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Progynova 2mg

Last Updated on eMC 11-Jan-2017 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 11-Jan-2017 and displayed until Current

Reasons for adding or updating:

  • Previous version of SPC reinstated

Date of revision of text on the SPC: 26-Nov-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Previous version of SPC re-instated

Updated on 02-Jan-2017 and displayed until 11-Jan-2017

Reasons for adding or updating:

  • 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC: 26-Nov-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 The key changes are:

·        Update of section 4.5, to introduce an update of section 4.5 of the SmPC and the corresponding section(s) of the PIL, including:

o   update of interactions with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors

o   update on the interaction with CYP3A4-inhibitors

o   deletion of interaction with antibiotics (penicillins and tetracyclines)

o   minor revision of the information on interaction with laboratory tests

 

·        Update to the section 4.4 and 4.8 on ovarian cancer with consequential updates to the PIL

Updated on 29-Jun-2016 and displayed until 02-Jan-2017

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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: 26-Nov-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key changes are:
  • SmPC updated to QRD template. 

Updated on 20-Dec-2012 and displayed until 29-Jun-2016

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC: 12-Dec-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



deletion of all references to the name “Fem Tab” from the products’ licence. As a consequence, sections 1, 4.2, 4.4, 4.6, 4.8, 5.1 and 5.2 of the Progynova 1mg and 2mg SmPC have been updated.

 

Updated on 18-Oct-2012 and displayed until 20-Dec-2012

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-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

  • The statement 'Trading as Bayer plc, Bayer Schering Pharma' has been removed from Section 7 'MARKETING AUTHORISATION HOLDER' of the SmPC. 

Updated on 25-May-2012 and displayed until 18-Oct-2012

Reasons for adding or updating:

  • Improved Electronic Presentation

Date of revision of text on the SPC: 01-Apr-2012

Legal Category:POM

Black Triangle (CHM): NO

Updated on 27-Apr-2012 and displayed until 25-May-2012

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 18-Apr-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

 

·        To update sections 4.3, 4.4, and 5.1 of the SmPC to reflect the changes to the company core data sheet as a result of revision 3 of the EU core SPC for Hormone Replacement Therapy (EU HRT core SPC).   

Updated on 19-Oct-2011 and displayed until 27-Apr-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: 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 23-Nov-2009 and displayed until 19-Oct-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 01-Jul-2008 and displayed until 23-Nov-2009

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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/ 0557
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 

Updated on 03-Apr-2008 and displayed until 01-Jul-2008

Reasons for adding or updating:

  • 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-Feb-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-Nov-2005 and displayed until 03-Apr-2008

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 23-Nov-2005 and displayed until 25-Nov-2005

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.3 - Contra-indications
  • 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 18-Dec-2003 and displayed until 23-Nov-2005

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 10 (date of (partial) revision of the text

Updated on 21-Aug-2001 and displayed until 18-Dec-2003

Reasons for adding or updating:

  • Correction of spelling/typing errors

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

estradiol valerate

Legal categories

POM - Prescription Only Medicine

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