Summary of Product Characteristics
last updated on the eMC:
04/04/2012
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 04/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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- Section 6.3 - Powder shelf-life changed from 3 to 4 years
- Section 10 – Change to the date of revision
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Updated on 17/10/2011 and displayed until 04/04/2012
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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- Section 4.6 – Inclusion of fertility statement ‘Non-clinical data for aztreonam for injection about fertility do not indicate any adverse effects’
- Section 4.8 – Additional statements for the undesirable effects section - inclusion of paragraph describing frequently occurring adverse reactions in the two phase 3 placebo controlled clinical studies and also an acute reduction of ≥ 15% in FEV1 is a complication associated with nebulised therapies, including Cayston
- Section 4.8 – The frequencies of the adverse reactions are tabulated
- Section 4.8- Addition of paragraph describing selected adverse reactions such as bronchospasm and allergic reactions
- Section 5.1 – Addition of statement from the EMA in the paediatric population section- ‘The European Medicines Agency has deferred the obligation to submit the results of studies with Cayston in one or more subsets of the paediatric population in cystic fibrosis patients with Pseudomonas aeruginosa pulmonary infection/colonisation (see section 4.2 for information on paediatric use)’
- Section 5.1- Removal of statement that Cayston has been authorised under a so called “conditional approval”
- Section 10 – Change to the date of revision
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Updated on 24/01/2011 and displayed until 17/10/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to Section 6.3 - Shelf-life
Shelf-life for powder vial extended from 2 years to 3 years
Change to Section 10
Date of revision is 01/2011
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Updated on 03/12/2010 and displayed until 24/01/2011
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to:
Section 5.3 - Preclinical Safety Data:
To align with the CHMP report; following assessment of the relevance of C-cell carcinoma using either nonclinical mechanistic studies or other relevant data. It was concluded that the clinical relevance of C-cell adenoma is likely to be low and is therefore deleted.
Section 10 - Date of Revision:
11/2010.
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Updated on 15/09/2010 and displayed until 03/12/2010
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 9- Addition of the 21st September 2010 as the latest authorisation renewal date
Section 10- Date of the revision of the test changed to 09/2010
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Updated on 04/05/2010 and displayed until 15/09/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to Section 6.5:
to include:
The following pack sizes are available:
· 28 day pack of Cayston
· Pack containing one 28 day pack of Cayston plus one Altera Nebuliser Handset
Not all pack sizes may be marketed.
Update to Section 8: Addition of a new MA number
Update to Section 10: Date of revision to 03/2010
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Updated on 12/11/2009 and displayed until 04/05/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3
Shelf life of 2 years has been changed to:
Powder vial: 2 years
Solvent: 4 years
Section 10
Changed to from 09/2009 to 10/2009
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Updated on 21/10/2009 and displayed until 12/11/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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