Administration
Notification of Registration of Medicines
MEDICINES CONTROL COUNCIL
NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) Application Number
Holder of Certificate of Registration
Proprietary Name
Active Compound
A38/34/0404
GROUP LABORATORIES S.A. (PTY) LTD
NIQUITIN CQ LOZENGE 2 mg
Each lozenge contains: NICOTINE POLACRILEX EQUIVALENT TO NICOTINE 2,0 mg
A38/34/0405
GROUP LABORATORIES S.A. (PTY) LTD
NIQUITIN CQ LOZENGE 4 mg
A40/20.2.8/0311
PHARMACARE LIMITED
ASPEN LAMIVUDINE & ZIDOVUDINE COMBIPACK
A40/5.2/0392
RANBAXY S.A. (PTY) LTD
RANTRAL MR 10
41/1.2/0046
DR REDDY’S LABORATORIES (PTY) LTD
DETRAX 50
41/1.2/0047
DR REDDY’S LABORATORIES (PTY) LTD
DETRAX 100
Each lozenge contains: NICOTINE POLACRILEX EQUIVALENT TO NICOTINE 4,0 mg Each combipack contains: ASPEN LAMIVUDINE TABLETS CONTAINING: LAMIVUDINE 150,0 mg ASPEN ZIDOVUDINE TABLETS CONTAINING: ZIDOVUDINE 300,0 mg Each tablet contains: ALFUZOSIN HYDROCHLORIDE 10,0 mg Each tablet contains: SERTRALINE HYDROCHLORIDE EQUIVALENT TO SERTRALINE 50,0 mg Each tablet contains: SERTRALINE HYDROCHLORIDE EQUIVALENT TO SERTRALINE 100,0 mg
12.56 Notification of Registration Nov10v1.doc
Dec 2010
Page 1 of 7
Administration
Application Number
Notification of Registration of Medicines
Holder of Certificate of Registration
Proprietary Name
Active Compound
41/8.4/0211
FRESENIUS KABI SOUTH AFRICA (PTY) LTD
VOLUVEN 6 % BALANCED
Each 1 000,0 ml solution contains: HETASTARCH 60,0 g SODIUM ACETATE TRIHYDRATE 4,63 g SODIUM CHLORIDE 6,02 g POTASSIUM CHLORIDE 0,30 g MAGNESIUM CHLORIDE 0,30 g
41/5.7.2/0295
PHARMAPLAN (PTY) LTD
GRANITRIL INJECTION
41/11.4.3/0344
SANDOZ S.A. (PTY) LTD
HEXAL PANTOPRAZOLE IV
41/11.4.3/0345
SANDOZ S.A. (PTY) LTD
TOPRALOC IV
Each 1,0 ml solution contains: GRANISETRON HYDROCHLORIDE EQUIVALENT TO GRANISETRON 1,0 mg Each vial contains: PANTOPRAZOLE SODIUM SESQUIHYDRATE EQUIVALENT TO PANTOPRAZOLE 40,0 mg Each vial contains: PANTOPRAZOLE SODIUM SESQUIHYDRATE EQUIVALENT TO PANTOPRAZOLE 40,0 mg
41/5.7.2/0364
PHARMAPLAN (PTY) LTD
GRANITRIL 1 mg TABLET
41/5.7.1/0420
JOHNSON & JOHNSON (PTY) LTD
41/34/0573
PFIZER LABORATORIES (PTY) LTD
SINUTAB SINUS ALLERGY EFFERVESCENT CHAMPIX 0,5 mg
41/34/0574
PFIZER LABORATORIES (PTY) LTD
CHAMPIX 1 mg
41/10.2.1/0618
ARROW PHARMA SOUTH AFRICA (PTY) LTD
SALBU-NEB 5
41/10.2.1/0619
ARROW PHARMA SOUTH AFRICA (PTY) LTD
SALBU-NEB 2,5
41/10.2.1/0699
ARROW PHARMA SOUTH AFRICA (PTY) LTD PHARMACEUTICAL ENTERPRISES (PTY) LTD
TROPIVENT
41/2.1/0807
12.56 Notification of Registration Nov10v1.doc
PE-ISOFLURANE
Dec 2010
Each tablet contains: GRANISETRON HYDROCHLORIDE EQUIVALENT TO GRANISETRON 1,0 mg Each tablet contains: CETIRIZINE DIHYDROCHLORIDE 10,0 mg Each tablet contains: VARENICLINE TARTRATE EQUIVALENT TO VARENICLINE 0,5 mg Each tablet contains: VARENICLINE TARTRATE EQUIVALENT TO VARENICLINE 1,0 mg Each 2,5 ml solution contains: SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 5,0 mg Each 2,5 ml solution contains: SALBUTAMOL SULPHATE EQUIVALENT TO SALBUTAMOL 2,5 mg Each 1,0 ml solution contains: IPRATROPIUM BROMIDE 250,0 µg Each 1,0 ml liquid contains: ISOFLURANE 1,0 ml
