Registration of Medicines Notification of Registration ec A - wf A A é A SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY NOTIFICATION OF REGISTRATION OF MEDICINES BY THE ACTING CEO OF SAHPRA IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965) [Products registered July 2018 - March 2019 April 2019 ] MS P NKAMBULE ACTING CHIEF EXECUTIVE OFFICER 12.102 Notification of Registration July 2018-March_2019 v2 April 2019 Registration of medicines Notification of registration Registration Registered |Product Proprietary Name Dosage form Applicant Ingredients number 52/20.2.8/0210 2018/08/31 |TRIDOLUVID TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0211.210 2018/08/31 |OLEGRATRIP TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg DAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0212.210 2018/08/31 |VOLUTRIP TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0199 2018/08/31 |ACRIPTEGA TABLET MYLAN (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0200.199 2018/08/31 |TENDOLA TABLET MYLAN (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0201.199 2018/08/31 |TELADOMYL TABLET MYLAN (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0450 2018/08/31 |TELADO TABLET CIPLA MEDPRO (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0451.450 2018/08/31 |REYDIN TABLET CIPLA MEDPRO (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 42/25.5.1/0691 2018/09/25 |IVEPRED 500 INJECTION PHARMAPLAN (PTY) LTD Each vial contains METHYLPREDNISOLONE SODIUM SUCCINATE equivalent to METHYLPREDNISOLONE 500,0 mg 42/21.5.1/0692 2018/09/25 |IVEPRED 1000 INJECTION PHARMAPLAN (PTY) LTD Each vial contains METHYLPREDNISOLONE SODIUM SUCCINATE equivalent to METHYLPREDNISOLONE 1000,0 mg 43/7.1.5/0015 2018/09/25 _|DYNA-SILDENAFIL 25 mg TABLET PHARMA DYNAMICS (PTY) LTD Each tablet contains SILDENAFIL CITRATE equivalent to SILDENAFIL 25,0 mg 43/7.1.5/0016 2018/09/25 _|DYNA-SILDENAFIL 50 mg TABLET PHARMA DYNAMICS (PTY) LTD Each tablet contains SILDENAFIL CITRATE equivalent to SILDENAFIL 50,0 mg 43/7.1.5/0017 2018/09/25 _|DYNA-SILDENAFIL 100 mg TABLET PHARMA DYNAMICS (PTY) LTD Each tablet contains SILDENAFIL CITRATE equivalent to SILDENAFIL 100,0 mg 43/32.2/0704 2018/09/25 _|PANGRAF 0,5 mg CAPSULES ADCOCK INGRAM LIMITED Each capsule contains TACROLIMUS 0,5 mg 43/32.2/0705 2018/09/25 _|PANGRAF 1 mg CAPSULES ADCOCK INGRAM LIMITED Each capsule contains TACROLIMUS 1,0 mg 43/32.2/0706 2018/09/25 _|PANGRAF 5 mg CAPSULES ADCOCK INGRAM LIMITED Each capsule contains TACROLIMUS 5,0 mg 44/20.2.8/0293 2018/09/25 |AURO-ABACAVIR/LAMIVUDINE TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg 600/300 mg TABLETS 44/20.2.8/0290 2018/09/25 _|AZADAR 600/300 mg TABLETS TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains ABACAVIR 600,0 mg LAMIVUDINE 300,0 mg 48/20.2.8/0572 2018/09/25 _|COZILAM TABLET TEVA PHARMACEUTICALS (PTY) LTD Each tablet contains DAMIVUDINE 150,0 mg ZIDOVUDINE 300,0 mg 49/20.1.1/0679 2018/09/25 |AUSTELL CLARITHROMYCIN LV. INJECTION CAMOX PHARMACEUTICALS (PTY) LTD Each vial contains