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Rurioctocog alfa pegol

Generic Name
Rurioctocog alfa pegol
Brand Names
Adynovi
Drug Type
Biotech
CAS Number
1417412-83-9

Overview

Rurioctocog alfa pegol is a pegylated recombinant human coagulation factor VIII or antihemophilic factor. Factor VIII is an essential protein involved in normal blood clotting; thus, a deficient level of functional factor VIII is associated with an elevated risk for excessive bleeding caused by spontaneous or secondary events like trauma or surgery. Hemophilia A is the most common inherited bleeding disorder leading to deficiency of factor VIII, which is caused by defects in the F8C gene that encodes coagulation factor VIII. Bleeding in joints is a common manifestation of hemophilia A, and bleeding episodes can be severe and life-threatening like intracranial hemorrhage. Rurioctocog alfa pegol aims to restore functional levels of factor VIII in patients with hemophilia A to manage and prevent bleeding episodes. It was first approved by the European Commission in January 2018. Rurioctocog alfa pegol is a covalent conjugate of octocog alfa, which is a recombinant factor VIII produced by recombinant DNA technology from a Chinese hamster ovary cell line. The presence of the polyethylene glycol (PEG) moiety increases the plasma half-life of the drug, thereby increasing the drug's duration of action.

Indication

Rurioctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in patients 12 years and above with hemophilia A (congenital factor VIII deficiency).

Associated Conditions

  • Bleeding caused by Hemophilia A

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
1/8/2018

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ADYNOVATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/2ML
N/A
N/A
N/A
2/27/2023

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
ADYNOVI 3000 UI/5 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
1171247016
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
ADYNOVI 250 UI/ 2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
1171247002
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
ADYNOVI 2000 UI/5 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
1171247014
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
ADYNOVI 500 UI/2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
1171247006
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
ADYNOVI 1000 UI/2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
1171247010
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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