TEPMETKO 225 mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Merck
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

qrcode image

Scan the QR code or enter an email to access and share this medicine:

Updated on 09 June 2024

File name

SPC-TEPMETKO IE NI TW3742582 current v4.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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

Updated on 09 June 2024

File name

IE NI PIL TEPMETKO alt admin.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 12 October 2023

File name

TEPMETKO IE NI TW4036292 current v3.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.8 and 5.1 due to 18 month clinical study report of VISION study. (Our ref.: TW4036292)

Updated on 24 July 2023

File name

IE NI PIL TEPMETKO.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update of the PIL for the drug-drug interaction studies

Internal Reference number: TW 3742641

Updated on 24 July 2023

File name

TEPMETKO IE NI TW3742641 current v2.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 of sections 4.4, 4.5 and 5.2 of the SmPC in order to remove the warnings on interactions with ‘CYP and P-gp inducers’ and ‘dual strong CYP3A and P-gp inhibitors, and P-gp inhibitors’ and to update pharmacokinetic information based on final results from the drug-drug interaction studies MS200095-0051 and MS200095-0053

Internal Reference number: TW 3742641

Updated on 04 March 2022

File name

IE NI PIL TEPMETKO.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 March 2022

File name

TEPMETKO IE NI TW2707602 current v1.pdf

Reasons for updating

  • New SPC for new product

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

Merck

Merck