Summary of Product Characteristics
last updated on the eMC:
17/03/2009
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 17/03/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 has been updated as follows:
- addition of frequencies based on clinical trials and ordering of information under SOC
- rewording to reflect MedDRA terminology
- 2 new side effects based on last PSUR (Atrial fibrillation and Myocardial ischaemia)
- inclusion of side effects previously only addressed in special precautions and warnings section
Section 10 – date has been revised
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Updated on 14/01/2009 and displayed until 17/03/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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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-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 Special warnings and precautions for use has been updated in line with the current CCDS documents for this product as detailed below:
removal of the heading Occular complications from the 2nd paragraph
addition of bladder-neck obstruction to paragraph 5 and minor changes to the ordering of the information to facilitate the inclusion of this
addition of a information on rare occurrences of myocardial ischaemia associated with salbutamol (paragraph 6)
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Updated on 04/04/2008 and displayed until 14/01/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 of this SPC has been revised to delete the non-marketed 5ml and 15 ml canisters. Section 10 has also been updated.
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Updated on 01/09/2006 and displayed until 04/04/2008
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 3. Addition of: Pressurised aluminium container closed with a metering valve containing a creamy-white suspension inserted into a grey plastic actuator (mouthpiece).
Section 4.2. Addition of: As the container is not transparent it is not possible to see when the contents are used up, but shaking the container will show if there is any remaining fluid.
The mouthpiece should always be kept clean and can be washed with warm water. If soap or detergent is used, the mouthpiece should be thoroughly rinsed in clear water.
Section 4.8. Pruritis added to allergic-type reactions.
Section 6.4. Addition of: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not try to open, puncture or burn the canister even when apparently empty.
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Updated on 17/02/2005 and displayed until 01/09/2006
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/07/2001 and displayed until 17/02/2005
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Transferred from eMC version 1
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Updated on 14/06/2000 and displayed until 24/07/2001
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Updated on 06/09/1999 and displayed until 14/06/2000
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