Approvals/HSA/SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML

Approved

THERAPEUTIC

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML

Patheon Italia S.P.A. (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Sep 10, 2025
Approval ID: 8006207bb560d4b1
Company: Patheon Italia S.P.A. (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 8006207bb560d4b1
Drug Name: SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML
Product Name: SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML
Approval Number: SIN17326P
Approval Date: 2025-09-10
Registrant: ABBVIE PTE. LTD.
Licence Holder: ABBVIE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 3. DOSAGE AND ADMINISTRATION 3.1 Recommended Dosage Crohn’s Disease The recommended dose is 600 mg administered by intravenous (IV) infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous (SC) injection at Week 12, and every 8 weeks thereafter. Ulcerative Colitis The recommended dose is 1200 mg administered by intravenous (IV) infusion at Week 0, Week 4, and Week 8, followed by 180 mg or 360 mg administered by subcutaneous (SC) injection at Week 12, and every 8 weeks thereafter. <ul> <li>A dose of 180 mg administered by subcutaneous injection is recommended for patients with adequate improvement in disease activity after induction</li> <li>A dose of 360 mg administered by SC injection is recommended for patients with inadequate improvement in disease activity after induction.</li> </ul> Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by Week 24. 3.2 Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 3.3 Dosing in Special Populations Pediatrics The safety and efficacy of SKYRIZI in pediatric patients with Crohn’s disease, or ulcerative colitis younger than 18 years of age have not yet been established. Geriatric No dose adjustment is required (see PHARMACOLOGIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is limited information in subjects aged ≥ 65 years. Renal or Hepatic Impairment No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of SKYRIZI. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see PHARMACOLOGIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: SUBCUTANEOUS
Indication Info: 2. INDICATIONS 2.1 Crohn’s Disease SKYRIZI is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. 2.2 Ulcerative Colitis SKYRIZI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy.
Contraindications: 4. CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients listed in section 15.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Clinically important active infections (e.g. active tuberculosis, see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 10, 2025

Approval ID

8006207bb560d4b1

Type

Therapeutic

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