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Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017

26 March 2018

A generic medicine is an additional brand of an existing medicine. It contains the same 'active ingredient' as the existing medicine; the 'active ingredient' is the chemical that is biologically active in the body and makes the medicine work. Active ingredients can be manufactured and sold by other sponsors once the patent for the existing brand medicine has expired.

Apart from containing the same active ingredient, generic medicines must also be 'bioequivalent'. This means that the same amount of active ingredient is absorbed by the body over the same period of time for the same dose of generic or existing medicine.

Generic prescription medicines meet the same standards of quality, safety and efficacy as the existing medicine. TGA continually monitors the safety of registered medicines once they become available on the Australian market.

2017 summary

cover of report

The Prescription medicines and biologicals: TGA annual summary 2017 publication provides details of all NCEs registered in 2017, as well as new or extended uses for existing medicines, priority determinations and orphan drug designations, biologicals, generic prescription medicines, biosimilar prescription medicines and Australian Public Assessment Reports (AusPARs).

Registrations of biosimilar prescription medicines, 2017

A biosimilar medicine is a version of a biological prescription medicine that is already registered and is referred to as the 'reference medicine'.

Both the biosimilar and its reference medicine will have similar core characteristics such as physicochemical, biological, immunological, efficacy and safety, which are demonstrated using comprehensive comparability studies. Most biosimilar medicines are likely to contain biotechnology-derived proteins as the active substance.

Please note that the indication for which each prescription medication is approved may be more specific than as described in general terms in this summary. For the full approved indications, please consult the ARTG.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. This timeframe is underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

All products were approved within the statutory 255 working day period.

November

RIXIMYO

Evaluation commenced: 30 November 2016

Registration decision: 21 November 2017

Entry onto ARTG: 30 November 2017

Approval time: 209 working days

rituximab

Sandoz Australia Pty Ltd

Non-Hodgkin's Lymphoma (NHL)

Riximyo is indicated for treatment of B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, Wegener's granulomatosis, and microscopic polyangiitis.

ERELZI

Evaluation commenced: 30 November 2016

Registration decision: 18 October 2017

Entry onto ARTG: 30 November 2017

Approval time: 195 working days

etanercept

Novartis Pharmaceuticals Pty Ltd

Erelzi is indicated for the treatment of:

  • in adults: rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis;
  • in children and adolescents: juvenile idiopathic arthritis, and paediatric plaque psoriasis.

AMGEVITA

Evaluation commenced: 3 May 2016

Registration decision: 18 October 2017

Entry onto ARTG: 9 November 2017

Approval time: 245 working days

adalimumab

Amgen Australia Pty Ltd

Amgevita is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, and uveitis.

Registrations of chemical entities: first generics, 2017

Of the 101 generic prescription medicines registered during 2017, 29 submissions resulted in the registration of the 'first generic' version that contains a particular active ingredient. The term 'first generic' is the first registration approval by TGA which permits a sponsor to market a generic drug product in Australia. First generics are significant because they create more affordable treatment options for patients - the listing of a first generic triggers a 16% price reduction under the Pharmaceutical Benefits Scheme (PBS).

Because the first generic version registered by TGA may not necessarily be the first that is PBS-listed, the PBS website should be consulted for further information.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. This timeframe is underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

All products were approved within the statutory 255 working day period.

The sponsor name reflects the information in the ARTG at the time of registration. As sponsors may change over time, please consult the ARTG for full information in relation to these products, including full indications

2017: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2017

DAPTOMYCIN PANPHARMA

Evaluation commenced: 31 May 2016

Registration decision: 8 December 2017

Entry onto ARTG: 14 December 2017

Approval time: 192 working days

daptomycin

Panpharma Australia Pty Ltd

Daptomycin injections are indicated for the treatment of complicated skin infections and bloodstream infections.

Dosage form: Powder for injection

LINCOMYCIN LWS, LINCOMYCIN SXP

Evaluation commenced: 30 November 2016

Registration decision: 21 November 2017

Entry onto ARTG: 4 December 2017

Approval time: 192 working days

lincomycin hydrochloride monohydrate

Southern Cross Pharma Pty Ltd

Lincomycin hydrochloride monohydrate injections are indicated in the treatment of serious infections due to susceptible strains of gram-positive aerobes such as streptococci, pneumococci and staphylococci.

Dosage form: Solution for injection

November 2017

There were no new entries for November.

October 2017

CIPLA ETORICOXIB, ETORICIP, E-COXIP

Evaluation commenced: 31 October 2016

Registration decision: 3 October 2017

Entry onto ARTG: 18 October 2017

Approval time: 190 working days

etoricoxib

Cipla Australia Pty Ltd

Etoricoxib tablets are indicated for the treatment of osteoarthritis, gouty arthritis, and period and dental pain.

