MEDICINES CONTROL COUNCIL

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1 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) 47/26/0920 SANOFI-AVENTIS SA 47/26/0919 SANOFI-AVENTIS SA ZALTRAP 200 mg/8 ml ZALTRAP 100 mg/4 ml 47/26/0918 WINTHROP ZALZEN 200 mg/8 ml 47/26/0917 WINTHROP ZALZEN 100 mg/4 ml 46/2.6.5/0085 SPECPHARM SPEC QUETIAPINE /2.6.5/0084 SPECPHARM SPEC QUETIAPINE /2.6.5/0083 SPECPHARM SPEC QUETIAPINE /2.6.5/0082 SPECPHARM SPEC QUETIAPINE 100 AFLIBERCEPT 200,0 mg AFLIBERCEPT AFLIBERCEPT 200,0 mg AFLIBERCEPT 300,0 mg 200,0 mg 1 46/2.6.5/0081 SPECPHARM SPEC QUETIAPINE 25 45/21.2/0669 MYLAN MYLAN METFORMIN mg METFORMIN HYDROCHLORIDE 1 000,0 mg 12.78_Notification_of Apr14_v1 April 2014 Page 1 of 5

2 43/7.1.5/0984 LASARA TRADERS (PTY) 43/7.1.5/0983 LASARA TRADERS (PTY) 43/7.1.5/0982 LASARA TRADERS (PTY) 43/7.1.5/0981 LASARA TRADERS (PTY) 43/7.1.5/0980 LASARA TRADERS (PTY) 43/7.1.5/0979 LASARA TRADERS (PTY) 43/5.10/0762 ARROW PHARMA SOUTH AFRICA 43/5.10/0761 ARROW PHARMA SOUTH AFRICA 43/1.2/0699 BIOTECH LABORATORIES (PTY) 43/1.2/0698 BIOTECH LABORATORIES (PTY) VITRIXA 100 VITRIXA 50 VITRIXA 25 VIDENA 100 VIDENA 50 VIDENA 25 ENTRAN INJECTION 4 mg/2 ml ARROW INJECTION 4 mg/2 ml BIOTECH TRAZODONE 100 BIOTECH TRAZODONE 50 43/20.1.1/0238 SANDOZ SA SANDOZ LEVOFLOXACIN 500 mg/100 ml 43/20.1.1/0233 SANDOZ SA SANDOZ LEVOFLOXACIN 250 mg/50 ml 43/20.1.1/0232 SANDOZ SA LEVONIC 500 mg/100 ml HYDROCHLORIDE DIHYDRATE 4,0 mg HYDROCHLORIDE DIHYDRATE 4,0 mg TRASODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE LEVOFLOXACIN 500,0 mg LEVOFLOXACIN 2 LEVOFLOXACIN 500,0 mg 43/20.1.1/0231 SANDOZ SA LEVONIC 250 mg/50 ml LEVOFLOXACIN 2 36/28/0137 BAYER ULTRAVIST ml Each 1,0 ml solution contains: IOPROMIDE IODINE 240,0 mg 12.78_Notification_of Apr14_v1 April 2014 Page 2 of 5

