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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 31/10/2011
SPC Primovist 0.25 mmol/ml, solution for injection, prefilled syringe

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 31/10/2011 and displayed until Current
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • 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. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


This SmPC has been extensively updated inline with the data from new Clincal Studies conducted within the scope of development of Primovist for regions outside the EU and a comprehensive evaluation of all ADRs from post-marketing surveillance. The PIL and labelling are updated to reflect these changes (and to change name of manufacturer in PIL to Bayer Pharma AG). Additionally, there are editorial changes to the SmPC to improve readability and bring it in line with the EU-SmPC guideline and current QRD template.

 

 

 

  
Updated on 27/07/2010 and displayed until 31/10/2011
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Extensive updates to SmPC  to comply with the Commission Decision following referral procedure under Article 31 of Directive 2001/83/EC for all Gadolinium containging contrast agents.
Updated on 05/08/2009 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   29-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 2 (Qualative and quantative composition) and Section 4.4 (Special warnings and precautions for use) - additional information on sodium content

Section 4.8 ( Undesirable effects) - paragraph on additional adverse reactions from postmarketing spontaneous reporting moved to table of adverse reactions.

Sectiom 10: Revision date is now 29 April 2009 

Updated on 16/03/2009 and displayed until 05/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
  • Company name change or merger
Date of revision of text on the SPC:   24-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 2 (Qualative & Quantative Composition) - this now incorporates the quantative composition per total content.

Section 6.3 ( Shelf life) - minor editorial changes have been made.

Section 7 (MAH) - amendment following Change of Ownership.

Section 10 (revision date) - updated to 24 June 2008
Updated on 12/06/2008 and displayed until 16/03/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008.

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0555
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 25/10/2007 and displayed until 12/06/2008
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:   10/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4: Update to include NSF warning, update to hypersensitivity warning.
Section 4.8: Update to side effects, addition of table and post marketing spontaneous reports
Section 10: Revision date amended to 18.10.07
Updated on 29/09/2006 and displayed until 25/10/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   03/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.8

 – changes have been made to the Adverse reactions table

The following reactions have moved from rare category to uncommon:

Nervous system disorders – parosmia

Respiratory, thoracic & mediastinal disorders – dyspnoea

Skin & subcutaneous tissue disorders – rash & pruritus

General disorders – injection site pain

The following reactions have been inserted

Gastrointestinal disorders – increased salivation has been added to the rare effects.

General disorders – thorax pain & malaise have been added to the rare side effects

Section 5.1

- The Pharmacotherapeutic group ATC code has changed from V08 C A to V08 C A10

– The pH value of Primovist ready to use solution has been amended from 7.0 to 7.4

Section 10 – Date of revision of text has been updated to 3 March 2006.

 
Updated on 06/03/2006 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.3 - Preclinical Safety Data
Updated on 18/05/2005 and displayed until 06/03/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  gadoxetic acid, disodium