Dosage form: Tablet

September 2017

APO-MELPHALAN, MELPHALAN APOTEX

Evaluation commenced: 30 June 2016

Registration decision: 6 September 2017

Entry onto ARTG: 15 September 2017

Approval time: 252 working days

melphalan hydrochloride

Apotex Pty Ltd

Melphalan hydrochloride injections are indicated for the treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Dosage form: Powder for injection

AMBRICIP, AMBRIS, CIPLA AMBRISENTAN

Evaluation commenced: 30 November 2016

Registration decision: 1 September 2017

Entry onto ARTG: 14 September 2017

Approval time: 143 working days

ambrisentan

Cipla Australia Pty Ltd

Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension.

Dosage form: Tablet

August 2017

GANCICLOVIR JUNO, GANCICLOVIR HHH

Evaluation commenced: 29 September 2016

Registration decision: 21 August 2017

Entry onto ARTG: 31 August 2017

Approval time: 178 working days

ganciclovir sodium

Horizon Hospital Healthcare Pty Ltd

Ganciclovir sodium, administered by IV infusion, is indicated for the treatment of cytomegalovirus disease in immunocompromised individuals and bone marrow transplant patients.

Dosage form: Powder for injection

ATAZANAVIR CIPLA, ZANAVIR CA, CIPLA ATAZANAVIR

Evaluation commenced: 31 May 2016

Registration decision: 18 August 2017

Entry onto ARTG: 30 August 2017

Approval time: 219 working days

atazanavir

Cipla Australia Pty Ltd

Atazanavir capsules are indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents.

Dosage form: Capsule

APO-FAMPRIDINE MR, FAMPRIDINE MR APOTEX

Evaluation commenced: 31 August 2016

Registration decision: 18 August 2017

Entry onto ARTG: 25 August 2017

Approval time: 175 working days

fampridine

Apotex Pty Ltd

Fampridine tablets are indicated for the symptomatic improvement of walking ability in adult patients with multiple sclerosis.

Dosage form: Modified release tablet

APO-AZELASTINE/FLUTICASONE, AZELASTINE/FLUTICASONE APOTEX

Evaluation commenced: 29 July 2016

Registration decision: 9 August 2017

Entry onto ARTG: 22 August 2017

Approval time: 146 working days

azelastine (as hydrochoride) / fluticasone propionate

Apotex Pty Ltd

Azelastine/fluticasone nasal spray is indicated for the treatment of allergic rhinitis and rhino-conjunctivitis.

Dosage form: Nasal spray

APO-FINGOLIMOD, FINGOLIMOD APOTEX

Evaluation commenced: 31 March 2016

Registration decision: 8 August 2017

Entry onto ARTG: 14 August 2017

Approval time: 253 working days

fingolimod hydrochloride

Apotex Pty Ltd

Fingolimod hydrochloride capsules are indicated for the treatment of multiple sclerosis.

Dosage form: Capsule

ANAGRELIDE MGH, ANAGRELIDE RMB, ANAGRELIDE SCP

Evaluation commenced: 30 June 2016

Registration decision: 27 July 2017

Entry onto ARTG: 3 August 2017

Approval time: 226 working days

anagrelide hydrochloride monohydrate

Southern Cross Pharma Pty Ltd

Anagrelide hydrochloride monohydrate capsules are indicated for the treatment of essential thrombocythaemia.

Dosage form: Capsule

July 2017

BENZATROPINE INJECTION

Evaluation commenced: 30 June 2016

Registration decision: 27 June 2017

Entry onto ARTG: 18 July 2017

Approval time: 182 working days

benzatropine mesilate

Phebra Pty Ltd

Benzatropine mesilate injections are indicated for all forms of Parkinsonism including arteriosclerotic, post-encephalitic, idiopathic, as well as drug induced extrapyramidal disorders (except tardive dyskinesia).

Dosage form: Solution for injection

HYOSCINE BUTYLBROMIDE LWS, HYOSCINE BUTYLBROMIDE SXP

Evaluation commenced: 31 August 2016

Registration decision: 3 July 2017

Entry onto ARTG: 12 July 2017

Approval time: 165 working days

hyoscine butylbromide

Southern Cross Pharma Pty Ltd

Hyoscine butylbromide injections are indicated for spasm of the gastrointestinal tract, biliary spasm, renal spasm, diagnostic aid in radiology.

