Federal Register of Legislation - Australian Government

Primary content

PB 71 of 2012 Other as amended, taking into account amendments up to National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 2) (PB 13 of 2021)
This instrument revokes and replaces the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to determine the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands, and provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Administered by: Health
Registered 31 Mar 2021
Start Date 01 Mar 2021
End Date 31 Mar 2021
Table of contents.

Commonwealth Coat of Arms of Australia

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953

Compilation No. 102

Compilation date:                              1 March 2021

Includes amendments up to:            PB 13 of 2021

Registered:                                         31 March 2021

This compilation is in 6 volumes

Volume 1:       sections 1–26 and Schedule 1 (Part 1: A–C)

Volume 2:       Schedule 1 (Part 1: D–K)

Volume 3:       Schedule 1 (Part 1: L–P)

Volume 4:       Schedule 1 (Part 1: Q–Z, Part 2), Schedules 2 and 3

Volume 5:       Schedule 4 (Part 1: A–R)

Volume 6:       Schedule 4 (Part 1: S–Z, Part 3), Schedules 5, 6 and
                        Endnotes

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that shows the text of the law as amended and in force on 1 March 2021 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Schedule 1—Ready‑prepared pharmaceutical benefits                                   1

Part 1—Ready‑prepared pharmaceutical benefits for prescription and supply       1


Schedule 1Ready‑prepared pharmaceutical benefits

Note:       See sections 5 to 10, 16 to 18, 20, 21 and 23 to 26.

Part 1Ready‑prepared pharmaceutical benefits for prescription and supply

  

 

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

Dabigatran etexilate

Capsule 75 mg (as mesilate)

Oral

 

Pradaxa

BY

MP NP

C4369 C4381 C4402

P4381

20

0

10

 

 

MP NP

C4369 C4381 C4402

P4369

20

1

10

 

 

MP NP

C4369 C4381 C4402

P4402

60

0

60

 

 

Capsule 110 mg (as mesilate)

Oral

 

Pradaxa

BY

MP NP

C4269 C4369 C4381 C4402

P4381

20

0

10

 

 

MP NP

C4269 C4369 C4381 C4402

P4369

20

1

10

 

 

MP NP

C4269 C4369 C4381 C4402

P4402

60

0

60

 

 

MP NP

C4269 C4369 C4381 C4402

P4269

60

5

60

 

 

Capsule 150 mg (as mesilate)

Oral

 

Pradaxa

BY

MP NP

C4269

 

60

5

60

 

 

Dabrafenib

Capsule 50 mg (as mesilate)

Oral

 

Tafinlar

NV

MP

C6013 C10130 C10131 C10148 C10157

P10130 P10131 P10148 P10157

120

3

120

 

 

MP

C6013 C10130 C10131 C10148 C10157

P6013

120

5

120

 

 

Capsule 75 mg (as mesilate)

Oral

 

Tafinlar

NV

MP

C6013 C10130 C10131 C10148 C10157

P10130 P10131 P10148 P10157

120

3

120

 

 

MP

C6013 C10130 C10131 C10148 C10157

P6013

120

5

120

 

 

Dalteparin

Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

 

 

20

0

10

 

 

MP NP

 

P4910

20

3

10

 

 

Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

 

 

20

0

10

 

 

MP NP

 

P4910

20

3

10

 

 

Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

 

 

10

1

10

 

 

MP NP

 

P4910

20

3

10

 

 

MP NP

 

P4967

30

5

10

 

 

Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

 

 

10

1

10

 

 

MP NP

 

P4910

20

3

10

 

 

MP NP

 

P4967

30

5

10

 

 

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

 

 

10

1

10

 

 

MP NP

 

P4910

20

3

10

 

 

MP NP

 

P4967

30

5

10

 

 

Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

C4967

 

30

5

10

 

 

Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe

Injection

 

Fragmin

PF

MP NP

C4967

 

30

5

10

 

 

Dantrolene

Capsule containing dantrolene sodium hemiheptahydrate 25 mg

Oral

 

Dantrium

PF

MP NP

C6359

 

100

2

100

 

 

Capsule containing dantrolene sodium hemiheptahydrate 50 mg

Oral

 

Dantrium

PF

MP NP

C6359

 

100

2

100

 

 

Dapagliflozin

Tablet 10 mg (as propanediol monohydrate)

Oral

 

Forxiga

AP

MP

C4991 C5629 C7495 C7506 C7528

 

28

5

28

 

 

NP

C4991 C5629 C7495 C7506

 

28

5

28

 

