Elleste Solo 1mg
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:
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 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 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- 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 17-Apr-2015 and displayed until 13-Oct-2015
Reasons for adding or updating:
- Improved presentation of SPC
Date of revision of text on the SPC: 22-Sep-2014
Legal Category:POM
Black Triangle (CHM): NO
Updated on 07-Oct-2014 and displayed until 17-Apr-2015
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 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 10 - Date of revision of the text
Date of revision of text on the SPC: 16-Sep-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Variation to change wording in line with agreed wording (CMDh/131/2003 Rev4) regarding HRT products (4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1)$0$0$0$0QRD template update to sections 1, 2, 3, 4.2, 4.6, 4.7, 5.1, 6.1, 6.5 and 6.6$0Updated on 26-Aug-2009 and displayed until 07-Oct-2014
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 HolderUpdated on 17-Apr-2009 and displayed until 26-Aug-2009
Reasons for adding or updating:
- Change to section 6. 5 - Nature and Contents of Container
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:
Amendment to section 6.5 Nature and content of container - addition of * for pack size 28.Updated on 25-Feb-2009 and displayed until 17-Apr-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 AuthorisationChange to Section 10. Date of Revision of the Text
Updated on 09-Jul-2008 and displayed until 25-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
Legal categories
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