Federal Register of Legislation - Australian Government

Primary content

PB 71 of 2012 Lists as amended, taking into account amendments up to National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 9) (PB 76 of 2019)
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 05 Nov 2019
Start Date 01 Oct 2019
End Date 31 Oct 2019
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. 84

Compilation date:                              1 October 2019

Includes amendments up to:            PB 76 of 2019

Registered:                                         5 November 2019

This compilation is in 6 volumes

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

Volume 2:       Schedule 1 (D–K)

Volume 3:       Schedule 1 (L–P)

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

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

Volume 6:       Schedule 4 (Part 1: S–Z, Part 3), Schedule 5 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 October 2019 (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


Schedule 1Ready‑prepared pharmaceutical benefits

(sections 5 to 10, 16 to 18, 20, 21, 23 to 26)

 

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 C6044

P6044

120

3

120

 

 

MP

C6013 C6044

P6013

120

5

120

 

 

Capsule 75 mg (as mesilate)

Oral

 

Tafinlar

NV

MP

C6013 C6044

P6044

120

3

120

 

 

MP

C6013 C6044

P6013

120

5

120

 

 

Daclatasvir

Tablet 30 mg

Oral

 

Daklinza

BQ

MP NP

C5969 C5972

P5969

28

2

28

 

 

MP NP

C5969 C5972

P5972

28

5

28

 

 

Tablet 60 mg

Oral

 

Daklinza

BQ

MP NP

C5969 C5972

P5969

28

2

28

 

 

MP NP

C5969 C5972

P5972

28

5

28

 

 

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

 

 

Danazol

Capsule 100 mg

Oral

 

Azol 100

AF

MP

C6242 C6259 C6285 C6293

 

100

5

100

 

 

Capsule 200 mg

Oral

 

Azol 200

AF

MP

C6242 C6259 C6285 C6293

 

100

5

100

 

 

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

 

 

Darbepoetin alfa

Injection 10 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 20 micrograms in 0.5 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 20 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 30 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 40 micrograms in 0.4 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 40 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 50 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 60 micrograms in 0.3 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 60 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 80 micrograms in 0.4 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 80 micrograms in 0.4 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 100 micrograms in 0.5 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 100 micrograms in 0.5 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Injection 150 micrograms in 0.3 mL pre-filled injection pen

Injection

 

Aranesp SureClick

AN

MP

C6260 C6294

 

8

5

1

 

D(100)

Injection 150 micrograms in 0.3 mL pre-filled syringe

Injection

 

Aranesp

AN

MP

C6260 C6294

 

8

5

4

 

D(100)

Darunavir

Tablet 150 mg (as ethanolate)

Oral

 

Prezista

JC

MP

C5094

 

240

5

240

 

D(100)

Tablet 600 mg (as ethanolate)

Oral

 

Prezista

JC

MP

C5094

 

120

5

60

 

D(100)

Tablet 800 mg (as ethanolate)

Oral

 

Prezista

JC

MP

C4313

 

60

5

30

 

D(100)

Darunavir with cobicistat

Tablet containing darunavir 800 mg with cobicistat 150 mg

Oral

 

Prezcobix

JC

MP

C6377 C6413 C6428

 

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

TX

MP

C6403 C6448 C9228 C9286

 

5

5

1

 

D(100)

Tablet 500 mg

Oral

 

Ferriprox

TX

MP

C6403 C6448 C9228 C9286

 

300

5

100

 

D(100)

 

Tablet 1000 mg

Oral

 

Ferriprox

TX

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

 

Hospira Pty Limited

PF

MP

C6394 C6408

 

400

5

10

 

D(100)

Powder for injection containing desferrioxamine mesilate 2 g

Injection

 

Hospira Pty Limited

PF

MP

C6394 C6408

 

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, 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

a

Pristiq

PF

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 50 mg

Oral

a

Desfax

AF

MP NP

C5650

 

28

5

28

 

 

a

DESVEN

RW

MP NP

C5650

 

28

5

28

 

 

a

Desvenlafaxine Actavis

EA

MP NP

C5650

 

28

5

28

 

 

a

Desvenlafaxine Sandoz

SZ

MP NP

C5650

 

28

5

28

 

 

Tablet (modified release) 50 mg (as benzoate)

Oral

a

APO-Desvenlafaxine MR

TX

MP NP

C5650

 

28

5

28

 

 

a

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

C7565 C7566 C7579 C8020 C8023 C8032 C8033

P7566

1

0

1

 

 

MP

C7565 C7566 C7579 C8020 C8023 C8032 C8033

P7565 P7579 P8020 P8023 P8032 P8033

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

 

 

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

Injection

a

Dexamethasone Mylan

AF

MP NP

 

 

5

0

5

 

 

a

Hospira Pty Limited

PF

MP NP

 

 

5

0

5

 

 

Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

Injection

a

Dexamethasone Mylan

AF

MP NP

 

 

5

1

5

 

 

a

Hospira Pty Limited

PF

MP NP

 

 

5

1

5

 

 

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

QA

MP NP

C6226 C6227

 

100

5

100

 

 

Diazepam

Injection 10 mg in 2 mL

Injection

 

Hospira Pty Limited

PF

MP NP PDP

 

 

5

0

5

 

 

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

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

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

Pharmacor Diclofenac 50

CR

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

Pharmacor Diclofenac 50

CR

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

QA

MP NP

 

 

2

3

1

 

 

Tablet 62.5 micrograms

Oral

a

Lanoxin-PG

QA

MP NP

 

 

200

1

200

 

 

a

Sigmaxin-PG

FM

MP NP

 

 

200

1

200

 

 

Tablet 250 micrograms

Oral

a

Lanoxin

QA

MP NP

 

 

100

1

100

 

 

a

Sigmaxin

FM

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 Actavis

ED

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

C6920 C7732

 

28

0

14

 

 

Capsule (modified release) 240 mg

Oral

 

Tecfidera

BD

MP

C6913

 

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

Capsule 200 mg (sustained release)

Oral

 

Persantin SR

BY

MP NP

C6385 C6411 C6473

 

60

5

60

 

 

Dipyridamole with aspirin

Capsule 200 mg (sustained release)-25 mg

Oral

a

Asasantin SR

BY

MP NP

C6424

 

60

5

60

 

 

a

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)

 

Docetaxel Sandoz

SZ

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

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

C4480 C4495

 

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

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 NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Arazil

AF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aricept

PF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aridon 5

RW

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aridon APN 5

RF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Chem mart Donepezil

CH

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil AN

EA

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil GH

HQ

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil Sandoz

SZ

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil-DRLA

RZ

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Terry White Chemists Donepezil

TW

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

Tablet containing donepezil hydrochloride 10 mg

Oral

a

APO-Donepezil

TX

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Arazil

AF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aricept

PF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aridon 10

RW

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Aridon APN 10

RF

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Chem mart Donepezil

CH

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil AN

EA

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil GH

HQ

MP NP

C4219 C4220 C4224

 

28

5

28

 

 

a

Donepezil Sandoz

SZ

MP NP

C4219 C4220 C4224

 

28

5

28