QOLARITHROMYCIN 500,0 mg 49/20.1.1/0680 2018/09/25 _|KLARISTELLIV INJECTION CAMOX PHARMACEUTICALS (PTY) LTD Each vial contains QLARITHROMYCIN 500,0 mg 49/26/0729 2018/09/25 _|SPEC PEMETREXED 100 INJECTION SPECPHARM (PTY) LTD Each vial contains BEMETREXED SODIUM equivalent to PEMETREXED 100,0 mg 49/26/0730 2018/09/25 _|SPEC PEMETREXED 500 INJECTION SPECPHARM (PTY) LTD Each vial contains BEMETREXED SODIUM equivalent to PEMETREXED 500,0 mg 49/26/0731 2018/09/25 _|SPEC PEMETREXED 1 000 INJECTION SPECPHARM (PTY) LTD Each vial contains BEMETREXED SODIUM equivalent to PEMETREXED 1 000,0 mg 46/7.1.3/0722 2018/09/25 _|TORTANDIO 40 TABLET ABEX PHARMACEUTICA (PTY) LTD Each tablet contains VALSARTAN 40,0 mg 46/7.1.3/0723 2018/09/25 _|TORDANDIO 80 TABLET ABEX PHARMACEUTICA (PTY) LTD Each tablet contains VALSARTAN 80,0 mg 46/7.1.3/0724 2018/09/25 _|TORTANDIO 160 TABLET ABEX PHARMACEUTICA (PTY) LTD Each tablet contains VALSARTAN 160,0 mg 46/7.1.3/0725 2018/09/25 _|TORTANDIO 320 TABLET ABEX PHARMACEUTICA (PTY) LTD Each tablet contains VALSARTAN 320,0 mg 49/34/0438 2018/09/25 |CAMOX ZOLEDRONIC ACID I.V INFUSION CAMOX PHARMACEUTICALS (PTY) LTD Each 5,0 ml solution contains ZOLEDRONATE TRISODIUM equivalent to ZOLEDRONIC ACID 4,0 mg 49/34/0439 2018/09/25 |AUSTELL ZOLEDRONIC ACID IV INFUSION CAMOX PHARMACEUTICALS (PTY) LTD Each 5,0 ml solution contains ZOLEDRONATE TRISODIUM equivalent to ZOLEDRONIC ACID 4,0 mg 49/34/0440 2018/09/25 |APEX ZOLEDRONIC ACID IV INFUSION CAMOX PHARMACEUTICALS (PTY) LTD Each 5,0 ml solution contains ZOLEDRONATE TRISODIUM equivalent to ZOLEDRONIC ACID 4,0 mg 12/17.1.6/14 2018/09/25 |POSATEX EARDROPS INTERVET SA (PTY) LTD Each 1,0 ml solution contains MOMETASONE FUROATE 0,855 mg ORBIFLOXACIN 8,549 mg BOSACONAZOLE 0,855 mg 49/30.1/0232 2018/09/25 _|COSENTYX 150 mg INJECTION NOVARTIS SOUTH AFRICA (PTY) LTD Each vial contains SECUKINUMAB 150,0 mg 49/30.1/0233 2018/09/25 |COSENTYX 150 mg /ml INJECTION NOVARTIS SOUTH AFRICA (PTY) LTD Each vial contains SECUKINUMAB 150,0 mg 51/20.2.8/0197 2018/09/25 _|VALHET 450 TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains VALGANCICLOVIR 450,0 mg 51/20.2.8/0198.197 2018/09/25 _|ROIVAN 450 TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains VALGANCICLOVIR 450,0 mg 51/20.2.8/0199.197 2018/09/25 _|QUIVALEX 450 TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains VALGANCICLOVIR 450,0 mg 51/7.1.3/0067 2018/09/25 |VALDOU 5/80 TABLET FORRESTER PHARMA (PTY) LTD Each tablet contains AMLODIPINE BESYLATE equivalent to AMLODIPINE 5,0 mg WALSARTAN 80,0 mg 51/7.1.3/0068 2018/09/25 |VALDOU 5/160 TABLET FORRESTER PHARMA (PTY) LTD Each tablet contains AMLODIPINE BESYLATE equivalent to AMLODIPINE 5,0 mg WALSARTAN 160,0 mg 51/7.1.3/0069 2018/09/25 |VALDOU 10/160 TABLET FORRESTER PHARMA (PTY) LTD Each tablet contains AMLODIPINE BESYLATE equivalent to AMLODIPINE 10,0 mg WALSARTAN 160,0 mg 51/20.2.8/0154 2018/09/25 _|NORVIR 100 mg ORAL POWDER POWDER ABBVIE (PTY) LTD Each sachet contains RITONAVIR 100,0 mg 12.102 Notification of Registration July_2018-March_2019_v2 