Cerazette 75 microgram film-coated tablet
- Name:
Cerazette 75 microgram film-coated tablet
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/01/20
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MSD Ireland (Human Health) Limited
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Company Products
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 10 January 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 January 2020 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
Update of section 4.8 to include information regarding hypersensitivity as an adverse event
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
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
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 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
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
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
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)