Dosage form: Solution for injection

MEFENAMIC ACID B&B, MEFENAMIC ACID MLABS, MEFENAMIC ACID MLPL, MENAMIC MLABS

Evaluation commenced: 31 May 2016

Registration decision: 16 June 2017

Entry onto ARTG: 7 July 2017

Approval time: 220 working days

mefenamic acid

Micro Labs Pty Ltd

Mefenamic acid capsules are indicated for the treatment of dysmenorrhea and menorrhagia, and for mild to moderate pain.

Dosage form: Capsule

June 2017

BUPRENORPHINE SDZ, BUPRENORPHINE SZ, BUPRENORPHINE SANDOZ

Evaluation commenced: 29 February 2016

Registration decision: 11 April 2017

Entry onto ARTG: 16 June 2017

Approval time: 230 working days

buprenorphine

Sandoz Pty Ltd

Buprenorphine sachets are indicated for the management of moderate to severe pain.

Dosage form: Transdermal drug delivery system sachet

TWYNIPINE, TELMISARTAN/AMLODIPINE GXP, TELMISARTAN/AMLODIPINE APOTEX, TELMISARTAN/AMLODIPINE GPPL, TELMISARTAN/AMLODIPINE GENPAR, AMLOTELMISARTAN, TELMISARTAN/AMLO

Evaluation commenced: 5 July 2016

Registration decision: 13 June 2017

Entry onto ARTG: 16 June 2017

Approval time: 182 working days

telmisartan and amlodipine (as besilate)

Generic Partners Pty Ltd

Telmisartan and amlodipine (as besilate) combination tablets are indicated for the treatment of hypertension.

Dosage form: Tablet

May 2017

DARUNAVIR MYLAN

Evaluation commenced: 31 March 2016

Registration decision: 13 January 2017

Entry onto ARTG: 26 May 2017

Approval time: 158 working days

darunavir

Alphapharm Pty Ltd

Darunavir tablets are indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents.

Dosage form: Tablet

HOPE PHARMACEUTICALS SODIUM NITRITE INJECTION

Evaluation commenced: 30 June 2016

Registration decision: 27 April 2017

Entry onto ARTG: 16 May 2017

Approval time: 157 working days

sodium nitrite

Hope Pharmaceuticals Pty Ltd

Sodium nitrite injections are indicated as an antidote in the treatment of cyanide poisoning in conjunction with sodium thiosulfate.

Dosage form: Solution for injection

April 2017

EVEROLIMUS-TEVA, TEVA-EVEROLIMUS

Evaluation commenced: 11 July 2016

Registration decision: 6 April 2017

Entry onto ARTG: 20 April 2017

Approval time: 109 working days

everolimus

Teva Pharma Australia Pty Ltd

Everolimus tablets are indicated for the treatment of breast cancer, neuroendocrine tumours of pancreatic origin, advanced renal cell carcinoma, subependymal giant cell astrocytoma, and tuberous sclerosis complex.

Dosage form: Tablet

MUPIROCIN AJS, MUPIROCIN SCP, APO-MUPIROCIN

Evaluation commenced: 5 July 2016

Registration decision: 11 April 2017

Entry onto ARTG: 12 April 2017

Approval time: 151 working days

mupirocin

Southern Cross Pharma Pty Ltd

Mupirocin ointment is indicated for the topical treatment of mild impetigo.

Dosage form: Ointment

TIGECYCLINE JUNO, TIGECYCLE, TYGALINE, TYGACYCLINE

Evaluation commenced: 30 June 2016

Registration decision: 7 April 2017

Entry onto ARTG: 11 April 2017

Approval time: 154 working days

tigecycline

Neo Health (Australia) Pty Ltd

Tigecycline injections are indicated for the treatment of complicated skin or intra-abdominal infections.

Dosage form: Powder for injection

MELATONIN MR GPPL, MELATONIN MR GXP, MELATONIN MR GENPAR, MELATONTAB MR, MELOTIN MR, MELATONIN MR APOTEX, CHEMMART MELATONIN MR, TERRY WHITE CHEMISTS MELATONIN MR, BLOOMS THE CHEMIST MELATONIN MR

Evaluation commenced: 31 July 2015

Registration decision: 22 December 2016

Entry onto ARTG: 4 April 2017

Approval time: 251 working days

melatonin

Generic Partners Pty Ltd

Melatonin tablets are indicated for the treatment of insomnia in patients aged 55 or over.

Dosage form: Tablet

March 2017

AL-CEFUROXIME, PHARMACOR CEFUROXIME

Evaluation commenced: 29 April 2016

Registration decision: 8 March 2017

Entry onto ARTG: 27 March 2017

Approval time: 173 working days

cefuroxime axetil

Pharmacor Pty Ltd

Cefuroxime axetil tablets are indicated for the treatment of mild to moderately severe infections in adults caused by sensitive bacteria.

