Cerazette 75 microgram film-coated tablet
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal 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
Updated on 26 January 2023
File name
CERAZETTE-SE-H-147-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 January 2023
File name
CERAZETTE-SE-H-147-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 August 2021
File name
CERAZETTE-SE-H-147-MAT-SPC-IE-en-CRT.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.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.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.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).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).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).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).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).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.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.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.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
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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 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
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
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
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)