Sections 14 and 14A Notice

 

 

On 30 September 2016, a delegate of the Secretary of the Department of Health, on the application of Sandoz Pty Ltd , consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of the products outlined in Attachment 1; that do not conform with the requirements of the sub-clause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels of the products do not contain the current company address.

The consent is effective from 30 June 2016 until 31 July 2017. 

The consent is subject to the following conditions:

  1. The labels of the products to which this consent applies are those previously approved and contain the previous company address as detailed in the application.
  2. Sandoz Pty Ltd’s contact details remain unchanged, and arrangements are in place for the prompt re-direction of mails and correspondence to the new company address.

 


Attachment 1

Submission No.

Products

PM-2016-02744-1-2 (Sponsor: Sandoz Pty Ltd)

  • 100011 - VANCOMYCIN SANDOZ vancomycin 1g (as hydrochloride) powder for injection vial
  • 100021 - VANCOMYCIN SANDOZ vancomycin 500mg (as hydrochloride) powder for injection vial
  • 100989 - ROXITHROMYCIN SANDOZ roxithromycin 150mg tablet blister pack
  • 101028 - ROXITHROMYCIN SANDOZ roxithromycin 300mg tablet blister pack
  • 101265 - CLARITHROMYCIN SANDOZ clarithromycin 250 mg film- coated tablets blister pack
  • 101462 - ATENOLOL SANDOZ atenolol 50mg tablet blister pack.
  • 101685 - TERBINAFINE SANDOZ terbinafine (as hydrochloride) 250 mg tablet blister pack
  • 101690 - CITALOPRAM SANDOZ citalopram hydrobromide 20mg film coated tablet bottle
  • 101691 - CITALOPRAM SANDOZ citalopram hydrobromide 20mg film coated tablet blister pack
  • 102013 - TRAMADOL SANDOZ tramadol hydrochloride 100 mg/2 mL injection ampoule
  • 104285 - FLUCONAZOLE SANDOZ fluconazole 50 mg capsules blister pack
  • 104288 - FLUCONAZOLE SANDOZ fluconazole 100 mg capsules blister pack
  • 104293 - FLUCONAZOLE SANDOZ fluconazole 200 mg capsules blister pack
  • 104301 - FLUCONAZOLE SANDOZ fluconazole 100 mg/50 mL injection vial
  • 104302 - FLUCONAZOLE SANDOZ fluconazole 200 mg/100 mL injection vial
  • 104396 - CARVEDILOL SANDOZ carvedilol 12.5 mg tablets blister pack
  • 106461 - CISPLATIN EBEWE cisplatin 100mg/100mL injection vial
  • 106463 - FRUSEMIDE SANDOZ furosemide (frusemide) 20mg/2mL injection ampoule
  • 107061 - CITALOPRAM SANDOZ citalopram (as hydrobromide) 40mg film coated tablet blister pack
  • 107330 - CYPROTERONE SANDOZ cyproterone acetate 50mg tablet bottle
  • 107331 - CYPROTERONE SANDOZ cyproterone acetate 100mg tablet blister pack
  • 111781 - VOXAM fluvoxamine maleate 50mg tablet blister pack
  • 111782 - VOXAM fluvoxamine maleate 100mg tablet blister pack
  • 117156 - MIRTAZAPINE SANDOZ mirtazapine 30mg tablets blister pack
  • 117157 - MIRTAZAPINE SANDOZ mirtazapine 45mg tablets blister pack
  • 117568 - DACARBAZINE SANDOZ Dacarbazine 200 mg powder for injection vial
  • 117865 - PHENYTOIN SANDOZ (phenytoin sodium) 250mg/ 5mL injection ampoule
  • 117872 - PHENYTOIN SANDOZ (phenytoin sodium) 100mg/ 2mL injection ampoule
  • 118321 - Metronidazole Sandoz IV (Metronidazole 500 mg/ 100 mL Injection Solution Bag
  • 120618 - METHOTREXATE EBEWE methotrexate 5000mg/50mL concentrated injection vial
  • 121781 - GLIMEPIRIDE SANDOZ glimepiride 1mg tablet blister pack
  • 121786 - GLIMEPIRIDE SANDOZ glimepiride 2 mg tablet blister pack
  • 121788 - GLIMEPIRIDE SANDOZ glimepiride 3 mg tablet blister pack
  • 121790 - GLIMEPIRIDE SANDOZ glimepiride 4 mg tablet blister pack
