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Femodette

Last Updated on eMC 25-Jul-2013 View document  | Bayer plc Contact details

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 25-Jul-2013 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 24-Apr-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SmPC for Femodette has recently been updated and approved by the MHRA in line with extensive changes agreed previously for Femodene.

Updated on 07-May-2013 and displayed until 25-Jul-2013

Reasons for adding or updating:

  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Apr-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updating sections 4.2, 4.3, 4.4, 4.5, 4.6, 48, 5.3 and section 10 in line with the ccds.

Updated on 08-Oct-2012 and displayed until 07-May-2013

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • 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: 28-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        SPC  section 6.3: reduction in shelf life from 4 to 3 years

·        SPC  section 6.4: addition of, Protect from light, in line with standard QRD terms

·        SPC  section 7: Deletion of the BSP trading style statement.

·        PIL update  update to the storage precautions as above,  removal of the BSP trading style and update to the name of the manufacturer.

Updated on 13-May-2011 and displayed until 08-Oct-2012

Reasons for adding or updating:

  • 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: 19-Jan-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key change is:

Section 6.6

 

has been updated in line with EC Guideline and now states 'No special requirements

 

Updated on 30-Jun-2009 and displayed until 13-May-2011

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • 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: 06-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

 

·       Section 6.5 (Nature and contents of container) – the text has been updated from:

 

     'The blister packs consist of hard tempered aluminium foil of thickness 20µm and transparent PVC film of thickness 250µm. 

           

            Presentation

            Cartons containing 1 or 3 blister memo-packs

            Each memo-pack contains 21 tablets'.

 

to:


           
'Primary containers:

The blister packs consist of hard tempered aluminium foil of thickness 20m and transparent PVC film of thickness 250m.

 

Presentation:

Blister calendar pack contaiing 21 tablets.'

 

·       Section 9 (Date of first authorisation / Renewal of the authorisation) has been updated to reflect the Renewal approval date of 06 March 2009. 

 

·       Section 10 (Date of revision of the text) has been updated to reflect the Renewal approval date of 06 March 2009. 

 

Updated on 28-May-2008 and displayed until 30-Jun-2009

Reasons for adding or updating:

  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 7 - Marketing Authorisation Holder
  • 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: 01-May-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0531
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 

Updated on 08-Jan-2002 and displayed until 28-May-2008

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use

Updated on 25-Jul-2001 and displayed until 08-Jan-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 21-Aug-2000 and displayed until 25-Jul-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Bayer plc

Company image
Address

Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA

Fax

+44 (0)1635 563 393

Telephone

+44 (0)1635 563 000

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?

Active ingredients

ethinylestradiol, gestodene

Legal categories

POM - Prescription Only Medicine

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