The official letter 18584/QLD-ĐK Update the pharmacological information about levonorgestrel – containing drugs use for emergency contraception

To:

– Provincial/Municipal Health Services

– Hospitals, institutes with beds directly under Ministry of Health

– Drug registration applicants in Vietnam

On December 07, 2016, Medicines and Healthcare products Regulatory Agency (MHRA) has approved the update information on interaction between levonorgestrel-containing emergency contraceptive and hepatic enzyme inducing drugs CYP3A4: barbiturate, phenytoin, carbamazepin, St. John’s Wort, rifampicin, ritonavir, rifabutin and griseofulvin in package insert. When concomitant use of liver enzyme inducers of CYP3A4 with levonogestrel, plasma levels of levonorgestrel can be decreased by around 50%. This interaction may reduce contraceptive efficacy and lead to unwanted pregnancy.

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Following Official Letter No. 4040/QLD-TT dated 30 March 2017 by Drug Administration of Vietnam about providing information on the safety and efficacy of levonorgestrel-containing drugs; and pursuant to the conclusions of the Drug Registration Advisory Council – Ministry of Health, aims to ensure the safe and effective use of drugs, Drug Administration of Vietnam requests as follow:

I. For Provincial/Municipal Health Services and Hospitals, institutes with beds directly under Ministry of Health

Continuing to notify medical facilities, drug business facilities in respective localities about the information related to recommendations from MHRA as prescribed in Official Letter No. 4040/QLD-TT dated 30 March, 2017 by Drug Administration of Vietnam and guideline in Annex of this Official Letter; At the same time, intensify monitoring the ADR in the use process and circulation of the drugs, report ADR (if any) to National DI & ADR Centre (13-15 Le Thanh Tong, Hanoi) or Regional Centre for Drug Information and Adverse Drug Reactions Monitoring in Ho Chi Minh City (201B Nguyen Chi Thanh, Dis.5, Ho Chi Minh City).

II. For drug registration applicants in Vietnam:

1. For Levonorgestrel -containing drugs granted registration numbers:

1.1. Within 03 months from signing date of this Official Letter, drug registration applicants are required to update and supplement information in Dosage and administration, Drug interactions sections on the label and package insert in accordance with the Annex enclosed with this Official letter.
1.2. Form of update: Drug registration applicants automatically update pursuant to the regulation under Clause 4 Article 9 Circular 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health on drug registration.

2. For registration dossiers of Levonorgestrel -containing drugs in process of approving at Drug Administration of Vietnam:

Drug Administration of Vietnam only considers to submit to Drug Registration Advisory Council after Drug registration applicant submit updated and supplement information of Dosage and Administration, Drug interactions in related part of registration dossier in accordance with the Annex enclosed with this Official letter and be validated that meeting requirement.
Drug administration of Vietnam notifies the facilities to know and comply.

For General Director

Vice General Director

(Signed and Sealed)

 Nguyen Tat Dat

For the Annex, please download full version

The official letter 18584/QLD-ĐK Update the pharmacological information about levonorgestrel – containing drugs use for emergency contraception

DOWNLOAD FULL ENGLISH VERSION HERE

18584_QLD_ĐK_2017_VNRAS_ENGLISH

Translated by Minh Van

Copy please refer to vnras.com