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Votrient 200 mg and 400 mg film coated tablets

Last Updated on eMC 08-Oct-2014 View document  | GlaxoSmithKline UK Contact details

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 08-Oct-2014 and displayed until Current

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 25-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Updated on 06-Oct-2014 and displayed until 08-Oct-2014

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • 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: 25-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 – To add HPRA contact details for ADR reporting

Section 5.1 – To update OS data for COMPARZ (VEG108844)

 

 

Updated on 20-Dec-2013 and displayed until 06-Oct-2014

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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

Date of revision of text on the SPC: 18-Dec-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black Triangle Removal
4.2 Cross references to 4.4
4.4 Updated warnings regarding liver monitoring in patients with abnormal liver function
4.8 Corrections to existing ADRs: TMA and PRES
5.1 Minor update to table numbers
5.2 Minor update to table numbers
10. Updated with new date of revision of text

Updated on 16-Jul-2013 and displayed until 20-Dec-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 01-Jul-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.4

Updated LFTs monitoring requirements

4.8

Updated to include new EU ADR reporting statements (per QRD9)

10.

Updated with new date of revision of text

Updated on 19-Jun-2013 and displayed until 16-Jul-2013

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Date of revision of text on the SPC: 14-Jun-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Several Minor administrative + layout changes to a number of subsections
4.8     Updated to include ADR information from VEG108844 (‘COMPARZ’) study in RCC patients
5.1     Update to include efficacy data from VEG108844, removal of the conditional licence wording which no longer applies
10.     Updated with new date of revision of text

Updated on 26-Mar-2013 and displayed until 19-Jun-2013

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: 21-Mar-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

7.     Change in address of marketing authorisation holder
10.   Updated with new date of revision of text

Updated on 16-Jan-2013 and displayed until 26-Mar-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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: 14-Jan-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.4     Updated to include information concerning Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leukoencephalopathy syndrome (RPLS) and thrombotic microangiopathy (TTA)

4.8     Updated to include information concerning Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leukoencephalopathy syndrome (RPLS) and thrombotic microangiopathy (TTA) as rare ADRs, where appropriate.

5.3     Updated juvenile toxicity information.

10.     Updated date of revision

Updated on 09-Nov-2012 and displayed until 16-Jan-2013

Reasons for adding or updating:

  • 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 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: 24-Oct-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.4 Cross-reference to Section 4.5 added under Interactions subsection
4.5 Change re. inhibitory effect of pazopanib on uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme and the consequence for the active metabolite of irinotecan (when taken concomitantly).
9. Updated with latest renewal date
10. Updated with new date of revision of text

Updated on 14-Sep-2012 and displayed until 09-Nov-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 30-Aug-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.2

Minor typo correction under Paediatric population (... cross reference to 5.32)

4.5

Updated to include guidance on concomitant use with PPIs, H2-antagonists and antacids

10.

Updated with new date of revision of text

Updated on 17-Aug-2012 and displayed until 14-Sep-2012

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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 03-Aug-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.1

New indication for the treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS)

4.2

Updated wording on paediatric use

4.4

Updated warnings on hypertension, cardiac dysfunction/heart failure, venous thromboembolic events, pneumothorax and paediatric use.

4.8

Include details of adverse reactions seen in pivotal STS trial

5.1

Information on pivotal STS trial design including eligible and non-eligible tumour types, and efficacy results

5.2

Data from juvenile toxicity studies in rats

10.

Updated with new date of revision of text

Updated on 28-Jun-2012 and displayed until 17-Aug-2012

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 25-May-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

2.

Minor wording change

4.2

Minor wording change and repositioning of existing information

4.3

Minor wording changes

4.4

Warning of hyperglycaemia with concomitant ketoconazole.

4.5

Updated wording on use with ketoconazole, CYP3A4 inhibitors

4.8

Minor heading changes

5.1

Minor formatting changes

5.2

Minor formatting changes

6.1

Minor formatting changes

10.

Updated with date of revision of text

Updated on 11-Apr-2012 and displayed until 28-Jun-2012

Reasons for adding or updating:

  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 03-Mar-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.2

Updated posology in hepatic impairment

4.3

Removal of severe hepatic impairment as a contra-indication

4.4

Updated warning statement regarding hepatic effects

5.2

Updated pharmacokinetic information in mild, moderate and severe hepatic impairment including a table presentation of

10.

Updated with new date of revision of text

Updated on 14-Nov-2011 and displayed until 11-Apr-2012

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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: 24-Oct-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SUMMARY Of CHANGE

4.4     Update to Section 4.4 of SPC with information regarding interaction with simvastatin, with information on infections and with a warning regarding concomitant administration with systemic chemotherapies

4.5     Update to Section 4.5 of SPC with information regarding interaction with simvastatin

4.8    Updated with information on infections

5.1    Updated with Overall Survival data

9        Date of last renewal has been added

10        Updated with new date of revision of text

Updated on 11-May-2011 and displayed until 14-Nov-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 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 02-May-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Summary of Change

Section 4.2 Addition of information to Section 4.2 Posology and Method of Administartion of the SPC regarding mild hepatic impairment

Section 4.4 Addition of information to Section 4.4 warnings and Precautions of the SPC regarding mild hepatic impairment

Section 5.2 Addition of information to Section 5.2 Pharmacokinetic Properties of the SPC regarding mild hepatic impairment

Section 10 Updated with new revision date

Updated on 08-Apr-2011 and displayed until 11-May-2011

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 01-Feb-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:


Section 1: Addition of registered trademark symbol to product name in Section 1 of the SPC

Updated on 21-Feb-2011 and displayed until 08-Apr-2011

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Feb-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Sections amended:

4.4 Addition of information to Section 4.4 Warnings and Precautions of the SPC regarding hypertensive crisis.

10 Updated with new revision date

Updated on 21-Jun-2010 and displayed until 21-Feb-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

GlaxoSmithKline UK

Company image
Address

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Fax

+44 (0)208 990 4328

Telephone

+44 (0)800 221 441

Medical Information e-mail

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?

Active ingredients

pazopanib hydrochloride

Legal categories

POM - Prescription Only Medicine

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