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1. 84604-20-6
2. Milkthistleextract
3. 65666-07-1
4. A835184
5. (2s)-3,5,7-trihydroxy-2-[(2s,3r)-3-(4-hydroxy-3-methoxyphenyl)-2-(hydroxymethyl)-2,3-dihydro-1,4-benzodioxin-6-yl]-2,3-dihydrochromen-4-one
6. (2s)-3,5,7-trihydroxy-2-[(2s,3r)-3-(4-hydroxy-3-methoxyphenyl)-2-(hydroxymethyl)-2,3-dihydro-1,4-benzodioxin-6-yl]-3,4-dihydro-2h-1-benzopyran-4-one
| Molecular Weight | 482.4 g/mol |
|---|---|
| Molecular Formula | C25H22O10 |
| XLogP3 | 2.4 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 4 |
| Exact Mass | 482.12129689 g/mol |
| Monoisotopic Mass | 482.12129689 g/mol |
| Topological Polar Surface Area | 155 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 750 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
EXPL THER The 2008 Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study, sponsored by the National Institutes of Health (NIH), found that hepatitis C patients who used silymarin had fewer and milder symptoms of liver disease and somewhat better quality of life but no change in virus activity or liver inflammation.
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
EXPL THER A 2012 clinical trial, cofunded by NCCAM and the National Institute of Diabetes and Digestive and Kidney Diseases, showed that two higher-than-usual doses of silymarin were no better than placebo for chronic hepatitis C in people who had not responded to standard antiviral treatment.
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
EXPL THER ...laboratory studies suggested that milk thistle may benefit the liver by protecting and promoting the growth of liver cells, fighting oxidation (a chemical process that can damage cells), and inhibiting inflammation. However, results from small clinical trials of milk thistle for liver diseases have been mixed, and two rigorously designed studies found no benefit.
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
EXPL THER Silymarin has been used in pregnant women who have a bile blockage in the liver, with no toxic effects to the patient or fetus. Silymarin have also been given to children intravenously for mushroom poisoning.
National Cancer Institute; Milk Thistle PDQ; Available from, as of November 2013: https://www.cancer.gov/cancertopics/pdq/cam/milkthistle/Patient/Page2#Section_10
For more Therapeutic Uses (Complete) data for Milk Thistle Extract (16 total), please visit the HSDB record page.
Milk thistle may lower blood sugar levels. People with diabetes or hypoglycemia, or people taking drugs or supplements that affect blood sugar levels, should use caution.
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
Milk thistle can produce allergic reactions, which tend to be more common among people who are allergic to plants in the same family (for example, ragweed, chrysanthemum, marigold, and daisy).
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
In clinical trials, milk thistle appears to be well tolerated in recommended doses. Occasionally, people report various gastrointestinal side effects.
NIH National Center forComplementary and Alternative Medicine; Milk Thistle; Available from, as of November 4, 2013: https://nccam.nih.gov/health/milkthistle/ataglance.htm
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 35256
Submission : 2022-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35254
Submission : 2022-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35255
Submission : 2022-08-02
Status : Active
Type : II
Certificate Number : CEP 2019-261 - Rev 01
Issue Date : 2024-01-19
Type : Herbal
Substance Number : 2071
Status : Valid
Certificate Number : CEP 2017-053 - Rev 01
Issue Date : 2024-03-08
Type : Herbal
Substance Number : 2071
Status : Valid
Registrant Name : Good Pharma Co., Ltd.
Registration Date : 2020-12-22
Registration Number : 20201222-18-K-58-09
Manufacturer Name : Euromed SA
Manufacturer Address : Pol. Can Magarola Carrer del Rec de Dalt, 21-23 08100 Mollet del Valles
Certificate Number : R0-CEP 2017-262 - Rev 01
Issue Date : 2021-02-04
Type : Herbal
Substance Number : 2071
Status : Valid
Certificate Number : R1-CEP 2011-379 - Rev 00
Issue Date : 2017-09-28
Type : Herbal
Substance Number : 2071
Status : Valid
Registrant Name : Good Pharma Co., Ltd.
