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ItemsRegistration information
ID570
No570
Brand NameNEPEXTO 25 MG/0.5 ML
IngredientsETANERCEPT (R-DNA ORIGIN) 25 MG/0.5 ML
Dosage FormSOLUTION FOR INJECTION
Primary PackagingPRE-FILLED SYRINGE
StorageSTORE AT 2-8C
Shelf Life2 YEARS
Pack Size1 MLSINGLE USE PRE-FILLED SYRINGE
Dispensing CategoryPrescription only
ATC ClassificationL04AB01
Pharmaceutical ClassANTINEOPLASTIC
IndicationsRHEUMATOID ARTHRITIS, JUVENILE IDIOPATHIC ARTHRITIS, PSORIATIC ARTHRITIS, AXIAL SPONDYLOARTHRITIS
ContraindicationsHYPERSENSITIVITY, SEPSIS OR RISK OF SEPSIS, ACTIVE INFECTION INCLUDNG CHRONIC ORLOCALIZED INFECTION
Side EffectsSITE REACTION, INFECTION, BRONCHITIS BLADDER INFECTION, SKIN INFECTION,
Unit Price
EDL No
DescriptionCLEAR, SLIGHTLY OPALESCENT, COLORLESS OR PALE YELLOW SOLUTION
Note
License OwnerDKSH LAOS COMPANY LIMITED
ManufacturerLUPIN LIMITED(BIOTECH DIVISION)
CountryINDIA
Import Registration NoPDVACC12 (FORM 28D)
Import Registration Date2019-07-22
ActivityCERTIFICATE RELEASED
Applied Date03-FEB-20222
FDD Registration No07 I 5560/23
FDD Registration Date2023-07-07
Expiry Date2026-07-06

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