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