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zameds

Gadoteric acid

Sold as Dotarem, Clariscan

No structure available

This product's active ingredient could not be matched to a single known compound.

Background

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Registration

Applicants
2
Registrations
3

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Guerbet South Africa (Pty) LtdDotaremprefilled syringes310550, 310551Not determinedNone
Ge Healthcare (Pty) LtdClariscan0.5 mmol/ml540559Not determinedPIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Dotarem

EACH 100,0 ml SOLUTION CONTAINS GADOTERIC ACID 27,932 g

Not listed31055031/28/0550RegisteredNot determinedNone
Dotarem prefilled syringes

EACH 100,0 ml SOLUTION CONTAINS GADOTERIC ACID 27,932 g

Prefilled syringes31055131/28/0551RegisteredNot determinedNone
Clariscan

EACH 1,0 ml SOLUTION CONTAINS GADOTERIC ACID 279,3 mg

0.5 mmol/mlSolution for injection54055954/28/0559Approved 14 September 2021RegisteredNot determinedPIPIL

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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