Summary of Product Characteristics
last updated on the eMC:
25/05/2012
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 25/05/2012 and displayed until Current
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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 of product licence name
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| Date of revision of text on the SPC: 20-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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1.
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Change in the expression of units to “10mg/g”
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Updated on 17/05/2012 and displayed until 25/05/2012
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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 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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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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. 6 - Instructions for use, handling and disposal
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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: 20-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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1.
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Change in the expression of units to “10 mg/g”
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2.
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Addition of:
“each gram of ointment”
“each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321)
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4.1
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Rewording of first paragraph
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4.2
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Addition of section headings and new information in each section:
“Special populations”
“Paediatric population”
“Method of administration”
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4.3
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Rewording of this section, the meaning is still the same
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4.4
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Addition of section headings:
“Sensitisation or severe local irritation”
“Eyes and mucous membranes”
“Ingestion”
“Re-evaluation of treatment”
“Abscesses”
“Methicillin-Resistant Staphylococcus aureus (MRSA)”
“Butylated hydroxytoluene”
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4.5
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Change in the expression of units to 10mg/g. Addition of new heading “Paediatric population”
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4.6
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Reword current headings, the meaning is unchanged. Addition of sub heading “Fertility”
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4.7
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Reword to say “Altargo ha sno or negligible influence on using machinery”
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4.8
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Rewording of section, and renaming of classification of frequency, addition of new sub heading “Paediatric population”
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5.1
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Change in name of Pharmacotherapeutic group.
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5.2
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Change in the expression of units to “10mg/g” and rewording the sub headings, meanings are the same.
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6.1
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Addition of E number for Butylated hydroxytoluene
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6.3
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Addition of words “tube and sachet”
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6.6
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Additional of the word “medicinal” meaning remains the same.
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9.
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New date of text
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10.
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Updated date
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Updated on 13/05/2011 and displayed until 17/05/2012
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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 5.1 - Pharmacodynamic 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: 20-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.1
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addition of reference to section 5.1
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5.1
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addition of results from recently completed study in the treatment of SIOW
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10
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date updated
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Updated on 11/03/2011 and displayed until 13/05/2011
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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: 28-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.8
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Addition of Hypersensitivity, including angioedema
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10.
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Date updated
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Updated on 23/09/2010 and displayed until 11/03/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.4 Epistaxis details added
10. Date of approval added
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Updated on 13/05/2010 and displayed until 23/09/2010
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic 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: 27-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 - Mechanism of resistance updated
Section 10 - Date of approval added
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Updated on 27/04/2010 and displayed until 13/05/2010
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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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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 15-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - Whole section updated
Section 4.8 - Burning sensation added
Section 5.2 - Age categories added including new section for 2 months to 24 months
Section 10 - Date of approval added
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Updated on 24/01/2008 and displayed until 27/04/2010
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Reasons for adding or updating:
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