  • 121813 - ENALAPRIL SANDOZ enalapril maleate - 5mg tablet blister pack
  • 121814 - ENALAPRIL SANDOZ enalapril maleate - 10mg tablet blister pack
  • 121816 - ENALAPRIL SANDOZ enalapril maleate - 20mg tablet blister pack
  • 123665 - METFORMIN SANDOZ metformin hydrochloride 1000mg tablets blister pack
  • 123673 - METFORMIN SANDOZ metformin hydrochloride 1000mg tablets bottle
  • 125661 - METFORMIN SANDOZ metformin hydrochloride 500mg tablet blister pack
  • 125662 - METFORMIN SANDOZ metformin hydrochloride 850mg tablet blister pack
  • 126490 - ENALAPRIL/HCT SANDOZ 20mg/6mg enalapril maleate 20mg and hydrochlorothiazide 6mg tablet blister pack
  • 126693 - VINORELBINE EBEWE 10 mg/1 mL (as tartrate) injection vial
  • 127084 - MELOXICAM SANDOZ meloxicam 7.5mg tablets blister pack
  • 127409 - FINASTA finasteride 5mg tablets blister pack
  • 127519 - RAMIPRIL SANDOZ ramipril 10mg tablet blister pack
  • 127718 - MELOXICAM SANDOZ meloxicam 15mg tablets blister pack
  • 127835 - OMEPRAZOLE SANDOZ IV omeprazole (as sodium) 40mg powder for injection vial
  • 131943 - EPIRUBICIN EBEWE epirubicin hydrochloride 10mg/5mL injection vial
  • 132327 - MITOZANTRONE EBEWE mitozantrone (as hydrochloride) 20mg/10mL solution for injection vial
  • 134981 - ALENDRONATE SANDOZ alendronic acid 70mg tablets blister pack
  • 135540 - FLUDARABINE EBEWE fludarabine phosphate 50 mg / 2 mL concentrated injection vial
  • 135762 - TOPIRAMATE SANDOZ topiramate 25 mg tablet bottle
  • 135779 - TOPIRAMATE SANDOZ topiramate 50 mg tablet bottle
  • 135794 - TOPIRAMATE SANDOZ topiramate 100 mg tablet bottle
  • 135810 - TOPIRAMATE SANDOZ topiramate 200 mg tablet bottle
  • 140840 - PIPERTAZ SANDOZ 4 g/ 0.5 g piperacillin (as sodium) 4g and tazobactam (as sodium) 0.5 g powder for injection bottle
  • 142746 - ANASTROZOLE SANDOZ anastrozole 1 mg tablet blister pack
  • 144867 - BISOPROLOL SANDOZ bisoprolol fumarate 2.5 mg film- coated tablet blister pack
  • 144884 - BISOPROLOL SANDOZ bisoprolol fumarate 5 mg film- coated tablet blister pack
  • 144888 - BISOPROLOL SANDOZ bisoprolol fumarate 10 mg film- coated tablet blister pack
  • 146907 - ESITALO escitalopram (as oxalate) 10mg tablets blister pack
  • 146908 - ESITALO escitalopram (as oxalate) 20mg tablets blister pack
  • 146979 - CURAM 125/31.25 amoxicillin (as trihydrate) 125mg/5mL clavulanic acid (as potassium clavulanate) 31.25mg/5mL powder   for suspension bottle
  • 147109 - CURAM DUO 400/57 amoxicillin 400 mg/5mL (as trihydrate) / clavulanic acid 57 mg/5mL (as potassium clavulanate) powder for suspension bottle
  • 147362 - PANTOPRAZOLE SANDOZ pantoprazole (as sodium sesquihydrate) 20mg enteric coated tablet blister pack
  • 147367 - PANTOPRAZOLE SANDOZ pantoprazole (as sodium sesquihydrate) 40mg enteric coated tablet blister pack
  • 147377 - PANTOPRAZOLE SANDOZ pantoprazole (as sodium) 40mg powder for injection vial
  • 147493 - CANDESARTAN SANDOZ candesartan cilexetil 8mg tablet blister pack
  • 147496 - CANDESARTAN SANDOZ candesartan cilexetil 32mg tablet blister pack
  • 147498 - CANDESARTAN SANDOZ candesartan cilexetil 16mg tablet blister pack
  • 147561 - PERINDOPRIL SANDOZ perindopril erbumine 2 mg tablet blister pack
  • 147566 - PERINDOPRIL SANDOZ perindopril erbumine 4 mg tablet blister pack
  • 147567 - PERINDOPRIL SANDOZ perindopril erbumine 8 mg tablet blister pack
  • 148225 - MYCOPHENOLATE SANDOZ mycophenolate mofetil 500mg tablet blister pack
  • 148227 - MYCOPHENOLATE SANDOZ mycophenolate mofetil 250mg capsule blister pack