Registration Date : 2020-12-22
Registration Number : 20201222-18-K-58-09
Manufacturer Name : Euromed SA
Manufacturer Address : Pol. Can Magarola Carrer del Rec de Dalt, 21-23 08100 Mollet del Valles
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Milk Thistle Fruit Dried Extract
Registrant Name : Good Pharma Co., Ltd.
Registration Date : 2020-12-22
Registration Number : 20201222-18-K-58-09
Manufacturer Name : Euromed SA
Manufacturer Address : Pol. Can Magarola Carrer del Rec de Dalt, 21-23 08100 Mollet del Valles
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2018-04-16
Registration Number : 20180416-18-K-32-04
Manufacturer Name : EUROMED, SA
Manufacturer Address : Pol. Can Magarola Carrer del Rec de Dalt, 21-23 08100 Mollet del Valles
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2018-08-16
Registration Number : 20180816-18-K-36-06
Manufacturer Name : EUROMED, SA
Manufacturer Address : Pol. Can Magarola Carrer del Rec de Dalt, 21-23 08100 Mollet del Valles
Milk Thistle Fruit Dried Extract
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-05-27
Registration Number : 20190527-18-K-48-07
Manufacturer Name : Zhejiang Huisong Pharmaceuti...
Manufacturer Address : FarFavour Pharmaceuticals Healthcare Industrial Park, Heping Changxing, Zhejiang, Chi...
Registrant Name : Alpibio Co., Ltd.
Registration Date : 2018-04-17
Registration Number : 20170914-18-K-1-01(1)
Manufacturer Name : Indena SpA
Manufacturer Address : Via Don Minzoni ,6-20090 SETTLA, Italy
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-04-13
Registration Number : 20200413-18-K-53-08
Manufacturer Name : Jiangsu Jianjia Pharmaceutic...
Manufacturer Address : The east side of the Dongtai No.2 Professional Middle School, Jiangsu, China
Milk Thistle Fruit Dried Extract
Registrant Name : Dasan Pharmaceutical Co., Ltd.
Registration Date : 2020-12-22
Registration Number : 20201222-18-K-59-10
Manufacturer Name : Liverd Pharma Co., Ltd.
Manufacturer Address : Gaosheng Economic Zone, Panjin City, Liaoning Province 124123
Registrant Name : Poonglim Pharmaceutical Co., Ltd.
Registration Date : 2018-07-03
Registration Number : 20180703-18-K-36-05
Manufacturer Name : Ningbo Green-Health Pharmace...
Manufacturer Address : Fenghua Xiwu Town Foreign Technological Garden, Ningbo, Zhejiang, China
Registrant Name : GeneuPharma Co., Ltd.
Registration Date : 2018-01-25
Registration Number : 20171226-18-K-20-03(4)
Manufacturer Name : Shaanxi Jiahe Pharmaceutical...
Manufacturer Address : No.45, Hongguang Road, Heping Industrial Park, Fengdong New Town, XiXian New Area, Sh...
Milk Thistle Fruit Dried Extract
Registrant Name : Korea Prime Pharmaceutical Co., Ltd.
Registration Date : 2020-08-06
Registration Number : 20171226-18-K-20-03(5)
Manufacturer Name : Shaanxi jiahe Pharmaceutical...
Manufacturer Address : No.45 Hongguang Road, Heping Industrial Park, Fengdong New Town, XiXian New Area Shaa...
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FDF Dossiers
Regulatory Info :
Registration Country : Spain
Cystine; Milk Thistle Extract; Pygeum Extract; Soybean Extract; Vitamin E; Calcium Pantothenate; Pyridoxine Hydrochloride; Biotin; Iron; Zinc Oxide
Brand Name : Complidermol 5alpha
Dosage Form : Capsule
Dosage Strength : 500MG; 50MG; 50MG; 10MG; 5MG; 2.5MG; 1MG; 0.075MG; 7.5MG; 7.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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