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zameds

Emicizumab

Sold as Hemlibra

No structure available

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

Background

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Registration

Applicants
1
Registrations
4

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Roche Products (Pty) LtdHemlibra30 mg/ml, 60 mg/0,4 ml, 105 mg/0,7 ml, 150 mg/ ml530071, 530072, 530073, 530074Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Hemlibra 30 mg/ml

EACH 1,0 ml CONTAINS EMICIZUMAB 30,0 mg

30 mg/ml53007153/30.1/0071RegisteredNot determinedNone
Hemlibra 60 mg/0,4 ML

EACH 0,4 ml CONTAINS EMICIZUMAB 60,0 mg

60 mg/0,4 ml53007253/30.1/0072RegisteredNot determinedNone
Hemlibra 105 mg/0,7 ML

EACH 0,7 ml CONTAINS EMICIZUMAB 105,0 mg

105 mg/0,7 ml53007353/30.1/0073RegisteredNot determinedNone
Hemlibra 150 mg/ ML

EACH 1,0 ml CONTAINS EMICIZUMAB 150,0 mg

150 mg/ ml53007453/30.1/0074RegisteredNot determinedNone

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

SAHPRA has not published a professional information or patient information leaflet for this product.

Research articles

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