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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: 13/03/2012
SPC Evorel 25, 50, 75 & 100 patches

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 13/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Contraindications

Additions bold and  underlined.
deletions scored out

Known, current or past, or suspected breast cancer

Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer) or pre-malignant tumours (e.g. untreated atypical endometrial hyperplasia)

Undiagnosed genital bleeding

Untreated endometrial hyperplasia

Previous idiopathic or current venous thrombo-embolism (deep venous thrombosis, pulmonary embolism)

Active or recent past arterial thrombo-embolic disease (eg cerebrovascular accident, angina, myocardial infarction)

Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal

Known thrombophilic conditions (e.g. protein C, protein S or antithrombin deficiency, see section 4.4)

Known hypersensitivity to the active substances or to any of the excipients

Porphyria
Updated on 05/03/2012 and displayed until 13/03/2012
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:   29-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4  Special warnings and precautions

Addition of :

Mastopathy

 Rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition

Otherwise no new information , the text has been updated with administrative changes
Updated on 10/01/2012 and displayed until 05/03/2012
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:   03-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Frequency category of side effects re-calculated and updated.

Plus addition of:

pruritus, breast enlargement, dysmenorrhoea, oedema (generalised, peripheral), flatulance, abdominal distension, diarrhoea, myocardial infarction, cerebrovascular accidenrs, epilpesy, migraine , dizziness, headache, depressed mood, hypersensitivity, endometrial cancer
Updated on 03/01/2012 and displayed until 10/01/2012
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.9-overdose.

Addition of breast pain and abdominal cramps or bloating
Updated on 18/11/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   14-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to SmPC to be inline with the core safety profile
Updated on 08/06/2009 and displayed until 18/11/2011
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:   02-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - Addition of lamotrigine wording.
Change to section 10 - Changed to 2 June 2009.
Updated on 16/01/2009 and displayed until 08/06/2009
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:   12-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 to

Janssen-Cilag Ltd

50 -100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

 

 

Change to section 10 – Date of revision of the text

Changed to 25 November 2008
Updated on 09/12/2008 and displayed until 16/01/2009
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:   25-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Addition of 'urticaria' wording.
Change to section 10 - Changed to 25 November 2008.
Updated on 19/05/2008 and displayed until 09/12/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.5 - add bosentan to list of interactions.
Updated on 12/09/2006 and displayed until 19/05/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 07/09/2006 and displayed until 12/09/2006
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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

Evorel® 25 Patch, Evorel 50 Patch, Evorel 75 Patch and Evorel 100 Patch and replaces the current situation (individual Evorel product)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Stated for each of the 4 patches

3.

PHARMACEUTICAL FORM

Concentrations provided for each of the patches

4.1

Therapeutic Indications

Of note Evorel 25 is not indicated for second line treatment of osteoporosis.

5.1

Pharmacodynamic properties

PD data for each patch presented

5.2

Pharmacokinetic properties

PK data for each patch presented

8.

MARKETING AUTHORISATION NUMBER(S)

All licences listed

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 November 1995

10.

DATE OF REVISION OF THE TEXT

 

 

September 2005
Updated on 04/12/2003 and displayed until 07/09/2006
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/10/2001 and displayed until 04/12/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 3 - Shelf Life
Updated on 22/08/2001 and displayed until 10/10/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  estradiol