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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: 01/03/2012
SPC Evra transdermal patch

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 01/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   28-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section  4.2 Posology

Admiistrative changes to text, no new information:

Section 4.4

Smoki ng warning strengthened, regarding use in women > 35 years who smoke.

 

Section 4.5

Addition of interaction with etoricoxib

 

Section 4.6

Administrative changes no new information

 

Section 4.8

 

ADRS now in a single table, following MeDRA terms
Updated on 21/01/2010 and displayed until 01/03/2012
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:   POM
Black Triangle (CHM):   NO

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 09/02/2009 and displayed until 21/01/2010
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:   22-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

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 16/10/2008 and displayed until 09/02/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   08-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Removal of Black Triangle                                                                                                                                                                                                                                      

Updated on 26/09/2008 and displayed until 16/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   08-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.3 – Contra-indications

Rewording of contra-indication for severe hypertension

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Interaction with lamotrigine

Change to section 4.8 – Undesirable effects

Inclusion of colitis

Change to section 10 – Date of revision of the text

Changed to 08/09/2008
Updated on 09/07/2008 and displayed until 26/09/2008
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:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Updated throughout

Change to section 10 – Date of revision of the text

Changed to 06/2008
Updated on 20/09/2007 and displayed until 09/07/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   06/2007
Legal Category:   POM
Black Triangle (CHM):   YES

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 28/02/2007 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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Change to section 4.4 – Update to VTE risk warning

Change to section 5.2 – Discussion on transdermal vs oral contraceptive PK properties

Change to section 10 – Changed to January 2007
Updated on 28/10/2003 and displayed until 28/02/2007
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 08/05/2003 and displayed until 29/09/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  ethinylestradiol
  norelgestromin