Estring
Last Updated on eMC 08-Dec-2015 View document | Pfizer Limited Contact details
Versions
- 08-Dec-2015 to Current
- 28-Oct-2014 to 08-Dec-2015
- 17-Mar-2014 to 28-Oct-2014
- 10-Sep-2013 to 17-Mar-2014
- 01-Aug-2011 to 10-Sep-2013
- 19-Jul-2011 to 01-Aug-2011
- 04-Jul-2011 to 19-Jul-2011
- 15-Mar-2011 to 04-Jul-2011
- 20-Dec-2010 to 15-Mar-2011
- 04-Mar-2009 to 20-Dec-2010
- 03-Sep-2007 to 04-Mar-2009
- 10-Aug-2004 to 03-Sep-2007
- 30-Sep-2003 to 10-Aug-2004
- 10-Jul-2001 to 30-Sep-2003
- 29-Nov-2000 to 10-Jul-2001
- 23-Mar-2000 to 29-Nov-2000
- 06-Sep-1999 to 23-Mar-2000
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 08-Dec-2015 and displayed until Current
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC: 01-Dec-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The SPC has been updated as follows: To update section 4.8 of the SmPC, following a recent update to the Core Data Sheet the MAH proposes to add the ADR ‘vaginal erosion/ulceration’ for Estring. This ADR was determined from post-marketing safety reportingUpdated on 28-Oct-2014 and displayed until 08-Dec-2015
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC: 01-Oct-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.4: Warning regarding hereditary angioedema addedUpdated on 17-Mar-2014 and displayed until 28-Oct-2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 8 - Marketing authorisation number(s)
Date of revision of text on the SPC: 01-Nov-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Update to sections:
1, 3, 4.2, 4.4, 4.5, 4.6, 5.1, 5.2 = strength and pharmaceutical form updated
Section 8 = new PL number
Updated on 10-Sep-2013 and displayed until 17-Mar-2014
Reasons for adding or updating:
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC: 01-Sep-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Updates to Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1Updated on 01-Aug-2011 and displayed until 10-Sep-2013
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 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 4.3 - Contraindications
Date of revision of text on the SPC: 01-Jul-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Changes to sections 4.3, 4.4 and 4.8. Section 4.8 updated in line with MedDRA and to further clarify the information regarding systemic oestrogen therapySections 4.2 and 4.6 minor typographical amendments only.
Updated on 19-Jul-2011 and displayed until 01-Aug-2011
Reasons for adding or updating:
- Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC: 01-Jul-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
SmPC – section 5.2 (pharmacokinetic properties) updatedUpdated on 04-Jul-2011 and displayed until 19-Jul-2011
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC: 01-Jun-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 5.1 updated with ‘There is limited clinical trial data beyond 2 years….’Updated on 15-Mar-2011 and displayed until 04-Jul-2011
Reasons for adding or updating:
- Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC: 11-Mar-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
SmPC:All applicable sections: spelling of estrogen corrected to oestrogen
Section 5.3: USP reference deleted
Tradename Elleste removed from previous version of the SmPC
Updated on 20-Dec-2010 and displayed until 15-Mar-2011
Reasons for adding or updating:
- Change to section 6. 4 - Special Precautions for Storage
- Change to section 6. 6 - Instructions for use, handling and disposal
- 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: 08-Dec-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
SmPC6.4 - Special precautions for storage
6.6 - added disposal instructions
7 - MAH changed from Pharmacia to Pfizer
8 - PL number revised to PL 00057/0974
9 - date revised to grant date of new licence: 26/11/2010
10 - date revised to approval date of last variation: 08/12/2010
Updated on 04-Mar-2009 and displayed until 20-Dec-2010
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: 12-Feb-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Update to sections 9 and 10 to include new date of renewal and revision date respectively.
Additionally, this opportunity has been taken to add the legal category to this document as this was not previously included (new section 11)
Updated on 03-Sep-2007 and displayed until 04-Mar-2009
Reasons for adding or updating:
- Change to section 10 date of revision of the text
- Change to MA holder contact details
Date of revision of text on the SPC: 01-May-2007
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
7.1 – Change to the MAH address
10 – Change in the date of revision
Updated on 10-Aug-2004 and displayed until 03-Sep-2007
Reasons for adding or updating:
- Change to section 4.1 - Therapeutic Indications
- 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 4.5 - Interactions with other Medicaments and other forms of Interaction
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.2 - Pharmacokinetic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 6. 4 - Special Precautions for Storage
Updated on 30-Sep-2003 and displayed until 10-Aug-2004
Reasons for adding or updating:
- Change to section 4.3 - Contra-indications
- Change to section 4.4 - Special Warnings and Precautions for Use
- Change to section 10 (date of (partial) revision of the text
Updated on 10-Jul-2001 and displayed until 30-Sep-2003
Reasons for adding or updating:
- Transferred from eMC version 1
Updated on 29-Nov-2000 and displayed until 10-Jul-2001
Reasons for adding or updating:
- No reasons supplied
Updated on 23-Mar-2000 and displayed until 29-Nov-2000
Reasons for adding or updating:
- No reasons supplied
Updated on 06-Sep-1999 and displayed until 23-Mar-2000
Reasons for adding or updating:
- No reasons supplied
Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
+44 (0)1304 656 221
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