Vietnam temporarily suspends import, circulation of 15 types of medicines

Illustrative image (Photo: suckhoedoisong.vn)

Hanoi (VNA) - 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.

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

In order to ensure safety for the users, DAV has required Vietnamese drug manufacturing, trading, importing and distributing establishments to suspend the import, distribution, circulation and use of medicines produced by ArenaGroup S.A.

Hospitals and institutes, and medical examination and treatment facilities nationwide have been also demanded 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 Healthcare Pte. 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. Registration number: 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. Expiry date: September 5, 2021. Registrant: Kien Viet Co., Ltd).

8. Itrozol 100 mg Capsules (active ingredient: Itraconazole (Itraconazole pellets 22%) 100 mg Dosage form: hard capsule. Packing: box of 3 blisters x 5 hard capsules. 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 2 blisters x 10 tablets. Registration number: 15828-12. Expiration date: December 31, 2024. Registrant: Euro Healthcare Pte. Ltd).

10. Nadecin 10mg (active ingredient: Isosorbid dinitrate (Isosorbid dinitrate 25% in lactose) 10mg. Dosage form: tablets. Packing: box of 3 blisters x 10 tablets. Registration number: 17014-13. Expiration date: 31 December 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. Expiration date: March 31, 2022. Registrant: Euro Healthcare Pte. Ltd).

12. Pimoint (active ingredient: Piroxicam 20mg. Dosage form: tablet. Packing: box of 2 blisters x 10 tablets. Registration number: 16214-13. Expiration date: May 11, 2027. Registrant: Euro Healthcare Pte. Ltd).

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

14. SITARA 50mg (active ingredient: Sertraline (Sertraline hydrochloride) 50mg. Dosage form: film-coated tablets. Packing: box of 3 blisters x 10 tablets. Registration number: 594110013323. Expiration date: March 1, 2028. Registrant: Viet Nga Pharmaceutical JSC ).

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