Sub menu

 
 

Reagila

Sponsor
Gedeon Richter Australia Pty Ltd
ARTGs
325476, 325477, 325478, 325479
325476, 325477, 325478, 325479
325476, 325477, 325478, 325479
325476, 325477, 325478, 325479
Device/Product name
Reagila
Active Ingredient
Cariprazine hydrochloride
Date of decision
Published
Submission type
New chemical entity
ATC codes
N05AX15
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application.

Description Date
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

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
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
Dose forms
Hard capsule
Strength
1.5 mg, 3 mg, 4.5 mg, 6 mg
Other ingredients
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.
Containers
Blister pack
Pack sizes
4.5 mg, 6 mg: 30, 60, 901.5 mg. 3 mg: 10, 30, 60, 90
Routes of administration
Oral
Dosage

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.

Pregnancy category
DDrugs 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.
What was approved

Reagila (cariprazine hydrochloride) was approved for the following therapeutic use:

Reagila is indicated for the treatment of schizophrenia in adult patients.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
  • 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.

Help us improve the Therapeutic Goods Administration site