Government Gazette Staatskoerant REPUBLIC OF SOUTH AFRICA REPUBLIEK VAN SUID-AFRIKA

June Vol. 564 Pretoria, 2012 8 Junie No. 35409

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CONTENTS INHOUD Page Gazette Bladsy Koerant No. No. No. No. No. No.

GENERAL NOTICE ALGEMENE KENNISGEWING

Health, Department of Gesondheid, Departement van Algemene Kennisgewing General Notice 455 Wet op Beheer van Medisyne en 455 Medicines and Related Substances Act Verwante Stowwe (101/1965): (101/1965): Medicines Control Council: Medisynebeheerraad: Voorwaardes vir Conditions of registration of a medicine die registrasie van 'n medisyne in terme in terms of the provisions of section 15(7) van die bepalings van artikel 15 (7) van of the Act ...... 3 35409 die Wet ...... 4 35409 STAATSKOERANT, 8 JUNIE 2012 No. 35409 3

GENERAL NOTICE ALGEMENE KENNISGEWING

NOTICE 455 OF 2012 MEDICINES CONTROL COUNCIL CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION 15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965)

1. The applicant shall ensure that the medicine is manufactured and controlled in terms of the current Good Manufacturing Practices as determined by Council 2. The manufacture of this medicine is subject to regular investigation and inspections by the inspectors appointed in terms of Section 26 of the Act, to assess compliance with current Good Manufacturing Practices. 3. The information in the package insert shall be updated on a regular basis to conform to the package insert recently approved by Council. 4. The applicant must comply with all the legal requirements of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). 5. The registration of this medicine shall be subject to review at intervals as determined by Council regardingitsquality, safety and efficacy, and the registration of this medicine may be varied subject to issues Council may deem fit. 6. The first two production batches must be fully validated in terms of the detailed process validation protocol submitted at the time of application for registration, and the validation report must be submitted within a month after completion of the validation. 7. The product may be advertised to the professions only. 8. The provisional shelf-life allocated must be confirmed with stability data over the full shelf-life period on the first two production batches (well-known API) or first three production batches (NCE) in accordance with the Stability Guideline. Stability testing submitted on any pilot batches must also be completed and reported on.The stability report must be submitted within six months after completion of the stability trial. However, Council has to be informed immediately if any parameter shows a significant change or out-of-specification result during the stability trial. 9. A post-registration inspection must be conducted on the first production batch manufactured by each local manufacturer. 10. A post-registration inspection must be conducted on the first production batch of the imported product. 11. Marketing of the product may only commence following a satisfactory post- registration inspection report. 12. One sample of every batch, together with four copies of the protocol for testing of the bulk lot and filling lot, and six copies of the certificate of release issued by a competent authority in the country in which the product was manufactured, must be submitted to the Council for lot release purposes. 13. The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year. 14. The strains of the master seed viruses must be approved by the Department of Health for each year. 4 No. 35409 GOVERNMENT GAZETTE, 8 JUNE 2012

KENNISGEWING 455 VAN 2012

MEDISYNEBEHEERRAAD VOORWAARDES VIR DIE REGISTRASIE VAN 'N MEDISYNE IN TERME VAN DIE BEPALINGS VAN ARTIKEL 15(7) VAN DIE WET OP BEHEER VAN MEDISYNE EN VERWANTE STOWWE, 1965 (WET 101 VAN 1965)

