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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 20/04/2017
SPC Premique 0.625mg/5mg Coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Oct-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as Follow:

The SPC has been updated in section 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2, 6.1 and 6.5

Updated on 09/03/2017 and displayed until 20/04/2017
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
  • SPC submitted in error
Date of revision of text on the SPC:   01-Oct-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



For Premique 0.625mg/5mg, SPC section 5.3 and Pfleet number in the footer of the document were corrected.

Updated on 27/10/2016 and displayed until 09/03/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Oct-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as Follow:

The SPC has been updated in section 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2, 6.1 and 6.5

Updated on 10/04/2014 and displayed until 27/10/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   03-Mar-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.8-updated in line with CMD(h) Core SPC for Hormone Replacement Therapy products
Section 5.1 -updated in line with CMD(h) Core SPC for Hormone Replacement Therapy products

Section 5.2-updated in line with CMD(h) Core SPC for Hormone Replacement Therapy products

Updated on 16/04/2013 and displayed until 10/04/2014
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

section 9 is corrected to reflect the date of first authorisation
Updated on 02/04/2013 and displayed until 16/04/2013
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 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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:   01-Mar-2013
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.2

Section 4.3

Section 4.4

Section 4.5

Section 4.6

Section 4.8

Section 5.3

Section 6.6

Section 10

Updated on 12/07/2011 and displayed until 02/04/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

MAH address change in section 7, PA number change section 8.
Updated on 25/06/2009 and displayed until 12/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   12-Jun-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 2: Information about excipients added
Section 6.1: Pharmaceutical names of excipients updated, E numbers added
Section 6.5: Packaging updated - sleeve removed, blister pack added
Updated on 29/10/2008 and displayed until 25/06/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.1 - addition of complete list of excipients
 
Section 6.5 - removal of sleeve from packaging
Updated on 20/04/2007 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8
 

The MAH has amended the Global Prescribing Information (company

core data sheet) and as such we have updated the Summary of

Product Characteristics.

Updated on 29/03/2006 and displayed until 20/04/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Updated on 29/11/2005 and displayed until 29/03/2006
Reasons for adding or updating:
  • Change from the BAN of the active substance to the rINN
Updated on 16/08/2005 and displayed until 29/11/2005
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 18/05/2005 and displayed until 16/08/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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