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HSA Approval

Irinotesin Concentrate for Solution for Infusion 20mg/ ml

SIN13857P

Irinotesin Concentrate for Solution for Infusion 20mg/ ml

Irinotesin Concentrate for Solution for Infusion 20mg/ ml

August 26, 2010

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantTEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Licence HolderTEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INFUSION, SOLUTION CONCENTRATE

INTRAVENOUS

Medical Information

L01XX19

xl 01 xx 19

Manufacturer Information

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

S.C. Sindan-Pharma S.R.L

ACTAVIS ITALY S.P.A.

Active Ingredients

Irinotecan Hydrochloride Trihydrate

20mg/ ml

Irinotecan

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