3 A40/32.5/0648 PHARMAFRICA HYLO-MAX EYE DROPS SOLUTION 46/20.2.8/0038 INGELHEIM 46/20.2.8/0037 INGELHEIM 45/5.2/0791 AUROBINDO PHARMA 45/5.2/0790 AUROBINDO PHARMA 45/5.2/0789 AUROBINDO PHARMA 45/20.2.3/0518 PHARMA DYNAMICS 44/8.2/1041 ASTRA ZENECA 43/20.2.8/0355 CIPLA LIFE SCIENCES 43/20.2.8/0353 CIPLA MEDPRO (PTY) 43/20.2.8/0226 INGELHEIM 41/7.5/0617 ARROW PHARMA SOUTH AFRICA 34/2.7/0290 RECKITT BENCKISER HEALTHCARE (SA) (PTY) ALVIR 50 mg/5 ml ALVIR 200 mg TABLETS BISBETA 10 mg BISBETA 5 mg BISBETA 2,5 mg DYNA ETHAMBUTOL 400 mg BRILINTA CIPLA EMTRICITABINE MEDPRO EMTRICITABINE 200 mg APTIVUS 250 mg BIOVAC SIMVASTATIN 80 mg IBUPROFEN RECKITT 200 Each 1,0 ml solution contains: SODIUM HYALURONATE 1,0 mg Each 5,0 ml suspension contains: NEVIRAPINE NEVIRAPINE 200,0 mg 10,0 mg 5,0 mg 2,5 mg ETHAMBUTOL HYDROCHLORIDE 400,0 mg TICAGRELOR 90,0 mg EMTRICITABINE 200,0 mg EMTRICITABINE 200,0 mg TIPRANAVIR 2 SIMVASTATIN 80,0 mg IBUPROFEN LYSINE equivalent to IBUPROFEN 200,0 mg A04/2.9/12 VIRBAC RSA SEDAXYLAN Each 1,0 ml solution contains: XYLAZINE HYDROCHLORIDE XYLAZINE 20,0 mg 45/11.4.3/0777 ASTRAZENECA 45/7.1.3/0626 ARROW PHARMA SOUTH AFRICA 45/7.1.3/0625 ARROW PHARMA SOUTH AFRICA 45/7.1.3/0624 ARROW PHARMA SOUTH AFRICA TRUSTAN 20 mg ESOMEPRAZOLE MAGNESIUM TRIHYDRATE ESOMEPRAZOLE 20,0 mg IRBESARTAN 300,0 mg IRBESARTAN 1 IRBESARTAN 75,0 mg 12.78_Notification_of Apr14_v1 April 2014 Page 3 of 5

4 45/7.1.3/0623 ARROW PHARMA SOUTH AFRICA 45/7.1.3/0622 ARROW PHARMA SOUTH AFRICA 45/7.1.3/0621 ARROW PHARMA SOUTH AFRICA 44/20.2.8/0016 BLISS cc 44/20.2.8/0015 BLISS cc 43/7.1.3/0445 ZYDUS HEALTHCARE SA 43/7.1.3/0444 ZYDUS HEALTHCARE SA 43/7.1.3/0443 ZYDUS HEALTHCARE SA 43/3.2/0132 WINTHROP 43/3.2/0131 WINTHROP 42/7.1.3/0094 AKACIA HEALTHCARE 42/7.1.3/0095 AKACIA HEALTHCARE 42/7.1.3/0096 AKACIA HEALTHCARE 42/7.1.3/0097 AKACIA HEALTHCARE 45/11.4.3/0778 ASTRAZENECA AROTAN 300 AROTAN 150 AROTAN 75 VORIOR HEVITREX 40 mg 20 mg 10 mg RISEDRONATE WINTHROP MONTHLY ACTONEL ONCE-A- MONTH LOZAAN 12,5 mg LOZAAN 25 mg LOZAAN 50 mg LOZAAN 100 mg TRUSTAN 40 mg IRBESARTAN 300,0 mg IRBESARTAN 1 IRBESARTAN 75,0 mg VALACICLOVIR 500,0 mg VALACICLOVIR 500,0 mg QUINAPRIL 40,0 mg QUINAPRIL 20,0 mg QUINAPRIL 10,0 mg RISEDRONATE SODIUM RISEDRONIC ACID 1 RISEDRONATE SODIUM RISEDRONIC ACID 1 12,5 mg ESOMEPRAZOLE MAGNESIUM TRIHYDRATE ESOMEPRAZOLE 40,0 mg 12.78_Notification_of Apr14_v1 April 2014 Page 4 of 5

5 45/30.1/0827 NOVARTIS SOUTH AFRICA MENVEO Each 0,5 ml solution contains: MENINGOCOCCAL GROUP A 10,0 ug MENINGOCOCCAL GROUP C MENINGOCOCCAL GROUP W MENINGOCOCCAL GROUP Y MS M HELA REGISTRAR OF MEDICINES 12.78_Notification_of Apr14_v1 April 2014 Page 5 of 5

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