| MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIET NAM ———————— |
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ——o0o—– |
| N0 4040/QLD-TT about: Provide the safety information of Levonorgestrel-containing emergency contraceptives, Direct acting antiviral drugs (DAA) for the treatment of hepatitis C, Warfarin-containing drugs | Hanoi, March 30, 2017 |
To: – Provincial/Municipal Health Services
– Hospitals, institutes with beds directly under Ministry of Health
On January 13, 2017, Drug Registration Advisory Council met to approve the registration stage 157th for domestic drugs and the stage 96th for foreign drugs and unify to update the safety information of: Levonorgestrel-containing emergency hormonal contraceptives interact with CYP3A4 enzyme inducers, Direct acting antiviral drugs (DAA) for the treatment of hepatitis C, Warfarin-containing drugs.
In order to ensure the safe and effective use of drugs, Drug Administration of Vietnam requires Provincial/Municipal Health Services, Hospitals, institutes with beds directly under Ministry of Health as follow:
- Inform medical facilities, pharmaceutical business in respective localities about the safety and efficacy information of above drugs as prescribed in Annex “Update the safety information of drugs” enclosed with this Official Letter; At the same time, it is uploaded on the portal of the Drug Administration of Vietnam at http://www.dav.gov.vn in the section “Drug information” so that health professionals may search and update information.
- Guiding medical facilities in respective localities to enhance monitoring, detection and management the adverse drug reactions of above drugs (if any) and report ADR to NationalDI & ADR Centre (13-15 Le Thanh Tong, Hanoi) or Regional Centre forDrug Information and Adverse Drug Reactions Monitoring in Ho Chi Minh City (201B Nguyen Chi Thanh, Dis.5, Ho Chi Minh City).
Drug Administration of Vietnam will continue update the safety information and management guideline of ADR of above drugs to require Drug registration applicants updating information to the label and package insert.
Drug administration of Vietnam notifies the facilities to know and comply.
For General Director
Vice General Director
(Signed and Sealed)
Nguyen Tat Dat
The official letter 4040/QLD-TT Provide the safety information of Levonorgestrel-containing emergency contraceptives, Direct acting antiviral drugs (DAA) for the treatment of hepatitis C, Warfarin-containing drugs
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