1. Die applikant sal verseker dat die medisyne vervaardig en beheer word ooreenkomstig huidige Goeie Vervaardigingspraktyke soos bepaal deur die Med isynebeheerraad. 2. Die vervaardiging van hierdie medisyne is onderhewig aan gereelde ondersoeke en inspeksies deur inspekteurs, aangestel ingevolge Artikel 25 van die Wet, om die nakoming van Goeie Vervaardigingspraktyke te bepaal. 3. Die inligting soos vervat in the voubiljet moet op 'n gereelde grondsiag opgedateer word in ooreenstemming met 'n voubiljet wat onlangs deur die Raad goekgekeur is. 4. Die applikant moet voldoen aan alle wetlike vereistes van die Wet op Medisyne en Verwante Stowwe, 1965 (Wet 101 van 1965). 5. Die registrasie van hierdie medisyne is onderhewig aan gereelde hersiening met tussenpose soos deur die Raad bepaal, rakende kwaliteit,veiligheid en effektiwiteit,en dieregistrasie van hierdie medisyne kan gewysig word onderhewig aan kwessies na goeddunke van die Raad. 6. Die eerste twee produksielotte moet ten voile gevalideer word ooreenkomstig die breedvoerige prosesvalidasie protokol wat ingedien is ten tye van die aansoek om registrasie, en die vaiidasieverslag moet binne die bestek van een maand na die voltooiing van die validasie ingedien word. 7. Die produk mag siegs aan die beroepe geadverteer word. 8. Die toegekende voorlopige rakleeftyd moet bevestig word met stabiiiteitsdata voigens die Stabiliteitsriglyn op die eerste twee produksielotte (bekende aktiewe bestanddele), of eerste drie produksielotte (nuwe chemiese entiteite), wat die voile rakleeftydperiode dek. Stabiliteitstoetse wat op proeflotte ingedien is, moet ook voltooi word en die verslae ingedien word. Die stabiliteitsversiag moet binne ses maande na voltooiing van die stabiliteitsproef ingedien word. Die Raad moet egter onmiddellik in kennis gestel word indien enige parameter 'n betekenisvolle verandering of buite-speskasieresultaat tydens die stabiliteitsproef lewer. 9. 'n Na-registrasie-inspeksie moet op die eerste produksielot van elke plaasiike vervaardiger uitgevoer word. 10. 'n Na-registrasie-inspeksie moet op die eerste produksielot van die ingevoerde produk uitgevoer word. 11. Bemarking van die produk mag siegs 'n aanvang neem nadat 'n bevredigende na-registrasie-inspeksieverslag gedien het. 12. Een monster van elke lot moet tesame met vier kopiee van die protokolle vir die toets vandiemassalot endievullot sowel as ses kopiee vandie vrysteilingsertifikaat wat uitgereik is deur die verantwoordelike beheeriiggaam in die land waar die produk vervaardig word, ingedien word by die Raad vir lotvrystel I ingsdoeleindes. 13. Die vervaldatum toegeken, sal gewysig word deur 'n verkiaring by te voeg dat die virusstamme tans vir Suid-Afrikaanse gebruik gedurende die gespesifiseerde jaar aanbeveel word. 14. Die stamme van die oorspronklike saadvirusse moet elke jaar deur die Departement van Gesondheid goedgekeur word. RegistrationMRF 15 number: 03/21.1/8 RegistrationMRF15 number: 07/3.1.1/18 MRF 15 Registration number: 07/3.1.1/19 DosageName of form: medicine: ORALQUINABIC SOLUTION 15 % DosageName of form: medicine: TABLETONSIORDOGS 5 mg TABLETS FOR DosageName of form: medicine: TABLETDOGSONSIOR 10 mg TABLETS FOR ConditionsActive ingredients: of registration: NORFLOXACIN150,0EACH mg 1,0 ml CONTAINS:NICOTINATE ActiveConditions ingredients: of registration: ROBENACOXIBEACH TABLET CONTAINS: 5,0 mg Active ingredients: ROBENACOXIBEACH TABLET CONTAINS: 10,0 mg Applicant: LTDTEVA1, 2, PHARMACEUTICALS 3, 4, 5, 6, 7 (PTY) Applicant: NOVARTS1, 2, 3, 4, 5, SA 6, 7(PTY) LTD Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, 5, SA6, 7 (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer:Packer: LTD,PHARMACEUTICAL JERUSALEM, ISRAELISRAEL INDUSTRIES Packer:Manufacturer: S.A.S,NOVARTIS HUNINGUE, SANTE FRANCEANIMALE Manufacturer:Packer: S.A.S,NOVARTIS HUNINGUE, SANTE FRANCEANIMALE Laboratory: FPRC: PHARMACEUTICALSABSISRAELINDUSTRIESTEVA PHARMACEUTICALCOMMERCIAL LTD, JERUSALEM, CHEMISTRY (PTY) LTD, Laboratory: FPRC: RSASPARTAN,NOVARTISS.A.S, HUNINGUE, KEMPTONSASANTE (PTY) FRANCEANIMALE LTD, PARK, Laboratory: FPRC: SPARTAN,NOVARTISS.A.S, HUNINGUE, KEMPTONSASANTE (PTY) FRANCEANIMALE LTD, PARK, INDUSTRIALRESEARCHGROENKLOOF,DEPARTMENT INSTITUTE PHARMACY, (PTY) PRETORIA, LTD, FOR RSA RSASANDTON,LIMBROM&L LABORATORY BUSINESS JOHANNESBURG, PARK,SERVICES, RSASANDTON,LIMBROM&L LABORATORY BUSINESS JOHANNESBURG, PARK,SERVICES, FPRR: TEVALTD,POTCHEFSTROOM,NORTH-WEST PHARMACEUTICALS RUIMSIG, UNIVERSITY,ROODEPOORT, RSA (PTY) FPRR: SPARTAN,NOVARTIS KEMPTONSA (PTY) LTD, PARK, FPRR: SPARTAN,NOVARTIS KEMPTONSA (PTY) LTD, PARK, DateShelf-life: of registration: 2524 NOVEMBERRSAmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERRSAmonths 2011 DateShelf-life: of registration: 2524RSA NOVEMBERmonths 2011 5 6 MRF 15 MRF15 MRF 15 GOVERNMENT GAZETTE, 8JUNE2012 No. 35409 NameRegistration of medicine: number: DOGSONSIOR07/3.1.1/20 20 mg TABLETS FOR NameRegistration of medicine: number: ONSIOR07/3.1.1/21DOGS 40 mg TABLETS FOR NameRegistration of medicine: number: CATSONSIOR07/3.1.1/22 6 mg TABLETS FOR ActiveDosage ingredients: form: ROBENACOXIBEACHTABLET TABLET CONTAINS: 