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Noriday Tablets 350 microgram

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Norethisterone

    *Additional information is available within the SPC or upon request to the company

Updated on 06 March 2023

File name

Reg SPC NO 12_1 IE Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 February 2023

File name

DEC202103501_Reg SPC NO 11_1 IE clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 February 2021

File name

DEC202109053_Reg PIL NO 14_0 IE clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 January 2021

File name

DEC202103501_Reg SPC NO 11_1 IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2021

File name

DEC202103501_Reg PIL NO 13_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 08 November 2019

File name

DEC201961890_Reg PIL NO 12_0 IE.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 April 2019

File name

DEC201920658_Reg PIL NO 10_0 IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 18 April 2019

File name

DEC201920658_Reg SPC NO 10_0 IE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 November 2018

File name

Reg SPC NO 9_1 IE.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018

File name

Reg_SPC_NO_9_1_IE_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sec 4.4 and 4.8 to add information on the association of the hepatic adenoma with the use of progesterone only pill

Updated on 24 May 2018

File name

Reg_SPC_NO_9_1_IE_clean.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sec 4.4 and 4.8 to add information on the association of the hepatic adenoma with the use of progesterone only pill.

Updated on 18 May 2018

File name

Reg PIL NO 9_1 IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 June 2016

File name

PIL_12428_984.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 June 2016

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 02 June 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 June 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as a result of the request from HPRA to update section 5.1 ‘Pharmacodynamic properties’ of SPC.

Updated on 03 February 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 – Undesirable effects – To remove pregnancy from section 4.8 in line with HPRA request

Updated on 06 October 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects- Update section with frequency following HPRA request from PSUR assessment.

Updated on 01 October 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 23 December 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability

Updated on 19 June 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change of MAH from Pharmacia to Pfizer and change of marketing authorisation number from PA 936/27/1 to PA 822/131/1

Updated on 19 June 2012

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 17 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC changes to sections 7 & 10

Updated on 14 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 24 August 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 07 June 2010

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

No update as part of a variation but a correction to the renewal date is included.

Updated on 04 June 2010

Reasons for updating

  • Change of manufacturer

Updated on 24 September 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2 – Addition of quantity for lactose monohydrate

3 – Addition of description to pharmaceutical form

6.1 – Reformatting of information

6.2 – Reformatting of information

6.6 – Reformatting of information

10 – Update to date

Updated on 20 September 2007

Reasons for updating

  • Change of licence holder
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to marketing authorisation holder address

Updated on 03 September 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)