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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: 22/06/2009
SPC Ortho-Gynest Pessaries

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 22/06/2009 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:   08-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 10 – Date of revision of the text

Update to revision date to 8th June 2009

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

Addition of the lamotrigine  wording
Updated on 26/01/2009 and displayed until 22/06/2009
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:   20-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


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

Addition of the bosentan wording

Change to section 4.8 – Undesirable effects

Addition of the urticaria, angioedema wording

Change to section 10 – Date of revision of the text

Update to revision date to 5th January 2009
Updated on 09/01/2009 and displayed until 26/01/2009
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:   05-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

Change of  address from

 

Janssen-Cilag Limited, Saunderton, High Wycombe, Buckinghamshire, HP14 4HJ, UK

to

Janssen-Cilag Limited, 50 -100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

 

Change to section 10 – Date of revision of the text

Update to revision date to 5th January 2009
Updated on 06/11/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.3 – Shelf Life

SL reduction from ‘Three years ‘ to ‘2 years’

Change to section 6.4 – Special Precautions for Storage

Increased from 25°C to 30°C

Change to section 10 – Date of revision of the text

Update to revision date to 31st October 2008
Updated on 02/04/2008 and displayed until 06/11/2008
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 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 1 –Name of the medicinal product

Reformat heading and add trade mark

Change to section 2 – quantitative and qualitative composition

Reformat heading, addition of text

Change to section 3 – pharmaceutical form

Reformat heading, update pharmaceutical form

Change to section 4.2 – Posology and |Method of Administration

Reformat heading, deletion of text relating to handling instructions

Change to section 4.3 – Contra-indications

Hypersensitivity statement added

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Reformat heading and additional statement

Change to section 5.1 - Pharmacodynamic properties

Reformat heading and addition of ATC group

Change to section 6.2 - Incompatibilities

Reformat heading and addition of standard wording

Change to section 6.5 – Nature and Contents of Container

Reformat heading and addition of units

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

Reformat heading and addition of deleted text from Scetion 4.2 regarding use of applicator

Change to section 9 – Date of Renewal of Authorisation

Reformat and addition of latest renewal

Change to section 10 – Date of revision of the text

Update to revision date to  March 2008
Updated on 02/03/2006 and displayed until 02/04/2008
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 - Contra-indications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • 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. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/06/2005 and displayed until 02/03/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 09/06/2005 and displayed until 15/06/2005
Reasons for adding or updating:
  • Change from BAN to rINN
Updated on 10/10/2001 and displayed until 09/06/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 22/08/2001 and displayed until 10/10/2001
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  estriol