Last Updated on eMC 01-12-2017 View medicine  | AstraZeneca UK Limited 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 4.1 - 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 10 - Date of revision of the text

Date of revision of text on the SPC:10-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1 – Addition of combination with basal insulin to indication.

Section 4.2 – Addition of instructions for use when used with insulin.

Section 4.4 – Update to concomitant medicinal product section to remove insulin as a medicinal product that has not been studied.

Section 4.8 – Update to information regarding clinical trials, addition of hypoglycaemia (with insulin) as a side effect. Editorial changes to the table footnote numbering. Addition of information regarding use of insulin with exenatide.

Section 5.1 – Update to reflect additional clinical studies completed. Addition of new clinical data for exenatide in combination with insulin glargine.

Section 10 – Update to revision date.

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 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
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:24-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1- Indication re written to state use in combination with other glucose-loweing medicinal products when the therapy in use together with diet and exercise does not provide adequate glycaemic control.

Section 4.2 minor editorial changes

Section 4.4- minor editorial changes

Section 4.8-minor editorial changes and update to UK reporting details

Section 5.1-Information on clinical efficacy and safety information updated with new figures, information and result data from clinical study on combination of prolonged-release exenatide and dapagliflozin added and minor editorial changes.

Section 5.2 minor editorial changes

section 6.5 spelling correction

Section 9- error in date of first authorisation corrected

Section 10- date of revision updated

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:30-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 Update to ATC Code and pharmacotherapeutic group

section 10 update to revision date

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:10-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 Updated information within the Glycaemic control section, data on uncontrolled study extension updated to reflect final data of study

Section 10 revision date amended

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 4.6 - Fertility, 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 – editorial

Secton 4.2 – editorial

Section 4.3 – editorial

Section 4.4 – editorial

Section 4.5 – editorial

Section 4.6 – editorial

Section 4.7 – editorial

Section 4.8 – editorial

Section 4.9 – editorial

Section 5.1 – editorial

Section 5.2 – editorial

Section 5.3 – editorial

Section 6.1 – editorial

Section 6.3 – editorial

Section 6.4 – editorial

Section 6.6 – editorial

Section 9 – editorial

Section 10 – date of revision

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:16-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 – editorial updates.  

Section 4.4 – reported frequencies updated for renal impairment, acute pancreatitis and interaction with warfarin.

Section 4.5 – reported frequencies updated for interaction with warfarin.

Section 4.8 – frequency of adverse events updated

Section 5.2 – editorial updates.

Section 10 – Date of revision updated.

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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:19-01-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.4 adding cholelithiasis as example of rapid weight loss.
- Section 4.8 Combine side effects into one table namely moving the following from one table to another; dehydration, dysgeusia,   hyperhidrosis, alopecia, asthenia, feeling jittery and
International normalised ratio investgation.

- Section 4.8 updating Malta adverse event reporting information.

- Section 10 Change to date of revision

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:01-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 7 MAH change
- section 10 updated date of revision

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:31-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



-       Section 4.8 Add ‘injection site abcesses and cellulitis’ as a side effect
- Section 10 updated date of revision

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:24-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.2: Wording for missed injection updated.

- Section 4.2: Paediatric population wording updated.  

- Section 4.3: Contraindications wording updated in line with QRD.

- Section 4.5: Paediatric population wording updated.  

- Section 4.8: Text in AE table reordered

- Section 4.8: AE reporting wording added.  

- Section 4.9: Overdose wording updated in line with Renewal changes.

- Section 6.1: excipient wording updated.

- Section 6.3: Reconstitution of injection advice clarified.

- Section 6.4: Storage conditions wording clarified.

Reasons for adding or updating:

  • 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 10 - Date of revision of the text

Date of revision of text on the SPC:25-04-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.4 Pancreatitis – to strengthen the warnings for use in patients with or a history of pancreatitis

- Section 4.8 corrected the address of the IMB for adverse event reporting
- Section 10 Updated date of revision

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • 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:08-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 1. - Removed black triangle symbol as it does not appear in the EU additional monitoring list

 

- Section 4.8

·     Addition of Intestinal Obstruction under Uncommon.

·         Also move Renal and urinary disorder: Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increase serum creatinine" from Table 2 (not observed with Bydureon) to Table 1 (Adverse reactions of Bydureon identified from clinical trials and spontaneous reports) with the frequency 'not known'.

Section 10 – revision date

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC:08-11-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Updating mg to mcg (where relevant)
Section 10 - updated date of revision

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:26-07-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.8 Movement of Acute Pancreatitis to association with Bydureon
Section 10 Updated date of revision

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

Date of revision of text on the SPC:29-05-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



- Section 4.8 Addition of statements on increased heart rate

- Section 5.1 Addition of Long term data for BYDUREON versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients).
-
Section 10 updated date of revision

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:21-03-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:




- Section 4.8 reformat and reclassification of AEs
- Section 10 Update date of revision

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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:13-03-2013

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.2 Paediatric Indication

Section 4.8 Add rash as a side effect

Section Date of revision changed to 13th March 2013.

MAH details have changed to:

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol-Myers Squibb House

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

United Kingdom

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:13-12-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Shelf-life extended.

 

6.3       Shelf life

 

2  3 years

 

After reconstitution

The suspension must be injected immediately.

 

 

 10.          DATE OF REVISION OF THE TEXT

 

Date changed

               

13 December 2012

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