Updated on 14/06/2011 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 4.5 - 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 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Addition of warnings re use with some other medicines as well as clarification of existing wording
4.5 Additional inforamtion regarding interactions with some other medicines
4.8 Updated frqquency information and photosensitivity reactions.
10.. Updated with new revision date
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Updated on 27/08/2009 and displayed until 14/06/2011
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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: 18-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.8 - Seizure added
Corrected superscript for renal impairments
10 -18 August 2009
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Updated on 09/07/2009 and displayed until 27/08/2009
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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 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: 25-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Added "Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Malarone. If patients experience an allergic reaction (see section 4.8) Malarone should be discontinued promptly and appropriate treatment initiated."
Section 4.8 - Corrected superscript typographical error for "palpitations".
Section 10 - Approval date "25 June 2009"
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Updated on 19/03/2009 and displayed until 09/07/2009
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 4.3 - Contraindications
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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 6.1 - List of Excipients
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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: 04-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Updated to include the strength in the name
Section 4.3 - Changed from "Hypersensitivity to Atovaquone or proguanil hydrochloride…" to "Hypersensitivity to the active substances…"
Section 4.8 - Addition of Stevens-Johnson syndrome, erythema multiforme, blister & skin exfoliation (frequency unknown). Rash and Urticaria relocated from Immune System disorders to Skin and subcutaneous tissue disorders.
Section 4.9 - Changed from "There have been no reports of overdosage …" to " No case of overdose has been reported…."
Section 6.1 - Removal of the pharmacopoeia references next to the excipient names.
Section 6.4 - Changed from: " No special precautions for storage" to "This medicinal product does not require any special storage conditions."
Section 10 - Updated to approval date
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Updated on 25/09/2008 and displayed until 19/03/2009
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 05-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - removal of black triangle
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Updated on 17/06/2008 and displayed until 25/09/2008
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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 4.8 - Undesirable Effects
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Change to section 2 - Qualitative and quantitative composition
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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: 10-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 2 - minor clarification
Section 4.2 - Method of administration moved to top of section.
Safety statement on treatment of children <5Kg added
Section 4.4 - Safety statement on treatment of children <5Kg added
Section 4.8 - Addition of psychiatric and Cardiac adverse events
Section 10 - Approval date updated
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Updated on 24/09/2007 and displayed until 17/06/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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section 4.8 'Vasculitis' and 'Cholestasis' will not be added.
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Updated on 27/06/2007 and displayed until 24/09/2007
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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 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: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.5: Addition of warfarin and related anticoagulants interaction statement
Section 4.8: Tabulation of adverse events section with addition of Hepatitis and Cholestasis under 'hepatobiliary disorders' and Vasculitis under 'immune system'
Section 10: Now 17/07/2007
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Updated on 08/05/2006 and displayed until 27/06/2007
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 24/03/06 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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 18/04/2006 and displayed until 08/05/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 12/04/2006 and displayed until 18/04/2006
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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 4.4 - 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 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 21/04/2005 and displayed until 12/04/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 15/04/2005 and displayed until 21/04/2005
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Reasons for adding or updating:
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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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Updated on 19/09/2003 and displayed until 15/04/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/12/2002 and displayed until 19/09/2003
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 16/12/2002 and displayed until 19/12/2002
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 12/12/2002 and displayed until 16/12/2002
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 26/11/2002 and displayed until 12/12/2002
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 06/08/2002 and displayed until 26/11/2002
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 29/07/2002 and displayed until 06/08/2002
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