Page 2 of 7
Administration
Application Number
Notification of Registration of Medicines
Holder of Certificate of Registration
Proprietary Name
Active Compound
42/20.2.8/0069
XIXIA PHARMACEUTICALS (PTY) LTD
MYLAN ACICLOVIR 250
Each vial contains: ACICLOVIR SODIUM EQUIVALENT TO ACICLOVIR 250,0 mg
42/20.2.8/0070
XIXIA PHARMACEUTICALS (PTY) LTD
MYLAN ACICLOVIR 500
42/34/0173
MEDICINE DEVELOPERS INTERNATIONAL cc
JMS BLOOD BAG CPDSAGM
42/34/0174
MEDICINE DEVELOPERS INTERNATIONAL cc
JMS BLOOD BAG CPDA-1
42/3.2/0235
PHARMA DYNAMICS (PTY) LTD
OSTEONATE 70 mg
42/21.5.4/0238
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
SALMEFLUT 25/50 INHALER
42/21.5.4/0239
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
SALMEFLUT 25/125 INHALER
Each vial contains: ACICLOVIR SODIUM EQUIVALENT TO ACICLOVIR 500,0 mg Each 100,0 ml solution contains: CPD SOLUTION: CITRIC ACID 0,299 g SODIUM CITRATE 2,630 g MONOBASIC SODIUM PHOSPHATE 0,222 g DEXTROSE 2,550 g SAGM SOLUTION: DEXTROSE 0,900 g SODIUM CHORIDE 0,877 g MANNITOL 0,525 g ADENINE 0,0169 g Each 100,0 ml solution contains: CITRIC ACID 0,299 g SODIUM CITRATE 2,630 g MONOBASIC SODIUM PHOSPHATE 0,222 g DEXTROSE 3,190 g ADENINE 0,0275 g Each tablet contains: TRIHYDRATE MONOSODIUM ALENDRONATE EQUIVALENT TO ALENDRONIC ACID 70,0 mg Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 50,0 µg Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 125,0 µg
42/21.5.4/0240
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
SALMEFLUT 25/250 INHALER
12.56 Notification of Registration Nov10v1.doc
Dec 2010
Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 250,0 µg
Page 3 of 7
Administration
Notification of Registration of Medicines
Application Number
Holder of Certificate of Registration
42/21.5.4/0244
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FOXAIR 25/50 INHALER
42/21.5.4/0245
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FOXAIR 25/125 INHALER
42/21.5.4/0246
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FOXAIR 25/250 INHALER
42/21.12/0259
ACCORD HEALTHCARE (PTY) LTD ACCORD HEALTHCARE (PTY) LTD THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD
ACCORD ANASTROZOLE WINTHROP ANASTROZOLE SCHIZOROL 0,5
42/2.6.5/0316
THEBE MEDICARE (PTY) LTD
SCHIZOROL 2
Each tablet contains: RISPERIDONE 2,0 mg
42/2.6.5/0317
THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD
SCHIZOROL 3
Each tablet contains: RISPERIDONE 3,0 mg Each tablet contains: RISPERIDONE 4,0 mg Each tablet contains: RISPERIDONE 6,0 mg Each tablet contains: RISPERIDONE 8,0 mg
42/21.12/0323
ACCORD HEALTHCARE (PTY) LTD
ACCORD LETROZOLE 2,5 mg
Each tablet contains: LETROZOLE 2,5 mg
42/21.12/0324
ACCORD HEALTHCARE (PTY) LTD ACCORD HEALTHCARE (PTY) LTD
WINTHROP LETROZOLE 2,5 mg ACCORD SUMATRIPTAN 50 mg
42/7.3/0357
ACCORD HEALTHCARE (PTY) LTD
ACCORD SUMATRIPTAN 100 mg
42/7.5/0358
ACCORD HEALTHCARE (PTY) LTD
PRAVACOR 40 mg
Each tablet contains: LETROZOLE 2,5 mg Each tablet contains: SUMATRIPTAN SUCCINATE EQUIVALENT TO SUMATRIPTAN 50,0 mg Each tablet contains: SUMATRIPTAN SUCCINATE EQUIVALENT TO SUMATRIPTAN 100,0 mg Each tablet contains: PRAVASTATIN SODIUM 40,0 mg
