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Marketing Authorisation Holder

Roche

FOREIGN

75

Total Medicines

68

Active

8

Dosage Forms

7

Countries

Kenya (43) Botswana (18) Zambia (7) Zimbabwe (2) Rwanda (2) Ghana (2) Tanzania (1)

Registration Status

Registered 68
Unknown 3
3 months to expiry 2
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 2

Therapeutic Classes

NEW/INNOVATOR 22

Local Agents / Applicants

ROCHE PRODUCTS (PTY) LTD... 15
F. HOFFMANN-LA ROCHE LTD 13
Roche Products 7
F. HOFFMAN LA ROCHE 4
RHONE-POULENC, RSA 3
F. HOFFMANN-LA ROCHE LTD. 3

Registered Medicines

Showing 20 of 75 · Page 2 of 4

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Product Country Status

HERCEPTIN SC 600MG

TRASTUZUMAB

Kenya Registered

KADCYLA 100 MG

TRASTUZUMAB EMTANSINE

Kenya Registered

KADCYLA 160 MG

TRASTUZUMAB EMTANSINE

Kenya Registered

Kadcyla

trastuzumab emtansine

Zambia Registered/Compliant

MABTHERA 100

RITUXIMAB

Kenya Registered

MABTHERA 100

RITUXIMAB

Kenya Registered

MABTHERA 500

RITUXIMAB

Kenya Registered

MIRCERA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Zimbabwe PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)

MIRCERA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Zimbabwe PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)

MIRCERA 120

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Kenya Registered

MIRCERA 75

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Kenya Registered

MIRCERA INJECTION

methoxy polyethylene glycol-epoetin beta

Botswana Registered/Compliant

MIRCERA INJECTION

-

Botswana Registered/Compliant

MIRCERA INJECTION

-

Botswana Registered/Compliant

MIRCERA INJECTION

methoxy polyethylene glycol-epoetin beta

Botswana Registered/Compliant

OCREVUS

OCRELIZUMAB

Kenya Registered

Ocrelizumab

Ocrelizumab

Zambia Registered/Compliant

Ocrevus IV

Alpha, alpha trehalose dihydate 400.0 mg mg per vial,Glacial Acetic Acid 2.5 mg mg per vial,Ocrelizumab 300 mg mg per vial,Polysorbate 20 2.0 mg mg per vial,Sodium Acetate Trihydrate 21.4 mga mg per vial,Water for injections 10.0 ml ml/vial

Zambia Registered/Compliant

PEGASYS 180

PEGINTERFERON ALFA-2A

Kenya

PERJETA

PERTUZUMAB

Ghana 3 months to expiry