HALF SINEMET CR 25mg/100mg Prolonged-Release Tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)*Additional information is available within the SPC or upon request to the company
Updated on 16 January 2024
File name
ie-QRD-Sinemet CR-Half Sinemet CR_PIL_UTI october 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 January 2024
File name
IE-Sinemet Half CR-EN-SPC-UTI-2023-10-13- CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 January 2023
File name
IE-Sinemet Half CR-EN-SPC-20220422-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 May 2022
File name
IE-Sinemet Half CR-EN-SPC-2022 MAT-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 04 May 2022
File name
IE-Sinemet CR 50mg200mg -EN-SPC-2022 MAT-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 04 May 2022
File name
Sinemet CR-Half Sinemet CR_PIL_MAT 2022 CRM.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 25 June 2019
File name
IE-Sinemet Half CR-EN-SPC-20171027-CRT.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
Converted the SPC from word format to pdf file format
Updated on 21 February 2019
File name
Sinemet CR-Half Sinemet CR_PIL_QRD_BRX_PRO_CRT.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 15 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 November 2017
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 4.8 - 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
Update to sections 4.4 & 4.8 C in line with the PRAC recommendation on carbidopa / levodopa regarding Dopamine dysregulation syndrome
Update to section 5.1 to insert the ATC code & pharmacotherapeutic group
Editorial amendments to section 4.2 of the SPC
Updated on 14 November 2017
File name
PIL_13244_625.pdf
Reasons for updating
- New PIL for new product
Updated on 14 November 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 14 January 2016
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
Updated on 29 July 2015
Reasons for updating
- Change of manufacturer
- Change to further information section
Updated on 13 February 2015
Reasons for updating
- Change to date of revision
Updated on 21 August 2014
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 20 August 2014
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 17 June 2013
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
MA Holder address change - Sections 7, 10
Updated on 18 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 19 February 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 13 July 2010
Reasons for updating
- Change to date of revision
Updated on 09 October 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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
- Section 1: Product name
- Section 6.4: Storage conditions
- Section 10: Date of revision
Updated on 08 October 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 24 August 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 8 - MA number
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
PA transfer (and change of distributor from BMS to MSD)
- Section 7: Change of MAH holder
- Section 8: Change of PA number
- Section 10: July 2009
Updated on 13 August 2009
Reasons for updating
- Change to further information section
Updated on 30 October 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 6.5 - Nature and contents of container
- 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
Changes have been made to the following sections: 1, 2, 3, 6.1, 6.5, 9 & 10.
Updated on 24 July 2008
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)
Free text change information supplied by the pharmaceutical company
The change relates to update section 4.4 to include warning in relation to melanoma.
Updated on 09 June 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 28 August 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)