42/21.12/0260 42/2.6.5/0314 42/2.6.5/0315
42/2.6.5/0318 42/2.6.5/0319 42/2.6.5/0320
42/7.3/0356
12.56 Notification of Registration Nov10v1.doc
Proprietary Name
SCHIZOROL 1
SCHIZOROL 4 SCHIZOROL 6 SCHIZOROL 8
Dec 2010
Active Compound Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 50,0 µg Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 125,0 µg Each actuation provides: SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 µg FLUTICASONE PROPIONATE 250,0 µg Each tablet contains: ANASTROZOLE 1,0 mg Each tablet contains: ANASTROZOLE 1,0 mg Each tablet contains: RISPERIDONE 0,5 mg Each tablet contains: RISPERIDONE 1,0 mg
Page 4 of 7
Administration
Application Number
Notification of Registration of Medicines
Holder of Certificate of Registration
Proprietary Name
Active Compound
42/7.5/0372
ACCORD HEALTHCARE (PTY) LTD
PRAVACOR 10 mg
Each tablet contains: PRAVASTATIN SODIUM 10,0 mg
42/7.5/0373
ACCORD HEALTHCARE (PTY) LTD
PRAVACOR 20 mg
42/21.12/0430
42/20.2.8/0563
ACCORD HEALTHCARE (PTY) LTD ACCORD HEALTHCARE (PTY) LTD PHARMACARE LIMITED
WINTHROP BICALUTAMIDE 50 mg ACCORD BICALUTAMIDE 50 mg VIRTRIUM 30/150/200
42/20.2.8/0564
PHARMACARE LIMITED
VIRTRIUM 40/150/200
42/10.2.1/0569
CIPLA LIFE SCIENCES (PTY) LTD
CIPLA IPRATROPIUM 20 HFA
Each tablet contains: PRAVASTATIN SODIUM 20,0 mg Each tablet contains: BICALUTAMIDE 50,0 mg Each tablet contains: BICALUTAMIDE 50,0 mg Each tablet contains: LAMIVUDINE 150,0 mg NEVIRAPINE 200,0 mg STAVUDINE 30,0 mg Each tablet contains: LAMIVUDINE 150,0 mg NEVIRAPINE 200,0 mg STAVUDINE 40,0 mg Each actuation contains: IPRATROPIUM BROMIDE 20 µg
42/7.1.3/0579
THEBE MEDICARE (PTY) LTD
LOZAAN CO 50 mg
42/7.1.3/0580
THEBE MEDICARE (PTY) LTD
LOZAAN CO 100 mg
42/2.9/0748
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
GSK REMIFENTANIL 1 mg
42/2.9/0749
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
GSK REMIFENTANIL 2 mg
42/2.9/0750
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
GSK REMIFENTANIL 5 mg
42/2.9/0751
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FORTIVA 1 mg
42/21.12/0431
12.56 Notification of Registration Nov10v1.doc
Dec 2010
Each tablet contains: LOSARTAN POTASSIUM 50,0 mg HYDROCHLOROTHIAZIDE 12,5 mg Each tablet contains: LOSARTAN POTASSIUM 100,0 mg HYDROCHLOROTHIAZIDE 25,0 mg Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 1,0 mg Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 2,0 mg Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 5,0 mg Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 1,0 mg
Page 5 of 7
Administration
Application Number
Notification of Registration of Medicines
Holder of Certificate of Registration
Proprietary Name
42/2.9/0752
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FORTIVA 2 mg
42/2.9/0753
GROUP LABORATORIES SOUTH AFRICA (PTY) LTD
FORTIVA 5 mg
42/2.5/0827
THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD THEBE MEDICARE (PTY) LTD BIOTECH LABORATORIES (PTY) LTD
PAMIRAM 25
PHARMA DYNAMICS (PTY) LTD ACCORD HEALTHCARE (PTY) LTD
POLLENTYME ND
42/3.2/1014
ACCORD HEALTHCARE (PTY) LTD
ACCORD ALENDRONATE 70