 

Dapagliflozin with metformin

Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

 

Xigduo XR 5/1000

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498

 

56

5

56

 

 

NP

C5631 C5657 C5739 C5798 C7492

 

56

5

56

 

 

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride

Oral

 

Xigduo XR 10/500

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498

 

28

5

28

 

 

NP

C5631 C5657 C5739 C5798 C7492

 

28

5

28

 

 

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

 

Xigduo XR 10/1000

AP

MP

C5631 C5657 C5739 C5798 C7492 C7498

 

28

5

28

 

 

NP

C5631 C5657 C5739 C5798 C7492

 

28

5

28

 

 

Dapsone

Tablet 25 mg

Oral

 

Link Medical Products Pty Ltd

LM

MP NP

 

 

100

1

100

 

 

Tablet 100 mg

Oral

 

Link Medical Products Pty Ltd

LM

MP NP

 

 

100

1

100

 

 

Daratumumab

Solution concentrate for I.V. infusion 100 mg in 5 mL

Injection

 

Darzalex

JC

MP

C11075 C11076 C11131 C11142

 

See Note 3

See Note 3

1

 

D(100)

Solution concentrate for I.V. infusion 400 mg in 20 mL

Injection

 

Darzalex

JC

MP

C11075 C11076 C11131 C11142

 

See Note 3

See Note 3

1

 

D(100)

Darbepoetin alfa

Injection 10 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 20 micrograms in 0.5 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 20 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 30 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 40 micrograms in 0.4 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 40 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 50 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 60 micrograms in 0.3 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 60 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 80 micrograms in 0.4 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 80 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 100 micrograms in 0.5 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 100 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Injection 150 micrograms in 0.3 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6294 C9688

 

8

5

1

 

D(100)

Injection 150 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6294 C9688

 

8

5

4

 

D(100)

Darunavir

Tablet 600 mg (as ethanolate)

Oral

 

Prezista

JC

MP NP

C5094

 

120

5

60

 

D(100)

Tablet 800 mg (as ethanolate)

Oral

 

Prezista

JC

MP NP

C4313

 

60

5

30

 

D(100)

Darunavir with cobicistat

Tablet containing darunavir 800 mg with cobicistat 150 mg

Oral

 

Prezcobix

JC

MP NP

C6377 C6413 C6428

 

60

5

30

 

D(100)

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg

Oral

 

Symtuza

JC

MP NP

C10317 C10324

 

60

5

30

 

D(100)

Dasatinib

Tablet 20 mg

Oral

 

Sprycel

BQ

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

60

 

 

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P6702 P6731 P6947 P9197 P9293

60

5

60

 

 

Tablet 50 mg

Oral

 

Sprycel

BQ

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

60

 

 

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P6702 P6731 P6947 P9197 P9293

60

5

60

 

 

Tablet 70 mg

Oral

 

Sprycel

BQ

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

60

 

 

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P6702 P6731 P6947 P9197 P9293

60

5

60

 

 

Tablet 100 mg

Oral

 

Sprycel

BQ

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

30

2

30

 

 

MP

C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549

P6702 P6731 P6947 P9197 P9293

30

5

30

 

 

Deferasirox

Tablet 90 mg

Oral

 

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

Tablet 180 mg

Oral

 

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D (100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

 

Tablet 360 mg

Oral

 

Jadenu

NM

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

30

 

D(100)

 

 

 

 

 

 

MP

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

30

 

D(100)

Deferiprone

Oral solution 100 mg per mL, 250 mL

Oral

 

Ferriprox

EU

MP

C6403 C6448 C9228 C9286

 

5

5

1

 

D(100)

Tablet 500 mg

Oral

 

Ferriprox

EU

MP

C6403 C6448 C9228 C9286

 

300

5

100

 

D(100)

 

Tablet 1000 mg

Oral

 

Ferriprox

EU

MP

C6403 C6448 C9590 C9623

 

300

5

50

 

D(100)

Degarelix

Powder for injection 80 mg (as acetate), injection set

Injection

 

Firmagon 80mg

FP

MP

C6952

 

1

5

1

 

 

Powder for injection 120 mg (as acetate), 2, injection set

Injection

 

Firmagon 120mg

FP

MP

C6976

 

1

0

1

 

 

Denosumab

Injection 60 mg in 1 mL pre-filled syringe

Injection

 

Prolia

AN

MP NP

C6524 C6548

 

1

0

1

 

 

Injection 120 mg in 1.7 mL

Injection

 

