Ketovite tablets *
Pharmacy Only: Non-prescription

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