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Femodette

Last Updated on eMC 01-Jul-2015 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 01-Jul-2015 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: 17-Jun-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

  • As a consequence of new knowledge on the potential for oral contraceptive products to interact with other medicinal products, amendment to section 4.5 of the SmPC.  To introduce information regarding substances that can decrease the clearance of COCs (CYP3A4 inhibitors and etoricoxib) and information regarding the effect that COCs can have on other drugs.

Updated on 18-Nov-2014 and displayed until 01-Jul-2015

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-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        Section 4.8, to introduce a summary of the safety profile. No new information is included, this amendment is to align to standard templates.

Updated on 19-Aug-2014 and displayed until 18-Nov-2014

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • 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: 31-Jul-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key changes are:
  • To implement the outcome of the EU referral procedure on the VTE/ATE risk for Combined Hormonal Contraceptives. 

Updated on 25-Jul-2013 and displayed until 19-Aug-2014

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

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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