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ItemsRegistration information
ID412
No412
Brand NameAKYNZEO
IngredientsPALONOSETRON HYDROCHLORIDE EQ.TO PALONOSETRON 0.5 MG, NETUPITANT 300 MG
Dosage FormCAPSULE
Primary PackagingALU-BLISTER
StorageDO NOT STORE ABOVE 30 C
Shelf Life4 YEARS
Pack SizeBOX OF 1 CAPSULE
Dispensing CategoryPrescription only
ATC ClassificationA01AA55
Pharmaceutical ClassANTIEMETICS
IndicationsPREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CISPLATIN BASED CANCER CHEMOTHERAPY, PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITIN ASSOCIATED WITH MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
ContraindicationsHYPERSENSIVITY, PREGNANCY
Side Effects
Unit Price
EDL No
DescriptionOPAQUE GELATIN CAPSULE OF SIZE 0 WITH WHITE BODY AND CARAMEL CAP WITH HE1 PRINTED ON THE BODY, THE HARD CAPSULE IS FILLED WITH TABLETS AND ONE SOFT CAPSULE
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerHELSINN BIREX PHARMACEUTICALS LTD
CountryIRELAND
Import Registration NoEU/1/15/1001/001-002
Import Registration Date27.5.2015
ActivityCERTIFICATE RELEASED
Applied Date2021-05-21
FDD Registration No04 I 5474/23
FDD Registration Date2023-04-25
Expiry Date2026-04-24

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