Summary of Product Characteristics
last updated on the eMC:
17/09/2009
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 17/09/2009 and displayed until Current
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 21-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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section 4.2 - Reference to use in preterm infants
section 4.3 -Removal of previous wording on use in HIV infants
section 4.4 - Wording on use in HIV infants. Removal of previous wording on use in premature children.
section 4.8 -Safety data in preterm infants and infants with HIV
section 5.1 - Immune response in preterm infants
section 6.3 -Revised in-use storage information
section 6.4 - Revised storage information
section 10 - Date of approval updated
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Updated on 25/09/2008 and displayed until 17/09/2009
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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 6. 6 - Instructions for use, handling and disposal
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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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 6.1 - List of Excipients
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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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-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - Administrative changes
Section 2 - Amendment to excipient statement and administrative changes
Section 4.2 - Administrative changes
Section 4.4 - Amendment to excipient statement and administrative changes
Section 4.6 - Administrative changes
Section 4.8 - Reordering of adverse events and administrative changes
Section 5.1 - Revised pharmaco-therapeutic group
Section 6.1 - Administrative changes
Setion 6.3 - Administrative changes
Section 6.5 - Administrative change
Section 6.6 - Administrative change
Section 10 - date of Commission Decision
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Updated on 21/08/2008 and displayed until 25/09/2008
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Reasons for adding or updating:
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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 10 date of revision of the text
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 19-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - update to wording regarding concomitant administration of OPV
Section 5.1 - update to include data from 2nd year of study 036
Section 10 - Approval date - 04/07/08
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Updated on 05/02/2008 and displayed until 21/08/2008
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: To include a warning on Apnoea
Section 4.8: To include Apnoea as an Undesirable Effect
Section 10: Approval date of variation
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Updated on 22/12/2006 and displayed until 05/02/2008
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Several sections have changed.
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Updated on 22/05/2006 and displayed until 22/12/2006
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Reasons for adding or updating:
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