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Items	Registration information
ID	79
No	79
Brand Name	PRADOX 50
Ingredients	TOPIRAMATE MICRONIZED 50 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
ATC Classification	N03AX11
Pharmaceutical Class	ANTIEPILEPTIC
Indications	MONOTHERAPY 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
Contraindications	HYPERSENSITIVITY, MIGRAINE PROPHYLAXIS IN PREGNANCY AND IN WOMEN OF CHILDBEARING POTENTIAL IF NOT USING A HIGLY EFFECTIVE METHOD OF CONTRACEPTION
Side Effects	ANOREXIA, ANXIETY, DIARRHEA, FATIGUE, FEVERE, INFECTION, WEIGHT DECRESE, COGNITIVE PROBLEMS, PARESTHESIA, SOMNOLENCE, TASTE PERVERSION, MOOD PROBLEM,NAUSEA,
Unit Price	4450
EDL	No
Description	PALE YELLOW, ROUND, BICONVEX, FILM COATED TABLET WITH ENGRAVED T ON ONE SIDE AND 50 ON THE OTHER
Note
License Owner	AI KEN PHARMA CO., LTD
Manufacturer	UNISON LABORATORIES CO., LTD
Country	THAILAND
Import Registration No	1A 23/59 (NG)
Import Registration Date	2016-07-15
Activity	CERTIFICATE RELEASED
Applied Date	2021-01-14
FDD Registration No	10 I 5294/22
FDD Registration Date	2022-10-14
Expiry Date	2025-10-13

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