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13 December 2019

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New biological entity
Product name
Active ingredients
Ravulizumab rch
ATC codes
Date of decision
8 October 2019
Date of entry onto ARTG
17 October 2019
ARTG numbers
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Alexion Pharmaceuticals Australasia Pty Ltd
Sponsor address
20 Rodborough Road, Frenchs Forest NSW 2086
Dose forms
Injection, intravenous solution
10 mg/mL
Other ingredients
Monobasic sodium phosphate, dibasic sodium phosphate, sodium chloride, polysorbate 80, water for injections
Pack sizes
Routes of administration
Intravenous infusion

The recommended dosing regimen for adult patients (≥ 18 years of age) with paroxysmal nocturnal haemoglobinuria (PNH) consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The doses to be administered are based on the patient's body weight. Maintenance doses should be administered at a once every 8 week interval, starting 2 weeks after loading dose administration.

For further information refer to the Product Information.

Pregnancy category

Category B2

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Ultomiris (ravulizumab rch) was approved for the following therapeutic use:

Ultomiris is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH).

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  1. Ultomiris (ravulizumab rch) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ultomiris must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  2. The Ultomiris European Union (EU)-Risk Management Plan (RMP) (version 1.4, dated 8 March 2018; DLP 2 May 2019), with Australian Specific Annex (version 2.0, dated 21 June 2019), included with submission PM-2018-05023-1-6, to be revised to the satisfaction of the TGA, will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  3. For all injectable products the Product Information must be included with the product as a package insert.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.