Summary of Product Characteristics
last updated on the eMC:
17/02/2009
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 17/02/2009 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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| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Transfer of licence from Janssen-Cilag Ltd to McNeil Products Ltd
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Updated on 18/03/2008 and displayed until 17/02/2009
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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 powder 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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Cutaneous powder
White Powder
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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 02/08/2007 and displayed until 18/03/2008
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Reasons for adding or updating:
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.3 – Shelf Life
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36 months
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Change to section 10 – Date of revision of the text
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27 July 2007
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Updated on 24/01/2007 and displayed until 02/08/2007
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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 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 4.9 - Overdose
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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 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 Powder (previously Daktarin Dual Action Powder).
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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 26/08/2004 and displayed until 24/01/2007
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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 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 26/09/2003 and displayed until 30/04/2004
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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 (partial) revision of the text
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Updated on 20/09/2001 and displayed until 26/09/2003
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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 4.4 - Special Warnings and Precautions for Use
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Updated on 22/08/2001 and displayed until 20/09/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 27/04/2001 and displayed until 22/08/2001
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Reasons for adding or updating:
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