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Vietnam temporarily suspends import, circulation of 15 types of medicines

The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) has just issued an official dispatch on suspending the import, distribution, circulation and use of 15 types of medicines produced by Arena Group S.A. of Romania.
Vietnam temporarily suspends import, circulation of 15 types of medicines ảnh 1Illustrative image (Photo: suckhoedoisong.vn)

Hanoi (VNA) - The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) hasjust issued an official dispatch on suspending the import, distribution,circulation and use of 15 types of medicines produced by Arena GroupS.A. of Romania.

ﷺ Earlier, the European Medicines Agency (EMA) had announced the revocation of the GMP certificate of Arena GroupS.A due to its failure to comply with GMP principles and regulations on drugproduction.

Inorder to ensure safety for the users, DAV has required Vietnamese drugmanufacturing, trading, importing and distributing establishments to suspendthe import, distribution, circulation and use of medicines produced byArenaGroup S.A.

Hospitalsand institutes, and medical examination and treatment facilities nationwide have been alsodemanded to temporarily stop using the medicines, which are listed as follows.

1. Apratam (active ingredient Piracetam 400mg. Dosage form:hard capsule. Packing: box of 3 blisters x 10 tablets. Registration number:VN-15827-12. Expiration date: December 31, 2024. Registrant: Euro HealthcarePte. Ltd).

2.Calmadon (active ingredient: Risperidone 2mg. Dosage form: film-coated tablet.Packing: box of 2 blisters x 10 tablets. Registration number: VN-22972 -21.Expiration date: November 29,2026. Registrant: Euro Healthcare Pte. Ltd).

3.Carbaro 200mg (active ingredient: Carbamazepine 200mg. Dosage form: tablets.Packing: box of 2 blisters x 10 tablets. Registration number: VN-19895-16.Expiration date: September 5, 2021. Registrant: Euro Healthcare Pte. Ltd).

4.Etrix 10mg (active ingredient: Enalapril maleate 10mg. Dosage form: tablets.Packing: box of 3 blisters x 10 tablets. Registration number: VN-19109-15.Expiry date: December 31, 2024. Registrant: Euro Healthcare Pte. Ltd).

5.Euronida 4mg (active ingredient: Cyproheptadine hydrochloride 4mg. Dosage form:tablets. Packing: box of 3 blisters x 10 tablets. Registration number: VN-18646-15. Expiration date: February 9, 2020. Registrant: An Dong Pharmaceutical JSC).

6.Europlin 25mg (active ingredient: Amitriptylin HCI 25mg. Dosage form:film-coated tablets. Packing: box of 5 blisters x 10 tablets. Registrationnumber: VN. -20472-17. Expiry date: June 8, 2022. Registrant: Kien Viet Co.,Ltd).

7.Eurovir 200mg (active ingredient: Aciclovir 200mg. Dosage form: hard capsule.Packing: box of 2 blisters x 10 tablets. Registration number: 19896-16. Expirydate: September 5, 2021. Registrant: Kien Viet Co., Ltd).

8.Itrozol 100 mg Capsules (active ingredient: Itraconazole (Itraconazole pellets22%) 100 mg Dosage form: hard capsule. Packing: box of 3 blisters x 5 hardcapsules. Registration number: 22913-21. Expiration date: September 10, 2026.Registrant: Euro Healthcare Pte. Ltd).

9.Mildocap (active ingredient: Captopril. Dosage form: tablets. Packing: box of 2blisters x 10 tablets. Registration number: 15828-12. Expiration date: December31, 2024. Registrant: Euro Healthcare Pte. Ltd).

10. Nadecin 10mg (active ingredient: Isosorbid dinitrate (Isosorbiddinitrate 25% in lactose) 10mg. Dosage form: tablets. Packing: box of 3blisters x 10 tablets. Registration number: 17014-13. Expiration date: 31December 2024. Registrant: Euro Healthcare Pte. Ltd).

11. Pasapil (active ingredient: Enalapril maleate. Dosage form: tablets.Packing: box of 3 blisters x 10 tablets. Registration number: 15829-12. Expirationdate: March 31, 2022. Registrant: Euro Healthcare Pte. Ltd).

12.Pimoint (active ingredient: Piroxicam 20mg. Dosage form: tablet. Packing: boxof 2 blisters x 10 tablets. Registration number: 16214-13. Expiration date: May11, 2027. Registrant: Euro Healthcare Pte. Ltd).

13. Camnoxi 20mg (active ingredient: Tenoxicam 20mg. Dosageform: tablets. Packing: box of 10 blisters x 10 tablets. Registration number:594110008823. Expiration date: March 1, 2028. Registrant: Viet NgaPharmaceutical JSC).

14.SITARA 50mg (active ingredient: Sertraline (Sertraline hydrochloride) 50mg. Dosageform: film-coated tablets. Packing: box of 3 blisters x 10 tablets. Registrationnumber: 594110013323. Expiration date: March 1, 2028. Registrant: Viet NgaPharmaceutical JSC ).

ꦫ 15.Eurozitum 60mg (active ingredient: Diltiazemhydrochloride 60mg. Dosage form: tablets. Packing: box of 5 blisters x 10tablets. Registration number: VN-16697 -13 new SDK: 594110027423. Expirationdate: March 2, 2028. Registrant: Euro Healthcare Pte Ltd)./.

VNA
#Drug Administration of Vietnam #import #distribution #circulation #Arena Group S.A #Vietnamplus #Vietnam news #Vietnam News Agency

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