| MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIET NAM ———————— |
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness ——o0o—– |
| N0 12312/QLD-TT | |
| About: Provide the safety information of Gadolinium-containing contrast agents; Codeine, Tramadol-containing drugs; Hyoscine butylbromide injections; Risperidone-containing drugs; Skin antiseptic chlorhexidine gluconate | Hanoi, August 15, 2017 |
To: – Provincial/Municipal Health Services
– Hospitals, institutes with beds directly under Ministry of Health
On May 19, 2017, Drug Registration Advisory Council met to approve registration stage 158th for domestic drugs and stage 97th for foreign drugs and unify to update the safety information of: Gadolinium-containing contrast agents; Codeine, Tramadol-containing drugs; Hyoscine butylbromide injections; Risperidone-containing drug; Skin antiseptic chlorhexidine gluconate.
In order to ensure the safe and effective use of drugs, Drug Administration of Vietnam requests Provincial/Municipal Health Services, Hospitals, institutes with beds directly under Ministry of Health as follow:
- Notify medical facilities, pharmaceutical business facilities 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 healthcare 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 request 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 12312/QLD-TT Provide the safety information of Gadolinium-containing contrast agents; Codeine, Tramadol-containing drugs; Hyoscine butylbromide injections; Risperidone-containing drugs; Skin antiseptic chlorhexidine gluconate
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