Dosage form: Film-coated tablet

DROPERIDOL SXP, DROPERIDOL AJS, DROPERIDOL RMB

Evaluation commenced: 31 August 2015

Registration decision: 28 July 2016

Entry onto ARTG: 6 March 2017

Approval time: 183 working days

droperidol

Southern Cross Pharma Pty Ltd

Droperidol injections are indicated for the treatment of nausea and vomiting in surgical and diagnostic procedures, and in the management of severe agitation or aggressiveness in psychotic disorders.

Dosage form: Solution for injection

February 2017

FLUOXETINE MLABS, FLUOXETINE MLPL, PROZET, FLUOXETINE B&B

Evaluation commenced: 29 April 2016

Registration decision: 16 February 2017

Entry onto ARTG: 23 February 2017

Approval time: 160 working days

fluoxetine hydrochloride

Micro Labs Pty Ltd

Fluoxetine hydrochloride capsules are indicated for treatment of depression, obsessive compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD).

Dosage form: Capsule

AMIKACIN SXP, AMIKACIN RMB, AMIKACIN AJS

Evaluation commenced: 30 November 2015

Registration decision: 17 October 2016

Entry onto ARTG: 7 February 2017

Approval time: 176 working days

amikacin sulfate

Southern Cross Pharma Pty Ltd

Amikacin sulfate injections are indicated for the treatment of serious infections and neonatal sepsis.

Dosage form: Solution for injection

January 2017

APO-RIVAROXABAN, RIVAROXABAN APOTEX

Evaluation commenced: 29 February 2016

Registration decision: 12 January 2017

Entry onto ARTG: 24 January 2017

Approval time: 172 working days

rivaroxaban

Apotex Pty Ltd

Rivaroxaban tablets are indicated for the treatment and/or prevention of venous thromboembolism, stroke, deep vein thrombosis, and pulmonary embolism.

Dosage form: Tablet

APO-DEXAMFETAMINE, DEXAMFETTABS, DEXAMFETAMINE GENPAR, DEXAMFETAMINE GPPL, DEXAMFETAMINE KINEDEXE, DEXAFET

Evaluation commenced: 29 February 2016

Registration decision: 6 January 2017

Entry onto ARTG: 18 January 2017

Approval time: 169 working days

dexamfetamine sulfate

Generic Partners Pty Ltd

Dexamfetamine sulfate tablets are indicated for narcolepsy and hyperkinetic behaviour disorders in children.

Dosage form: Tablet

APO-ZONISAMIDE, CHEMMART ZONISAMIDE, TERRY WHITE CHEMISTS ZONISAMIDE, ZONISAMIDE APOTEX

Evaluation commenced: 24 December 2015

Registration decision: 12 December 2016

Entry onto ARTG: 11 January 2017

Approval time: 197 working days

zonisamide

Apotex Pty Ltd

Zonisamide capsules are indicated as treatment of partial seizures in patients with epilepsy.

Dosage form: Capsule

Registrations of chemical entities: other generics, 2017

The sponsor name reflects the information in the ARTG at the time of registration. As sponsors may change over time, please consult the ARTG for full information in relation to these products, including full indications.

2017: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2017

APO-ACAMPROSATE, ACAMPROSATE APOTEX

Entry onto ARTG: 21 December 2017

acamprosate calcium

Apotex Pty Ltd

Dosage form: Enteric coated tablet

Therapeutic use: Alcohol dependence

TOBRAMYCIN SUN

Entry onto ARTG: 15 December 2017

tobramycin

Sun Pharma ANZ Pty Ltd

Dosage form: Solution for inhalation ampoule

Therapeutic use: Infection associated with cystic fibrosis

GABAPENTIN B&B, GABAPENTIN MLABS, GABALEP, MIPENTINE

Entry onto ARTG: 5 December 2017

gabapentin

Micro Labs Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Seizures, neuropathic pain

CEFTRIX, CEFTRIXN, CEFTRIAXON, CFTRIAX

Entry onto ARTG: 8 December 2017

ceftriaxone sodium

Neo Health (Australia) Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Infection

