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SINEMET CR 50mg/200mg Prolonged-release Tablets

*
Pharmacy Only: Prescription

  • Company:

    Organon Pharma (Ireland) Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    CarbidopaLevodopa

    *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 CR 50mg200mg-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 CR 50mg200mg-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 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 15 July 2019

File name

Sinemet CR-Half Sinemet CR_PIL_QRD_BRX_PRO_CRT (002).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 28 August 2018

File name

IE-Sinemet CR-EN-PL-20171027-CRT (2).pdf

Reasons for updating

  • New PIL for new product

Updated on 28 August 2018

File name

IE-Sinemet CR-EN-SPC-20171027-CRT (2).pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 14 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 November 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • 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

Update to sections 4.4 & 4.8 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

Updated on 14 November 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 & 4.8 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

Updated on 15 January 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Reasons for submission: Change to Section 3 - Pharmaceutical form
Which SPC sections have changed: Sections 3, 10

Detailed SPC change information: Amendment to tablet description in section 3 (scoreline and “521” are now on opposite sides)


Updated on 15 January 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Reasons for submission: Change to Section 3 - Pharmaceutical form
Which SPC sections have changed: Sections 3, 10

Detailed SPC change information: Amendment to tablet description in section 3 (scoreline and “521” are now on opposite sides)


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
  • 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 4.5, 4.8, 10 - Added warning regarding use with dopamine-depleting agents

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
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Sections 4.5, 4.8, 10 - Added warning regarding use with dopamine-depleting agents

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 17 June 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

MA Holder address change - Sections 7, 10

 

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

Update to Sections 4.4, 4.8, 10.

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

Free text change information supplied by the pharmaceutical company

Update to Sections 4.4, 4.8, 10.

Updated on 16 October 2009

Reasons for updating

  • Change to section 4.9 - Overdose
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Post BSR

 

(correction)
Typo correction Section 4.9

 

Updated on 16 October 2009

Reasons for updating

  • Change to section 4.9 - Overdose
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Post BSR

 

(correction)
Typo correction Section 4.9

 

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 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

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 24 August 2009

Reasons for updating

  • 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

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 24 August 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

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 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 24 July 2008

Reasons for updating

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

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 28 August 2007

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 28 August 2007

Reasons for updating

  • New SPC for medicines.ie