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Australian Register of Therapeutic Goods list of Approved Drug Products. Original Data : Therapeutic Goods Administration Website

Approved Drug Products in Australia

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01 6Sanofi-aventis Healthcare Pty Ltd

02 207sanofi-aventis Australia Pty Ltd

03 202AbbVie Pty Ltd

04 315Aspen Pharmacare Australia Pty Limited

05 77Strides Pharma Science Pty Ltd

06 143M Pharmaceuticals Australia Pty Ltd

07 35A.Menarini Australia Pty Limited

08 57AFT Pharmaceuticals (AU) Pty Ltd

09 6ANTENGENE (AUS) PTY. LTD.

10 8AU Pharma Pty Ltd

11 6Abbott Australasia Pty Ltd

12 85Accord Healthcare Pty. Ltd.

13 4Actavis Pty Ltd

14 29Alcon Laboratories (Australia) Pty Ltd

15 30Alexion Pharmaceuticals Australasia Pty Ltd

16 1Alphapharm PTY Ltd

17 1386Alphapharm Pty Ltd

18 43Amdipharm Mercury (Australia) Pty Limited

19 86Amgen Australia Pty Limited

20 1051Apotex Pty Ltd

21 375Arrotex Pharmaceuticals Pty Ltd

22 806Arrow Pharma Pty Ltd

23 1Ascensia Diabetes Care Australia Pty Limited

24 39Astellas Pharma Australia Pty Ltd

25 134AstraZeneca Pty Ltd

26 147Avallon Pharmaceuticals Pty Limited

27 1B. Braun Australia Pty Ltd

28 32BSN medical (Aust.) Pty Ltd

29 2BTC Speciality Health Pty Ltd

30 8Bausch & Lomb (Australia) Pty Ltd

31 24Baxter Healthcare Pty Limited

32 94Bayer Australia Ltd

33 4BeiGene AUS Pty Ltd

34 4Beiersdorf Australia Ltd

35 6Besins Healthcare Australia Pty Ltd

36 2Bio Revive Pty Ltd

37 14BioMarin Pharmaceutical Australia Pty Ltd

38 30Biogen Australia Pty Ltd

39 2Biomed Aust Pty Limited

40 2Blackmores Limited

41 104Boehringer Ingelheim Pty Ltd

42 18Boucher & Muir Pty Ltd

43 14Bridgewest Perth Pharma Pty Ltd

44 152Bristol-Myers Squibb Australia Pty Ltd

45 4CNS Pharma Pty Ltd

46 8Camurus Pty Ltd

47 1Care Pharmaceuticals Pty Limited

48 86Celgene Pty Limited

49 174Celltrion Healthcare Australia Pty Ltd

50 27Chiesi Australia Pty Ltd

51 1Church & Dwight (Australia) Pty Ltd

52 243Cipla Australia Pty Ltd

53 109Clinect Pty Ltd

54 1Colgate Oral Care

55 16Coloplast Pty Ltd

56 4Contact Lens Centre Australia Limited

57 21ConvaTec Australia Pty Ltd

58 15Cortex Health Pty Ltd

59 2De Fries Industries Pty Ltd

60 24Dr Falk Pharma Australia Pty Ltd

61 188Dr Reddy's Laboratories (Australia) Pty Ltd

62 18EUGIA PHARMA (AUSTRALIA) PTY LTD

63 9Echo Therapeutics Pty Ltd

64 22Ego Pharmaceuticals Pty Ltd

65 34Eisai Australia Pty Ltd

66 46Eli Lilly Australia Pty Ltd

67 3Encapsulate Pharma Pty Ltd

68 33Ferring Pharmaceuticals Pty Limited

69 98Fresenius Kabi Australia Pty Limited

70 8Galderma Australia Pty Ltd

71 10Gedeon Richter Australia Pty Ltd

72 318Generic Health Pty Ltd

73 23Gilead Sciences Pty Limited

74 67GlaxoSmithKline Australia Pty Ltd

75 1Glenmark Pharmaceuticals (Australia) Pty Ltd

76 2HALEON AUSTRALIA PTY LTD

77 4HAMELN PHARMA PTY. LTD.

78 7Indivior Pty Ltd

79 19InterPharma Pty Ltd

80 40Ipsen Pty Ltd

81 4JAZZ PHARMACEUTICALS ANZ PTY LTD

82 234Janssen-Cilag Pty Ltd

83 2Johnson & Johnson Medical Pty Ltd

84 9Johnson & Johnson Pacific Pty Limited

85 6Juniper Biologics Pty Ltd

86 258Juno Pharmaceuticals Pty Ltd

87 6KCI Medical Australia Pty Ltd

88 6KYOWA KIRIN AUSTRALIA PTY LTD

89 4Kendall Australasia Pty Ltd

90 7Key Pharmaceuticals Pty Ltd

91 1Lawley Pharmaceuticals Pty Ltd

92 29Leo Pharma Pty Ltd

93 62Link Medical Products Pty Ltd

94 7Lohmann & Rauscher Pty Ltd

95 21Lundbeck Australia Pty Ltd

96 3Lupin Ltd

97 1MAXX PHARMA PTY LTD

98 18MEDISON PHARMA AUSTRALIA PTY LIMITED

99 1MS Health Pty Ltd

100 25Mayne Pharma International Pty Ltd

101 9Mayne Products Pty Ltd

102 1Medical Developments International Limited

103 1Medis Pharma Pty Ltd

104 63Medsurge Healthcare Pty Ltd

105 2Medtas Pty Ltd

106 2Mentholatum Australasia Pty Ltd

107 63Merck Healthcare Pty Ltd

108 52Merck Sharp & Dohme (Australia) Pty Ltd

109 58Molnlycke Health Care Pty Ltd

110 127Mundipharma Pty Limited

111 5Nestle Australia Ltd

112 3Nice-Pak Products Pty. Ltd

113 4Norgine Pty. Ltd.