20,0 mg ActiveDosage ingredients: form: ROBENACOXIBEACHTABLET TABLET CONTAINS: 40,0 mg ActiveDosage ingredients: form: ROBENACOXIBEACHTABLET TABLET CONTAINS: 6,0 mg Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, SA 5, 6,(PTY) 7 LTD Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, SA 5, 6,(PTY) 7 LTD Applicant:registration:Conditions of NOVARTIS1, 2, 3, 4, 5, SA6, 7 (PTY) LTD Manufacturer:Packer: NOVARTISS.A.S, HUNINGUE, SANTE ANIMALEFRANCE Packer:Manufacturer: NOVARTISHUNINGUE, SANTE FRANCE ANIMALE S.A.S, Packer:Manufacturer: NOVARTISS.A.S, HUNINGUE, SANTE ANIMALEFRANCE Laboratory: FPRC: NOVARTISS.A.S, HUNINGUE, SASANTE (PTY) FRANCEANIMALE LTD, Laboratory: FPRC: NOVARTISHUNINGUE, SASANTE FRANCE (PTY) ANIMALE LTD, S.A.S, Laboratory: FPRC: S.A.S,NOVARTISS.A.S, HUNINGUE, HUNINGUE, SANTE FRANCE ANIMALEFRANCE LIMBROM&LRSASPARTAN, LABORATORY BUSINESS KEMPTON PARK,SERVICES, PARK, SANDTON,LIMBROM&LSPARTAN, LABORATORY BUSINESS KEMPTONJOHANNESBURG, PARK,SERVICES, PARK, RSA RSA SANDTON,M&LSPARTAN,NOVARTISLIMBRO LABORATORY KEMPTONSAJOHANNESBURG,BUSINESS (PTY) SERVICES, LTD, PARK,PARK, RSA FPRR: SPARTAN,NOVARTISRSASANDTON, KEMPTONSAJOHANNESBURG, (PTY) LTD, PARK, FPRR: SPARTAN,NOVARTIS KEMPTONSA (PTY) LTD, PARK, RSA FPRR: SPARTAN,NOVARTISRSA KEMPTONSA (PTY) LTD, PARK, RSA DateShelf-life: of registration: 24 25RSAmonths NOVEMBER 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 RegistrationMRF 15 number: 36/20.1.2/0399 RegistrationMRF15 number: 37/20.1.2/0223 MRF 15 Registration number: A39/5.7.1/0220 DosageName of form: medicine: INJECTIONSTERILENORBROOK POWDER PENICILLIN FOR G FOR DosageName of form: medicine: STERILEINJECTIONFORNORBROOK INJECTION POWDER AMPICILLIN FOR DosageName of form: medicine: DROPSHISTADEX Active ingredients: BENZYLPENICILLINEACH VIAL CONTAINS: 600,0 mg Active ingredients: AMPICILLINEQUIVALENTEACH VIAL SODIUM CONTAINS: TO Active ingredients: DEXCHLORPHENIRAMINECONTAINS:EACH 1,0 ml SOLUTION 500,0 MALEATE 0,4 No.35409 mg STAATSKOERANT, 8JUNIE2012 Applicant:Conditions of registration: NORBROOK1, 2, 3, 4, 5, 6, LABORATORIES 7 Applicant:Conditions of registration: mgNORBROOK1, 2, 3, 4, 5, 6, 7 Applicant:registration:Conditions of EQUITY1, 2, 3, 4, 5, 6, 7 Manufacturer: LIMITED,NORBROOKSA (PTY) LTD STATION LABORATORIES WORKS, Manufacturer: LABORATORIESLTDNORBROOKLABORATORIES LIMITED, SA (PTY) Manufacturer: PHARMA-Q,LTDPHARMACEUTICALS INDUSTRIA- (PTY) Packer: LIMITED,NORBROOKNEWRY, NORTHERN STATION LABORATORIES WORKS, IRELAND Packer: LABORATORIESNORBROOKNORTHERNSTATION WORKS, IRELAND LIMITED, NEWRY, Packer: WEST,PHARMA-Q, JOHANNESBURG INDUSTRIA- Laboratory: FPRC: NORBROOKNEWRY, NORTHERN LABORATORIES IRELAND Laboratory: FPRC: NORBROOKNORTHERNSTATION WORKS, IRELAND NEWRY, Laboratory: FPRC: WEST, JOHANNESBURGPHARMA-Q, INDUSTRIA- FPRR: NORBROOKNEWRY,LIMITED, NORTHERN STATION LABORATORIES WORKS, IRELAND FPRR: NORBROOKNORTHERNSTATIONLABORATORIES WORKS, IRELAND LIMITED, NEWRY, WEST, JOHANNESBURG Shelf-life: 24MIDRAND,(PTY) months LTD, RSARANDJESPARK, Shelf-life: 36RSARANDJESPARK,LABORATORIES MIDRAND, (PTY) LTD,months FPRR: EQUITY

PHARMACEUTICALS, 7 Date of registration: 25 NOVEMBER 2011 Date of registration: 25 NOVEMBER 2011 DateShelf-life: of registration: 25 NOVEMBER24IRENE, months CENTURION 2011 8 o 50 GOVERNMENT GAZETTE, 8JUNE2012 No. 35409 NameMRFRegistration 15 of medicine: number: A40/16.5/0065INFLAMMATORYCEPACOL ANTI- THROAT NameRegistrationMRF15 of medicine: number: A40/4/0182MACAINE VIAFLEX 0,1 % v1RF 15 NameRegistration of medicine: number: LIPOSURFA40/10.2.2/0243 ActiveDosage ingredients: form: EACHSPRAY 15,0 ml CONTAINS: ActiveDosage ingredients: form: EACHINFUSION 1000,0 SOLUTION ml CONTAINS: ActiveDosage ingredients: form: EACHSUSPENSION 1,0 ml CONTAINS: registration:Conditions of 1,BENZYDAMINE 2, 3, 4, 5, 6, 8 HCI 22,5 g registration:Conditions of 1,BUPIVACAINE 2, 3, 4, 5, 6, 7 HCI 1,0 g registration:Conditions of 1,PHOSPHOLIPIDS 2, 3, 4, 5, 6, 7 27,0 mg Manufacturer:Applicant ADCOCK(WADEVILLE),HEALTHCARE INGRAM WADEVILLE,(PTY) LIMITED LTD Applicant:Manufacturer: ADCOCKJOHANNESBURG,(PTY)ADCOCK LTD, INGRAM INGRAM AEROTON, CRITICAL RSALIMITED CARE Applicant:Manufacturer: LONDON,BLESCIPLA BIOCHEMICALS MEDPRO ONTARIO, (PTY) CANADA INC.,LTD Packer: ADCOCKGERMISTON, INGRAM RSA ' Packer: ADCOCK INGRAM CRITICAL CARE Packer: BLES BIOCHEMICALS INC., Laboratory: FPRC: ADCOCKGERMISTON,(WADEVILLE),HEALTHCARE INGRAM RSA WADEVILLE, (PTY) LTD Laboratory: FPRC: ADCOCKJOHANNESBURG,(PTY) LTD, INGRAM AEROTON, CRITICAL