Vietnam temporarily suspends import, circulation of 15 types of medicines

Illustrative image (Photo: suckhoedoisong.vn)

Hanoi (VNA) – The (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 , , 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)./.