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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG , UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Summary of Product Characteristics last updated on medicines.ie: 20/01/2010
SPC Evra transdermal patch

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/01/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   22-Dec-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to section 4.5 – Revisions to section format & content

Change to section 4.8 - Addition of 'abnormal taste' to 4.8.2 Postmarketing Data

Change to section 10 – Changed to 22 December 2009
Updated on 04/02/2009 and displayed until 20/01/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 2 quantitative and qualitative composition

Each 20 cm2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).

 

Each transdermal patch releases an average of 203150 micrograms of NGMN and 33.920 micrograms of EE per 24 hours. Medicinal product exposure is more appropriately characterized by the pharmacokinetic profile (see section 5.2).h.

 

For a full list of excipients, see section 6.1.

Change to section 3 pharmaceutical form

Transdermal patch.

 

EVRA is a thin, matrix-type transdermal patch consisting of three layers.

 

The outside of the backing layer is beige and heat-stamped EVRA 150/20.

 

Change to section 10 Date of revision of the text

Changes to 22 December 2008
Updated on 01/07/2008 and displayed until 04/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Tick

Change

IPHA – Fragments submitted to IMB

Change to section 4.4 – Special Warnings and Precautions for Use

 

Change to section 10 – Date of revision of text

 

 
Updated on 20/09/2007 and displayed until 01/07/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 2 – quantitative and qualitative composition

 

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

 

Change to section 10 – Date of revision of the text

 

Change to joint SPC covering all presentations                                                                                                                                                                                                                 

 
Updated on 26/02/2007 and displayed until 20/09/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Update to warnings statement concerning VTE risk

Change to section 5.2 – Update to include discussion on PK properties of the patch vs. the oral COC

Change to section 10 – Changed to January 2007
Updated on 28/10/2003 and displayed until 26/02/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 29/09/2003 and displayed until 28/10/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 10/07/2003 and displayed until 29/09/2003
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 05/06/2003 and displayed until 10/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ethinyloestradiol
  Norelgestromin