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Food and Drug Administration Ministry of Public Health
Show details of medicinal product [Details of Medicinal Product]
Drug registration number [Marketing Authorization Number] :
2C 4/66 (NBC)
Approval Date [Approval Date] :
8 May 2023
Expiration date [Validity Date] :
7 May 2030
Thai trade name [Tradename in Thai] :
Qdenka
English trade name [Tradename in English] :
QDENGA
Medicine category [Basic Dose Form] :
medicine powder
Drug form [Pharmaceutical Dose Form in Thai] :
-
Drug form [Pharmaceutical Dose Form in English] :
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Type of medicine [Category by point of use] :
medicine for internal use
Category of legally controlled drugs [Category by legislation class] :
Specially controlled drugs
Drug formula group [ATC likes Classification] :
No. : 1 Code : J07BX04
Drug Formulary Group : DENGUE VIRUS VACCINE
Details : J07BX04
Indications for use [Indication] :
Used to prevent hemorrhagic disease caused by various strains of dengue virus. In people aged 4 years and up to 60 years.
Active ingredients per unit [Formular : Shown only Active Ingradients] :
Components of the drug in this drug formula (quantity/unit)
Formula number 1/1 1 unit is 0.5 milliliter
1. LIVE ATTENUATED DENGUE VIRUS SEROTYPE 1 quantity/unit >=3.3 log(10) PFU/dose at end of shelf life
2. LIVE ATTENUATED DENGUE VIRUS SEROTYPE 2 quantity/unit >= 2.7 log(10) PFU/dose at end of shelf life
3. LIVE ATTENUATED DENGUE VIRUS SEROTYPE 3 dose/unit >=4.0 log(10) PFU/dose at end of shelf life
4. LIVE ATTENUATED DENGUE VIRUS SEROTYPE 4 dose/unit >=4.5 log(10) PFU/dose at end of shelf life
Veterinary drug information [Information for Veterinary use only] :
Type of animal : -
Type of animal : -
Use : -
Consumable parts : -
Stopping period : -
Size and method of use :
Contraindications [Contraindications] :
https://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/pop-up_drug_ex.aspx?Newcode=U1DR2C1072660000411C 1/2
2024/4/26 上午9:56 Check the product
License number [License Number] :
NY1 กท 224/2526
Name of licensee [Name of Licensee] :
Takeda (Thailand) Company Limited
Place name [Name of Establishment] :
Takeda (Thailand) Company Limited
Location [Address] :
House number 57, Park Ventures Ecoplex Building, 15th Floor, Wireless Road, Lumpini Subdistrict, Pathumwan District, Bangkok
10330 Tel. 0 2697 9300
Reference number for License per Invoice [Newcodes for LPI] :
U1DR2C1072660000411C
Details of Manufacturer [Detail of Manufacturer(s)]:
No. : 1 Manufacturer's name IDT BIOLOGIKA GMBH
City name DESSAU-ROSSLAU
Country name Federal Republic of Germany
Duty to produce ready-made medicines
No. : 2 Manufacturer's name IDT BIOLOGIKA GMBH
City name DESSAU-ROSSLAU
Country name Federal Republic of Germany
Duty to repack
No. No. : 3 Manufacturer's name TAKEDA GMBH
City name SINGEN
Country name Federal Republic of Germany
Duty to repack drug products that do not come into contact with drugs
No. : 4 Manufacturer's name TAKEDA GMBH
City name SINGEN
Country name Federal Republic of Germany
Duty to inspect, release or pass for For sale
Distributor Name [Distributor Name] :
Registration status [Marketing Authorization Status] :
remain
Reason for canceling request [Reason for non-active MA Status] :
-
Cancellation date [Cancel or Revoke Date] :
-
Updated data as of [Update Data] :
8 May 2023 11:13:38
Show information as of [Date Shown] :
26 April 2024 9:51:47
Food and Drug Administration Office: 88/24 Tiwanon Road, Mueang District, Nonthaburi Province 11000 Telephone 0-2590-7000
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