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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 16-Oct-2019 09:58:10

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • GP Practices

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION / ACTION, AVENTIS PHARMA LIMITED T/A SANOFI, RIFADIN (RIFAMPICIN) 150MG CAPSULES

Broadcast content:
Sanofi has informed us that a change to the Patient Information Leaflet (PIL) for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required timeline. For the affected batch (9G020A) healthcare professionals are asked to remove the PIL in the pack and provide a copy of the correct version, which can be downloaded from the following link https://www.medicines.org.uk/emc/product/6382/pil.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts.


Additional information: GP Practices: please note this information is for dispensing GP practices to action.
NHS England Regional Offices: please cascade this alert to community pharmacy.


Alert reference: EL (19)A/25

Attachments:
Cascade to:
  • #GP#
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency