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Norgine Limited

Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC MOVIPREP Orange, powder for oral solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/07/2017 and displayed until Current
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:   20-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The MOVIPREP Orange SmPC  has been updated following the approval of the renewal application.

 

The only changes that have been made are a change to the ‘date of first authorisation/renewal of the authorisation’ and a change to the ‘date of revision of the text’.

 

Updated on 12/05/2016 and displayed until 13/07/2017
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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   01-Apr-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The following changes have been made.

 

Section 2 - Update to the statement re the excipients

Section  4.2 – the inclusion of the word clinical before procedure through the various paragraphs

Section 4.7 – update to the comment regarding effect on ability to drive and use machines

Section 4.8 – clarification on the definition of the frequencies for reporting adverse effects

Section 5.3 – inclusion of additional information on reproductive toxicology studies

Section 10 – date of revision of the text

 

Minor editorial changes have been made through the document.

Updated on 22/10/2015 and displayed until 12/05/2016
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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-Oct-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



SMPC changes are as follows:

 

Section 2        

  -addition of the title – ‘Excipients with known affect’

 

Section 4.2      

 -an additional dosing option has been added to include the option of ‘two litres in the morning of the clinical procedure’. Further information around the dosing has been added.

-information around the method of administration has been added.

 

Section 4.3

 -statement about the hypersensitivity to excipients has been aligned with QRD wording.

 

Section 4.4      

-addition of the sentence ‘ The fluid content of Moviprep when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained’

-addition of statements regarding those at risk of arrhythmia

-addition of statements regarding the content of absorbable sodium, potassium and aspartame in relation to at risk patients.

 

Section 4.6      

-general information added about use in pregnancy and breastfeeding.

 

Section 4.8      

 -the addition of the adverse event  arrhythmia, to cardiac disorders

-the order of some adverse events has been amended

-addition of the statement  ‘Dehydration may occur as a result of diarrhoea and/or vomiting.’

- addition of information regarding adverse event reporting.

 

Section 6.6     

 -information added to the precautions for disposal

 

General

-the spelling of Sulphate has been changed from Sulphate and Sulfate throughout.

-MOVIPREP uppercase text has been changed to lowercase text throughout.

 

 

Updated on 02/08/2013 and displayed until 22/10/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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