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ItemsRegistration information
ID67
No67
Brand NameMONTULAIR 10
IngredientsMONTELUKAST SODIUM 10.4 MG EQ.TO MONTELUKAST 10 MG
Dosage FormFILM-COATED TABLET
Primary PackagingALU-ALU
StorageSTORE BELOW 30 C
Shelf Life2 YEARS
Pack SizeBOX OF 10 X 10'S
Dispensing CategoryPRESCRITON ONLY
ATC ClassificationXXX
Pharmaceutical ClassANTIASTHMA
IndicationsTREATMENT OF ASTHMA AS ADD-ON THERAPY IN THOSE PATIENT WITH MILD TO MODERATE PERSISTENT ASTHMA WHO ARE INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROID, PROPHYLAXIS OF ASTHMA IN WHICH THE PREDOMINANT COMPONENT IS EXERCISE-INDUCED BRONCHOCONSTRICTION.
ContraindicationsHYPERSENSITIVITY
Side EffectsHEADACHE, PHARYNGITIS, INFLUENZA, FEVER, SINUSITIS, DIARRHEA, UPPER RESPIRATORY TRACT INFECTION, COUGH, ABDOMINAL PAIN, OTITIS MEDIA,
Unit Price
EDL Yes
DescriptionLIGHT PEACH, SQUARE-SHAPE, BICONVEX FILM COATED TABLETS WITH ENGRAVED M10 ON ONE SIDE AND PLAIN ON THE OTHER SIDE
Note
License OwnerAI KEN PHARMA CO., LTD
ManufacturerUNISON LABORATORIES CO.,LTD
CountryTHAILAND
Import Registration No1A 17/58 (NG)
Import Registration Date2015-09-14
ActivityCERTIFICATE RELEASED
Applied Date2022-02-18
FDD Registration No10 I 4815/19
FDD Registration Date2022-08-05
Expiry Date2025-08-04

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