SAE Report from Foreign Country in 2016 - SamscaName of Company: PT Otsuka Indonesia

Date of Update: 28-Jan-16

No File Code MFR Control No. Product Country Report Source Report Type Event Term/Describe Reaction(s) Version

1 2015_015280-2-YNY-27-Jan-2016-161110.324 2015_015280 Samsca Japan FU2 3.0.196 27-Jan-16

28-Jan-16

30-Jan-16

2 2016_001628-0-YNY-27-Jan-2016-195404.503 2016_001628 Samsca Japan Initial 2.0.151 28-Jan-16 30-Jan-16

Date Received by PTOI

Date Forwarded to RA

Date Forwarded to BPOM (by

RA)

Submission Deadline

Health Professional, Other

Cardiac failure aggravated (Pleural effusion); [Cardiac failure aggravated]; Hepatic function disorder [Hepatic function disorder]

Health Professional, Other

Other Serious Criteria: Medically Significant; Increased levels of sugar blood and haemoglobin A1c [Haemoglobin A1C increased]; Increased levels of sugar blood and haemoglobin A1c [Sugar blood level increased]; Symptoms like diabetes mellitus [Diabetes mellitus]

SAE Report from Foreign Country in 2016

No MFR Control No. Product

1 2015_015280 Samsca 27-Jan-16

2 2016_001628 Samsca 28-Jan-16

Date Received by Email

Date Submission by Email