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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 19/10/2011
SPC Progynova 1mg

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 19/10/2011 and displayed until Current
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:   05-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to section 4.8 (Undesirable effects) of the SmPC in line with the current labelling guidance by converting the adverse event terms to the newest MeDRA version and the internationally agreed SOC order; and to include the relevant changes from Revision 3 of the EU Core SPC for HRT products.
Updated on 20/11/2009 and displayed until 19/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   09-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 ( Special warnings) - hereditary angiodema has been added to the conditions which require supervision.

Section 4.8 ( Undesirable effects) - the warning concerning the induction or exacerberation of symptoms in angiodema in women with hereditaty angiodema has been inserted.

Section 10 (Revision date) - this is now 09.11.2009
Updated on 27/05/2008 and displayed until 20/11/2009
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/ 0556
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 03/04/2008 and displayed until 27/05/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Following MHRA approval of the Renewal of the licence, the date in Section 9 and 10 has been amended. 

Updated on 25/11/2005 and displayed until 03/04/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 23/11/2005 and displayed until 25/11/2005
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 23/11/2005
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  estradiol valerate