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Approvals/Health Canada/ORFADIN

Authorized

STANDARD

ORFADIN

Swedish Orphan Biovitrum AB (Publ)🇨🇦 Health Canada

Approval Date: Jul 4, 2025
Approval ID: 96c843542e6969e8
Company: Swedish Orphan Biovitrum AB (Publ)
Type: Standard

Approval Details

Approval Id: 96c843542e6969e8
Drug Approval Canada Name: ORFADIN
Product Name: ORFADIN
Status: Marketed
Status Date: 2018-07-10
Original Market Date: 2018-07-10
Din: 02469693
Drug Class: Human
Dosage Form: Suspension
Route Of Administration: Oral
Schedule: Prescription
Ahfs: 92:92.00
Atc Original: A16AX04 NITISINONE
Atc Name: a 16 ax 04
Aig Number: 0158450005
Company Name: Swedish Orphan Biovitrum AB (Publ)
Company Address: Tomtebodav 23a, Stockholm, --, Sweden, 11276
Company Detail Path: /organization/swedish-orphan-biovitrum-ab-publ

Company Information

Pharmaceutical Company Name: Swedish Orphan Biovitrum AB (publ)
Name En: Swedish Orphan Biovitrum AB (publ)
Name Zh: 索比制药
Country Name: Sweden
Province Name: stockholm,country_se
City Name: solna,stockholm,country_se
Address: Tomtebodavägen 23A
Website: https://www.sobi.com
Description: International biopharmaceutical company focused on rare diseases in haematology, immunology and specialty care; operates in around 30 countries with headquarters in Stockholm. Listed on Nasdaq Stockholm (SOBI).

Active Ingredients

NITISINONE

4 MG / ML

Authorized

Quick Info

Agency

Health Canada

Country

🇨🇦

Approval Date

Jul 4, 2025

Approval ID

96c843542e6969e8

Type

Standard

Back to Health Canada Approvals

ORFADIN - Health Canada Drug Approval Details