Summary of Product Characteristics
last updated on the eMC:
21/01/2011
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 21/01/2011 and displayed until Current
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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 4.8 - Undesirable Effects
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special warnings and special precautions for use): substantial changes (incl. discussion of blood pressure)
Section 4.8 (Undesirable effects): completely re-written (incl. the addition of cystitis/haemorrhagic cystitis)
Section 6.3 (Shelf life): Typo corrections
Section 10 (Date of revision of the text): updated as a consequence of the above revisions
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Updated on 21/01/2010 and displayed until 21/01/2011
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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 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updates are made to section 6.3 (Shelf-life) of the SPC, Label and PIL, increasing the shelf-life for Ketalar 10mg/ml and 50mg/ml Injections, from 36 months to 60 months. Please be advised that the shelf-life remains to 36 months for Ketalar 100mg/ml injection. In addition, section 6.4 (Special storage precautions), for 3 strengths of Ketalar, has been updated with the following, ‘This medicinal product does not require any special storage conditions.’
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Updated on 09/06/2009 and displayed until 21/01/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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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| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - Updated in line with core data sheet - contra-indications info
Section 4.4 - Updated in line with core data sheet - multiple text edits
Section 4.5 - Updated in line with core data sheet - multiple text edits
Section 4.8 - Updated in line with core data sheet - multiple text edits
Section 5.1 - Updated in line with core data sheet - Mechanism of Action information
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Updated on 04/04/2006 and displayed until 09/06/2009
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 18/09/2003 and displayed until 04/04/2006
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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