Mektovi 15 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Pierre Fabre Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 23 February 2023

File name

Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V4.0_final approved_clean_24.01.22_1644250514.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 February 2022

File name

Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V4.0_final approved_clean_24.01.22_1644250514.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes have been made to:

Section 7: Updated MA holder address

Section 10: Updated revision date

Updated on 07 February 2022

File name

Mektovi_15mg_film_coated_tablets_PIL_UK(NI)_IE_V4.0_final approved_24.01.22_1644250311.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Changes have been made to:

Section 6: Updated MA holder address

Section 6: Updated revision date

Updated on 20 August 2021

File name

Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V3 clean_1629454168.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The ATC Code was updated in Section 5.1, Pharmacodynamic Properties.

Section 10, Date of Revision of the Text was updated to reflect the approval of this change.

Updated on 12 August 2019

File name

Mektovi_15mg_film_coated_tablets_PIL_EN_V3.0_20190808 No header_1565614590.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Addition of manufacturer

Updated on 25 February 2019

File name

Mektovi_15mg_film_coated_tablets_PIL_EN_V2.0_20181030 No header_1551104706.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 25 February 2019

File name

Mektovi_15mg_film_coated_tablets_SPC_EN_V2.0_20181030 no header_1551104785.pdf

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of a new pack size, see details in 6.5 and 8.

Updated on 23 October 2018

File name

Mektovi_15mg_film_coated_tablets_PIL_EN_V1.0_20180920 No header_1538133768.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 October 2018

File name

Mektovi_15mg_film_coated_tablets_SPC_EN_V1.0_20180920 No header_1539948917.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 September 2018

File name

Mektovi_15mg_film_coated_tablets_PIL_EN_V1.0_20180920 No header_1538133768.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 September 2018

File name

Mektovi_15mg_film_coated_tablets_SPC_EN_V1.0_20180920 No header_1538133791.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)