The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
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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
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Summary of Product Characteristics last updated on the eMC: 20/11/2009
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 20/11/2009 and displayed until Current
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


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