National Health Act 1953 - Amendment determination under section 84AF - responsible persons (No. PB 89 of 2010) (Australia)

National Health Act 1953 - Amendment determination under section 84AF - responsible persons (No. PB 89 of 2010)

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COMMONWEALTH OF AUSTRALIA
Instrument number PB 89 of 2010
Amendment determination under section 84AF of the National Health Act 1953
I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under section 84AF of the National Health Act 1953.
Dated   17 September 2010

DAVID LEARMONTH
Deputy Secretary
Department of Health and Ageing

Amendment determination – responsible persons
1              Commencement
                This instrument commences on 1 October 2010.
2              Amendment of PB 69 of 2010
                Schedule 1 amends PB 69 of 2010.
Schedule 1            Amendments

[1]                        Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
insert in the columns in the order indicated:
Amoxycillin with Clavulanic Acid
Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
Oral
Amoxycillin/ Clavulanic Acid 500/125 generichealth
Generic Health Pty Ltd
93 110 617 859
[2]                        Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
insert in the columns in the order indicated:
Amoxycillin with Clavulanic Acid
Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
Oral
Amoxycillin/ Clavulanic Acid 875/125 generichealth
Generic Health Pty Ltd
93 110 617 859
[3]                        Schedule 1, after item dealing with Electrolyte Replacement, Solution in the form Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium cluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L
insert in the columns in the order indicated:
Eletriptan
Tablet 40 mg (as hydrobromide)
Oral
Relpax
Pfizer Australia Pty Ltd
50 008 422 348

Eletriptan
Tablet 80 mg (as hydrobromide)
Oral
Relpax
Pfizer Australia Pty Ltd
50 008 422 348

[4]                        Schedule 1, after item dealing with Lamotrigine in the form Tablet 5 mg (Seaze 5)
insert in the columns in the order indicated:
Lamotrigine
Tablet 50 mg
Oral
APO-Lamotrigine
Apotex Pty Ltd
52 096 916 148
[5]                        Schedule 1, items dealing with Lisinopril in the form Tablet 10 mg
                      omit from the columns in the order indicated:
Lisinopril
Tablet 10 mg
Oral
Lisinobell
Bellwether Pharma Ltd
15 109 403 287
[6]                        Schedule 1, items dealing with Lisinopril in the form Tablet 20 mg
                      omit from the columns in the order indicated:
Lisinopril
Tablet 20 mg
Oral
Lisinobell
Bellwether Pharma Ltd
15 109 403 287
[7]                        Schedule 1, items dealing with Lisinopril in the form Tablet 5 mg
                      omit from the columns in the order indicated:
Lisinopril
Tablet 5 mg
Oral
Lisinobell
Bellwether Pharma Ltd
15 109 403 287
[8]                        Schedule 1, after item dealing with Memantine in the form Oral drops containing memantine hydrochloride 10 mg per g, 50 g (Ebixa)
insert in the columns in the order indicated:
Memantine
Tablet containing memantine hydrochloride 10 mg
Oral
APO-Memantine
Apotex Pty Ltd
52 096 916 148
[9]                        Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Formet 1000)
insert in the columns in the order indicated:
Metformin
Tablet containing metformin hydrochloride 1 g
Oral
Glucohexal
Sandoz Pty Ltd
60 075 449 553
[10]                   Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (GenRx Metformin)
insert in the columns in the order indicated:
Metformin
Tablet containing metformin hydrochloride 500 mg
Oral
Glucohexal
Sandoz Pty Ltd
60 075 449 553
[11]                   Schedule 1, items dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg
                      omit from the columns in the order indicated:
Metformin
Tablet containing metformin hydrochloride 500 mg
Oral
Metforbell
Bellwether Pharma Ltd
15 109 403 287
[12]                   Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg (GenRx Metformin)
insert in the columns in the order indicated:
Metformin
Tablet containing metformin hydrochloride 850 mg
Oral
Glucohexal
Sandoz Pty Ltd
60 075 449 553
[13]                   Schedule 1, items dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg
                      omit from the columns in the order indicated:
Metformin
Tablet containing metformin hydrochloride 850 mg
Oral
Metforbell
Bellwether Pharma Ltd
15 109 403 287
[14]                   Schedule 1, after item dealing with Omeprazole in the form Tablet 20 mg (Meprazol)
insert in the columns in the order indicated:
Omeprazole
Tablet 20 mg
Oral
Omeprazole generichealth
Generic Health Pty Ltd
93 110 617 859
[15]                   Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Panto)
insert in the columns in the order indicated:
Pantoprazole
Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
Oral
Pantofast 20
Dr Reddy's Laboratories (Australia) Pty Ltd
16 120 092 408
[16]                   Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoloc)
insert in the columns in the order indicated:
Pantoprazole
Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
Oral
Pantoprazole generichealth
Generic Health Pty Ltd
93 110 617 859
[17]                   Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Panto)
insert in the columns in the order indicated:
Pantoprazole
Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
Oral
Pantofast 40
Dr Reddy's Laboratories (Australia) Pty Ltd
16 120 092 408
[18]                   Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoloc)
insert in the columns in the order indicated:
Pantoprazole
Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
Oral
Pantoprazole generichealth
Generic Health Pty Ltd
93 110 617 859
[19]                   Schedule 1, after item dealing with Ranitidine in the form Tablet 300 mg (as hydrochloride) (Ranihexal)
insert in the columns in the order indicated:
Ranitidine
Tablet 300 mg (as hydrochloride)
Oral
Ranitidine Sandoz
Sandoz Pty Ltd
60 075 449 553
[20]                   Schedule 1, items dealing with Rosiglitazone with Metformin
omit from the columns in the order indicated:
Rosiglitazone with Metformin
Tablet 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

