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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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Summary of Product Characteristics last updated on the eMC: 30/04/2012
SPC Tyverb

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 30/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   13-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section

Summary of change

2.

Minor text change

4.3

Cross-reference to Section 6.1 for list of excipients

4.6

Minor changes to headings and sub-headings

5.1

Minor change to sub-heading

6.6

Minor text change

9.

Dates updated

10.

Date updated
Updated on 04/07/2011 and displayed until 30/04/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6. 5 - Nature and Contents of Container
  • 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:   23-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Summary of Change

Sections:

4.5 Addition of information to section 4.5 Interaction with other medicinal products and other forms of interaction of the SPC regarding interaction with acid-lowering drugs

6.5 Addition of information to section 6.5 Nature of contents of containeer of the SPC with addition of bottle packs

9 Addition of information to Section 9 Date of First Authorisation/Renewal of the Authorisation of the SPC with the revised renewal date

10 Updated with new revision date
Updated on 12/08/2010 and displayed until 04/07/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Additional information regarding acute renal failure, secondary to dehydration, due to diarrhoea
Section 10 - Revision date updated to July 2010
Updated on 24/06/2010 and displayed until 12/08/2010
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:   17-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1
New indication: Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
-   in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1)
- in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.  The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (See section 5.1).
Section 4.2 - extensive changes
Section 4.3 - deletion of capecitabine PI reference
Section 4.4 - extensive changes
Section 4.5 - extensive changes
Section 4.6 - change from lapatinib to Tyverb
Section 4.7 - extensive changes
Section 4.8 - extensive changes
Section 4.9 - extensive changes
Section 5.1 - extensive changes
Section 6.5 - extensive changes
Section 8 - addition of licence number EU/1/07/440/003
Section 10 - date of revision
Updated on 20/11/2009 and displayed until 24/06/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 - 4.8 Undesirable effects - Inclusion of hypersensitivity reactions including anaphylaxis, and nail disorders including paronychia as additional AES

Section 10 - Date of Revision of the Text - updated to 05/11/2009
Updated on 24/08/2009 and displayed until 20/11/2009
Reasons for adding or updating:
  • 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:   12-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 9 - Dates Updated
Section 10 - Dates updated
Updated on 02/04/2009 and displayed until 24/08/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • 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:   26-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 5.3 - New paragraph added:
"In oral carcinogenicity studies with lapatinib, severe skin lesions were seen at the highest doses tested which produced exposures based on AUC up to 2-fold in mice and male rats, and up to 15-fold in female rats, compared to humans given 1250 mg of lapatinib once daily. There was no evidence of carcinogenicity in mice. In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls. There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily. The relevance of these findings for humans is uncertain."

Section 9 - "date of first authorisation" added

Section 10 - Section added with date - 26 Feb 09

 
Updated on 17/06/2008 and displayed until 02/04/2009
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

 
  lapatinib ditosylate monohydrate