Xgeva

AN

MP NP

C4150 C4158 C4504

 

1

5

1

 

 

Desferrioxamine

Powder for injection containing desferrioxamine mesilate 500 mg

Injection

 

DBL Desferrioxamine Mesilate

PF

MP

C6394 C9696

 

400

5

10

 

D(100)

Powder for injection containing desferrioxamine mesilate 2 g

Injection

 

DBL Desferrioxamine Mesilate

PF

MP

C6394 C9696

 

60

5

1

 

D(100)

Desmopressin

Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle

Nasal

 

Minirin

FP

MP

C5266

 

5

5

1

 

 

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

Nasal

 

Desmopressin Acetate (Medsurge)

DZ

MP

C5266 C5267 C5342

P5267 P5342

1

5

1

 

 

 

 

 

 

 

NP

C5267 C5342

 

1

5

1

 

 

 

 

 

 

 

MP

C5266 C5267 C5342

P5266

2

5

1

 

 

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL

Nasal

 

Minirin Nasal Spray

FP

MP

C5266 C5267 C5342

P5267 P5342

1

5

1

 

 

NP

C5267 C5342

 

1

5

1

 

 

MP

C5266 C5267 C5342

P5266

2

5

1

 

 

Tablet containing desmopressin acetate 200 micrograms

Oral

 

Minirin

FP

MP

C5266 C5295 C5413

P5295 P5413

30

5

30

 

 

NP

C5295 C5413

 

30

5

30

 

 

MP

C5266 C5295 C5413

P5266

90

5

30

 

 

Wafer 120 micrograms (as acetate)

Sublingual

 

Minirin Melt

FP

MP NP

C5226 C5412

 

30

5

30

 

 

Wafer 240 micrograms (as acetate)

Sublingual

 

Minirin Melt

FP

MP NP

C5226 C5412

 

30

5

30

 

 

Desvenlafaxine

Tablet (extended release) 50 mg (as succinate)

Oral

 

Pristiq

PF

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 50 mg

Oral

 

Desfax

AF

MP NP

C5650

 

28

5

28

 

 

 

DESVEN

RW

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine Actavis

EA

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine Sandoz

SZ

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 50 mg (as benzoate)

Oral

 

APO-Desvenlafaxine MR

TX

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine GH XR

GQ

MP NP

C5650

 

28

5

28

 

 

Tablet (extended release) 100 mg (as succinate)

Oral

 

Pristiq

PF

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 100 mg

Oral

 

Desfax

AF

MP NP

C5650

 

28

5

28

 

 

 

DESVEN

RW

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine Actavis

EA

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine Sandoz

SZ

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 100 mg (as benzoate)

Oral

 

APO-Desvenlafaxine MR

TX

MP NP

C5650

 

28

5

28

 

 

 

Desvenlafaxine GH XR

GQ

MP NP

C5650

 

28

5

28

 

 

Dexamethasone

Eye drops 1 mg per mL, 5 mL

Application to the eye

 

Maxidex

NV

AO

 

 

1

0

1

 

 

MP NP

 

 

1

2

1

 

 

Intravitreal injection 700 micrograms

Implantation

 

Ozurdex

AG

MP

C7566 C10713 C10822 C10861 C10904 C10933 C10978

P7566

1

0

1

 

 

MP

C7566 C10713 C10822 C10861 C10904 C10933 C10978

P10713 P10822 P10861 P10904 P10933 P10978

1

1

1

 

 

Tablet 500 micrograms

Oral

 

Dexmethsone

AS

MP NP

 

 

30

4

30

 

 

Tablet 4 mg

Oral

 

Dexmethsone

AS

MP NP

 

 

30

4

30

 

 

Dexamethasone with framycetin and gramicidin

Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL

Application to the ear

a

Otodex

AV

MP NP

 

 

1

2

1

 

 

a

Sofradex

SW

MP NP

 

 

1

2

1

 

 

Dexamfetamine

Tablet containing dexamfetamine sulfate 5 mg

Oral

 

Aspen Pharma Pty Ltd

AS

MP NP

C6226 C6227

 

100

5

100

 

 

Diazepam

Oral liquid 1 mg in 1 mL, 100 mL

Oral

 

Diazepam Elixir

ON

MP NP

C4244

 

1

0

1

 

 

Tablet 2 mg

Oral

a

Antenex 2

AF

MP NP PDP

 

 

50

0

50

 

 

a

APO-Diazepam

TX

MP NP PDP

 

 

50

0

50

 

 

a

Valpam 2

RW

MP NP PDP

 