April 2019 2 of 4 Registration of medicines Notification of registration Registration Registered |Product Proprietary Name Dosage form Applicant Ingredients number 52/20.2.8/0718 2018/10/10 |LANOGRAV TABLET RANBAXY PHARMACEUTICALS (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0719.718 2018/10/10 |TELATRI TABLET RANBAXY PHARMACEUTICALS (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0770 2018/10/10 |VIRATEN TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0771.770 2018/10/10 |JORNITRAZ TABLETS TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0772.770 2018/10/10 |KOVATRAX TABLETS TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0946 2018/10/10 |DOVIMIL TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0947.946 2018/10/10 |MILUTIN TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0948.946 2018/10/10 |LUVIGEN TABLET HETERO DRUGS SA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg DAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0949 2018/10/10 |NUVACO TABLET ADCOCK INGRAM LIMITED Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0950.949 2018/10/10 |ADCO DOLUTEGRAVIR, LAMIVUDINE, |TABLET ADCOCK INGRAM LIMITED Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg TENOFOVIR 50/300/300 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0944 2018/10/10 |DAMTOV TABLET SPECPHARM HOLDINGS (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg CAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0945 2018/10/10 |TLADEEZ TABLET KIARA HEALTH (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg DAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 53/20.2.8/0089 2018/10/10 |TEMIV TABLET EMCURE PHARMACEUTICALS SA (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 52/20.2.8/0090.089 2018/10/10 |LAVEM TABLET EMCURE PHARMACEUTICALS SA (PTY) LTD Each tablet contains DOLUTEGRAVIR 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 53/20.2.8/0087 2018/10/10 |TRIDOZIA TABLET PHARMACARE LIMITED Each tablet contains DOLUTEGRAVIR SODIUM 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 53/20.2.8/0088.087 2018/10/10 |TRIDOLVIR TABLET PHARMACARE LIMITED Each tablet contains DOLUTEGRAVIR SODIUM 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 53/20.2.8/0082 2018/10/10 |EMDOLTEN TABLET PHARMACARE LIMITED Each tablet contains DOLUTEGRAVIR SODIUM 50,0 mg LAMIVUDINE 300,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg 42/32.16/0693 2018/10/26 _|IVEPRED DILUENT INJECTION PHARMAPLAN (PTY) LTD Each ampoule contains WATER FOR INJECTIONS 1,0 ml 45/20.1.1/0246 2018/10/26 |AZIMAX FORTE TABLET PHARMASCRIPT PHARMACEUTICALS LTD Each tablet contains AZITHROMYCIN DIHYDRATE equivalent to AZITHROMYCIN 500,0 mg 46/17.1/0060 2018/10/26 |ROCURONIUM FRESENIUS 10 mg/ml JINFUSION FRESENIUS KABI SOUTH AFRICA (PTY) LTD Each 2,5 ml solution contains ROCURONIUM BROMIDE 25,0 mg (25 mg/ 2,5 ml) 46/17.1/0061 2018/10/26 |ROCURONIUM FRESENIUS 10 mg/ml JINFUSION FRESENIUS KABI SOUTH AFRICA (PTY) LTD Each 5,0 ml solution contains ROCURONIUM BROMIDE 50,0 mg (50 mg /5 ml) 46/17.1/0062 