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Ketovite tablets *

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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 12 October 2020

File name

kettab pil_1602504072.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 October 2020

File name

ket tab_1602503757.pdf

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 06 January 2020

File name

KetTab-PL-IE-4a 20191118_1578306122.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 06 January 2020

File name

KetTab-PL-IE-3-20190528_1561626541.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

File name

KetTab-PL-IE-3-20190528_1561626541.pdf

Updated on 12 June 2019

File name

ie-mockup.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 12 June 2019

File name

KetTab-SPC-IE-3-20190528_1560345150.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Supply through pharmacy only

Updated on 22 June 2018

File name

KetTab-SPC-IE-1a-clean.docx

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of Anaphylactic reaction. 

Align to QRD.

Updated on 22 June 2018

File name

ie-mockup.pdf

Reasons for updating

  • Change to side-effects

Updated on 19 June 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 19 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects)  the statement about how to report side effects has been added:$0$0Reporting ofsuspected adverse reactions:$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via $0$0HPRA Pharmacovigilance$0$0Earlsfort Terrace $0$0IRL - Dublin 2$0$0Tel: +353 1 6764971$0$0Fax: +353 1 6762517$0$0Website: www.hpra.ie$0$0e-mail: medsafety@hpra.ie$0$0

Updated on 17 June 2015

File name

PIL_15511_811.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 June 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 05 October 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 03 October 2012

Reasons for updating

  • New PIL for medicines.ie