 

50

0

50

 

 

a

Antenex 2

AF

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

APO-Diazepam

TX

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

Valpam 2

RW

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

Tablet 5 mg

Oral

a

Antenex 5

AF

MP NP PDP

 

 

50

0

50

 

 

a

APO-Diazepam

TX

MP NP PDP

 

 

50

0

50

 

 

a

NOUMED DIAZEPAM

VO

MP NP PDP

 

 

50

0

50

 

 

a

Valium

RO

MP NP PDP

 

 

50

0

50

 

 

a

Valpam 5

RW

MP NP PDP

 

 

50

0

50

 

 

a

Antenex 5

AF

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

APO-Diazepam

TX

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

NOUMED DIAZEPAM

VO

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

Valium

RO

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

a

Valpam 5

RW

MP NP

 

P6176

50
CN6176

3
CN6176

50

 

 

Diclofenac

Suppository containing diclofenac sodium 100 mg

Rectal

 

Voltaren 100

NV

PDP

 

 

40

0

20

 

 

MP NP MW

 

 

40

3

20

 

 

MP NP

 

P6149

40

3

20

 

 

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

a

APO-Diclofenac

TX

PDP

C6256 C6282

 

100

0

50

 

 

a

Clonac 25

RW

PDP

C6256 C6282

 

100

0

50

 

 

a

Diclofenac Amneal

ED

PDP

C6256 C6282

 

100

0

50

 

 

a

Diclofenac AN

EA

PDP

C6256 C6282

 

100

0

50

 

 

a

Diclofenac Sandoz

SZ

PDP

C6256 C6282

 

100

0

50

 

 

a

Fenac 25

AF

PDP

C6256 C6282

 

100

0

50

 

 

a

Voltaren 25

NV

PDP

C6256 C6282

 

100

0

50

 

 

a

APO-Diclofenac

TX

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Clonac 25

RW

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Diclofenac Amneal

ED

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Diclofenac AN

EA

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Diclofenac Sandoz

SZ

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Fenac 25

AF

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

a

Voltaren 25

NV

MP NP

C6149 C6214 C6283

 

100

3

50

 

 

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

a

APO-Diclofenac

TX

PDP

C6256 C6282

 

50

0

50

 

 

a

Clonac 50

RW

PDP

C6256 C6282

 

50

0

50

 

 

a

Diclofenac Amneal

ED

PDP

C6256 C6282

 

50

0

50

 

 

a

Diclofenac AN

EA

PDP

C6256 C6282

 

50

0

50

 

 

a

Diclofenac Sandoz

SZ

PDP

C6256 C6282

 

50

0

50

 

 

a

Fenac

AF

PDP

C6256 C6282

 

50

0

50

 

 

a

Voltaren 50

NV

PDP

C6256 C6282

 

50

0

50

 

 

a

APO-Diclofenac

TX

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Clonac 50

RW

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Diclofenac Amneal

ED

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Diclofenac AN

EA

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Diclofenac Sandoz

SZ

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Fenac

AF

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

a

Voltaren 50

NV

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

Dicloxacillin

Capsule 250 mg (as sodium)

Oral

a

Dicloxacillin Mylan 250

AL

PDP

C5268

 

24

0

24

 

 

MP NP MW

C5415

 

24

0

24

 

 

a

Distaph 250

AF

PDP

C5268

 

24

0

24

 

 

MP NP MW

C5415

 

24

0

24

 

 

Capsule 500 mg (as sodium)

Oral

a

Dicloxacillin Mylan 500

AL

MP

C5415 C6188

P5415

24

0

24

 

 

PDP

C5268

 

24

0

24

 

 

NP MW

C5415

 

24

0

24

 

 

a

Distaph 500

AF

MP

C5415 C6188

P5415

24

0

24

 

 

PDP

C5268

 

24

0

24

 

 

NP MW

C5415

 

24

0

24

 

 

a

Dicloxacillin Mylan 500

AL

MP

C5415 C6188

P6188

48

1

24

 

 

a

Distaph 500

AF

MP

C5415 C6188

P6188

48

1

24

 

 

Digoxin

Paediatric oral solution 50 micrograms per mL, 60 mL

Oral

 

Lanoxin

AS

MP NP

 

 

2

3

1

 

 

Tablet 62.5 micrograms

Oral

a

Lanoxin-PG

AS

MP NP

 

 

200

1

200

 

 

a

Sigmaxin-PG

LN

MP NP

 

 

200

1

200

 

 