and substitute:
Rosiglitazone with Metformin
Tablet containing 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet containing 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet containing 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

Rosiglitazone with Metformin
Tablet containing 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
Avandamet
GlaxoSmithKline Australia Pty Ltd
47 100 162 481

[21]                   Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride) (Xydep 100)
                      omit from the columns in the order indicated:

Pfizer Australia Pty Ltd
50 008 422 348
insert in the columns in the order indicated:

Ascent Pharmaceuticals Limited
17 003 854 626

[22]                   Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Xydep 50)
                      omit from the columns in the order indicated:

Pfizer Australia Pty Ltd
50 008 422 348
insert in the columns in the order indicated:

Ascent Pharmaceuticals Limited
17 003 854 626
[23]                   Schedule 1, items dealing with Simvastatin in the form Tablet 10 mg
                      omit from the columns in the order indicated:
Simvastatin
Tablet 10 mg
Oral
Simvabell
Bellwether Pharma Ltd
15 109 403 287
[24]                   Schedule 1, items dealing with Simvastatin in the form Tablet 20 mg
                      omit from the columns in the order indicated:
Simvastatin
Tablet 20 mg
Oral
Simvabell
Bellwether Pharma Ltd
15 109 403 287
[25]                   Schedule 1, items dealing with Simvastatin in the form Tablet 40 mg
                      omit from the columns in the order indicated:
Simvastatin
Tablet 40 mg
Oral
Simvabell
Bellwether Pharma Ltd
15 109 403 287
[26]                   Schedule 1, items dealing with Simvastatin in the form Tablet 5 mg
                      omit from the columns in the order indicated:
Simvastatin
Tablet 5 mg
Oral
Simvabell
Bellwether Pharma Ltd
15 109 403 287
[27]                   Schedule 1, items dealing with Simvastatin in the form Tablet 80 mg
                      omit from the columns in the order indicated:
Simvastatin
Tablet 80 mg
Oral
Simvabell
Bellwether Pharma Ltd
15 109 403 287
[28]                   Schedule 1, items dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)
                      omit from the columns in the order indicated:
Terbinafine
Tablet 250 mg (as hydrochloride)
Oral
Terbinafine-DP
Ascent Pharmaceuticals Limited
17 003 854 626
[29]                   Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine 250)
insert in the columns in the order indicated:
Terbinafine
Tablet 250 mg (as hydrochloride)
Oral
Terbinafine-DRLA
Dr Reddy's Laboratories (Australia) Pty Ltd
16 120 092 408

Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.