2018/10/26 |ROCURONIUM FRESENIUS 10 mg/ml JINFUSION FRESENIUS KABI SOUTH AFRICA (PTY) LTD Each 10,0 ml solution contains ROCURONIUM BROMIDE 100,0 mg (100 mg /10 ml) 50/30.1/0148 2018/10/26 |SYNAGIS INJECTION ABBVIE (PTY) LTD Each 1,0 ml solution contains PALIVIZUMAB 100,0 mg 51/20.2.8/0913 2018/10/26 |DOLUVID TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg 51/20.2.8/0914.913 2018/10/26 |OLEGRA TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg 51/20.2.8/0915.913 2018/10/26 _|VIRUVID TABLET AUROBINDO PHARMA (PTY) LTD Each tablet contains DOLUTEGRAVIR SODIUM equivalent to DOLUTEGRAVIR 50,0 mg 51/20.2.3/0853.852 2018/10/26 |RIPYSO PAED 75/50 TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg RIFAMPICIN 75,0 mg 51/20.2.3/0854.852 2018/10/26 |ORIZIT PAED 75/50 TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg RIFAMPICIN 75,0 mg 51/20.2.3/1081 2018/10/26 _|PRIFTIN TABLET SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD Each tablet contains RIFAPENTINE 150,0 mg 52/20.2.3/0306 2018/10/26 |CO-AFARIS PAED 75/50/150 TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg BYRAZINAMIDE 150,0 mg RIFAMPICIN 75,0 mg TABLETS 52/20.2.3/0307.306 2018/10/26 |CO-RIPYSO PAED 75/50/150 TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg BYRAZINAMIDE 150,0 mg RIFAMPICIN 75,0 mg TABLETS 52/20.2.3/0308.306 2018/10/26 |CO-ORIZITPAED 75/50/150 TABLETS |TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg BYRAZINAMIDE 150,0 mg RIFAMPICIN 75,0 mg 47/11.4.3/0800 2018/10/26 _|MITOGUT 40 INJECTION DR REDDY'S LABORATORIES (PTY) LTD Each vial contains BSOMEPRAZOLE 40,0 mg 12.102 Notification of Registration July_2018-March_2019_v2 April 2019 3 of 4 Registration of medicines Notification of registration Registration Registered |Product Proprietary Name Dosage form Applicant Ingredients number 51/20.2.3/0852 2018/10/26 |AFARIS PAED 75/50 TABLET MACLEODS PHARMACEUTICALS SA (PTY) LTD |Each tablet contains ISONIAZID 50,0 mg [ISONIAZID 50,0 mg RIFAMPICIN 75,0 mg RIFAMPICIN 75,0 mg 51/30.1/0838 2019/03/20 _|VAXIGRIP TETRA INJECTION SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD Each 0,5 ml suspension contains INFLUENZA VIRUS 38/16.1/0328 2019/03/25 _|GRAYS MILK OF MAGNESIA SUSPENSION _|MEDICINE DEVELOPERS INTERNATIONAL cc Each 5,0 ml suspension contains MAGNESIUM HYDROXIDE 400,0 mg 48/30.1/0370 2019/03/25 |PERJATA INFUSION ROCHE PRODUCTS (PTY) LTD Each vial contains BERTUZUMAB 420,0 mg 48/21.2/1349 2019/03/25 _|RISTABEN 25 TABLET MSD (PTY) LTD Each tablet contains SITAGLIPTIN PHOSPHATE equivalent to SITAGLIPTON 25,0 mg 48/21.2/1350 2019/03/25 _|RISTABEN 50 TABLET MSD (PTY) LTD Each tablet contains SITAGLIPTIN PHOSPHATE equivalent to SITAGLIPTON 50,0 mg 48/21.2/1351 2019/03/25 _|RISTABEN 100 TABLET MSD (PTY) LTD Each tablet contains SITAGLIPTIN PHOSPHATE equivalent to SITAGLIPTON 100,0 mg 46/20.1.1/0799 2019/03/25 _|PLANITEC 400 INJECTION SANDOZ SOUTH AFRICA (PTY) LTD Each vial contains TEICOPLANIN 400,0 mg 46/32.4/0800 2019/03/25 _|PLANITEC SOLVENT INJECTION SANDOZ SOUTH AFRICA (PTY) LTD