List of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204

13:30, 15/08/2024

The Drug Administration of Vietnam (Ministry of Health) issues the list of 08 drugs and medicinal materials granted the marketing authorization in Vietnam (Batch 204) attached to Decision 590/QD-QLD.

List of 08 medicines and pharmaceutical materials granted marketing authorization in Vietnam - Batch 204

List of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204 (Internet image)

List of drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204

Promulgated together with Decision 590/QD-QLD on August 12, 2024, is the list of 08 drugs and medicinal materials granted the marketing authorization in Vietnam - Batch 204. To be specific:

** List of 04 domestically produced drugs and medicinal materials granted 5-year marketing authorization (Appendix I attached to Decision 590/QD-QLD)

No	Medicine Name	Main Active Ingredient - Dosage	Dosage Form	Packaging Specification	Standard	Shelf Life (months)	Registration Number

1. Registration Entity: Agimexpharm Pharmaceutical Joint Stock Company (Address: 27 Nguyen Thai Hoc, My Binh Ward, Long Xuyen City, An Giang Province, Vietnam)

1.1. Manufacturing Entity: Agimexpharm Pharmaceutical Joint Stock Company - Pharmaceutical Manufacturing Factory Agimexpharm (Address: Lot C4 Binh Hoa Industrial Park, Binh Hoa Commune, Chau Thanh District, An Giang Province, Vietnam)

1	Acetakan 40	Dry extract of Ginkgo leaves (Extractum Folii Ginkgo siccus) (equivalent to 9.6mg flavonol glycoside) 40mg	Hard capsule	Box of 3, 10 blisters x 10 tablets, aluminum - PVC blisters, contained within aluminum bags; Box of 3, 10 blisters x 10 tablets, aluminum - aluminum blisters; Box of 1 bottle x 30, 60, 90 tablets	NSX	36	893210722624
2	Kim Tien Thao AGI 400	Dry extract of Kim Tien Thao (Extractum herbae Desmodii styracifolii siccum) (equivalent to 5000mg Kim Tien Thao) 400mg	Hard capsule	Box of 3, 6, 10 blisters x 10 tablets, aluminum - PVC blisters, contained within aluminum bags; Box of 3, 6, 10 blisters x 10 tablets, aluminum - aluminum blisters; Box of 1 bottle x 60, 100, 200 tablets	NSX	36	893210722724

2. Registration Entity: An Thien Pharmaceutical Joint Stock Company (Address: 314 Bong Sao, Ward 5, District 8, Ho Chi Minh City, Vietnam)

2.1. Manufacturing Entity: An Thien Pharmaceutical Joint Stock Company (Address: Lot C16, Street No. 9, Hiep Phuoc Industrial Park, Hiep Phuoc Commune, Nha Be District, Ho Chi Minh City, Vietnam)

3	A.T Gingloba 40	10ml vial containing: Dry Ginkgo leaf extract (Ginkgo biloba extract) (Extractum Folii Ginkgo siccus) (equivalent to 9.6mg total flavonoids calculated as quercetin) 40mg	Liquid extract	Box of 20 vials, 30 vials, 50 vials x 10ml	NSX	24	893200722824

3. Registration Entity: Traphacosapa One Member Ltd. (Address: Group 2, Phan Si Pang Ward, Sapa district-level town, Lao Cai Province, Vietnam)

3.1. Manufacturing Entity: Traphacosapa One Member Ltd. (Address: Lot F5, Dong Pho Moi Industrial Park, Pho Moi Ward, Lao Cai City, Vietnam)

4	Artichoke Dry Extract EP	10kg of dry extract equivalent to 588kg of fresh Artichoke leaf (Folium Cynarae scolymi)	Pharmaceutical material (Dry extract)	Bag 500g; Bag 10kg; Bag 20kg	NSX	36	893500722924

Note:

How to write the quality standard of the medicine in column (6):

- Manufacturer (NSX), Manufacturer's Standard (TCNSX), Internal Standard (TCCS), In-house have equivalent meanings, which are quality standards of medicines established by the manufacturer and can all be written on the medicine label.

