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ItemsRegistration information
ID76
No76
Brand NamePRADOX 100
IngredientsTOPIRAMATE MICRONIZED 100 MG
Dosage FormFILM COATED TABLET
Primary PackagingALU-ALU
StorageSTORE AT TEMPERATURE NOT MORE THAN 30 C
Shelf Life3 YEARS
Pack SizeBOX OF 6 X 10'S
Dispensing CategoryPRESCRIPTION
ATC ClassificationN03AX11
Pharmaceutical ClassANTIEPILEPTIC
IndicationsMONOTHERAPY IN ADULTS, ADOLESCENTS AND CHILDREN OVER 6 YEARS OF AGE WITH PARTIAL SEIZURES WITH OR WITHOUT SECONDARY GENERALISED SEIZURES AND PRIMARY GENERALIZED TONIC CLONIC SEIZURES, ADJUNCTIVE THERAPY IN CHILDREN AGED 2 YEARS AND ABOVE, ADOLESCENTS AND ADULTS WITH PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALISED SEIZURES AND PRIMARY GENERALIZED TONIC CLONIC SEIZURES AND FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
ContraindicationsHYPERSENSITIVITY, MIGRAINE PROPHYLAXIS IN PREGNANCY AND IN WOMEN OF CHILDBEARING POTENTIAL IF NOT USING A HIGLY EFFECTIVE METHOD OF CONTRACEPTION
Side EffectsANOREXIA, ANXIETY, DIARRHEA, FATIGUE, FEVERE, INFECTION, WEIGHT DECRESE, COGNITIVE PROBLEMS, PARESTHESIA, SOMNOLENCE, TASTE PERVERSION, MOOD PROBLEM,NAUSEA,
Unit Price6950
EDL No
DescriptionYELLOW, ROUND, BICONVEX, FILM COATED TABLET WITH ENGRAVED T ON ONE SIDE AND 100 ON THE OTHER
Note
License OwnerAI KEN PHARMA CO., LTD
ManufacturerUNISON LABORATORIES CO., LTD
CountryTHAILAND
Import Registration No1A 24/59 (NG)
Import Registration Date2016-07-15
ActivityCERTIFICATE RELEASED
Applied Date2021-01-14
FDD Registration No10 I 5292/22
FDD Registration Date2022-10-14
Expiry Date2025-10-13

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