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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/02/2011
SPC Pevaryl 1% Topical Cream

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 09/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   03-Feb-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 4.5 has been updated to aligh with the CSP

Econazole administered systemically is known to inhibit CYP3A4/2C9.  Due to the limited systemic availability after topical application, clinically relevant interactions are rare.  However, in patients on oral anticoagulants, such as warfarin and acenocoumarol, caution should be exercised and anticoagulant effect should be monitored more frequently.

                               

Adjustment of the oral anticoagulant dosage may be necessary during the treatment with econazole and after its termination.
Updated on 01/04/2010 and displayed until 09/02/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Mar-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.6 – Pregnancy and Lactation

Use in caution in pregnancy changed to not recommended in pregnancy.

 

Addition of information regarding use in breast feeding

 

 

Change to section 10 – Date of revision of the text

 March 2010
Updated on 03/03/2010 and displayed until 01/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Feb-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 – Undesirable effects

Addition of  pruritus, skin burning sensation, erythema pain at administration site, discomfort, swelling, hypersensitivity, angiodema, contact dermatitis, rash urticaria, blister, skin exfoliation

Change to section 10 – Date of revision of the text

 Changed to 16 february 2010
Updated on 18/09/2009 and displayed until 03/03/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Sep-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.3 - Contraindications

Addition of : Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Change to section 10 – Date of revision of the text

Changed to 11th September 2009

Updated on 03/09/2009 and displayed until 18/09/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Aug-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 1 –Name of the medicinal product*

Pevaryl 1% Topical cream

Change to section 2 – quantitative and qualitative composition*

Addition of excipient warnings

Change to section 4.2 – Posology and |Method of Administration

Changed from topical to cutaneous

Change to section 6.6 –  Instructions for use, handling and disposal*

Standard disposal statement added

Change to section 10 – Date of revision of the text

Changed to August 2009
Updated on 28/05/2009 and displayed until 03/09/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Mar-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 9 – Date of Renewal of Authorisation

18th March 2009

Change to section 10 – Date of revision of the text

18th March 2009
Updated on 11/12/2008 and displayed until 28/05/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.3 – Shelf Life

Reduce shelf life form 36months to 24 months

Change to section 10 – Date of revision of the text

18th June 08
Updated on 04/04/2008 and displayed until 11/12/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7 - changed to 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Change to section 10 - changed to 28th March 2008
Updated on 26/08/2004 and displayed until 04/04/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/08/2001 and displayed until 26/08/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 29/08/2001 and displayed until 30/08/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  econazole nitrate