Summary of Product Characteristics
last updated on the eMC:
12/12/2008
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 12/12/2008 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 4.4 - Special warnings and precautions for Use
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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 5.2 - Pharmacokinetic 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-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Switch from body surface area (BSA)-based dosing (mg/m2) to bodyweight-based dosing (mg/kg), and the change from three times a day dosing to twice daily (BID) dosing
Section 4.4 - correction typographical error - superscripts
Section 4.6 - correction typographical error - superscripts
Section 4.8 - correction typographical error - superscripts
Section 5.2 - Renal impairment updated
Section 10 - Approval date
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Updated on 15/11/2007 and displayed until 12/12/2008
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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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 4.2 - Dosage adjustments in patients with haematological adverse reactions + Dosage in hepatic impairment
Update to section 4.4 and 4.8 - Osteonecrosis updates
Update to section 5.2 - Pharmacokinetics/distribution data in adults and children.
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Updated on 15/12/2006 and displayed until 15/11/2007
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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 4.2 - 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 4.7 - 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 6. 4 - Special Precautions for Storage
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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: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 26/09/2005 and displayed until 15/12/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/09/2005 and displayed until 26/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/08/2005 and displayed until 26/09/2005
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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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Updated on 20/01/2005 and displayed until 25/08/2005
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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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Updated on 14/01/2005 and displayed until 20/01/2005
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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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Updated on 04/06/2004 and displayed until 14/01/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/05/2004 and displayed until 04/06/2004
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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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Updated on 13/01/2004 and displayed until 18/05/2004
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 13/01/2004 and displayed until 13/01/2004
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 10/03/2003 and displayed until 13/01/2004
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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 7 - Marketing Authorisation Holder
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Updated on 06/02/2003 and displayed until 10/03/2003
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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 6. 5 - Nature and Contents of Container
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Updated on 19/09/2002 and displayed until 06/02/2003
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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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