  • 148268 - METFORMIN SANDOZ metformin hydrochloride 500mg tablet bottle
  • 148567 - SILDENAFIL SANDOZ sildenafil (as citrate) 50 mg tablet blister pack
  • 148568 - SILDENAFIL SANDOZ sildenafil (as citrate) 100 mg tablet blister pack
  • 148570 - SILDENAFIL SANDOZ sildenafil (as citrate) 25 mg tablet blister pack
  • 148870 - PROPOFOL SANDOZ propofol 200mg/20mL emulsion for injection vial
  • 148871 - PROPOFOL SANDOZ propofol 500mg/50mL emulsion for injection vial
  • 148872 - PROPOFOL SANDOZ propofol 1000mg/100mL emulsion for injection vial
  • 150170 - CEFALEXIN SANDOZ cefalexin monohydrate 250 mg capsules blister pack
  • 152450 - PRAVASTATIN SANDOZ pravastatin sodium 40 mg tablet blister pack
  • 152451 - PRAVASTATIN SANDOZ pravastatin sodium 10 mg tablet blister pack
  • 152452 - PRAVASTATIN SANDOZ pravastatin sodium 80 mg tablet blister pack
  • 152458 - PRAVASTATIN SANDOZ pravastatin sodium 20 mg tablet blister pack
  • 152568 - FENTANYL SANDOZ fentanyl 75 micrograms/hour transdermal drug delivery system sachet
  • 152569 - FENTANYL SANDOZ fentanyl 25 micrograms/hour transdermal drug delivery system sachet
  • 152571 - FENTANYL SANDOZ fentanyl 50 micrograms/hour transdermal drug delivery system sachet
  • 152572 - FENTANYL SANDOZ fentanyl 12 micrograms/hour transdermal drug delivery system sachet
  • 152576 - FENTANYL SANDOZ fentanyl 100 micrograms/hour transdermal drug delivery system sachet
  • 153591 - OXYCODONE SANDOZ oxycodone hydrochloride 80mg modified release tablet blister pack
  • 153597 - OXYCODONE SANDOZ oxycodone hydrochloride 10mg modified release tablet blister pack
  • 153605 - OXYCODONE SANDOZ oxycodone hydrochloride 5mg modified release tablet blister pack
  • 153611 - OXYCODONE SANDOZ oxycodone hydrochloride 40mg modified release tablet blister pack
  • 153615 - OXYCODONE SANDOZ oxycodone hydrochloride 20mg modified release tablet blister pack
  • 153744 - TACROLIMUS SANDOZ tacrolimus 0.5mg capsule blister pack
  • 153745 - TACROLIMUS SANDOZ tacrolimus 1mg capsule blister pack
  • 153746 - TACROLIMUS SANDOZ tacrolimus 5mg capsule blister pack
  • 154464 - VALACICLOVIR SANDOZ valaciclovir (as hydrochloride) 500 mg film-coated tablet blister pack
  • 154854 - RISEDRONATE SANDOZ risedronate sodium 35mg tablet blister pack
  • 157195 - GABAPENTIN SANDOZ gabapentin 400mg capsule blister pack
  • 157197 - GABAPENTIN SANDOZ gabapentin 300mg capsule blister pack
  • 157639 - ROCURONIUM SANDOZ rocuronium bromide 50mg/5ml solution for injection
  • 157812 - TEICOPLANIN SANDOZ teicoplanin 400mg powder for injection vial with diluent ampoule
  • 157837 - DONEPEZIL SANDOZ donepezil hydrochloride (as monohydrate) 10mg film-coated tablet blister pack
  • 157842 - DONEPEZIL SANDOZ donepezil hydrochloride (as monohydrate) 5mg film-coated tablet blister pack
  • 157942 - CANDESARTAN/HCT SANDOZ 16mg/12.5mg candesartan cilexetil/hydrochlorothiazide 16 mg/12.5 mg tablet blister pack
  • 158099 - QUETIAPINE SANDOZ quetiapine fumarate 200mg film- coated tablets blister pack
  • 158100 - LISINOPRIL SANDOZ lisinopril dihydrate 5mg tablet blister pack
  • 158101 - LISINOPRIL SANDOZ lisinopril dihydrate 10mg tablet blister pack
  • 158104 - QUETIAPINE SANDOZ quetiapine fumarate 25mg film- coated tablets blister pack
  • 158106 - QUETIAPINE SANDOZ quetiapine fumarate 300mg film- coated tablets blister pack
  • 158108 - LISINOPRIL SANDOZ lisinopril dihydrate 20mg tablet blister pack
  • 158109 - QUETIAPINE SANDOZ quetiapine fumarate 100mg film- coated tablets blister pack
  • 158292 - AZITHROMYCIN SANDOZ azithromycin (as dihydrate) 500mg tablet blister pack
