MedPath
HSA Approval

DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML

SIN15973P

DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML

DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML

July 6, 2020

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Regulatory Information

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, SOLUTION

INTRAVENOUS

Medical Information

V08CA02

gadoteric acid

Manufacturer Information

BAYER (SOUTH EAST ASIA) PTE LTD

Sanochemia Pharmazeutika GmbH

Active Ingredients

gadoterate meglumine eqv gadoteric acid

279.32mg/ml (equivalent to 0.5 mmol/ml)

Gadoteric acid

Documents

Package Inserts

Dotagraf PI.pdf

Approved: January 26, 2021

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DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML - HSA Approval | MedPath