Cerazette 75 microgram film-coated tablet

  • Name:

    Cerazette 75 microgram film-coated tablet

  • Company:
    info
  • Active Ingredients:

    Desogestrel

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/12/19

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Summary of Product Characteristics last updated on medicines.ie: 30/4/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
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1 - 0 of 84 items.Total: Infinity pages

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 2 December 2019 PIL

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 PIL

Reasons for updating

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

Updated on 30 April 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 October 2017 PIL

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 PIL

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 April 2016 SmPC

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 PIL

Reasons for updating

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

Updated on 16 July 2015 SmPC

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 5 June 2015 SmPC

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 4 June 2015 PIL

Reasons for updating

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

Updated on 27 May 2014 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 23 July 2013 SmPC

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 PIL

Reasons for updating

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

Updated on 21 November 2012 PIL

Reasons for updating

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

Updated on 5 September 2012 SmPC

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 PIL

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 8 June 2012 SmPC

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 PIL

Reasons for updating

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

Updated on 26 August 2009 SmPC

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