- Abbreviations for standard pharmacopoeias: Vietnamese Pharmacopoeia (DDVN), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (CP), European Pharmacopoeia (EP), International Pharmacopoeia (IP)…

** List of 04 foreign medicines granted 5-year marketing authorization (Appendix II attached to Decision 590/QD-QLD)

No	Medicine Name	Main Active Ingredient - Dosage	Dosage Form	Packaging Specification	Standard	Shelf Life (months)	Registration Number
(1)	(2)	(3)	(4)	(5)	(6)	(7)	(8)

1. Registration Entity: Duy Tan Pharmaceutical Joint Stock Company (Address: 38/6i Nguyen Van Troi, Ward 15, Phu Nhuan District, Ho Chi Minh City, Vietnam)

1.1. Manufacturing Entity: Dr. Willmar Schwabe GmbH & Co. KG (Address: Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany)

1	Cebrex S	Dry Ginkgo biloba leaf extract (Extractum Folium Ginkgo biloba Siccus) (35-67:1) [standardized to 19.2mg ginkgo flavon glycosides and 4.8mg terpene lactones (ginkgolides, bilobalide)] Solvent of extraction: 60% acetone (w/w) 80mg	Film-coated tablet	Box of 6 blisters x 20 tablets	NSX	60	400200723024

2. Registration Entity: DO HA Pharmaceutical Co., Ltd (Address: No. 30 Tran Phu Collective, Alley 105, Nguyen Phong Sac Street, Group 16, Dich Vong Hau Ward, Cau Giay District, Hanoi, Vietnam)

2.1. Manufacturing Entity: S.C. Slavia Pharm S.R.L. (Address: B-dul Theodor Pallady nr. 44C, sector 3, cod 032266, Bucuresti, Romania)

2	Goliot	Each hard capsule contains dry Ginkgo biloba leaf extract (Ginkgo biloba L.), (containing 25.08-34.02mg Ginkgo flavone glycoside, 2.96-4.03mg Bilobalide, and 3.19-4.28mg Ginkgolides A, B, C) 120mg	Hard capsule	Box of 2 blisters x 10 capsules; Box of 3 blisters x 10 capsules; Box of 12 blisters x 10 capsules	NSX	36	594210723124
3	Goliot	Each hard capsule contains dry Ginkgo biloba leaf extract (Ginkgo biloba L.), (containing 16.72-22.68mg Ginkgo flavone glycoside, 1.98-2.69mg Bilobalide, and 2.13-2.86mg Ginkgolides A, B, C) 80mg	Hard capsule	Box of 2 blisters x 10 capsules; Box of 3 blisters x 10 capsules; Box of 12 blisters x 10 capsules	NSX	36	594210723224

3. Registration Entity: Pharmaceutical Works POLPHARMA S.A. (Address: ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland)

3.1. Manufacturing Entity: Pharmaceutical Works POLPHARMA S.A.; Medana Branch in Sieradz (Address: 57 Polskiej Organizacji Wojskowej St, 98-200 Sieradz, Poland)

Production Lot Facility: Pharmaceutical Works POLPHARMA S.A.; Medana Branch in Sieradz (Address: 10 Wladyslawa Lokietka St., 98-200 Sieradz, Poland)

4	HeliPico	Dry extract of Ivy leaf (Hederae helicis folii extractum siccum, DER 4-8:1). Extractive solvent: 30% ethanol (w/w) 27.78mg/5ml (equivalent to 166.68mg ivy leaf)	Syrup	Box of 1 Bottle x 100ml	NSX	24	590200723324

Note:

1. How to write the quality standard of the medicine in column (6):

More details can be found in Decision 590/QD-QLD which comes into force in Vietnam from August 12, 2024.

Tran Huyen Trang

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