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HSA Approval

Meropenem Labatec IV Powder for Injection or Infusion 1g/vial

SIN14528P

Meropenem Labatec IV Powder for Injection or Infusion 1g/vial

Meropenem Labatec IV Powder for Injection or Infusion 1g/vial

March 25, 2014

ALLIANCE PHARM PTE. LTD.

ALLIANCE PHARM PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantALLIANCE PHARM PTE. LTD.
Licence HolderALLIANCE PHARM PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01DH02

meropenem

Manufacturer Information

ALLIANCE PHARM PTE. LTD.

ACS Dobfar S.p.A

ACS Dobfar S.p.A. (intermediate)

Active Ingredients

Meropenem Trihydrate 1140mg eqv to Meropenem anhydrous

1000 mg

Meropenem

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Meropenem Labatec IV Powder for Injection or Infusion 1g/vial - HSA Approval | MedPath