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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: 27/04/2010
SPC Evorel 50 micrograms per 24 hours 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 27/04/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


1.

Trade Name of the Medicinal Product

Evorel® 50 Transdermal PatchEvorel 50 micrograms per 24 hours Transdermal Patch

 

2.

Qualitative and Quantitative Composition

3.2 mg estradiol hemihydrate per patch, releasing a nominal 50 micrograms (µg) estradiol per 24 hours.

 

For a full list of excipients, see Section 6.1.

 

6.2

Incompatibilities

None knownNot applicable

 

9.

Date of First Authorisation/Renewal of Authorisation

Date of first authorisation: 10 June 1999

Date of last renewal: 10 June 2009

10.

DATE OF REVISION OF THE TEXT

 

Changed to 9th April 2010

 
Updated on 22/05/2009 and displayed until 27/04/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Apr-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Update to section 4.5 - Addition of interaction with bosentan and  lamotrigine
Update to section 10 - Changed to 30th April 2009
Updated on 28/11/2008 and displayed until 22/05/2009
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:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to section 7 - Change of MAH address to:
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
 
Change to section 10 - Changed to 24th November 2008
Updated on 17/10/2008 and displayed until 28/11/2008
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:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.8

Undesirable effects

Addition of adverse events.

10.

DATE OF REVISION OF THE TEXT

 

Changed from 21st July 2005  to 8th October 2008

 
Updated on 08/11/2005 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 09/08/2005 and displayed until 08/11/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 27/08/2004 and displayed until 09/08/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Updated on 30/07/2004 and displayed until 27/08/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Updated on 26/08/2003 and displayed until 30/07/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 26/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Estradiol Hemihydrate