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Chemistry

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FDA Orange Book

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Biotech Showcase
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Biotech Showcase
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OCRELIZUMAB

Brand Name : OCREVUS

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 30MG/1ML

Approval Date :

Application Number : 761053

RX/OTC/DISCN :

RLD :

TE Code :

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Biotech Showcase
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OCRELIZUMAB AND HYALURONIDASE-OCSQ

Brand Name : OCREVUS ZUNOVO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG;1000UNITS PER ML

Approval Date :

Application Number : 761371

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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BIO Partnering at JPM
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Ocrelizumab

Brand Name : Ocrevus

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 300mg/10ml

Packaging :

Approval Date : 20/09/2017

Application Number : 66185

Regulatory Info : Allowed

Registration Country : Switzerland

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BIO Partnering at JPM
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BIO Partnering at JPM
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Ocrelizumab

Brand Name : Ocrevus subcutaneously

Dosage Form : Solution For Injection

Dosage Strength : 920mg/23ml

Packaging :

Approval Date : 15/11/2024

Application Number : 68988

Regulatory Info : Allowed

Registration Country : Switzerland

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BIO Partnering at JPM
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BIO Partnering at JPM
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Okrelizumab

Brand Name : Ocrevus

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 300mg

Packaging :

Approval Date : 08/01/2018

Application Number : 20160427000077

Regulatory Info : Approved

Registration Country : Sweden

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04

BIO Partnering at JPM
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BIO Partnering at JPM
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Okrelizumab

Brand Name : Ocrevus

Dosage Form : Injectable Solution

Dosage Strength : 920mg

Packaging :

Approval Date : 21/06/2024

Application Number : 20230925000050

Regulatory Info : Approved

Registration Country : Sweden

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BIO Partnering at JPM
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BIO Partnering at JPM
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Ocrelizumab

Brand Name : Ocrevus

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 300MG

Packaging :

Approval Date : 2018-02-02

Application Number : 1171231001

Regulatory Info : Authorized

Registration Country : Spain

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