Gadovist 1.0 mmol/ml solution for injection in prefilled syringe/cartridge
Last Updated on eMC 12-May-2016 View document | Bayer plc 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 12-May-2016 and displayed until Current
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: 11-May-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
Updated on 11-Feb-2016 and displayed until 12-May-2016
Reasons for adding or updating:
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 03-Feb-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
- Section 6.5 ‘Nature and contents of container’ - Information on the plastic syringe has been added and it has been made clear which of the previous text is relevant for the glass syringe and which of the previous text is relevant for the cartridge.
Updated on 06-Aug-2015 and displayed until 11-Feb-2016
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 5.3 - Preclinical safety data
Date of revision of text on the SPC: 02-Jul-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
They key changes are :
4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.8 Undesirable effects, 5.1 Pharmacodynamic properties, 5.2 Pharmacokinetic properties and 5.3 Preclinical safety data. Subsequent changes have been made to the PIL.
Updated on 22-Jul-2015 and displayed until 06-Aug-2015
Reasons for adding or updating:
- Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC: 01-Jul-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are :
Update with the hospital pack details.
Updated on 13-Nov-2014 and displayed until 22-Jul-2015
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-Oct-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
· Update to Section 4.8 to include the following text: Fluctuations of renal function parameters including increases of serum creatinine have been observed after administration of Gadovist.
Updated on 15-Apr-2014 and displayed until 13-Nov-2014
Reasons for adding or updating:
- Removal of black triangle
Date of revision of text on the SPC: 29-Jul-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Correction - removal of black triangle.Updated on 11-Dec-2013 and displayed until 15-Apr-2014
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC: 29-Jul-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
The main changes that were introduced with this variation include:
· Update to section 4.4 (Special warnings and precautions for use). The warning on hypersensitivity has been substantially extended to include more information. This section now also includes a warning about patients with cardiovascular disease being more susceptible to serious or even fatal outcomes of severe hypersensitivity reactions.
· Update to section 4.6 to add information on fertility.
· Update to section 4.8 to change the frequency of hypersensitivity/anaphylactoid reaction from rare to uncommon as well as adding information on adverse event reporting. Information has also been added about paediatric population to say that it is expected to be comparable to the adverse event profile known in adults.
· Update to section 5.1 to include new study data comparing Gadovist against gadoterate meglumine
· Update to section 5.2 adding additional information on distribution, biotransformation and change in the information on elimination.
Updated on 22-Oct-2013 and displayed until 11-Dec-2013
Reasons for adding or updating:
- Change to section 6.3 - Shelf life
Date of revision of text on the SPC: 29-Jul-2013
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
The SmPC, leaflet and labels for Gadovist PFS have been updated following a variation to extend the in-use stability affecting section 6.3 of the SmPC.Updated on 29-Nov-2012 and displayed until 22-Oct-2013
Reasons for adding or updating:
- New individual SPC (was previously included in combined SPC)
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
The key changes are:
·
Whole Body Indication added to section 4.1 and 4.2 of the SmPC
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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