EZETIMIBE KP, EZETIMIBE CW, EZETIMIBE ML, EZETIMIBE AN

Entry onto ARTG: 4 December 2017

ezetimibe

Amneal Pharma Australia Pty Ltd

Dosage form: Tablet

Therapeutic use: High cholesterol, cardiovascular disease

QUETIAPINE XR KP, QUETIAPINE XR AN, QUETIAPINE XR CH, QUETIAPINE XR CW, QUETIAPINE XR AMNEAL

Entry onto ARTG: 4 December 2017

quetiapine fumarate

Amneal Pharma Australia Pty Ltd

Dosage form: Tablet

Therapeutic use: Bipolar disorder, schizophrenia, depression, anxiety

DOCETAXEL WOCKHARDT, DOCETAXEL WKT

Entry onto ARTG: 4 December 2017

docetaxel

Wockhardt Bio Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Cancer

November 2017

ABACAVIR / LAMIVUDINE

Entry onto ARTG: 17 November 2017

lamivudine and abacavir sulfate

Alphapharm Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: HIV-1 infection

MODAGIL, MODANIL, MVIGIL, MODAFINIL GXP, MFINIL, MODAFINIL GPPL, MOFINIL

Entry onto ARTG: 15 November 2017

modafinil

Generic Partners Pty Ltd

Dosage form: Tablet

Therapeutic use: Narcolepsy

HETINIB, HETLEVAC, HEVEC, IMATERO, NIBTERO, TERONIB, GILMAT

Entry onto ARTG: 14 November 2017

imatinib mesilate

Hetero Australia Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Cancer

FINGOLIMOD INTAS, FINGOLIMOD ASTRON, FINGOLINTAS, FINGOLIMOD AMEDA, FINGOLIMOD AN, FINGOLIMOD GH

Entry onto ARTG: 14 November 2017

fingolimod hydrochloride

Accord Healthcare Pty Ltd

Dosage form: Capsule

Therapeutic use: Multiple sclerosis

APO-TENOFOVIR / EMTRICITABINE, TENOFOVIR / EMTRICITABINE APOTEX

Entry onto ARTG: 10 November 2017

emtricitabine and tenofovir disoproxil fumarate

Apotex Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: HIV-1 infection

GILENOFIR, FILENDYA, FINGOLIMOD-FBM, GILIMOD, GILMEDYA, FINGOLIMOD-SCP, FINGOLIMOD ARW, FINGOLIMOD GXP, FINGOLEYA

Entry onto ARTG: 7 November 2017

fingolimod hydrochloride

Arrow Pharma Pty Ltd

Dosage form: Capsule

Therapeutic use: Multiple sclerosis

EZETIMIBE / SIMVASTATIN-MEDIS, EZETIMIBE / SIMVASTATIN SANDOZ, EZETIMIBE / SIMVASTATINAS, EZETIMIBE / SIMVASTATIN-ZP, EZETIMIBE / SIMVASTATIN-GX, APO EZETIMIBE SIMVASTATIN

Entry onto ARTG: 6 November 2017

simvastatin and ezetimibe

Medis Pharma Pty Ltd

Dosage form: Tablet

Therapeutic use: High cholesterol, cardiovascular disease

October 2017

OXALIPLATIN WOCKHARDT, OXALIPLATIN WKT

Entry onto ARTG: 13 October 2017

oxaliplatin

Wockhardt Bio Pty Ltd

Dosage form: Solution for infusion

Therapeutic use: Colon or oesophagogastric cancer

IRINOTECAN WOCKHARDT, IRINOTECAN WKT

Entry onto ARTG: 13 October 2017

irinotecan hydrochloride trihydrate

Wockhardt Bio Pty Ltd

Dosage form: Solution for infusion

Therapeutic use: Colon or rectum cancer

ABACAVIR / LAMIVUDINE LUPIN, ABACAVIR / LAMIVUDINE LAPL, ABACAVIR / LAMIVUDINE GH, ABACAVIR / LAMIVUDINE GENERIC HEALTH

Entry onto ARTG: 6 October 2017

abacavir hydrochloride monohydrate and lamivudine

Lupin Australia Pty Limited

Dosage form: Tablet

Therapeutic use: HIV-1 infection

APO-NICORANDIL, NICORANDIL APOTEX

Entry onto ARTG: 3 October 2017

nicorandil

Apotex Pty Ltd

Dosage form: Tablet

Therapeutic use: Angina

September 2017

HYDRALAZINE LINK

Entry onto ARTG: 22 September 2017

hydralazine hydrochloride

Link Medical Products Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Emergency hypertension

CEFTAZIDIME-AFT

Entry onto ARTG: 22 September 2017

ceftazidime pentahydrate

AFT Pharmaceuticals Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Infection

PIPTAZ-AFT

Entry onto ARTG: 21 September 2017

piperacillin sodium and tazobactam sodium

AFT Pharmaceuticals Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Bacterial infection