RSA CARE Laboratory: FPRC: BLESLONDON, BIOCHEMICALS ONTARIO, CANADA INC., GERMISTON,(WADEVILLE),HEALTHCARE RSA WADEVILLE,(PTY) LTD JOHANNESBURG,(PTY) LTD, AEROTON, RSA NUCRO-TECHNICS,CANADAMISSISSAUGA,SGSLONDON, LABORATORIES, ONTARIO, ONTARIO, CANADA FPRR: ADCOCKHEALTHCARE INGRAM (PTY) LTD FPRR: ADCOCK(PTY) LTD, INGRAM AEROTON, CRITICAL CARE FPRR ROSENCIPLACANADASCARBOROUGH, MEDPRO PARK, BELLVILLE, (PTY) ONTARIO, LTD, RSAERANDADCOCKGERMISTON,(WADEVILLE), GARDENS, INGRAM RSA WADEVILLE, LIMITED, MIDRAND, ADCOCKJOHANNESBURG,RSAERAND INGRAM GARDENS, LIMITED,RSA MIDRAND, RSA DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 RegistrationMRF 15 number: RegistrationMRF15 number: F 15 DosageName of form: medicine: INJECTIONKEMOPLAT41/26/0156 10 DosageName of form: medicine: INJECTIONKEMOPLAT41/26/0157 50 DosageNameRegistration of form: medicine: number: TABLETMYLAN41/2.6.5/0951 QUETIAPINE 25 Active ingredients: CISPLATINEACH 20,0 ml VIAL CONTAINS: 10,0 mg Active ingredients: CISPLATINEACH 50,0 ml VIAL CONTAINS: 50,0 mg Active ingredients: QUETIAPINEEQUIVALENTEACH TABLET FUMARATE TO CONTAINS: 25,0 mg Applicant:Conditions of registration: CIPLA1, 2, 3, MEDPRO4, 5, 6, 7 (PTY) LTD Applicant:Conditions of registration: CIPLA1, 2, 3, MEDPRO4, 5, 6, 7 (PTY) LTD Applicant:Conditions of registration: LTDXIXIA1, 2,PHARMACEUTICALS 3, 4, 5, 6, 7, 8 (PTY) Manufacturer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Manufacturer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Manufacturer: BARCELONA,MERCK FARMA SPAIN y QUIMICA S.A., No.35409 STAATSKOERANT, 8JUNIE2012 Packer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Packer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Packer: GERARDLABORATORIES,MCDERMOTTKINGDOMBAR,GENERICS HERTFORDSHIRE, UK LABORATORIES LIMITED, POTTERSUNITED T/A Laboratory: FPRC: CIPLA LTD, UNIT V, VERNA, Laboratory: FPRC: CIPLA LTD, UNIT V, VERNA, Laboratory: FPRC GENERICSBARCELONA,MERCKETOBICOKE, FARMA UK ONTARIOSPAIN LIMITED, y QUIMICA CANADA POTTERS S.A., SALCETTE, GOA, INDIA SALCETTE, GOA, INDIA ETOBICOKE,GERARDLABORATORIES,MCDERMOTTKINGDOMBAR, HERTFORDSHIRE, ONTARIO LABORATORIES CANADA UNITED T/A WESTINDUSTRIALRESEARCHBARCELONA,MERCK UNIVERSITY, FARMA INSTITUTE PHARMACY, SPAIN y QUIMICA FOR NORTH- S.A., PRETORIA,DEPARTMENT,PHARMACEUTICALSABSPOTCHEFSTROOM, COMMERCIAL RSA GROENKLOOF, CHEMISTRYRSA (PTY) LTD, FPRR: WADEVILLE,MANUFACTURING(PTY)MERCK PHARMACEUTICAL GERMISTON, LTD, RSA CIPLA MEDPRO, FPRR CIPLA MEDPRO, ROSENPARK, FPRR: XIXIA PHARMACEUTICALS (PTY) 9 DateShelf-life: of registration: 2524ROSENPARK, NOVEMBERmonths BELLVILLE, 2011 RSA DateShelf -life:of registration: 2524 NOVEMBERmonthsBELLVILLE, RSA2011 DateShelf-life: of registration: 2524LTD,MODDERFONTEIN, NOVEMBERmonths (Provisional) 2011 RSA 10 MRFRegistration 15 number: 41/2.6.5/0952 RegistrationMRF15 number: 41/2.6.5/0953 vIRF 15 Registration number: 41/2.6.5/0954 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosageName ingredients: form: of medicine: TABLETEACHMYLAN TABLET QUETIAPINE CONTAINS: 100 ActiveDosageName ingredients: of form: medicine: TABLETEACHMYLAN TABLET QUETIAPINE CONTAINS: 150 ActiveDosageName ofingredients: form: medicine: EACHTABLETMYLAN TABLET QUETIAPINE CONTAINS: 200 Conditions of registration: QUETIAPINE1,EQUIVALENTQUETIAPINE 2, 3, 4, 5, 6, FUMARATETO7, 8 100,0 mg Conditions of registration: 1,QUETIAPINEEQUIVALENT 2, 3, 4, 5, 6, FUMARATE7,TO 8 150,0 mg Conditions of registration: 1,QUETIAPINEEQUIVALENT 2, 3, 4, 5, 6, FUMARATE7,TO 8 200,0 mg Applicant:Manufacturer: MERCKLTDXIXIA PHARMACEUTICALS FARMA y QUIMICA S.A.,(PTY) Manufacturer:Applicant: MERCK(PTY)XIXIA PHARMACEUTICALSLTD FARMA y QUIMICA Applicant:Manufacturer: MERCK(PTY)XIXIA PHARMACEUTICALSLTD FARMA y QUIMICA Packer: KINGDOMBAR,GENERICSBARCELONA, HERTFORDSHIRE, UK SPAIN LIMITED, POTTERSUNITED Packer: HERTFORDSHIRE,POTTERSGENERICSS.A., BARCELONA, BAR, UK LIMITED, UNITEDSPAIN Packer: HERTFORDSHIRE,POTTERSGENERICSS.A., BARCELONA, BAR, UK LIMITED, UNITEDSPAIN BARCELONA,MERCKETOBICOKE,GERARDLABORATORIES,MCDERMOTT FARMA ONTARIOSPAINLABORATORIES y QUIMICA CANADA S.A., T/A CANADAETOBICOKE,T/AMCDERMOTTKINGDOM GERARD LABORATORIES,ONTARIO LABORATORIES T/AMCDERMOTTCANADAETOBICOKE,KINGDOM GERARD LABORATORIES, LABORATORIES ONTARIO Laboratory: FPRC: BAR,GENERICS HERTFORDSHIRE, UK LIMITED, POTTERSUNITED Laboratory: FPRC: POTTERSGENERICSS.A.,MERCK BARCELONA, FARMA BAR, UK LIMITED, y QUIMICA SPAIN Laboratory::FPRC GENERICSPOTTERSS.A.,MERCK BARCELONA, FARMAUK BAR, LIMITED, y