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Merz Pharma UK Ltd
260 Centennial Park, Elstree Hill, South Elstree, Herts, WD6 3SR
Telephone: +44 (0)208 236 0000
Fax: +44 (0)208 236 3501
WWW: http://www.merzpharma.co.uk
Medical Information Direct Line: +44 (0)333 200 4143
Medical Information e-mail: medical.information@merz.com
Customer Care direct line: +44 (0)333 200 4144
Medical Information Fax: +44 (0)333 200 4142

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: 27/05/2011
SPC Xeomin 100 Units

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 27/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of product name to Xeomin 100 Units
Updated on 11/03/2011 and displayed until 27/05/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5, pack sizes of 4 vials (multi-packs) included
Updated on 15/10/2010 and displayed until 11/03/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   13-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of black triangle
Updated on 29/12/2009 and displayed until 15/10/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Main change is the addition of a new indication for the symptomatic treatment of post-stroke spacsticity of the upper limb presenting with flexed wrist and clenched fist in adults. This change is reflected in sections: 4.1; 4.2; 4.4; 4.8 and 5.1.

Other updates not related to the new indication include:-
Section 4.4 Special Warnings & Precautions for use: addition of dyphagia
Section 4.8 Undesirable effects: localised effects; addition of dysphagia, angle closure glaucoma, seizures, hypersensitivity and other generalised Botulinum toxins
Section 7 Marketing Authorisation: change of address
Updated on 01/05/2009 and displayed until 29/12/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   04-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 6.3 the shelf life for the unopened vial has been increased from 3 years to 4 years
Updated on 22/02/2008 and displayed until 01/05/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  botulinum toxin type a