PHARMACOR ATORVASTATIN, AKM-ATORVASTATIN

Entry onto ARTG: 11 September 2017

atorvastatin calcium trihydrate

Pharmacor Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: High cholesterol

CASPOFUNGIN APOTEX

Entry onto ARTG: 4 September 2017

caspofungin

Apotex Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Fungal infection

VORICONAZOLE MYX

Entry onto ARTG: 1 September 2017

voriconazole

Mayne Pharma International Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Fungal infection

August 2017

FENOFIBRATE SANDOZ

Entry onto ARTG: 31 August 2017

fenofibrate

Sandoz Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: High cholesterol, dyslipidaemia

OXYCODONE JUNO, OXYCONE

Entry onto ARTG: 31 August 2017

oxycodone hydrochloride

Juno Pharmaceuticals Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Pain

BOSENTAN AN, BOSENTAN CH, BOSENTAN CW, BOSENTAN AMNEAL

Entry onto ARTG: 22 August 2017

bosentan monohydrate

Amneal Pharma Australia Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Pulmonary arterial hypertension

CYKLOTRANEXAMIC, TRANEXAMIC ACID GENPAR, TRANEXAMIC ACID MYLAN, TRANEXAMIC ACID GPPL, CYKLOTRAN, TRANEXAMIC ACID IV APOTEX

Entry onto ARTG: 7 August 2017

tranexamic acid

Generic Partners Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Blood loss

B. BRAUN PARACETAMOL

Entry onto ARTG: 1 August 2017

paracetamol

B Braun Australia Pty Ltd

Dosage form: Solution for infusion

Therapeutic use: Pain

July 2017

APO-TELMISARTAN / AMLODIPINE, GENRX TELMISARTAN / AMLODIPINE

Entry onto ARTG: 26 July 2017

telmisartan and amlodipine besilate

Apotex Pty Ltd

Dosage form: Tablet

Therapeutic use: Hypertension

ALIMETREX, PEMETREXED GENPAR, PEMETREXED GPPL, PEMETREXED GXP, PEMETREXED PFI

Entry onto ARTG: 19 July 2017

pemetrexed disodium

Generic Partners Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Mesothelioma, lung cancer

IPCA-METFORMIN, PIP-METFORMIN, PTIN-METFORMIN, TN-METFORMIN, GTAMETFORMIN, METMIN, EMNORM

Entry onto ARTG: 19 July 2017

metformin hydrochloride

Ipca Pharma (Australia) Pty Ltd

Dosage form: Tablet

Therapeutic use: Diabetes

MEDICIANZ MUPIROCIN OINTMENT

Entry onto ARTG: 6 July 2017

mupirocin

Medicianz Healthcare Pty Ltd

Dosage form: Ointment

Therapeutic use: Impetigo

June 2017

PHARMACOR EZETIMIBE, AKM EZETIMIBE

Entry onto ARTG: 7 June 2017

ezetimibe

Pharmacor Pty Ltd

Dosage form: Tablet

Therapeutic use: High cholesterol, sitosterolaemia, cardiovascular disease

TEICOPLANIN SXP, TEICOPLANIN LWS, TEICOPLANIN MGH

Entry onto ARTG: 7 June 2017

teicoplanin

Southern Cross Pharma Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Serious infection

May 2017

TADALAFIL RRH, CIDALA, TADCIAL, TADALAFIL TIH, TADALAFIL ARW, TADALAFIL RRH PHT, CIDALA PHT, TADCIAL PHT, TADALAFIL TIH PHT, TADALAFIL ARW PHT

Entry onto ARTG: 26 May 2017

tadalafil

Arrow Pharma Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Erectile dysfunction, benign prostatic hyperplasia, pulmonary arterial hypertension

LINEZOLID KABI

Entry onto ARTG: 19 May 2017

linezolid

Fresenius Kabi Australia Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Infection

AZACCORD, AZACITIDINE ACCORD, AZACITIDINE INTAS

Entry onto ARTG: 8 May 2017

azacitidine

Accord Healthcare Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Leukaemia, myelodysplastic syndromes

April 2017

KETOROLAC KABI

Entry onto ARTG: 28 April 2017

ketorolac trometamol

Fresenius Kabi Australia Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Pain following surgery

GABALEX MLABS, GABAPENTIN MLPL, GABAPENTIN MLABS, GABAPENTIN B&B

Entry onto ARTG: 28 April 2017

gabapentin

Micro Labs Pty Ltd

Dosage form: Capsule

Therapeutic use: Seizures, neuropathic pain

URSODEOXYCHOLIC ACID APOTEX, APO-URSODEOXYCHOLIC ACID

Entry onto ARTG: 20 April 2017

ursodeoxycholic acid

Apotex Pty Ltd

Dosage form: Capsule

Therapeutic use: Chronic cholestatic liver disease

CASFUNGIN, CASPODAS, CASPOFUNGIN JUNO, CANCIGIN

Entry onto ARTG: 19 April 2017

caspofungin acetate

Neo Health (Australia) Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Fungal infection