  • 162222 - PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 30mg tablet blister pack
  • 162223 - PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 15mg tablet blister pack
  • 162225 - PIOGLITAZONE SANDOZ pioglitazone (as hydrochloride) 45mg tablet blister pack
  • 162498 - OXYTOCIN SANDOZ oxytocin 5IU/1mL injection ampoule
  • 162499 - OXYTOCIN SANDOZ oxytocin 10IU/1mL injection ampoule
  • 162522 - OMNITROPE somatropin (rbe) 10mg/1.5mL solution for injection cartridge
  • 162851 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 200mg/20mL solution for injection ampoule
  • 162852 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 75mg/10mL solution for injection ampoule
  • 162853 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 40mg/20mL solution for injection ampoule
  • 162856 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 100mg/10mL solution for injection ampoule
  • 162857 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 400mg/200mL solution for injection infusion bag
  • 162859 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 150mg/20mL solution for injection ampoule
  • 162866 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 20mg/10mL solution for injection ampoule
  • 162869 - ROPIVACAINE SANDOZ ropivacaine hydrochloride (as monohydrate) 200mg/100mL solution for injection infusion bag
  • 162931 - IDARUBICIN EBEWE idarubicin hydrochloride 10mg/10mL concentrated injection vial
  • 162933 - IDARUBICIN EBEWE idarubicin hydrochloride 5mg/5mL concentrated injection vial
  • 166738 - FLUOROURACIL EBEWE fluorouracil 2500 mg/50 mL solution for injection vial
  • 166741 - FLUOROURACIL EBEWE fluorouracil 5000 mg/100 mL solution for injection vial
  • 167406 - IRBESARTAN SANDOZ irbesartan 75mg film-coated tablet blister pack
  • 167407 - IRBESARTAN SANDOZ irbesartan 300mg film-coated tablet blister pack
  • 167409 - IRBESARTAN SANDOZ irbesartan 150mg film-coated tablet blister pack
  • 167717 - RILUZOLE SANDOZ riluzole 50mg film-coated tablet blister pack
  • 169291 - INDAPAMIDE SANDOZ indapamide hemihydrate 2.5mg tablet blister pack
  • 171691 - LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle
  • 171734 - CEFEPIME SANDOZ cefepime (as hydrochloride) 2 g powder for injection vial
  • 171736 - CEFEPIME SANDOZ cefepime (as hydrochloride) 1 g powder for injection vial
  • 172124 - LETROZOLE SANDOZ letrozole 2.5mg tablet blister pack
  • 173080 - RABEPRAZOLE SANDOZ rabeprazole sodium 20 mg tablet blister pack
  • 173081 - RABEPRAZOLE SANDOZ rabeprazole sodium 10 mg tablet blister pack
  • 174337 - EXEMESTANE SANDOZ exemestane 25mg tablet blister pack
  • 176179 - OMEPRAZOLE SANDOZ omeprazole (as magnesium) 20 mg enteric-coated tablet blister pack
  • 179823 - ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 40 mg tablets blister pack
  • 179833 - ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 80 mg tablets blister pack
  • 179842 - ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 20 mg tablets blister pack
  • 179845 - ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 10 mg tablets blister pack
  • 183401 - MIRTAZAPINE SANDOZ ODT 15 mirtazapine 15 mg orally disintegrating tablets blister pack
  • 183402 - MIRTAZAPINE SANDOZ ODT 30 mirtazapine 30 mg orally disintegrating tablets blister pack
  • 183403 - MIRTAZAPINE SANDOZ ODT 45 mirtazapine 45 mg orally disintegrating tablets blister pack
  • 183577 - ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 5 mg film-coated tablets blister pack
