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ItemsRegistration information
ID562
No562
Brand NameMOTILIUM
IngredientsDOMPERIDONE 10 MG
Dosage FormFILM COATED TABLET
Primary PackagingALU/PVC BLISTER
StorageSTORE BELOW 30'C
Shelf Life3 YEARS
Pack SizeBOX OF 3 X 10’S
Dispensing CategoryPrescription only
ATC ClassificationA03FA03
Pharmaceutical ClassANTIVERTIGO
IndicationsTHE DYSPEPTIC SYMPTOM COMPLEX THAT IS OFTEN ASSOCIATED WITH DELAYED GASTRIC EMPTYING, GASTRO - ESOPHAGEAL REFLUX AND ESOPHAGITIS. NAUSEA AND VOMITING, OF FUNCTIONAL, ORGANIC, INFECTIOUS OR DIETARY ORIGIN. NAUSEA AND VOMITING INDUCED BY RADIOTHERAPY OR DRUG THERAPY.
ContraindicationsMOTILIUM - M IS CONTRAINDICATED IN THE FOLLOWING SITUATIONS : KNOW HYPERSENSITIVITY TO DOMPERIDONE OR ANY OF THE EXCIPIENTS.
Side EffectsTHE SAFETY OF MOTILIUM - M WAS EVALUATED IN 1221 PATIENTS WITH GASTROPARESIS, DYSPEPSIA, GASTRO - OESOPHAGEAL REFLUX DISORDER(GERD), OR OTHER RELATED CONDITIONS IN 45 CLINICAL TRAILS INCLUDED IN THE SAFETY DATABASE.
Unit Price
EDL Yes
DescriptionWHITE TO FAINTLY CREAM-COLORED ROUND TABLETS (WITH ''JANSSEN'' PRINTED ON ONE SIDE AND 'M/10 ON THE OTHER SIDE.
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerLUSOMEDICAMENTA SOCIEDADE TECNICA FARMACEUTICA, S.A
CountryPORTUGAL
Import Registration No9512814
Import Registration Date1980-09-10
ActivityCERTIFICATE RELEASED
Applied Date2022-02-25
FDD Registration No05 I 5518/23
FDD Registration Date2023-05-15
Expiry Date2026-05-14

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