Subject: RE: Gilead Query MCN 2018-0331147, Patient: 48 year old male, DOB 27-DEC-1969, Adverse Event(s): Anemia, HARVONI
From: "Maia Nikoleishvili" <[email-masked]>
To: "Elizabeth A" <Larson>
Cc: "Sopo" <Belkania>
Date: Tue, 24 Apr 2018 14:07:47 +0400

Dear Ms. Larson,

Per your request I would like to provide you with the filled Post Market Query form regarding the patient M.A. DOB 27-DEC-1969.

Kind regards,

Maia

Maia Nikoleishvili MPA

Chief Specialist of International Relations Division

HR Management and International Relations Department

Ministry of Labour, Health and Social Affairs of Georgia

144 Tsereteli ave., 0159 Tbilisi, Georgia

Tel.: +995 32 2510034 (0803)

Cell phone: +995 577272713

E-mail: [email-masked]

From: Elizabeth A Larson [mailto:[email-masked]]
Sent: Wednesday, April 18, 2018 7:29 PM
To: Maia Nikoleishvili <[email-masked]>
Subject: Gilead Query MCN 2018-0331147, Patient: 48 year old male, DOB 27-DEC-1969, Adverse Event(s): Anemia, HARVONI

Pharmacovigilance & Epidemiology

MCN: 2018-0331147

Dear colleague,

This is regarding a report for Patient: 48 year old male,  DOB 27-DEC-1969,  Adverse Event(s): Anemia while on HARVONI

To comply with our global regulatory reporting obligations and as part of our pharmacovigilance process we are required to report adverse events that may be associated with our product. Patient confidentiality will be maintained in accordance with applicable laws/policies.*

Following review of the reported information, the safety physician would like to request additional information regarding this case.

1. Please complete the attached Post Marketed Questionnaire.

If the requested information is not available, please provide a response to this query indicating that the requested information is not available.

Please reply to fax number 650-522-5477 or e-mail your response to [email-masked].

Thank you for your assistance with this case.

Elizabeth Larson

Gilead Sciences

Pharmacovigilance & Epidemiology

333 Lakeside Drive
Foster City, CA 94404
Telephone: 650-522-4713

[email-masked]

Please be aware that information provided to Gilead relating to you, may be used to comply with applicable laws and regulations.   By providing us with information you are consenting to the control and processing of this personal or sensitive data by Gilead in accordance with applicable data protection laws and the Gilead privacy policy, available to you either on www.gilead.com/privacy or upon request.