Summary of Product Characteristics
last updated on the eMC:
06/05/2011
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 06/05/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 14-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes made due to Article 30 referral:
Section 2 - addition of soya lecithin
Section 4.1 - Removal of indication for treatment of mild reflux disease and amendment from long-term "treatment" to "management" of reflux oesophagitis.
Section 4.2 - rewording of recommendation on not chewing or crushing tablet and use in children under 12 , removal of reference to mild reflux disease and rewording of section.
Section 4.3 - included hypersensitivity to substituted benzimidazoles and soya lecithin.
Section 4.4 - addition of section on coadministration with atazanavir and warning for soya lecithin content. Rewording of other parts of the section.
Section 4.5 - Section restructured and inclusion of info about lack of interaction with antibiotics.
Section 4.6 - Section reworded. Under lactation animal study data included.
Section 4.7 - Section reworded
Sectin 4.8 - Inclusion of most commoly occuring side effects at beginning and update of adverse events table.
Section 4.9 - added info re protein binding and reworded.
Section 5.1 - Section reworded.
Section 5.2 - Reworded, sections on use in special populations expanded.
Section 5.3 - reworded
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Updated on 19/11/2010 and displayed until 06/05/2011
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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: 09-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3: Shelf life increased from 30 months to 36 months
Section 10: Date of revision of text amended accordingly
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Updated on 27/04/2010 and displayed until 19/11/2010
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 14-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 12/05/2009 and displayed until 27/04/2010
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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):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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