  • 183595 - ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 10 mg film-coated tablets blister pack
  • 183597 - ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 20 mg film-coated tablets blister pack
  • 183599 - ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 40 mg film-coated tablets blister pack
  • 193204 - LEVETIRACETAM SANDOZ levetiracetam 500 mg /5 mL concentrate solution for IV infusion vial.
  • 195065 - ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe
  • 195066 - ZARZIO filgrastim (rbe) 300 microgram/0.5 mL solution for injection pre-filled syringe
  • 195278 - Candesartan/HCT Sandoz 32/25 32mg/25mg tablet blister pack
  • 195279 - Candesartan/HCT Sandoz 32/12.5 32mg/12.5mg tablet blister pack
  • 199661 - MELOXICAM SANDOZ meloxicam 7.5 mg capsule blister pack
  • 199662 - MELOXICAM SANDOZ meloxicam 15 mg capsule blister pack
  • 199698 - TELMISARTAN SANDOZ telmisartan 80mg tablets blister pack
  • 199699 - TELMISARTAN SANDOZ telmisartan 40mg tablets blister pack
  • 201359 - TELMISARTAN/HCT SANDOZ 80mg/12.5mg telmisartan 80mg / hydrochlorothiazide 12.5mg blister pack
  • 201800 - Capecitabine Sandoz capecitabine 500mg film coated tablet blister pack
  • 204403 - Latanoprost/Timolol Sandoz 50/5 latanoprost 50 microgram/mL timolol 5 mg/mL Eye Drops
  • 205625 - OMNITROPE somatropin (rbe) 15mg/1.5mL solution for injection cartridge
  • 210630 - CELECOXIB SANDOZ celecoxib 100mg hard capsule blister pack
  • 210632 - CELECOXIB SANDOZ celecoxib 200mg hard capsule blister pack
  • 211972 - DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bottle
  • 219057 - CLOPIDOGREL/ASPIRIN SANDOZ 75/100 clopidogrel (as hydrogen sulfate) and aspirin 75 mg/100 mg uncoated tablet blister pack
  • 224622 - OMNITROPE somatropin (rbe) 5mg/1.5mL injection cartridge with pre-assembled cartridge holder
  • 224623 - OMNITROPE somatropin (rbe) 10mg/1.5mL solution for injection cartridge with pre-assembled cartridge holder
  • 60838 - DILTIAZEM SANDOZ diltiazem hydrochloride 60mg tablet blister pack
  • 61416 - CAPTOPRIL SANDOZ captopril 25mg tablet blister pack
  • 61419 - CAPTOPRIL SANDOZ captopril 12.5mg tablet blister pack
  • 61420 - CAPTOPRIL SANDOZ captopril 50mg tablet blister pack
  • 62560 - METOPROLOL SANDOZ metoprolol tartrate 50mg tablet blister pack
  • 62561 - METOPROLOL SANDOZ metoprolol tartrate 100mg tablet blister pack
  • 62646 - DILTIAZEM SANDOZ diltiazem hydrochloride 60mg tablet bottle
  • 63332 - AMOXYCILLIN SANDOZ amoxicillin 250mg (as trihydrate) capsule blister pack
  • 63333 - AMOXYCILLIN SANDOZ amoxicillin 500mg (as trihydrate) capsule blister pack
  • 63664 - DICLOFENAC SANDOZ diclofenac sodium 25mg tablet blister pack
  • 64718 - FRUSEMIDE SANDOZ furosemide (frusemide) 40mg tablet bottle
  • 65905 - ALLOPURINOL SANDOZ Allopurinol 100mg tablet bottle
  • 65906 - ALLOPURINOL SANDOZ Allopurinol 300mg tablet bottle
  • 66302 - DOXYCYCLINE SANDOZ doxycycline 100mg (as monohydrate) tablet blister pack
  • 69049 - DOXYCYCLINE SANDOZ doxycycline (as monohydrate) 50mg tablet blister pack
  • 70325 - RANITIDINE SANDOZ ranitidine 150mg (as hydrochloride) tablet blister pack
  • 70356 - RANITIDINE SANDOZ ranitidine 300mg (as hydrochloride) tablet blister pack
  • 74404 - AZATHIOPRINE SANDOZ azathioprine 25mg tablet blister pack
  • 74407 - AZATHIOPRINE SANDOZ azathioprine 50mg tablet blister pack
  • 75241 - ISOMONIT Isosorbide mononitrate 60mg modified release tablet blister pack
  • 75771 - RANITIDINE SANDOZ ranitidine 50mg/5mL (as hydrochloride) concentrated injection ampoules
  • 75959 - CEFTRIAXONE SANDOZ ceftriaxone 1g (as sodium) powder for injection vial
  • 76050 - MAXAMOX amoxicillin (as trihydrate) 1000 mg tablet blister pack
  • 76899 - NORFLOXACIN SANDOZ norfloxacin 400mg tablet film coated blister pack
  • 76934 - MOCLOBEMIDE SANDOZ moclobemide 150mg tablet blister pack
  • 76935 - MOCLOBEMIDE SANDOZ moclobemide 300mg tablet blister pack
  • 77739 - AMIODARONE SANDOZ amiodarone hydrochloride 200mg tablet blister pack
  • 78186 - PROBITOR omeprazole 20mg enteric capsule bottle
  • 78211 - CARBAMAZEPINE SANDOZ Carbamazepine 200mg tablet blister pack
  • 78217 - CARBAMAZEPINE SANDOZ Carbamazepine 100mg tablet blister pack
  • 78971 - MIDAZOLAM SANDOZ midazolam 5mg/5mL injection ampoule
  • 78972 - MIDAZOLAM SANDOZ midazolam 5mg/1mL injection ampoule
  • 78976 - MIDAZOLAM SANDOZ midazolam 50mg/10mL injection ampoule
  • 78980 - CEFALEXIN SANDOZ cefalexin (as monohydrate) 500mg capsule blister pack
  • 78981 - CEFALEXIN SANDOZ cefalexin (as monohydrate) 125mg/5mL powder for suspension bottle
  • 78982 - CEFALEXIN SANDOZ cefalexin (as monohydrate) 250mg/5mL powder for suspension bottle
  • 80076 - TAMOXIFEN SANDOZ tamoxifen 20mg (as citrate) tablet blister pack
  • 81460 - CIPROFLOXACIN SANDOZ ciprofloxacin (as hydrochloride) 250 mg tablet blister pack
  • 81461 - CIPROFLOXACIN SANDOZ ciprofloxacin (as hydrochloride) 500 mg tablet blister pack
  • 81462 - CIPROFLOXACIN SANDOZ ciprofloxacin (as hydrochloride) 750 mg tablet blister pack
  • 82211 - OMNITROPE somatropin (rbe) 5mg/1.5mL injection cartridge
  • 82474 - OMEPRAZOLE SANDOZ omeprazole 20mg enteric capsule bottle
  • 82551 - PAROXETINE SANDOZ paroxetine (as hydrochloride) 20mg tablet blister pack
  • 82757 - PROBITOR omeprazole 20mg enteric capsule blister pack
  • 82829 - CURAM DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet strip pack
  • 82830 - CURAM DUO 500/125 amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium) tablet strip pack
  • 82994 - DOBUTAMINE SANDOZ dobutamine 250mg/20mL (as hydrochloride) injection ampoule
  • 90915 - CEFTAZIDIME SANDOZ ceftazidime 1g (as pentahydrate) powder for injection vial
  • 90916 - CEFTAZIDIME SANDOZ ceftazidime 2g (as pentahydrate) powder for injection vial
  • 93720 - AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle
  • 93721 - AMOXYCILLIN SANDOZ amoxicillin trihydrate 125mg/5mL powder for oral suspension bottle
  • 93722 - MAXAMOX amoxicillin trihydrate 500mg/5mLpowder for oral suspension bottle
  • 96641 - ETOPOSIDE EBEWE etoposide 100mg/5mL injection vial
  • 98539 - CALCIUM FOLINATE EBEWE folinic acid 50mg/ 5mL (as calcium folinate) injection ampoule.
  • 98541 - CALCIUM FOLINATE EBEWE folinic acid 100mg/ 10mL (as calcium folinate) injection vial.
  • 98545 - FLUOROURACIL EBEWE fluorouracil 1000mg/ 20mL solution for injection vial
  • 98697 - SERTRALINE SANDOZ sertraline hydrochloride 50mg tablet blister pack
  • 98698 - SERTRALINE SANDOZ sertraline hydrochloride 100mg tablet blister pack
  • 98758 - AMOXYCILLIN SANDOZ amoxicillin (as trihydrate) 1000 mg tablet blister pack
  • 99239 - TRAMADOL SANDOZ SR tramadol hydrochloride 100mg modified release tablet blister pack
  • 99252 - TRAMADOL SANDOZ SR tramadol hydrochloride 150mg modified release tablet blister pack
  • 99258 - TRAMADOL SANDOZ SR tramadol hydrochloride 200mg modified release tablet blister pack
  • 99420 - ACICLOVIR SANDOZ aciclovir 200mg tablet blister pack
  • 99421 - ACICLOVIR SANDOZ aciclovir 800mg tablet blister pack
  • 99724 - VINORELBINE EBEWE 50mg/5mL (as tartrate) injection vial