QUIMICA SPAIN MERCKETOBICOKE,GERARDMCDERMOTTKINGDOM FARMA LABORATORIES, ONTARIO LABORATORIES y QUIMICA CANADA S.A., T/A ETOBICOKE,T/AMCDERMOTTKINGDOMHERTFORDSHIRE, GERARD LABORATORIES,ONTARIO LABORATORIES UNITED T/AMCDERMOTTKINGDOMETOBICOKE,HERTFORDSHIRE, GERARD LABORATORIES, LABORATORIES ONTARIO UNITED POTCHEFSTROOM,WESTBARCELONA,INDUSTRIALRESEARCH UNIVERSITY, SPAIN INSTITUTE PHARMACY, RSA FOR NORTH- INDUSTRIALRESEARCHS.A.,MERCKCANADA BARCELONA, FARMA INSTITUTE PHARMACY, y QUIMICA SPAIN FOR INDUSTRIALRESEARCHS.A.,MERCKCANADA BARCELONA, FARMA INSTITUTE PHARMACY, y QUIMICA SPAIN FOR MERCKPRETORIA,DEPARTMENT,PHARMACEUTICALSABS COMMERCIAL PHARMACEUTICAL RSA GROENKLOOF, CHEMISTRY (PTY) LTD, SABSLTD,POTCHEFSTROOM,NORTH-WEST COMMERCIAL PHARMACEUTICAL UNIVERSITY, (PTY) RSA LTD,SABSPOTCHEFSTROOM,NORTH-WEST PHARMACEUTICAL COMMERCIAL UNIVERSITY, RSA (PTY) WADEVILLE,MANUFACTURING GERMISTON, (PTY) LTD, RSA MANUFACTURINGMERCKCHEMISTRYRSAGROENKLOOF, PHARMACEUTICAL DEPARTMENT, (PTY)PRETORIA, LTD, MANUFACTURINGMERCKRSAGROENKLOOF,CHEMISTRY PHARMACEUTICAL DEPARTMENT, PRETORIA, (PTY) LTD, FPRR: XIXIALTD,MODDERFONTEIN, PHARMACEUTICALS (PTY)RSA FPRR: RSA(PTY)XIXIAWADEVILLE, PHARMACEUTICALSLTD,MODDERFONTEIN, GERMISTON, FPRR XIXIA(PTY)RSAWADEVILLE, PHARMACEUTICALS LTD, MODDERFONTEIN, GERMISTON, DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 DateShelf-life: of registration: 25 NOVEMBER24RSA months (Provisional) 2011 RegistrationMRF 15 number: 41/2.6.5/0955 RegistrationMRF15 number: 41/5.3/0989 F 15 Registration number: 42/26/0044 ActiveDosageName ingredients: of form: medicine: EACHTABLETMYLAN TABLET QUETIAPINE CONTAINS: 300 ActiveDosageName ofingredients: form: medicine: TABLETASPENEACH GALANTAMINE TABLET CONTAINS: 4 mg ActiveDosageName ofingredients: form: medicine: ASPENEACHINJECTION DACARBAZINE 20,0 ml VIAL CONTAINS: Conditions of registration: 1,QUETIAPINE 2, 3, 4, 5, 6, FUMARATE7, 8 EQUIVALENT TO 300,0 mg Conditions of registration: GALANTAMINE1, 2, 3, 4, 5, 6, 7, 8 4,0 mg registration:Conditions of 1,DACARBAZINE 2, 3, 4, 5, 6, 7 200,0 mg Applicant:Manufacturer: BARCELONA,MERCKXIXIA PHARMACEUTICALS FARMA SPAIN y QUIMICA S.A.,(PTY) LTD Manufacturer.Applicant: ALPHAPHARMPARK,PHARMACARE QUEENSLAND, PTY LIMITED LTD, CAROLE AUSTRALIA Manufacturer:Applicant: ROMANIAS.C.PHARMACARE SINDAN-PHARMA LIMITED S.R.L, BUCHAREST, Packer: GENERICS UK LIMITED, POTTERS BAR, Packer: ALPHAPHARM PTY LTD, CAROLE Packer: S.C. SINDAN-PHARMA S.R.L, BUCHAREST, No.35409 STAATSKOERANT, 8JUNIE2012 MERCKONTARIOGERARDMCDERMOTTHERTFORDSHIRE, FARMA LABORATORIES,CANADA LABORATORIES y QUIMICA UNITED ETOBICOKE,KINGDOMSA., T/A GENERICSIRELANDGERARDHERTFORDSHIRE,PARK, QUEENSLAND, UK, LABORATORIES, POTTERS UK BAR,AUSTRALIA DUBLIN, ASPENWILSONIA,ELIZABETH,PHARMACAREROMANIA PHARMACARE EAST RSA LTD, LONDON, EAST KORSTEN, LONDON, RSA PORT Laboratory: FPRC: MCDERMOTTHERTFORDSHIRE,GENERICSBARCELONA, UK SPAIN LABORATORIESLIMITED, UNITED POTTERS KINGDOM T/A BAR, Laboratory: FPRC: ALPHAPHARMGENERICSPARK QUEENSLAND, UK,PTY POTTERS LTD, CAROLE AUSTRALIA BAR, Laboratory: FPRC: SABSROMANIAS.C. SINDAN-PHARMA COMMERCIAL (PTY) S.R.L, LTD BUCHAREST, RESEARCHBARCELONA,MERCKONTARIOGERARD FARMA LABORATORIES,CANADA INSTITUTE SPAIN y QUIMICA FOR ETOBICOKE,S.A., INDUSTRIAL M&LLIMBROIRELANDGERARDHERTFORDSHIRE, LABORATORY BUSINESS LABORATORIES, SERVICES, UK PARK, MIDRAND,DUBLIN, PHARMACY,RESEARCHRSADEPARTMENT,PHARMACEUTICAL INSTITUTE NORTH-WEST GROENKLOOF, CHEMISTRY FOR UNIVERSITY, INDUSTRIAL PRETORIA, DEPARTMENT,PHARMACEUTICALSABSPOTCHEFSTROOM,PHARMACY, COMMERCIAL NORTH-WEST GROENKLOOF, CHEMISTRYRSA (PTY) LTD, UNIVERSITY, WESTPOTCHEFSTROOMINDUSTRIALRESEARCHGAUTENG, UNIVERSITY, RSA INSTITUTE PHARMACY, FOR NORTH- JOHANNESBURG,BUSINESSM&LPOTCHEFSTROOM LABORATORY PARK, SANDTON,RSA SERVICES, LIMBRO WADEVILLE,MANUFACTURINGMERCKPRETORIA, PHARMACEUTICAL RSA GERMISTON, (PTY) LTD, RSA PHARMACEUTICALSABSSPAINMOLLETMERCK COMMERCIAL FARMA DEL VALLES, y QUIMICA CHEMISTRY (PTY) BARCELONA, LTD,S.A., FPRR: LTD,MODDERFONTEIN,XIXIA PHARMACEUTICALS RSA (PTY) FPRR: SANDTON,PHARMACAREPRETORIADEPARTMENT, RSA LTD,GROENKLOOF, WOODMEAD, FPRC/FPRR: ELIZABETHPHARMACARE LTD, KORSTEN, PORT Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) FPRR: SANDTON,PHARMACAREWILSONIA,ASPEN PHARMACARE RSAEAST LTD, LONDON, WOODMEAD, EAST RSA LONDON, Date of registration: 25 NOVEMBER 2011 Date of registration: 25 NOVEMBER 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 11 12 MRFNameRegistration 15 of medicine: number: 42/21.2/0249DYNA GLICLAZIDE 