INFORMED CONSENT for ACTEMRA UN-LICENSED INDICATION

RS St Elisabeth
Hospital _____________________ hereby certify that:

Actemra 400 mg ____

The purchase order to PT Tempo for product _____________, 2 vials (as per
Purchase Order number _________ as per-attached) is intended for the treatment of
hospitalized COVID-19 patients.

Patient Initial(s): ny. PSIC

Treating Physician(s):

Hospital ____________________ is fully aware that the usage of drugs as mentioned

above is for an unlicensed indication in Indonesia.

Hospital Authorized Person,

Name
Title
Date

[ In Indonesia, Actemra (tocilizumab) is approve by BPOM for Rheumatoid Arthritis

(RA), Polyarticular Juvenile Idiopathic Arthritis (pJIA), and Systemic Juvenile Idiopathic
Arthritis (sJIA). It is not approved for the treatment of hospitalized COVID-19 patients.
As evaluating the risk-benefit profile of Actemra use is important for Patient Safety Risk
Management, Roche encourage HCP to report the use of Actemra in COVID-19
patients and its adverse event through online form: https://cprt.roche.com/ or contact
Roche Patient Safety at indonesia.safety@roche.com].