Summary of Product Characteristics
last updated on the eMC:
22/10/2008
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 22/10/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 10-Jul-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of Marketing Authorisation Holder from Janssen-Cilag Ltd to McNeil Products Ltd with a new Marketing Authorisation Number
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Updated on 19/03/2008 and displayed until 22/10/2008
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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 3 - Pharmaceutical form
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Change to section 6. 4 - Special Precautions for Storage
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 2 – quantitative and qualitative composition
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Miconazole Nitrate Ph.Eur 2.0% w/w
(Each gram of cream contains 20mg of miconazole nitrate)
For excipients, see Section 6.1
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Change to section 3 – pharmaceutical form
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Cream
White homogeneous cream
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Change to section 6.4 – Special Precautions for Storage
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Change to section 6.5 – Nature and Contents of Container
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*Not all pack sizes may be marketed.
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Change to section 6.6 – Instructions for use, handling and disposal
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Change to section 10 – Date of revision of the text
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10th March 2008
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Updated on 19/12/2007 and displayed until 19/03/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.1 – List of Excipients
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PEG-6, PEG-32 and glycol stearate
Oleoyl macroglycerides
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Change to section 10 – Date of revision of the text
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14th December 2007
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Updated on 24/01/2007 and displayed until 19/12/2007
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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 4.4 - 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 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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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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REASON(S) FOR SUBMISSION
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Change
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eMC - Summary of Change Details Per Section
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Change to section 1 – Name of the medicinal product
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Daktarin Aktiv Cream (previously Daktarin Dual Action Cream).
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Change to section 4.4 – Special Warnings and Precautions for Use
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addition of wording re sensitivity
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Change to section 4.6 – Pregnancy and Lactation
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new sub-heading to paragraph on pregnancy and addition of paragraph re lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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minor wording change only
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Change to section 4.8 – Undesirable effects
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post marketing data added and information expanded
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Change to section 4.9 - Overdose
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description of symptoms added
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Change to section 5.1 - Pharmacodynamic properties
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Pharmacotherapeutic classification and ATC code added
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Change to section 5.2 - Pharmacokinetic properties
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wording changed to present three distinct subparagraphs: ‘Absorption’, ‘Distribution’ and ‘Metabolism and Excretion’
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Change to section 5.3 - Preclinical Safety Data
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Reference to Preclinical data added
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Change to section 10 – Date of revision of the text
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12 January 2007
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Updated on 21/06/2006 and displayed until 24/01/2007
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.3 - Contra-indications 'None' changed to '[Name ] is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.'
Change to section 10 (date of revision of the text)
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Updated on 26/08/2004 and displayed until 21/06/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/04/2004 and displayed until 26/08/2004
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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 5.3 - Preclinical Safety Data
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Change to section 7 - Marketing Authorisation Holder
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/08/2001 and displayed until 30/04/2004
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 25/10/2000 and displayed until 22/08/2001
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Reasons for adding or updating:
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