30 mg MRF15NameRegistration of medicine: number: MYLAN-METHYLPREDNISOLONE42/21.5.1/0309 40 F 15 NameRegistration of medicine: number: GLENMARK42/3.1/0321 MELOXICAM TABLETS GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: TABLETEACH TABLET CONTAINS: ActiveDosage ingredients: form: EACHINJECTION VIAL CONTAINS: ActiveDosage ingredients: form: EACHTABLET7,5 mg TABLET CONTAINS: Conditions of registration: 1,GLICLAZIDE 2, 3, 4, 5, 6, 30,0 7, 8 mg Conditions of registration: 40,0equivalentMethylprednisolone1, mg 2, 3, to4, Methylprednisolone5, 6, 7 hemisuccinate Conditions of registration: 1,MELOXICAM 2, 3, 4, 5, 6, 7 7,5 mg Manufacturer:Applicant TECHNIKONKRKA,PHARMA D.D., LABORATORIESDYNAMICS NOVO MESTO, (PTY) (PTY) LTDSLOVENIA Manufacturer:Applicant: XIXIAS.R.L.,BIOLOGICILTD PHARMACEUTICALS MASATE ITALIA (MILANO), LABORATORIES (PTY) ITALY Manufacturer.Applicant: LIMITED,GLENMARKSA (PTY) LTDBARDEZ, PHARMACEUTICALS GOA, INDIA RSAJEPPESTOWN,LABORATORIESHERSOLLTD, ROBERTVILLE, MANUFACTURING JOHANNESBURG, (PTY) FLORIDA, LTD, RSA ATTICA,VIANEX SA-GREECE PLANT C, PALLINI- Packer: TECHNIKONLABORATORIESHERSOLLTD,KRKA, ROBERTVILLE, D.D., MANUFACTURINGLABORATORIES NOVO (PTY) MESTO, FLORIDA, LTD, (PTY) SLOVENIA RSA Packer: ATTICA,VIANEXPHARMA-Q,S.R.L.,BIOLOGICI SAGREECE MASATE -PLANT ITALIA INDUSTRIA, (MILANO), C, LABORATORIES PALLINI- ITALY Packer: LIMITED,GLENMARK BARDEZ, PHARMACEUTICALS GOA, INDIA RSA(PTY)PHARMACEUTICALJEPPESTOWN, LTD, N'DABENI, JOHANNESBURG, ENTERPRISES PINELANDS, JOHANNESBURG, RSA Laboratory: FPRC: TECHNIKONLABORATORIESHERSOLLTD,KRKA, ROBERTVILLE, D.D., MANUFACTURINGLABORATORIES NOVO (PTY) MESTO, FLORIDA, LTD, (PTY) SLOVENIA RSA Laboratory: FPRC: JOHANNESBURG,PHARMA-Q,WADEVILLE,MANUFACTURINGMERCK PHARMACEUTICALS INDUSTRIA, GERMISTON, RSA(PTY) LTD, RSA Laboratory: FPRC: MIDRAND,(PTY)GLENMARKLIMITED, LTD, BARDEZ, RSAVORNA PHARMACEUTICALPHARMACEUTICALS GOA,VALLEY, INDIA SA ATLASVILLE,LABORATORIESCONSULTINGRSAJEPPESTOWN, BOKSBURG, CHEMICAL JOHANNESBURG, (PTY) LTD,RSA SABSPOTCHEFSTROOM,WESTINDUSTRIALRESEARCH COMMERCIALUNIVERSITY, INSTITUTE PHARMACY, RSA (PTY) FOR NORTH- LTD S.R.L.,BIOLOGICIPRETORIA,DEPARTMENT,PHARMACEUTICAL MASATE ITALIARSA GROENKLOOF, (MILANO), LABORATORIES CHEMISTRY ITALY FPRR: WESTLAKE,PHARMA CAPEDYNAMICS TOWN, (PTY) RSA LTD, FPRR: MODDERFONTEIN,XIXIAATTICA,VIANEX PHARMACEUTICALS, SA-GREECE PLANT GAUTENG,C, PALLINI- RSA FPRR: (PTY)GLENMARK LTD, VORNA PHARMACEUTICAL VALLEY, SA DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2536MIDRAND, NOVEMBERmonths RSA 2011 NameMRFRegistration 15 of medicine: number: GLENMARK42/3.1/0322 MELOXICAM NameRegistrationMRF15 of medicine: number: NEVIR42/20.2.8/0661 VIRF 15 NameRegistration of medicine: number: ZYDUS42/18.10/0722 TAMSULOSIN SR ActiveDosage ingredients: form: TABLETTABLETS 15 mg ActiveDosage ingredients: form: TABLET Dosage form: CAPSULE registration:Conditions of 1,MELOXICAMEACH 2, 3, TABLET4, 5, 6, 7 CONTAINS: 15,0 mg Conditions of registration: 1,NEVIRAPINEEACH 2, 3, TABLET4, 5, 6, 200,07, CONTAINS: 8 mg Activeregistration:Conditions ingredients: of TAMSULOSINEACH1, 2, CAPSULE 3, 4, 5, 6,HCI 7,CONTAINS: 80,4 mg Applicant: GLENMARK Applicant: DEZZO TRADING 392 (PTY) Applicant ZYDUS HEALTHCARE SA (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: GLENMARKPHARMACEUTICALSLTD LIMITED,SA (PTY) Manufacturer: EMCUREPHARMALIMITED,PHARMACEUTICALS T/A INDO Manufacturer: ZYDUS CADILA HEALTHCARE Packer: BARDEZ,GLENMARKPHARMACEUTICALSBARDEZ, GOA, GOA, INDIA INDIA LIMITED, Packer: PHARMACEUTICALSEMCURELIMITED, PUNE, INDIA Packer: LIMITED,ZYDUSINDIA CADILA SANAND, HEALTHCARE AHMEDABAD, Laboratory: FPRC GLENMARKBARDEZ,PHARMACEUTICALS GOA, INDIA LIMITED, Laboratory: FPRC: LIMITED,PHARMACEUTICALSEMCURE PUNE, INDIA Laboratory: FPRC: ZYDUSINDIALIMITED, CADILA SANAND, HEALTHCARE AHMEDABAD, MIDRAND,LTD,PHARMACEUTICAL VORNA RSA VALLEY, SA (PTY) ATLASVILLE,RSALABORATORIES,CONSULTING BOKSBURG, CHEMICAL INDUSTRIALSERVICES,RESEARCHPRETORIA,INSTITUTE SILVERTONDALE, PHARMACY, FOR RSAINSTITUTE PHARMACEUTICAL NORTH-FOR FPRR: GLENMARKPHARMACEUTICAL SA (PTY) FPRR: DEZZO TRADING 392 (PTY) FPRR: ZYDUSPOTCHEFSTROOM,WEST UNIVERSITY, HEALTHCARE RSA (PTY) LTD, Shelf-life: 36MIDRAND,LTD, months VORNA RSA VALLEY, Shelf-life: 24 PHARMA,LIMITED,months (Provisional) T/A LENASIA, INDO RSA Shelf-life: 24POTCHEFSTROOM, months (Provisional) RSA Date of registration: 25 NOVEMBER 2011 Date of registration: 25 NOVEMBER 2011 Date of registration: 25 NOVEMBER 2011 13 14

MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: 42/7.1.3/0766CO MICARDIS 80/25 mg NameRegistrationMRF15 of medicine: number: 42/7.1/0790DYNA INDAPAMIDE SR MRF 15 NameRegistration of medicine: number: ALLERGAN42/15.4/0835 BIMATOPROST 0,01 % ActiveDosage ingredients: form: EACHTABLETTABLETS TABLET CONTAINS: ActiveDosage ingredients: form: EACHTABLET TABLET CONTAINS: ActiveDosage ingredients: form: EACHSOLUTION 1,0 ml SOLUTION CONTAINS: Conditions of registration: 25,0HYDROCHLOROTHIAZIDETELMISARTAN1, mg2, 3, 4, 5, 6, 80,0 7 mg Conditions of registration: INDAPAMIDE 1,5 mg Conditions of BIMATOPROST 0,1 mg Applicant: LTDPHARMACEUTICALSINGELHEIM (PTY) Applicant: PHARMA1, 2, 3, 4, 5,DYNAMICS 6, 7 (PTY) LTD Applicant:registration: ALLERGAN(PTY)1, 2, 3, LTD 4, PHARMACEUTICALS5, 6, 7, 8 Manufacturer: GERMANYINGELHEIMPHARMABOEHRINGER GmbH am,RHEIN, INGELHEIM & Co.KG, Manufacturer: MESTO,KRKA, d.d. SLOVENIA NOVO MESTO, NOVO Manufacturer: ALLERGAN, INC., WACO, TEXAS, USA Packer: GERMANYINGELHEIMPHARMABOEHRINGER GmbH am INGELHEIM RHEIN, & Co.KG, Packer: MESTO,KRKA, d.d. SLOVENIA NOVO MESTO, NOVO Packer: ALLERGAN, INC., WACO, TEXAS, USA Laboratory: FPRC: GERMANYINGELHEIMPHARMABOEHRINGER GmbH am INGELHEIM RHEIN, & Co.KG, Laboratory: FPRC: LABORATORIESCONSULTINGMESTO,KRKA, d.d. NOVO CHEMICAL (PTY) MESTO, LTD, NOVO Laboratory: FPRC: ALLERGAN,PRETORIA,SERVICES,INSTITUTE INC., FORSILVERTONDALE,RSA WACO, PHARMACEUTICAL TEXAS, USA SGSGERMANYHOMBURG/SAAR,PHAST INSTITUTA &GmbH, M STABTEST, FRESENIUS GERMANY MAINZ, ATLASVILLE, BOKSBURG, RSA WINTHROPLTD,PHARMACEUTICALSGERMANYGmbH, WALTLOO, TAUNUSSTEIN, PRETORIA, (PTY) FPRR: LTD,PHARMACEUTICALSINGELHEIMRSA RANDBURG, GAUTENG, (PTY) FPRR: WESTLAKE,PHARMA DYNAMICSCAPE TOWN, (PTY) RSA LTD, FPRR: MIDRAND,(PTY)ALLERGAN LTD, RSAHALFWAY PHARMACEUTICALS HOUSE, DateShelf-life: of registration: 2536RSA NOVEMBERmonths 2011 DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 RegistrationMRF 15 number: 42/1.2/1009 RegistrationMRF15 number: 42/1.2/1010 MRF 15 Registration number: 42/1.2/1067 ActiveDosageName ofingredients: form: medicine: EACHTABLETBIO CITALOPRAM TABLET CONTAINS: 10 ActiveDosageName ofingredients: form: medicine: TABLET CITALOPRAM 20 DosageName of form: medicine: TABLETBIO CITALOPRAM 30 CITALOPRAMEQUIVALENTCITALOPRAM TOHYDROBROMIDE 10,0 mg CITALOPRAM TABLET CONTAINS: TO 20,0 mg Active ingredients: CITALOPRAMEQUIVALENTHYDROBROMIDEEACH TABLET TO30,0 CONTAINS: mg Applicant:Conditions of registration: (PTY)BIOTECH1, 2, LTD 3, 4,LABORATORIES 5, 6, 7 Applicant:Conditions of registration: (PTY)BIOTECH LTD LABORATORIES2, 3, 4, 5, 6, 7 Applicant:Conditions of registration: (PTY)BIOTECH1, 2, 3, LTD 4, 5, LABORATORIES 6, 7 Packer:Manufacturer: SWITZERLANDRIVOPHARM SA, MANNO, Packer:Manufacturer: SWITZERLANDRIVOPHARM SA, MANNO, Packer:Manufacturer: SWITZERLANDRIVOPHARM SA, MANNO, No.35409 STAATSKOERANT, 8JUNIE2012 Laboratory: FPRC: PHARMACEUTICALINSTITUTESWITZERLANDRIVOPHARM FOR SA, MANNO, SERVICES, Laboratory: FPRC: PHARMACEUTICALINSTITUTESWITZERLANDRIVOPHARM FOR SA, MANNO, Laboratory: FPRC PHARMACEUTICALINSTITUTESWITZERLANDRIVOPHARM FOR SA, MANNO, NORTH-WESTSILVERTONDALE,INDUSTRIALRESEARCHRSA UNIVERSITY,INSTITUTE PHARMACY, PRETORIA, FOR NORTH-WESTRESEARCHPRETORIA,SERVICES,INDUSTRIAL SILVERTONDALE,RSAINSTITUTE UNIVERSITY, PHARMACY, FOR FORRESEARCHPRETORIA,SILVERTONDALE,SERVICES, INDUSTRIAL RSAINSTITUTE ATLASVILLE,M&LLABORATORIESCONSULTINGPOTCHEFSTROOM, LABORATORY BOKSBURG, CHEMICAL (PTY) SERVICES,RSA LTD, RSA ATLASVILLE,LABORATORIESCONSULTINGPOTCHEFSTROOM, BOKSBURG, CHEMICAL (PTY) RSA LTD, CONSULTINGPOTCHEFSTROOM,UNIVERSITY,PHARMACY, NORTH-WEST CHEMICAL RSA RSASANDTON,LIMBRO BUSINESS JOHANNESBURG, PARK, JOHANNESBURG,BUSINESSSERVICES,M&LRSA LABORATORY PARK, LIMBRO SANDTON,RSA ATLASVILLE,SERVICES,M&LRSALABORATORIES LABORATORY BOKSBURG, LIMBRO (PTY) LTD, FPRR: BIOTECH LABORATORIES FPRR: BIOTECH LABORATORIES FPRR: JOHANNESBURG,SANDTON,BUSINESS PARK, RSA (PTY) LTD, MIDRAND, (PTY) LTD, MIDRAND, (PTY)BIOTECH LTD, LABORATORIES MIDRAND, 15 DateShelf-life: of registration: 2524GAUTENG, NOVEMBERmonths RSA 2011 DateShelf-life: of registration: 2524GAUTENG, NOVEMBERmonths RSA 2011 DateShelf-life: of registration: 2524GAUTENG, NOVEMBERmonths RSA 2011 16

