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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: 21/05/2009
SPC Evorel Conti

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 21/05/2009 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 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


4.5

Interaction with other medicinal products and other forms of interaction

Addition of interaction with lamotrigine

10.

DATE OF REVISION OF THE TEXT

Changed to 30th April 2009
Updated on 28/10/2008 and displayed until 21/05/2009
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:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

7.

MARKETING AUTHORISATION HOLDER

Changed to

Janssen-Cilag Ltd

50 100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

 

10.

DATE OF REVISION OF THE TEXT

Changed from June 2008 to 17th October 2008

 

 
Updated on 30/06/2008 and displayed until 28/10/2008
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:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Addition of 2 adverse events

Change to section 10 – Date of revision of text

Change to June 2008
Updated on 01/05/2008 and displayed until 30/06/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Updated to include pharmaceutical form and strength

Change to section 2 – quantitative and qualitative composition

Update to add ‘full list of excipients’

Change to section 4.4 – Special Warnings and Precautions for Use

Editorial changes and removal of paragraph relating to breast cancer and HRT use

 

Addition of warning relating to renal insufficiency

Change to section 6.1 – List of Excipients

Addition of tradenames to accompany generic names and in listed format

Change to section 6.3 – Shelf Life

Removed additional text and replaced with ‘2 years’

Change to section 6.4 – Special Precautions for Storage

Remove ‘Keep out of sight of children and other additional text.

Change to section 9 – Date of Renewal of Authorisation

Update Section to include the date of first authorisation and last renewal

Change to section 10 – Date of revision of text

Update revision date to ‘April 2008’
Updated on 12/03/2008 and displayed until 01/05/2008
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:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

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

Add ‘bosentan’

Change to section 10 – Date of revision of text

Change to ‘March 2008’

 
Updated on 02/09/2004 and displayed until 12/03/2008
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 10 - Date of revision of the text
Updated on 11/08/2004 and displayed until 02/09/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 06/08/2004 and displayed until 11/08/2004
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 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 06/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Estradiol Hemihydrate
  Norethisterone acetate