Source: Australian Therapeutic Goods Administration
26 November 2020
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
New chemical entity
|Date of decision||
12 November 2020
|Date of entry onto ARTG||
18 November 2020
|Original publication date||
26 November 2020
325476, 325477, 325478, 325479
|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
1.5 mg, 3 mg, 4.5 mg, 6 mg
Capsule content; pregelatinised maize starch, magnesium stearate. Capsule shell; gelatin. Capsule shell colouring (varies based on strength); allura red AC, brilliant blue FCF, iron oxide yellow, titanium dioxide. Printing ink (varies based on strength); shellac, iron oxide black, propylene glycol, potassium hydroxide, simethicone.
4.5 mg, 6 mg: 30, 60, 90
1.5 mg. 3 mg: 10, 30, 60, 90
|Routes of administration||
The recommended starting dose of Reagila is 1.5 mg once daily. Thereafter the dose can be increased in 1.5 mg increments according to efficacy and tolerability to a maximum dose of 6 mg/day, if needed. The lowest effective dose should be maintained according to the clinical judgement of the treating physician
For further information refer to the Product Information.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
Reagila (cariprazine hydrochloride) was approved for the following therapeutic use:
Reagila is indicated for the treatment of schizophrenia in adult patients.
Reagila is an atypical antipsychotic. The mechanism of action of cariprazine, as with other medicines having efficacy in schizophrenia, is not fully understood. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2L and D2S receptors and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Reagila was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||2 December 2019|
|First round evaluation completed||3 June 2020|
|Sponsor provides responses on questions raised in first round evaluation||29 July 2020|
|Second round evaluation completed||17 August 2020|
|Delegate’s overall benefit-risk assessment and request for Advisory Committee advice||1 September 2020|
|Sponsor’s pre-Advisory Committee response||14 September 2020|
|Advisory Committee meeting||1-2 October 2020|
|Registration decision (Outcome)||12 November 2020|
|Completion of administrative activities and registration on ARTG||18 November 2020|
|Number of working days from submission dossier acceptance to registration decision*||197|
- Reagila (cariprazine hydrochloride) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Reagila 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.
- The cariprazine hydrochloride European Union (EU)-Risk Management Plan (RMP) (version 1.7, dated 23 July2019, data lock point 11 July 2019), with Australian Specific Annex (version 2.0, dated 26 August 2020), included with submission PM-2019-04790-1-1, and any subsequent revisions, as agreed with 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 the 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.