01 1Pharmacare Limited, Woodmead
02 6Roche Products (Pty) Ltd
01 1Macrogol
02 6Methoxy Polyethylene Glycol-Epoetin Beta
01 2INJ
02 4PFS
03 1SAC
01 1Klean-prep
02 1Mircera 200 µg/0,3 Ml
03 1Mircera 250 µg/0,3 Ml
04 4Mircera®
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Klean-prep
Dosage Form : SAC
Dosage Strength : 59g
Packaging : 4X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera®
Dosage Form : PFS
Dosage Strength : 50mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera®
Dosage Form : PFS
Dosage Strength : 75mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera®
Dosage Form : PFS
Dosage Strength : 100mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera®
Dosage Form : PFS
Dosage Strength : 150mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera 200 µg/0,3 Ml
Dosage Form : INJ
Dosage Strength : 200mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Methoxy Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera 250 µg/0,3 Ml
Dosage Form : INJ
Dosage Strength : 250mcg/0.3ml
Packaging : 0.3X1mcg/0.3ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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