BIMTOP

Entry onto ARTG: 18 April 2017

bimatoprost

Aspen Pharma Pty Ltd

Dosage form: Eye drops

Therapeutic use: Intraocular pressure

KNT-AMLODIPINE, TCW-AMLODIPINE, GTA-AMLODIPINE, BESIDEP, IPCA-AMLODIPINE, PIPAMLODIPINE, TN-AMLODIPINE

Entry onto ARTG: 13 April 2017

amlodipine besilate

Ipca Pharma (Australia) Pty Ltd

Dosage form: Tablet

Therapeutic use: Hypertension, angina

MYLAN, MEDREICH DICLOFENAC, DICLOFENAC GH, GX DICLOFENAC

Entry onto ARTG: 4 April 2017

diclofenac sodium

Medreich Australia Pty Ltd

Dosage form: Modified release tablet

Therapeutic use: Rheumatism

MODAFINIL AN, MODAFINIL MYLAN, MODAFINIL SANDOZ, MODAFINIL CH

Entry onto ARTG: 3 April 2017

modafinil

Southern Cross Pharma Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Narcolepsy

March 2017

PREGABALIN MYLAN, LYZALON

Entry onto ARTG: 30 March 2017

pregabalin

Alphapharm Pty Ltd

Dosage form: Capsule

Therapeutic use: Neuropathic pain

TADACIP, TADALIS, CIPLA TADALAFIL

Entry onto ARTG: 27 March 2017

tadalafil

Cipla Australia Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Erectile dysfunction, benign prostatic hyperplasia

PALOCIP, CIPLA PALONOSETRON, PALONOSETRON CIPLA

Entry onto ARTG: 27 March 2017

palonosetron hydrochloride

Cipla Australia Pty Ltd

Dosage form: Solution for injection

Therapeutic use: Nausea, vomiting

VORIWOK, VORICONAZOLE WOCKHARDT

Entry onto ARTG: 21 March 2017

voriconazole

Geosun Pty Ltd

Dosage form: Powder for injection

Therapeutic use: Fungal infection

APO-MODAFINIL, MODAFINIL APOTEX

Entry onto ARTG: 20 March 2017

modafinil

Apotex Pty Ltd

Dosage form: Tablet

Therapeutic use: Narcolepsy

LAPROSTIM, LATANOPROST / TIMOLOL GXP, LATANOMOL, LATANOPROST / TIMOLOL GENPAR, LATANOPROST / TIMOLOL GPPL, XATANOTIM, LAPROSTAMOL, LANTIM

Entry onto ARTG: 20 March 2017

latanoprost and timolol maleate

Generic Partners Pty Ltd

Dosage form: Eye drops

Therapeutic use: Intraocular pressure

IRBESARTAN HCTZ MLABS, IRBESARTAN HCTZ MLPL

Entry onto ARTG: 14 March 2017

irbesartan and hydrochlorothiazide

Micro Labs Pty Ltd

Dosage form: Tablet

Therapeutic use: Hypertension

ESTOPRAM, ESCITALOPRAM B&B, ESITAL, ESCIT

Entry onto ARTG: 14 March 2017

escitalopram oxalate

Micro Labs Pty Ltd

Dosage form: Tablet

Therapeutic use: Depression, anxiety, obsessive-compulsive disorder

MOMASONE

Entry onto ARTG: 6 March 2017

mometasone furoate

Aspen Pharma Pty Ltd

Dosage form: Ointment

Therapeutic use: Dermatitis

February 2017

FAMCICLOVIR GPPL, FAMCICLOVIR GENPAR, FCICLOVIR, FAMCICLO, FACLOVIR, FAMVEER, FAMCICLOVIR GXP, FAMCLOVIR

Entry onto ARTG: 24 February 2017

famciclovir

Generic Partners Pty Ltd

Dosage form: Tablet

Therapeutic use: Herpes

IPCA-ALLOPURINOL, ALLOPURINOL APOTEX, PIP-ALLOPURINOL, MPI-ALLOPURINOL, CM ALLOPURINOL, TN-ALLOPURINOL, PTIN-ALLOPURINOL, TW ALLOPURINOL, GTAALLOPURINOL

