Cerazette 75 microgram film-coated tablet *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

When a pharmaceutical company changes any document, 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 26 August 2021

File name

CERAZETTE-SE-H-147-MAT-SPC-IE-en-CRT_1629985421.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 26 August 2021

File name

QRD-IE-CERAZETTE-LFT-MAT Jul 21CRT_1629975386.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 26 August 2021

File name

CERAZETTE-SE-H-147-MAT-SPC-IE-en-CRT_1629975196.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 25 August 2021

File name

Cerazette_1629899895.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 24 November 2020

File name

QRD-IE-CERAZETTE-LFT-IA-585-112020-CRT (002)_1606230455.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 November 2020

File name

CERAZETTE-IE-IA-585-SPC-CRT (002)_1606230299.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Update following PRAC signal on suppressed lactation with desogestrel.

 

Updated on 10 January 2020

File name

QRD_CERAZETTE-SE-H-xxxx-WS-301-PIL-IE_CRT (002)_1578664624.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 January 2020

File name

CERAZETTE-SE-H-xxxx-WS-301-SPC-en-CRT (002)_1578664463.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Update of section 4.8 to include information regarding hypersensitivity as an adverse event

Updated on 02 December 2019

File name

QRD_CERAZETTE-SE-H-0147-IA-520-PIL-IE_CRT (002)_1575279729.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Change to section 4 - how to report a side effect – removal of nurse

Section 6 - Addition of copyright statement

 

Updated on 20 November 2019

File name

QRD_CERAZETTE-SE-H-0147-IA-520-PIL-IE_CRT_1574264927.pdf

Reasons for updating

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

Updated on 30 April 2019

File name

CERAZETTE-SE-H-0147-IA-028-PIL-en-CRT_1556620347.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 30 April 2019

File name

CERAZETTE-SE-H-0147-IA-028-SPC-en-CRT_1556620641.pdf

Reasons for updating

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

Change to section 4.4: addition of safety warning for increased risk of suicidality with hormonal contraceptives

 

Updated on 24 October 2017

File name

PIL_14382_848.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 October 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 25 November 2016

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 21 November 2016

Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the 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



SPC change details: Updates following approval of SE/H/xxxx/WS/130 (CRN2176215) - Type II C.I.4 : Drug-Drug Interactions

Updated on 21 November 2016

Reasons for updating

  • New SPC for new product

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

Updated on 01 April 2016

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Section 5.3 - Preclinical safety date, section 6.6 - Special precautions for disposal and Section 10 – Date of revision of text
Update to sections 5.3 Preclinical safety date, 6.6 Special precautions for disposal and section 10 Date of revision of the text following approval of a Type II C.I.13 :  Final ERA Study Reports.

Updated on 31 March 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change of special precautions for disposal

Updated on 16 July 2015

Reasons for updating

  • 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

Change to Section 10: Date of Revision of the SPC

Updated on 05 June 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8 – Undesirable effects &Section 10 – Date of revision of text
Update to section 4.8 to change the AE reporting details to HPRA and date of revision

Updated on 04 June 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 May 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Sections 2 – Qualitative and Quantitative Composition, Section 4.2 – Posology and method of administration, Section 4.6 – Fertility, pregnancy and lactation, Section 4.8 – Undesirable effects, Section 5.2 – Pharmacokinetic properties, Section 7 – Marketing Authorisation Holder, Section 8 – Marketing Authorisation Number, Section 10 – Date of revision of text

Updated on 24 July 2013

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 23 July 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Updates to the SPC include sections 6.3 – Shelf life, 6.4 Special precautions for storage and section 10 date of revision.


Updated on 22 November 2012

Reasons for updating

  • Introduction of new pack/pack size
  • Correction of spelling/typing errors

Updated on 21 November 2012

Reasons for updating

  • Introduction of new pack/pack size
  • Correction of spelling/typing errors

Updated on 05 September 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

PVC/Aluminium blister.

Each blister contains 28 tablets. Each carton contains 1, 3, 6 or 13 blisters packed separately in an aluminium laminated sachet.

Updated on 24 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 08 June 2012

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 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

Updates to the SPC include the addition of information on sections 4.3 - Contra-indications, 4.6 - Pregnancy and Lactation, 4.8 - Undesirable effects and 5.1 Pharmacodynamic properties

Updated on 27 August 2009

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 26 August 2009

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided