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Elleste Solo MX80 micrograms Transdermal Patch

Last Updated on eMC 13-May-2016 View document  | Meda Pharmaceuticals 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 13-May-2016 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: 04-Mar-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

IAIN Variation -C.I.z - Change(s) in the Summary of product Characteristics, Labelling orPackage Leaflet intended to implement the outcome of a PRAC signal recommendation:implementation of wording agreed by the competent authority that do not requireany further assessment 

Updated on 17-Apr-2015 and displayed until 13-May-2016

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC: 22-Jan-2014

Legal Category:POM

Black Triangle (CHM): NO

Updated on 09-Jul-2014 and displayed until 17-Apr-2015

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients

Date of revision of text on the SPC: 11-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Type IB variation to change the excipients to section 6.1

Updated on 24-Apr-2012 and displayed until 09-Jul-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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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: 15-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update sections 4.1, 4.3, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SPC in line with the core HRT SPC and BNF

Updated on 19-Aug-2009 and displayed until 24-Apr-2012

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Aug-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to Section 7. Marketing Authorisation Holder details  

Updated on 27-Mar-2009 and displayed until 19-Aug-2009

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-Mar-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 9. Date of First Authorisation
Section 10. Date of Revision of Text

Updated on 05-Sep-2008 and displayed until 27-Mar-2009

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Meda Pharmaceuticals

Company image
Address

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU

Fax

0845 460 0002

Medical Information e-mail
Out of Hours contact

+44 (0)1748 828 810

Telephone

0845 460 0000

Medical Information Direct Line

+44 (0)1748 828 810

Medical Information Fax

+44 (0)1748 828 801

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 hemihydrate

Legal categories

POM - Prescription Only Medicine

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