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INFORMED CONSENT for ACTEMRA UN-LICENSED INDICATION

Hospital Sumber Waras Cirebon hereby certify that:

order to PT Tempo for product ACTEMRA, 2 vials (as per


Purchase Order number two as per-attached) is intended for the treatment of
hospitalized COVID-19 patients.

Patient Initial(s): Tn A

Treating Physician(s): dr. H.Edy Kurniawan Sp.P

Hospital Sumber Waras Cirebon is fully aware that the usage of drugs as mentioned
above is for an unlicensed indication in Indonesia.

Hospital Authorized Person,

dr. H.Edy Kurniawan Sp.P


Pulmonologist
March 03 2021

[ 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].

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