Entry onto ARTG: 22 February 2017

allopurinol

Apotex Pty Ltd

Dosage form: Tablet

Therapeutic use: Urate / uric acid deposition

FLUAIR INHALER, FLUTICASONE CIPLA INHALER

Entry onto ARTG: 21 February 2017

fluticasone propionate

Cipla Australia Pty Ltd

Dosage form: Inhaler

Therapeutic use: Asthma

AKM-PREGABALIN, PHARMACOR PREGABALIN

Entry onto ARTG: 14 February 2017

pregabalin

Southern Cross Pharma Pty Ltd

Dosage form: Capsule

Therapeutic use: Neuropathic pain

January 2017

TENOFOVIR EMT LUPIN, TENOFOVIR EMT GH, TENOFOVIR EMT LAPL

Entry onto ARTG: 31 January 2017

tenofovir disoproxil phosphate / emtricitabine

Lupin Australia Pty Limited

Dosage form: Film-coated tablet

Therapeutic use: HIV-1 infection

APO-TRANEXAMIC ACID, TRANEXAMIC ACID SCP, TRANEXAMIC ACID RMB

Entry onto ARTG: 30 January 2017

tranexamic acid

Southern Cross Pharma Pty Ltd

Dosage form: Tablet

Therapeutic use: Angioneurotic oedema, hyphaema, menorrhagia

TENOFOVIR LUPIN, TENOFOVIR GH, TENOFOVIR LAPL

Entry onto ARTG: 30 January 2017

tenofovir disoproxil phosphate

Lupin Australia Pty Limited

Dosage form: Film-coated tablet

Therapeutic use: HIV-1 infection, chronic hepatitis B

NEVIRAPINE XR APOTEX

Entry onto ARTG: 25 January 2017

nevirapine

Apotex Pty Ltd

Dosage form: Modified release tablet

Therapeutic use: HIV-1 infection

RIVASTIG PATCH, RIVASTIGMINE APOTEX PATCH, RIVASTIGMINE SG PATCH, RIVASTIGMINE GPPL PATCH, CHEMMART RIVASTIGMINE PATCH, RIVASTIGMINE GENPAR PATCH, APORIVASTIGMINE PATCH, RIVASTIGMELON PATCH, RIVASTIGMINE AML PATCH, RIVASTIGMINE GXP PATCH, TERRY WHITE CHEMISTS RIVASTIGMINE PATCH

Entry onto ARTG: 25 January 2017

rivastigmine

Generic Partners Pty Ltd

Dosage form: Transdermal drug delivery system sachet

Therapeutic use: Alzheimer's disease

LINEZOLID CA, CIPLA LINEZOLID, LINEZOLID CIP

Entry onto ARTG: 24 January 2017

linezolid

Cipla Australia Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Infection

APO-NALTREXONE, NALTREXONE-APOTEX

Entry onto ARTG: 24 January 2017

naltrexone hydrochloride

Apotex Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Alcohol dependence

CASPOFUNGIN APOTEX

caspofungin acetate

Sandoz Pty Ltd

Dosage form: Powder for injection

Entry onto ARTG: 17 January 2017

Therapeutic use: Fungal infection

MEDREICH COAMOXICLAV, AMOXICILLIN CLAVULANIC ACID MYLAN, APO-AMOXY/ CLAV, AMOXYCLAV GENERICHEALTH, AMOXYCLAV SANDOZ

Entry onto ARTG: 17 January 2017

amoxicillin and clavulanic acid

Medreich Australia Pty Ltd

Dosage form: Tablet

Therapeutic use: Bacterial infection

GENRX DORZOLAMIDE, APO-DORZOLAMIDE

Entry onto ARTG: 17 January 2017

dorzolamide hydrochloride

Apotex Pty Ltd

Dosage form: Eye drops

Therapeutic use: Intraocular pressure

APO-DORZOLAMIDE / TIMOLOL, DORZOLAMIDE / TIMOLOL APOTEX

Entry onto ARTG: 11 January 2017

dorzolamide hydrochloride / timolol maleate

Apotex Pty Ltd

Dosage form: Eye drops

Therapeutic use: Intraocular pressure

IRBESARTAN MLPL, IRBESARTAN MLABS, IRBESARTAN MLPL, IRBERAK MLABS, IRBESTRAZ MLABS

Entry onto ARTG: 10 January 2017

irbesartan

Micro Labs Pty Ltd

Dosage form: Film-coated tablet

Therapeutic use: Hypertension

LINEZOLID SANDOZ, LINEZOLID SZ

Entry onto ARTG: 4 January 2017

linezolid

Sandoz Pty Ltd

Dosage form: Injection

Therapeutic use: Infection