Mektovi 15 mg and 45 mg film-coated tablets
*Company:
Pierre Fabre LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 January 2025
File name
Mektovi_15mg_45mg_SPC_IE_V10.0_WF_clean_final_08.01.25.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to remove Northern Ireland from reporting of side effects due to Windsor Framework implementation.
Updated on 08 January 2025
File name
Mektovi_15mg_45mg_PIL_IE_V9.0_WF_clean_final_08.01.25.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Update to remove Northern Ireland from reporting of side effects due to Windsor Framework implementation.
Updated on 09 September 2024
File name
Mektovi_15mg_45mg_PIL_NI_IE_V8.0_NSCLC_clean_final_29.08.24.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 09 September 2024
File name
Mektovi_15mg_45mg_SPC_NI_IE_V8.0_NSCLC_clean_final_29.08.24.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2024
File name
Mektovi_15mg_45mg_SPC_NI_IE_V7.0_45mg_clean_final_17.06.24.pdf
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 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2024
File name
Mektovi_15mg_45mg_PIL_NI_IE_V7.0_45mg_clean_final_17.06.24.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 22 March 2024
File name
Mektovi_15mg_SPC_NI_IE_V6.0_PRAC_clean_final_21.03.24.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V5.0_final_clean_23.06.23.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V4.0_final approved_clean_24.01.22.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Mektovi_PIL_UK(NI)_IE_V5.0_renewal_final_clean_23.06.23.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 23 February 2023
File name
Mektovi_15mg_film_coated_tablets_SPC_UK(NI)_IE_V4.0_final approved_clean_24.01.22.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.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.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.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.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.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.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.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.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.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Pierre Fabre Limited
Address:
250 Longwater Avenue, Green Park, Reading, Berkshire, RG2 6GP, United KingdomMedical Information E-mail:
ie_mi@pierre-fabre.comTelephone:
+44 (0)118 334 8003Medical Information Direct Line:
1800 812 464 , +44 (0) 800 085 5292