Tablet 250 micrograms

Oral

a

Lanoxin

AS

MP NP

 

 

100

1

100

 

 

a

Sigmaxin

LN

MP NP

 

 

100

1

100

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

a

Cardizem CD

SW

MP NP

 

 

30

5

30

 

 

a

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

30

 

 

a

Vasocardol CD

AV

MP NP

 

 

30

5

30

 

 

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

a

Cardizem CD

SW

MP NP

 

 

30

5

30

 

 

a

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

30

 

 

a

Vasocardol CD

AV

MP NP

 

 

30

5

30

 

 

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

a

Cardizem CD

SW

MP NP

 

 

30

5

30

 

 

a

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

30

 

 

a

Vasocardol CD

AV

MP NP

 

 

30

5

30

 

 

Tablet containing diltiazem hydrochloride 60 mg

Oral

a

Cardizem

SW

MP NP

 

 

90

5

90

 

 

a

Diltiazem AN

EA

MP NP

 

 

90

5

90

 

 

a

Vasocardol

AV

MP NP

 

 

90

5

90

 

 

Dimethyl fumarate

Capsule (modified release) 120 mg

Oral

 

Tecfidera

BD

MP

C10139 C10140

 

28

0

14

 

 

Capsule (modified release) 240 mg

Oral

 

Tecfidera

BD

MP

C10139

 

56

5

56

 

 

Diphenoxylate with atropine

Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate monohydrate 25 micrograms

Oral

a

Lofenoxal

IL

MP NP

 

 

20

0

20

 

 

a

Lomotil

IM

MP NP

 

 

20

0

20

 

 

Diphtheria and tetanus vaccine, adsorbed, diluted for adult use

Injection 0.5 mL in pre-filled syringe

Injection

 

ADT Booster

CS

MP NP

 

 

5

0

5

 

 

Dipyridamole with aspirin

Capsule 200 mg (sustained release)-25 mg

Oral

 

Diasp SR

RW

MP NP

C6424

 

60

5

60

 

 

Disopyramide

Capsule 100 mg

Oral

 

Rythmodan

SW

MP NP

 

 

100

5

100

 

 

Docetaxel

Solution concentrate for I.V. infusion 80 mg in 4 mL

Injection

 

Docetaxel Accord

OC

MP

 

 

See Note 3

See Note 3

1

 

D(100)

Solution concentrate for I.V. infusion 80 mg in 8 mL

Injection

 

DBL Docetaxel Concentrated Injection

PF

MP

 

 

See Note 3

See Note 3

1

 

D(100)

Solution concentrate for I.V. infusion 160 mg in 8 mL

Injection

 

Docetaxel Accord

OC

MP

 

 

See Note 3

See Note 3

1

 

D(100)

Solution concentrate for I.V. infusion 160 mg in 16 mL

Injection

 

DBL Docetaxel Concentrated Injection

PF

MP

 

 

See Note 3

See Note 3

1

 

D(100)

Docosahexaenoic acid with carbohydrate

Sachets of oral powder 4 g containing 200 mg docosahexaenoic acid, 30 (docomega)

Oral

 

docomega

VF

MP NP

C6141

 

4

5

1

 

 

Dolutegravir

Tablet 50 mg (as sodium)

Oral

 

Tivicay

VI

MP NP

C4454 C4512

 

60

5

30

 

D(100)

Dolutegravir with abacavir and lamivudine

Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg

Oral

 

Triumeq

VI

MP NP

C9981 C10116

 

60

5

30

 

D(100)

Dolutegravir with lamivudine

Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg

Oral

 

Dovato

VI

MP NP

C9987 C11066

 

60

5

30

 

D(100)

Dolutegravir with rilpivirine

Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride)

Oral

 

Juluca

VI

MP NP

C8214 C8226

 

60

5

30

 

D(100)

Domperidone

Tablet 10 mg

Oral

 

Motilium

JC

MP NP

 

 

25

0

25

 

 

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

a

APO-Donepezil

TX

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Arazil

AF

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Aricept

PF

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Aridon 5

RW

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Aridon APN 5

RF

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Donepezil AN

EA

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Donepezil GH

HQ

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Donepezil Sandoz

SZ

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

Donepezil-DRLA

RZ

MP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

 

 

 

a

APO-Donepezil

TX

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

 

 

 

a

Arazil

AF

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

 

 

 

a

Aricept

PF

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5

28

 

 

 

 

 

a

Aridon 5

RW

MP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

 

 

 

 

 

 

NP

C10108

 

28

5