Elleste Duet 2mg
Last Updated on eMC 01-Dec-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 01-Dec-2016 and displayed until Current
Reasons for adding or updating:
- Improved presentation of SPC
Date of revision of text on the SPC: 19-Apr-2016
Legal Category:POM
Black Triangle (CHM): NO
Updated on 13-May-2016 and displayed until 01-Dec-2016
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:
Type IAIN Variation -C.I.z - Change(s) in the Summary of product Characteristics, Labelling orPackage Leaflet intended to implement the outcome of a PRAC signalrecommendation: implementation of wording agreed by the competent authoritythat do not require any further assessmentUpdated on 13-Oct-2015 and displayed until 13-May-2016
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 02-Oct-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
$0(1)To update Section 2 of the leaflet to reflect Core package Leaflet for HormonalReplacement Therapy products based on core SPC HRT revision 3, Dec2009 – concerning mammography screening programs (CMDh/240/2011, Rev. 2November 2014).Updated on 06-Jun-2014 and displayed until 13-Oct-2015
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 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 4.8 - Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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: 01-Jun-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Changes to SmPC in line with the CSP for estradiol/norethisterone acetate.$0Addition of ADR reporting statement to section 4.8$0Updated on 17-Sep-2013 and displayed until 06-Jun-2014
Reasons for adding or updating:
- Change to section 1 - Name of the medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Date of revision of text on the SPC: 04-Sep-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
All the changes were undertaken to bring the SPC in line with the core text for HRT products and QRD in addition Meda's Glasgow address has been removed from Section 7Updated on 07-Sep-2009 and displayed until 17-Sep-2013
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 detailsUpdated on 26-Feb-2009 and displayed until 07-Sep-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-Feb-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Change to Section 9. Date of First Authorisation/Renewal of the Authorisation
Change to Section 10. Date of Revision of the Text
Updated on 03-Jul-2008 and displayed until 26-Feb-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
Meda Pharmaceuticals
Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
0845 460 0002
+44 (0)1748 828 810
0845 460 0000
+44 (0)1748 828 810
+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
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