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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 20/12/2011
SPC Xarelto 10 mg film-coated tablets

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 20/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 4.7 and 5.1 of the SmPC have been updated. 
Updated on 24/08/2011 and displayed until 20/12/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The key changes are:

The name of the Marketing Authorisation Holder and manufacturers have changed from Bayer Schering Pharma AG to Bayer Pharma AG.

Updated on 08/02/2011 and displayed until 24/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The SmPC has been updated as follows:

minor changes to section 4.2: the word 'Posology' has been added; 'Patients above 65 years' has been replaced by 'Elderly population'; 'Children and adolescents' has been amended to 'Paediatric population' and some text changes have been made in this section. 'Method of administration' has also been added.

addition to section 4.4: a sentence on the use of appropriate prophylactic treatment of ulcerative GI disease has been added.

minor change to section 4.6: title changed to Fertility, pregnancy and breast feeding and separate section created for fertility.

minor change to section 4.7: the sentence stating that no studies have been performed has been deleted.

changes to section 4.8: re-positioning of paragraphs on mode of action and haemorrhagic complications. Some new UEs have been added and others have been re-assigned to different frequencies. If you require further information on this please let me know and I can send a track changes copy of the table.

addition to section 5.1: a paragraph has been added on Paediatric population.

minor change to section 5.2: gender and elderly population are now two separate headings rather than being combined.

change to section 5.3: a sentence has been added on fertility in rats.
Updated on 30/06/2010 and displayed until 08/02/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The Xarelto SmPC has been updated to include the new unit doses and an additional pack size. The following sections have been amended:
Section 6.5 to include the unit doses;
Section 8 to include the new Marketing Authorisation Numbers;
Section 10 date of revision amended to June 2010. 

Updated on 21/05/2009 and displayed until 30/06/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder) has changed to Bayer Schering Pharma AG

Section 10 (Date of Revision) is now May 2009 
Updated on 16/10/2008 and displayed until 21/05/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  Rivaroxaban