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Items	Registration information
ID	78
No	78
Brand Name	PRADOX 25
Ingredients	TOPIRAMATE MICRONIZED 25 MG
Dosage Form	FILM COATED TABLET
Primary Packaging	ALU-ALU
Storage	STORE AT TEMPERATURE NOT MORE THAN 30.C
Shelf Life	3 YEARS
Pack Size	BOX OF 6 X 10'S
Dispensing Category	PRESCRIPTION ONLY
ATC Classification	N03AX11
Pharmaceutical Class	ANTIEPILEPTIC
Indications	MONOTHERAPY IN ADULTS, ADOLESCENTS AND CHILDREN OVER YEARS OF AGE WITH PARTIAL SEIZURES WITH OR WITH SECONDARY GENERALIZED, PRIMARY GENERALISED TONIC-CLONIC SEIZURES, AGJUNCTIVE THERAPY IN CHILDREN AGED 2 YEARS AND ABOVE, ADOLESCENTS AND ADULTS WITH PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALIZATION OR PRIMARY GENERALISED TONIC-CLINIC SEIZURES AND FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
Contraindications	HYPERSENSITIVITY, MIGRAINE PROPHYLAXIS IN PREGNANCY AND IN WOMEN OF CHILDREN POTENTIAL IF NOT USING A HIGHLY EFFECTIVE METHOD OF CONTRACEPTION
Side Effects	ANOREXIA, ANXIETY, DIARRHEA, FATIGUE, FEVER, INFECTION, WEIGHT DECREASE, COGNITIVE PROBLEMS, PARESTHESIA, SOMNOLENCE, TASTE PERVERSION, MOOD PROBLEMS, NAUSEA, NERVOUSNESS, CONFUSION
Unit Price
EDL	No
Description	WHITE, ROUND, BICONVEX, FILM COATED TABLET WITH ENGRAVED T ON ONE SIDE AND 25 ON THE OTHER
Note
License Owner	AI KEN PHARMA CO., LTD
Manufacturer	UNISON LABORATORIES CO., LTD
Country	THAILAND
Import Registration No	1A 22/59(NG)
Import Registration Date	2016-07-15
Activity	CERTIFICATE RELEASED
Applied Date	2021-04-22
FDD Registration No	10 I 5293/22
FDD Registration Date	2022-10-14
Expiry Date	2025-10-13

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