Public View of Products Under Renewal Review

Product Details

#Product Registration NoProduct Trade NameInn Of ApiDosage Form NameCountry of OriginMah Company NameLocal Technical RepresentativeLocal ForeignProduct Status
1H2006/186/R1Cotrimoxazole 960mg TabletsSulphamethoxazole B.P & Trimethoprim B.PTabletKenyaHarley's limitedHARLEYS LTD-NAIROBILocalUnder Renewal Review and SmPC Like Information
2H2011/7350Cataflam 50mgTabletsDiclofenac PotassiumCoated TabletSwitzerlandNovartis Pharma Services IncNVS KENYA LTDForeignUnder Renewal Review and SmPC Like Information
3H2015/CTD2890/467Vitamin A Capsules USP 200000 IUVitamin A PalmitateCapsule, SoftIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
4H2009/20962/633CABALIN 150PregabalinCapsuleIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
5H2010/21777/648ACINET 156 DRY SYRUPAmoxicillin sodium clavulanate potassiumPowder For Oral SuspensionIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
6H2008/19603/732ACINET 228 DRY SYRUPAmoxicillin sodium clavulanate potassiumPowder For Oral SuspensionIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
7H2009/20961/635CABALIN 75PregabalinCapsuleIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
8H2018/CTD2536/621ERACINET DRY SYRUP 457mg/5mlAmoxicillin Trihydrate & Clavulanate PotassiumPowder For Oral SuspensionIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
9H2008/19602/996ACINET 1000Amoxicillin Trihydrate & Clavulanate PotassiumFilm-Coated TabletIndiaGALAXY PHARMACEUTICAL LIMITEDGALAXY PHARMACEUTICAL LIMITEDForeignUnder Renewal Review and SmPC Like Information
10H2022/CTD8845/16856Tacrocord 1Tacrolimus 1 mg USPCapsule, HardIndiaCONCORD BIOTECH LIMITEDWESSEX PHARMACEUTICALS LTDForeignUnder Renewal Review and SmPC Like Information
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