Last Updated on eMC 27-11-2017 View medicine  | 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.

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 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:10-11-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - Moved paragraph on transitioning from IV to subcutaneous administration
Section 4.5: Addition of interaction information
Section 4.8: Update to summary and description of adverse reactions. Addition of side effects to the table (urinary tract infection, upper respiratory tract infection, injection site reaction, angioedema. Deletion of insomnia.
Section 5.1 - clarity that biomarkers were seen in clinical trials with Benlysta administered intravenously.
Section 5.2: Transitioning from intravenous to subcutaneous administration added.

Reasons for adding or updating:

  • Change to section 4.9 - Overdose
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-09-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.9 – Update to product information text in relation to overdose.

 

Section 6.3 and 6.6 - update the product information text in relation to compatibility with reconstitution diluents and container closure system and regarding compatibility with needle gauge.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:14-07-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.4          Special warnings and precautions for use - infections can be severe and fatal and to consider dose interruption of immunosuppressant therapy

in the midst of acute infection.

4.6          Fertility, pregnancy and lactation - Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to

the foetus.

4.8          Undesirable effects - Some infections were severe or fatal.

9.            DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION - 18 February 2016 added.

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:23-06-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.4          Special warnings and precautions for use – text added around immunisations and study evaluating the response to a 23-valent pneumococcal vaccine.

Removal of following text: There are insufficient data to draw conclusions regarding the ability of subjects receiving Benlysta to mount protective responses to vaccines.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:04-04-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.5 Removal of reference to 'Latex Free'

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:04-04-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 5.1 - Update to Pharmacodynamic effects

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 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:18-02-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



2.            QUALITATIVE AND QUANTITATIVE COMPOSITION – minor formatting changes

4.2          Posology and method of administration – removal of ‘There are no or insufficient data available on the effects of Benlysta in patients with severe active lupus nephritis or severe active central nervous system lupus. Therefore, Benlysta cannot be recommended to treat these conditions (see section 4.4).

Minor QRD changes.

4.4          Special warnings and precautions for use - Addition of: Sodium content. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

6.5   - Nature and contents of container – removal of ‘latex free’ rubber stopper

6.6 - Special precautions for disposal and other handling – formatting changes

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:25-04-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.4 – Addition of Progressive Multifocal Leukoencephalopathy as it has been reported with Benlysta treatment for SLE.

Section 4.8 – Addition of text to clarify data from postmarketing reports are included

 

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
  • 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:17-12-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



QRD changes

Section 4.4 Addition of the following text:

Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema.

Section 4.8 Addition of Delayed-type, non-acute hypersensitivity reactions under immune system disorders with a frequency of rare.

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:15-07-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.8 Rewording of sentence under Opportunistic infections
10  Change to reivsion date

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:17-05-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

6.5 Shelf life update – from 4 years to 5 years

10. Updated with new date of revision of text

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:21-03-2013

Legal Category:POM

Black Triangle (CHM): YES

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:25-04-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

4.8 

INFECTIONS paragraph:

Removal of sentences [In one case, the causal relationship is unlikely. No opportunistic infections were reported in the placebo group.]

Reworded the sentence: Opportunistic infections were have been reported in three patients treated with Benlysta.

10.  Revision date amended

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:21-03-2013

Legal Category:POM

Black Triangle (CHM): YES

Reasons for adding or updating:

  • 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:21-03-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 5.1    to include information on long term B cell/lgG data

Section 10   updated with new date of revision of text

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:21-03-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 7
Change in address of marketing authorisation holder

Section 10
Updated with new date of revision of text

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:24-10-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Minor word changes 

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:25-05-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section

Summary of change

4.8

addition of Bacterial Infections as very common adverse event

10.

Change in revision date

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
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC:19-03-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.2        - Development of Hypersensitivity and clinical supervision

Section 4.4        – observations and impact of hypersensitivity reactions and infusion reactions   

Section 4.8        - addition of Infections as a very common adverse event

                        - observations of hypersensitivity reactions

Section 6.3        - Shelf life increased to 4 years

Section 6.6        - 400 mg - deletion of ‘sterile’ during reconstitution with water for injections.

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:05-01-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



SPC section 6.3 –Shelf Life

4 years

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES