TEPMETKO 225 mg film-coated tablets
*Company:
MerckStatus:
No Recent UpdateLegal 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
Updated on 04 May 2026
File name
TEPMETKO IE TW5379902 current v5 clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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
Change in the composition of the finished product to replace the current non-functional film-coating system Opadry® II pink (33G240013) of the finished product TEPMETKO 225 mg film-coated tablets, with non-functional film-coating system Opadry® II pink (85F34311-CN).
Minor change in the manufacturing process of the finished product to adapt the target value for the CPP “outlet air temperature” (45°C) to a slightly higher target value of 48°C.
Internal reference number: TW5379902
Updated on 04 May 2026
File name
IE PIL TEPMETKO film-coating.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Change in the composition of the finished product to replace the current non-functional film-coating system Opadry® II pink (33G240013) of the finished product TEPMETKO 225 mg film-coated tablets, with non-functional film-coating system Opadry® II pink (85F34311-CN).
Minor change in the manufacturing process of the finished product to adapt the target value for the CPP “outlet air temperature” (45°C) to a slightly higher target value of 48°C.
Internal reference number: TW5379902
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
Address:
Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@merckgroup.comTelephone:
+353 1 468 7590Fax:
+353 1 466 3446Medical Information Facsimile:
+44 (0)208 818 7274Medical Information Direct Line:
+44 (0)208 818 7373