The official letter 15466/QLD-TT about providing the safety information of Methylprednisolone injections containing lactose

To:         – Provincial/Municipal Health Services

– Hospitals, institutes with beds directly under Ministry of Health

On September 12, 2017, Drug Registration Advisory Council – Ministry of Health met to approve registration stage 159^th for domestic drugs and stage 98^th for foreign drugs and unify to update the safety information of Methylprednisolone injections containing lactose as an excipient.

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:

1. Notify medical facilities, pharmaceutical business facilities in respective localities about the safety and efficacy information of Methylprednisolone injections containing lactose as an excipient as prescribed in Annex “Update the safety information of drug” 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.
2. Instruct 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 to 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

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The official letter 15466/QLD-TT about providing the safety information of Methylprednisolone injections containing lactose

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15446_QLD_TT_2017_VNRAS_ENGLISH

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Translated by Minh Van