Summary of Product Characteristics
last updated on the eMC:
24/11/2011
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 24/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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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: 17-Nov-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update SPC section 5.3 Pre-clinical with consequential change to 4.6 Pregnancy and lactation.
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Updated on 05/05/2011 and displayed until 24/11/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 15-Apr-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| to revise SPC section 4.8 Undesirable Effects
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Updated on 21/03/2011 and displayed until 05/05/2011
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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: 11-Mar-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to SPC section 4.4 ‘Special Warnings and Special Precautions for Use’.
Miconazole nitrate 2%w/w; Hydrocortisone acetate equivalent to hydrocortisone 1%w/w
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Updated on 21/01/2010 and displayed until 21/03/2011
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 15-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 5.2 (Pharmacokinetic properties) of the SPC to include more detail on the pharmacokinetic properties of miconazole nitrate and hydrocortisone.
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Updated on 17/09/2009 and displayed until 21/01/2010
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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 4.3 - Contraindications
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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: 14-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update SPC section 4.8 to add irritation, skin burning sensation, anaphylactic reaction, contact dermatitis and erythema as additional undesirable effects, bringing it in line with the company core data sheet. In addition to make minor administrative corrections to section 4.1 (Therapeutic indications) and 4.3 (Contraindications) of the SPC.
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Updated on 16/07/2009 and displayed until 17/09/2009
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 08-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 4.4 (Special warnings and precautions for use) of the SPC to include a specific warning on use of warfarin and other anticoagulants. To update section 4.5 (Interactions) of the SPC with regard to the possibility of higher serum hydrocortisone levels with the combination product rather than when hydrocortisone is used alone. Changes do not affect the product labelling
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Updated on 13/03/2009 and displayed until 16/07/2009
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 27-Feb-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Date of First Authorisation/Renewal of Authorisation
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Updated on 19/11/2008 and displayed until 13/03/2009
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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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| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Transfer of MAH from Janssen-Cilag Ltd to McNeil Products Ltd
New MAH number
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Updated on 02/06/2005 and displayed until 19/11/2008
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 10 (date of (partial) revision of the text
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Updated on 02/06/2005 and displayed until 02/06/2005
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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 26/08/2004 and displayed until 02/06/2005
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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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/09/2002 and displayed until 26/08/2004
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 12/12/2001 and displayed until 20/09/2002
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Reasons for adding or updating:
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