EAMS scientific opinion issued to Merck Serono Limited for
tepotinib in the treatment of non-small cell lung cancer that has
certain abnormal changes in the mesenchymal-epithelial transition
factor gene (MET) and which has spread and/or cannot be removed
by surgery.
From:
Medicines and Healthcare
products Regulatory Agency
Published
13 July 2021
Documents
tepotinib: Public
Assessment Report (PAR)
HTML
tepotinib: Public
Assessment Report (PAR)
PDF, 135KB,
3 pages
tepotinib: Treatment
protocol: Information for healthcare professionals
HTML
tepotinib: Treatment
protocol: Information for healthcare professionals
PDF, 274KB,
14 pages
tepotinib:Treatment
protocol: Information for patients
HTML
tepotinib: Treatment
protocol: Information for patients
PDF, 169KB,
6 pages
tepotinib: Treatment
protocol: Information on the Pharmacovigilance
System
HTML
tepotinib: Treatment
protocol: Information on the Pharmacovigilance
System
PDF, 145KB,
3 pages
tepotinib: Information for
NHS Medical Directors
HTML
tepotinib: Information for
NHS Medical Director
PDF, 116KB,
4 pages
Details
For the full EAMS indication please see section 4.1 of the
Treatment protocol: Information for healthcare professionals.
The scientific opinion includes:
- a public assessment report (PAR)
- a treatment protocol:
- for healthcare professionals
- for patients
- on the pharmacovigilance system
- Information for NHS Medical Directors
Information and details regarding patient access
For new patients wishing to access EAMS medicines in England,
trusts must register patients on the NHS England web-based
registration system. Queries to NHS England regarding the scheme
can be submitted to england.eams@nhs.net.
For information about access in Northern Ireland, contact Chief
Pharmaceutical Officer and secondary.care@health-ni.gov.uk.
For information about access in Scotland contact the Scottish
Government Directorate General Health & Social Care at
medicines.policy@gov.scot.
For information about access in Wales, contact the Welsh
Government Health and Social Services Group by emailing Andrew
Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of
Pharmacy and Prescribing policy at Pharmacyand.PrescribingBranch@gov.wales.