Each ampoule contains WATER FOR INJECTIONS 3,0 ml 46/10.1/0087 2019/03/25 |DIPHAL EXPECTORANT SOLUTION MEDICINE DEVELOPERS INTERNATIONAL cc Each 5,0 ml solution contains AMMONIUM CHLORIDE 136,0 mg DIPHENHYDRAMINE HYDROCHLORIDE 14,0 mg 46/1 1.4.2/0086 2019/03/25 |MEDDEV SUSPENSION |MEDICINE DEVELOPERS INTERNATIONAL cc Each 10,0 ml suspension contains DICYCLOMINE HYDROCHLORIDE 5,0 mg DRIED ALUMINIUM HYDROXIDE 400,0 mg LIGHT MAGNESIUM OXIDE 200,0 mg 51/26/0714 2019/03/25 _|BERTRED 3,5 INJECTION DR REDDY'S LABORATORIES (PTY) LTD Each vial contains BORTEZOMIB 3,5 mg 51/32.2/0817 2019/03/25 _| TAFINLAR 50 mg CAPSULES NOVARTIS SOUTH AFRICA (PTY) LTD Each capsule contains DABRAFENIB 50,0 mg 51/32.2/0818 2019/03/25 _| TAFINLAR 75 mg CAPSULES NOVARTIS SOUTH AFRICA (PTY) LTD Each capsule contains DABRAFENIB 75,0 mg 51/32.2/0819 2019/03/25 _ | MEKINIST 0,5 mg TABLET NOVARTIS SOUTH AFRICA (PTY) LTD Each tablet contains TRAMETINIB 0,5 mg 51/32.2/0820 2019/03/25 _|MEKINIST 2 mg TABLET NOVARTIS SOUTH AFRICA (PTY) LTD Each tablet contains TRAMETINIB 2,0 mg 51/20.1/0734 2019/03/25 _|DRYMRED 500 INFUSION DR REDDY'S LABORATORIES (PTY) LTD Each vial contains DAPTOMYCIN 500,0 mg 52/20.2.3/0460 2019/03/25 _|DELTYBA TABLET MYLAN (PTY) LTD Each tablet contains DELAMANID 50,0 mg 47/16.1/0790 2019/03/29 |OXYMETAZOLINE CIPLA 0,025 NASAL SPRAY _|CIPLA MEDPRO (PTY) LTD Each 1,0 ml solution contains OXYMETAZOLINE HYDROCHLORIDE 0,25 mg 47/16.1/0791 2019/03/29 _|OXYMETAZOLINE CIPLA 0,05 NASAL SPRAY_|CIPLA MEDPRO (PTY) LTD Each 1,0 ml solution contains OXYMETAZOLINE HYDROCHLORIDE 0,5 mg 47/16.1/0792 2019/03/29 _|OXYMIST 0,025 NASAL SPRAY_|CIPLA MEDPRO (PTY) LTD Each 1,0 ml solution contains OXYMETAZOLINE HYDROCHLORIDE 0,25 mg 47/16.1/0793 2019/03/29 |OXYMIST 0,05 NASAL SPRAY _|CIPLA MEDPRO (PTY) LTD Each 1,0 ml solution contains OXYMETAZOLINE HYDROCHLORIDE 0,5 mg 46/13.9.1/0615 2019/03/29. |DOVOBET GEL GEL ADCOCK INGRAM LIMITED Each 1,0 g gel contains BETAMETHASONE DIPROPIONATE equivalent to BETAMETHASONE 0,5 mg QALCIPOTRIOL 50,0 ug 48/21.10/0402 2019/03/29. |MERIONAL HG 751.U. and SOLVENT = JINJECTION DELFRAN PHARMACEUTICALS (PTY) LTD Each vial contains FOLLICLE STIMULATING HORMONE 75 I.U. and LUTEINISING HORMONE 75 LU. 52/21.2/0090 2019/03/29 _|METFORMIN XR 500 mg ACCORD TABLET ACCORD HEALTHCARE (PTY) LTD Each tablet contains METFORMIN HYDROCHLORIDE 500,0 mg 51/20.2.2/1050 2019/03/29 _|CIRION 50 INFUSION CIPLA MEDPRO (PTY) LTD Each vial contains QASPOFUNGIN ACETATE equivalent to CASPOFUNGIN 50,0 mg 51/20.2.2/1051 2019/03/29 _|CIRION 70 INFUSION CIPLA MEDPRO (PTY) LTD Each vial contains QASPOFUNGIN ACETATE equivalent to CASPOFUNGIN 70,0 mg 51/20.2.2/1052.1050 2019/03/29 _|CASPOFUNGIN 50 CIPLA INFUSION CIPLA MEDPRO (PTY) LTD Each vial contains QASPOFUNGIN ACETATE equivalent to CASPOFUNGIN 50,0 mg §1/20.2.2/1053.1051 2019/03/29 _|CASPOFUNGIN 70 CIPLA INFUSION CIPLA MEDPRO (PTY) LTD Each vial contains QASPOFUNGIN ACETATE equivalent to CASPOFUNGIN 70,0 mg 12.102 Notification of Registration July_2018-March_2019_v2 April 2019 4of 4