8 of the SmPC has been updated to add nasal and throat irritation as specific examples of mucous membrane irritation.
Updated on 03/11/2009 and displayed until 05/02/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   15-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


For information it is section 4.4 of the SmPC that has been updated to add:

 

 

Not for use under tight bandages.

 

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.

 

And to remove:

After applying Axsain Cream with the fingers, hands should be washed immediately.
Updated on 23/10/2008 and displayed until 03/11/2009
Reasons for adding or updating:
  • Change to MA holder contact details
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
Update MAH address from Oxford to Welwyn Garden City
Updated on 12/06/2007 and displayed until 23/10/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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

Section 7 - Marketing Authorisation Holder changed from:

 

Zeneus Pharma Limited

The Magdalen Centre

Oxford Science Park

Oxford

OX4 4GA

United Kingdom

 

to:

 

Cephalon Limited

The Magdalen Centre

Oxford Science Park

Oxford

OX4 4GA

United Kingdom
Updated on 12/06/2007 and displayed until 12/06/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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
Section 7 - Marketing Authorisation Holder changed from:
 

Zeneus Pharma Limited

The Magdalen Centre

Oxford Science Park

Oxford

OX4 4GA

United Kingdom

 

to:

 

Cephalon Limited

The Magdalen Centre

Oxford Science Park

Oxford

OX4 4GA

United Kingdom
Updated on 13/03/2006 and displayed until 12/06/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/09/2005 and displayed until 13/03/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/05/2004 and displayed until 15/09/2005
Reasons for adding or updating:
  • Company name change or merger
Updated on 19/11/2001 and displayed until 28/05/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/07/2001 and displayed until 19/11/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/10/2000 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/03/2000 and displayed until 03/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/01/2000 and displayed until 06/03/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  capsaicin