114 7Nova Pharmaceuticals Australasia Pty Ltd

115 528Novartis Pharmaceuticals Australia Pty Limited

116 35Novo Nordisk Pharmaceuticals Pty. Limited

117 68Nutricia Australia Pty Limited

118 4Omegapharm Pty Ltd

119 2Oraderm Pharmaceuticals Pty Ltd

120 1Oral B Laboratories Pty Ltd

121 77Organon Pharma Pty Ltd

122 9Orion Laboratories Pty. Ltd.

123 19Orion Pharma (Aus) Pty Limited

124 11Orpharma Pty Ltd

125 18Otsuka Australia Pharmaceutical Pty. Ltd

126 20Paul Hartmann Pty Ltd

127 39Petrus Pharmaceuticals Pty Ltd

128 621Pfizer Australia Pty Ltd

129 49Pharmaco (Australia) Limited

130 344Pharmacor Pty Limited

131 28Phebra Pty Ltd

132 12Pierre Fabre Australia Pty Ltd

133 4Pro Pharmaceuticals Group Pty. Ltd.

134 2Procter & Gamble Pharmaceuticals Australia Pty Ltd

135 11Reach Pharmaceuticals Pty Ltd

136 3Reckitt Benckiser (Australia) Pty Limited

137 11Recordati Rare Diseases Australia Pty. Ltd.

138 238Roche Products Pty Ltd

139 1SSL Australia Pty Ltd

140 9STADA Pharmaceuticals Australia Pty Limited

141 1161Sandoz Pty Ltd

142 8SciGen (Australia) Pty Limited

143 8Seekwell Pty Ltd

144 45Seqirus (Australia) Pty Ltd

145 48Servier Laboratories (Aust.) Pty. Ltd.

146 10Sigma Company Limited

147 52Smith & Nephew Pty Limited

148 5Southern Cross Pharma Pty Ltd

149 8Southern XP Pty Ltd

150 4Specialised Therapeutics Australia Pty Ltd

151 4Specialised Therapeutics Pharma Pty Ltd

152 1Specialised Therapeutics Pm Pty Ltd

153 6Stallergenes Australia Pty Ltd

154 220Sun Pharma ANZ Pty Ltd

155 10Swedish Orphan Biovitrum Pty Ltd

156 94Takeda Pharmaceuticals Australia Pty. Ltd.

157 1Te Arai BioFarma Limited

158 8Terumo BCT Australia Pty Limited

159 242Teva Pharma Australia Pty Ltd

160 1Teva Pharmaceutical Industries

161 7The Trustee for ORSPEC PHARMA UNIT TRUST

162 20Theramex Australia Pty Ltd

163 75UCB Australia Proprietary Limited

164 1Unilever Australia Limited

165 2Unomedical Pty Ltd

166 48Upjohn Australia Pty Ltd

167 25Urgo Medical Australia Pty Ltd

168 38Vertex Pharmaceuticals (Australia) Pty. Ltd.

169 97Viatris Pty Ltd

170 6Vifor Pharma Pty Limited

171 18ViiV Healthcare Pty Ltd

172 49Vitaflo Australia Pty Limited

173 51iNova Pharmaceuticals (Australia) Pty Limited

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

ACAMPROSATE CALCIUM

Brand Name : Campral

Dosage Form : Tablet

Dosage Strength : 333mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

sunitinib

Brand Name : Sunitinib MSN

Dosage Form : capsule

Dosage Strength : 12.5 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Atorvastatin; Ezetimibe

Brand Name : Ezetast

Dosage Form : Tablet

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Atorvastatin; Ezetimibe

Brand Name : Ezetast

Dosage Form : Tablet

Dosage Strength : 40MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Atorvastatin; Ezetimibe

Brand Name : Ezetast

Dosage Form : Tablet

Dosage Strength : 20MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

sunitinib

Brand Name : Sutent

Dosage Form : capsule

Dosage Strength : 12.5 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

sunitinib

Brand Name : Sunitinib Sandoz

Dosage Form : capsule

Dosage Strength : 12.5 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Lenalidomide Hydrochloride

Brand Name : Lenalidomide - teva

Dosage Form : Capsule

Dosage Strength : 25MG

Packaging : Blister Pack

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Israel

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09

Norgine Pty. Ltd.

Country
AAPS 2024
Not Confirmed
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Norgine Pty. Ltd.

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AAPS 2024
Not Confirmed

rifaximin

Brand Name : Xifaxan

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Novartis Pharmaceuticals Australia Pty L...

Country
AAPS 2024
Not Confirmed
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Novartis Pharmaceuticals Australia Pty L...

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AAPS 2024
Not Confirmed

dabrafenib

Brand Name : Tafinlar

Dosage Form :

Dosage Strength :

Packaging : 120

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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