PM-2016-02759-1-1 (Sponsor: Sanofi- Aventis Australia Pty Ltd)

  • 128095 - ZOLPIDEM SANDOZ zolpidem tartrate 10mg tablet blister pack
  • 128803 - RAMIPRIL SANDOZ ramipril 1.25mg tablet blister pack
  • 128806 - RAMIPRIL SANDOZ ramipril 2.5mg tablet blister pack
  • 128808 - RAMIPRIL SANDOZ ramipril 5.0mg tablet blister pack
  • 128811 - RAMIPRIL SANDOZ ramipril 10mg capsule hard blister pack
  • 128985 - AMISULPRIDE SANDOZ 100 amisulpride 100 mg tablet blister pack
  • 128993 - AMISULPRIDE SANDOZ 200 amisulpride 200 mg tablet blister pack
  • 128994 - AMISULPRIDE SANDOZ 400 amisulpride 400 mg tablet blister pack
  • 130902 - OXYBUTYNIN SANDOZ oxybutynin hydrochloride 5mg tablet bottle
  • 131137 - COMFAROL FORTE paracetamol 500mg and codeine phosphate hemihydrate 30mg tablet blister pack
  • 131298 - DILTIAZEM SANDOZ CD diltiazem hydrochloride 180mg capsule bottle
  • 131300 - DILTIAZEM SANDOZ CD diltiazem hydrochloride 240mg capsule bottle
  • 131304 - DILTIAZEM SANDOZ CD diltiazem hydrochloride 360mg capsule bottle (unprinted)
  • 134367 - SODIUM VALPROATE SANDOZ sodium valproate 200mg enteric coated tablet blister pack
  • 134368 - SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack

