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Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ

Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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?

Summary of Product Characteristics last updated on the eMC: 04/08/2011

SPC	Premarin Tablets

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 04/08/2011 and displayed until Current

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: 21-Jul-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 7: MA Holder name and address (Wyeth Pharmaceuticals, Taplow to Pfizer Limited, Sandwich) Section 8: MA Numbers Section 9: Date of First Authoisation Section 10: Date of revision of the text

Updated on 05/04/2011 and displayed until 04/08/2011

Reasons for adding or updating:
Change to section 4.3 - Contraindications
Date of revision of text on the SPC: 22-Mar-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Addition to contra-indications section: • Inclusion of the contraindication ‘Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4)’

Updated on 25/01/2011 and displayed until 05/04/2011

Reasons for adding or updating:
Correction of spelling/typing errors
Date of revision of text on the SPC: 09-Aug-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
None provided

Updated on 17/08/2010 and displayed until 25/01/2011

Reasons for adding or updating:
Change to section 4.8 - Undesirable Effects Change to section 4.9 - Overdose
Date of revision of text on the SPC: 09-Aug-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.8: Amend ADR table to show whether reactions are common, uncommon or rare. Section 4.8: Adverse Reactions updated Section 4.9: Text entirely replaced with new text.

Updated on 13/07/2010 and displayed until 17/08/2010

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC: 05-Jul-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.4 Additional Text 17. Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.

Updated on 26/01/2010 and displayed until 13/07/2010

Reasons for adding or updating:
Change to section 1 -Name of the Medicinal product Change to section 10 date of revision of the text
Date of revision of text on the SPC: 14-Jan-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Name of product changed to add 'Coated Tablets'

Updated on 23/01/2008 and displayed until 26/01/2010

Reasons for adding or updating:
Change to section 3 - Pharmaceutical form Change to section 6.1 - List of Excipients
Date of revision of text on the SPC: 04/2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
To add branding to tablets Section 3 has been changed to include tablet markings Section 6 has been changed to include extra excipients

Updated on 18/07/2007 and displayed until 23/01/2008

Reasons for adding or updating:
Correction of spelling/typing errors

Updated on 23/05/2007 and displayed until 18/07/2007

Reasons for adding or updating:
Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC: 04/2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Change to Sectio 3 - to add marked tablets

Updated on 13/03/2007 and displayed until 23/05/2007

Reasons for adding or updating:
Change to section 3 - Pharmaceutical form Change to section 10 date of revision of the text
Date of revision of text on the SPC: 11/2006
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 3 - To add 0.3mg as the minimum effective dose.

Updated on 02/02/2006 and displayed until 13/03/2007

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 4.4 - Special Warnings and Precautions for Use Change to section 4.8 - Undesirable Effects Change to section 5.1 - Pharmacodynamic Properties Change to section 10 (date of (partial) revision of the text

Updated on 13/04/2005 and displayed until 02/02/2006

Reasons for adding or updating:

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 - 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 4.9 - Overdose
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
Change to section 7 - Marketing Authorisation Holder

Updated on 19/02/2004 and displayed until 13/04/2005

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

Updated on 26/09/2003 and displayed until 19/02/2004

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 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic Properties
Change to section 5.2 - Pharmacokinetic Properties
Change to section 7 - Marketing Authorisation Holder

Updated on 06/02/2002 and displayed until 26/09/2003

Reasons for adding or updating:
Change to section 4.4 - Special Warnings and Precautions for Use

Updated on 18/07/2001 and displayed until 06/02/2002

Reasons for adding or updating:
Change to section 4.4 - Special Warnings and Precautions for Use Change from datasheet to SPC

Updated on 03/07/2000 and displayed until 18/07/2001

Reasons for adding or updating:
No reasons supplied

Updated on 24/05/2000 and displayed until 03/07/2000

Reasons for adding or updating:
No reasons supplied

Updated on 06/09/1999 and displayed until 24/05/2000

Reasons for adding or updating:
No reasons supplied

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Active Ingredients/Generics

oestrogens, conjugated

Versions

	04/08/2011 to Current
	05/04/2011 to 04/08/2011
	25/01/2011 to 05/04/2011
	17/08/2010 to 25/01/2011
	13/07/2010 to 17/08/2010
	26/01/2010 to 13/07/2010
	23/01/2008 to 26/01/2010
	18/07/2007 to 23/01/2008
	23/05/2007 to 18/07/2007
	13/03/2007 to 23/05/2007
	02/02/2006 to 13/03/2007
	13/04/2005 to 02/02/2006
	19/02/2004 to 13/04/2005
	26/09/2003 to 19/02/2004
	06/02/2002 to 26/09/2003
	18/07/2001 to 06/02/2002
	03/07/2000 to 18/07/2001
	24/05/2000 to 03/07/2000
	06/09/1999 to 24/05/2000

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Pfizer Limited

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Free-text change information supplied by the pharmaceutical company

Document Links

Active Ingredients/Generics

Versions