42/3.2/1015
ACCORD HEALTHCARE (PTY) LTD
OSTENA 10
42/3.2/1016
ACCORD HEALTHCARE (PTY) LTD
OSTENA 70
42/20.2.8/1020
ROCHE PRODUCTS (PTY) LTD ROCHE PRODUCTS (PTY) LTD MSD (PTY) LTD
TAMIFLU 30 mg
43/20.2.6/0225
NOVARTIS SOUTH AFRICA (PTY) LTD
COARTEM 20 mg/120 mg DISPERSIBLE TABLETS
43/31/0309
PHARMAPLAN (PTY) LTD
REPLAGAL
42/2.5/0828 42/2.5/0829 42/2.5/0830 42/5.7.2/0836
42/5.7.1/0849 42/3.2/1013
42/20.2.8/1021 43/5.7.2/0001
12.56 Notification of Registration Nov10v1.doc
PAMIRAM 50 PAMIRAM 100 PAMIRAM 200 BIO DOMPERIDONE 10
ACCORD ALENDRONATE 10
TAMIFLU 45 mg IVEMEND
Dec 2010
Active Compound Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 2,0 mg Each vial contains: REMIFENTANIL HYDROCHLORIDE EQUIVALENT TO REMIFENTANIL 5,0 mg Each tablet contains: TOPIRAMATE 25,0 mg Each tablet contains: TOPIRAMATE 50,0 mg Each tablet contains: TOPIRAMATE 100,0 mg Each tablet contains: TOPIRAMATE 200,0 mg Each tablet contains: DOMPERIDONE 10,0 mg Each tablet contains: DESLORATADINE 5,0 mg Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10 mg Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70 mg Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 10 mg Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70 mg Each capsule contains: OSELTAMAVIR 30,0 mg Each capsule contains: OSELTAMAVIR 45,0 mg Each vial contains: FOSAPREPITANT DIMEGLUMINE EQUIVALENT TO FOSAPREPITANT 115,0 mg Each tablet contains: ARTEMETHER 20,0 mg LUMEFANTRINE 120,0 mg Each 1,0 ml solution contains: AGALSIDASE ALFA 1,0 mg Page 6 of 7
Administration
Application Number
Notification of Registration of Medicines
Holder of Certificate of Registration
Proprietary Name
Active Compound
43/3.2/0751
DR REDDY’S LABORATORIES (PTY) LTD
DRL ALENDRONATE 70
Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg
43/3.2/0752
DR REDDY’S LABORATORIES (PTY) LTD
DENFOS 70
44/30.1/0002
PFIZER LABORATORIES (PTY) LTD
PREVENAR 13
44/20.2.8/0210
ADCOCK INGRAM LIMITED
TRILAMSTAN
44/20.2.8/0211
ADCOCK INGRAM LIMITED
44/20.2.8/0212
ADCOCK INGRAM LIMITED
ADCO LAMIVUDINE STAVUDINE & NEVIRAPINE 150 mg/40 mg/200 mg TRI-NESTLAM 150/30/200
44/20.2.8/0213
ADCOCK INGRAM LIMITED
TRI-NESTLAM 150/40/200
Each tablet contains: ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg Each 0,5 ml dose contains: SACCHARIDE FOR SEROTYPES 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F 2,2 µg SACCHARIDE FOR SEROTYPE 6B 4,4 µg Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 30,0 mg NEVIRAPINE 200,0 mg Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 40,0 mg NEVIRAPINE 200,0 mg Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 30,0 mg NEVIRAPINE 200,0 mg Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 40,0 mg NEVIRAPINE 200,0 mg
44/20.2.8/0214
ADCOCK INGRAM LIMITED
TRI-STARIELAM 150/30/200
44/20.2.8/0215
ADCOCK INGRAM LIMITED
TRI-STARIELAM 150/40/200
Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 30,0 mg NEVIRAPINE 200,0 mg Each tablet contains: LAMIVUDINE 150,0 mg STAVUDINE 40,0 mg NEVIRAPINE 200,0 mg
REGISTRAR OF MEDICINES MS MANDISA HELA
12.56 Notification of Registration Nov10v1.doc
Dec 2010
Page 7 of 7