PM-2016-02758-1-1 (Sponsor: Generic Health Pty Ltd)

  • 151875 - VENLAFAXINE SANDOZ XR venlafaxine (as hydrochloride) 150mg modified release capsule blister
  • 151880 - VENLAFAXINE SANDOZ XR venlafaxine (as hydrochloride) 75mg modified release capsule blister

PM-2016-02760-1-3 (Sponsor: Servier Laboratories (Australia) Pty Ltd)

  • 34266 - IDAPREX 2 perindopril erbumine 2mg tablet blister pack
  • 34267 - IDAPREX 4 perindopril erbumine 4mg tablet blister pack
  • 94527 - IDAPREX COMBI 4/1.25 perindopril erbumine 4mg and indapamide hemihydrate 1.25mg tablet blister pack
  • 96738 - IDAPREX 8 perindopril erbumine 8mg tablet blister pack

PM-2016-02762-1-5 (Sponsor: Accord Healthcare Pty Ltd)

  • 169424 - OXALIPLATIN SZ 5 mg/ml, 20 ml oxaliplatin 5 mg/ml, concentrate for solution for infusion, 20 ml
  • 184830 - MONTELUKAST SANDOZ 10 montelukast 10 mg (as sodium) film-coated tablet blister pack
  • 184832 - MONTELUKAST SANDOZ 4 montelukast 4 mg (as sodium) chewable tablet blister pack
  • 184833 - MONTELUKAST SANDOZ 5 montelukast 5 mg (as sodium) chewable tablet blister pack
  • 187214 - SUMATRIPTAN SANDOZ Tablets 50 mg Sumatriptan (as succinate) 50 mg Tablets Blister
  • 187215 - SUMATRIPTAN SANDOZ Tablets 100 mg Sumatriptan (as succinate) 100 mg Tablets Blister
  • 188702 - SILDENAFIL SANDOZ PHT 20 sildenafil (as citrate) 20 mg film-coated tablets blister pack

PM-2016-02757-1-4 (Sponsor: Dr Reddy’s Laboratories Australia Pty Ltd)

  • 163438 - ONDANSETRON SZ ondansetron (as hydrochloride dihydrate) 4 mg film-coated tablet blister pack
  • 163439 - ONDANSETRON SZ ondansetron (as hydrochloride dihydrate) 8 mg film-coated tablet blister pack
  • 163653 - ONDANSETRON SZ ODT ondansetron 4 mg orally disintegrating tablet blister pack
  • 163654 - ONDANSETRON SZ ODT ondansetron 8 mg orally disintegrating tablet blister pack

PM-2016-02761-1-1 (Sponsor: Southern Cross Pharma Pty Ltd)

  • 141240 - TRAMADOL SANDOZ tramadol hydrochloride 50 mg capsule blister pack
  • 159268 - LEVETIRACETAM SZ levetiracetam 250 mg tablet blister pack
  • 159269 - LEVETIRACETAM SZ levetiracetam 500 mg tablet blister pack
  • 159271 - LEVETIRACETAM SZ levetiracetam 1000 mg tablet blister pack
  • 210905 - LEFLUNOMIDE SANDOZ leflunomide 10mg tablet bottle
  • 210906 - LEFLUNOMIDE SANDOZ leflunomide 20mg tablet bottle