№ files_lp_3_process_7_068309
The document is a pharmaceutical submission outlining a request for a listing of Lanadelumab for routine prophylaxis of hereditary angioedema (HAE) in Australia.
Year: 2023
Region / City: Australia
Topic: Hereditary Angioedema (HAE) Treatment
Document Type: Pharmaceutical Submission
Author: Shire Australia Pty Ltd
Target Audience: Medical Practitioners, Healthcare Professionals
Period of Validity: Not specified
Approval Date: Not specified
Modification Date: Not specified
Application: Section 85 Authority Required listing
Clinical Criteria: Diagnosis of hereditary C1-inhibitor deficiency or dysfunction, HAE attack frequency or life-threatening attack history
Prescription Type: Specialist Immunologist or Allergist
Treatment: Routine Prophylaxis for HAE with Lanadelumab
Comparison: Intravenous C1-INH (Berinert)
Indication: Patients with HAE who have not responded to danazol treatment
Treatment Phase: Initial and Continuing
Price: 8 / 10 USD
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