MRF 15 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: TABLETTREDAPTIVE42/7.5/1092 DosageNameRegistration of form: medicine: number: TABLETTRUVALIN43/2.6.5/0159 25 mg DosageNameRegistration of form: medicine: number: TABLETTRUVALIN43/2.6.5/0160 100 mg Active ingredients: LAROPIPRANTNIACINEACH TABLET CONTAINS: 1 000,0 mg 20,0 mg Active ingredients: QUETIAPINEEQUIVALENTEACH TABLET 25,0FUMARATE TO mgCONTAINS: Active ingredients: QUETIAPINEEQUIVALENTEACH TABLET FUMARATE TO CONTAINS: 100,0 mg Applicant:registration:Conditions of MSD1,2,3,4,5,6,7,6 (PTY) LTD Applicant:registration:Conditions of ASTRAZENECAPHARMACEUTICALS1, 2, 3, 4, 5, 6, 7 (PTY) Applicant:registration:Conditions of ASTRAZENECAPHARMACEUTICALS1, 2, 3, 4, 5, 6, 7 (PTY) LTD Manufacturer: PATHEONTECNOLOGYMERCK SHARP PHARMACEUTICALS LTD, & DOHME SINGAPORE Manufacturer: ASTRAZENECAUKMACCLESFIELD,LTD UK LTD, CHESHIRE, Manufacturer: ASTRAZENECAMACCLESFIELD, UK LTD, CHESHIRE, UK Packer: MERCKINC., CINCINNATI, SHARP & DOHMEOHIO, USA BV, Packer: ASTRAZENECANEWARK,PHARMACEUTICALS, DELAWARE, UK LTD, USA Packer: ASTRAZENECADELAWARE,PHARMACEUTICALS, USAUK LTD, NEWARK, CRAMLINGTON,MERCKMADRID,MSDHAARLEM, FROSST SHARP SPAIN NETHERLANDS IBERICA & DOHME S.A, LTD, FORESTPHARMACEUTICALSBRECONUKMACCLESFIELD, ROAD, HAY-ON- CHESHIRE, LTD, BRECONHEREFORD,FORESTMACCLESFIELD, ROAD,PHARMACEUTICALS UK HAY-ON-WYE, CHESHIRE, UK LTD, HOUSE,MSDNORTHUMBERLAND, (PTY) MIDRAND, LTD, HALFWAY RSA ENGLAND WYE,WYE,BRECONPHARMACEUTICALS HEREFORD, HEREFORD, ROAD, UK HAY-ON- UK LTD, HEREFORD,BRECON ROAD, UK HAY-ON-WYE, Laboratory: FPRC: HOUSE,MSDTECNOLOGYMERCK (PTY) SHARPMIDRAND, LTD, LTD, & HALFWAY DOHME SINGAPORERSA Laboratory: FPRC: ASTRAZENECAPHARMACEUTICALS,UKMACCLESFIELD, UK LTD, CHESHIRE, Laboratory: FPRC: DELAWARE,PHARMACEUTICALS,ASTRAZENECAMACCLESFIELD, USA UK CHESHIRE, LTD, NEWARK, UK ATLASVILLE,RSALABORATORIES,CONSULTINGNEWARK, DELAWARE,BOKSBURG, CHEMICAL USA BOKSBURG,LABORATORIES,CONSULTING RSA CHEMICAL ATLASVILLE, FPRR: HOUSE,MSD (PTY) MIDRAND, LTD, HALFWAY RSA FPRR: ASTRAZENECAJOHANNESBURG,SUNNINGHILL,PHARMACEUTICALS, RSA FPRR: SUNNINGHILL,PHARMACEUTICALS,ASTRAZENECA JOHANNESBURG, DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 Shelf-life:Date of registration: 2536RSA NOVEMBERmonths 2011 MRF 15 MRF15 MRF 15 DosageNameRegistration of form: medicine: number: TABLETTRUVALIN43/2.6.5/0161 200 mg DosageNameRegistration of form: medicine: number: TABLETTRUVALIN43/2.6.5/0162 300 mg DosageNameRegistration of form: medicine: number: CAPSULEBINRONTIN43/2.5/0288 100 mg CAPSULES Active ingredients: QUETIAPINEEQUIVALENTEACH TABLET FUMARATETO200,0 CONTAINS: mg Active ingredients: QUETIAPINEEQUIVALENTEACH TABLET FUMARATETO300,0 CONTAINS: mg Active ingredients: GABAPENTINEACH CAPSULE CONTAINS: 100,0 mg Applicant:Conditions of registration: ASTRAZENECAPHARMACEUTICALS1, 2, 3, 4, 5, 6, 7 (PTY) LTD Applicant:Conditions of registration: ASTRAZENECAPHARMACEUTICALS1, 2, 3, 4, 5, 6, 7 (PTY) Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, 6, PHARMA7, 8 (PTY) LTD Manufacturer: ASTRAZENECA UK LTD, Manufacturer: ASTRAZENECALTD UK LTD, Manufacturer: AUROBINDO PHARMA LTD, UNIT III, No.35409 STAATSKOERANT, 8JUNIE2012 ASTRAZENECADELAWARE,PHARMACEUTICALS,MACCLESFIELD, USA CHESHIRE, NEWARK, UK ASTRAZENECAMACCLESFIELD,NEWARK,PHARMACEUTICALS,UK DELAWARE, CHESHIRE, USA INDIAHYDERABAD,QUTHUBULLAPUR ANDHRA MANDAL, PRADESH, Packer: ASTRAZENECALTD,BRECONMACCLESFIELD, FOREST PHARMACEUTICALS OK ROAD, LTD, CHESHIRE, HAY-ON- UK Packer: ASTRAZENECABRECONUKMACCLESFIELD, PHARMACEUTICALS UK LTD, CHESHIRE, Packer: INDIAHYDERABAD,QUTHUBULLAPURAUROBINDO PHARMA ANDHRA MANDAL, LTD,PRADESH, UNIT III, WYE,LTD,BRECON HEREFORD, BRECON PHARMACEUTICALS ROAD, UK HAY-ON- WYE,LTD,BRECON BRECONFOREST HEREFORD, PHARMACEUTICALS ROAD,ROAD, UK HAY-ON-HAY-ON- Laboratory: FPRC: ASTRAZENECAMACCLESFIELD,PHARMACEUTICALS, UK CHESHIRE, LTD, NEWARK, UK Laboratory: FPRC: ASTRAZENECAUKMACCLESFIELD, UK CHESHIRE, LTD, Laboratory: FPRC AUROBINDOINDIAHYDERABAD,QUTHUBULLAPUR PHARMA ANDHRA MANDAL, LTD, PRADESH, UNIT III, BOKSBURG,LABORATORIES,CONSULTINGDELAWARE, USARSA CHEMICAL ATLASVILLE, BOKSBURG,LABORATORIES,CONSULTINGPHARMACEUTICALS,NEWARK, RSADELAWARE, CHEMICAL ATLASVILLE, USA SERVICES,KHULULEKANIJOHANNESBURG,BUSINESSM&L LABORATORY PARK, MIDRAND, LABORATORY SANDTON, RSA SERVICES, RSA LIMBRO FPRR: JOHANNESBURG,SUNNINGHILL,ASTRAZENECAPHARMACEUTICALS, RSA FPRR: JOHANNESBURG,SUNNINGHILL,PHARMACEUTICALS,ASTRAZENECA RSA FPRR: ROSEBANK,AUROBINDO JOHANNESBURG,PHARMA (PTY) LTD, RSA DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 Shelf-life:Date of registration: 2536 NOVEMBERmonths 2011 Shelf-life:Date of registration: 2524 NOVEMBERmonths (Provisional) 2011 17 18 MRF 15 MRF15 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: CAPSULE43/2.5/0289BINRONTIN 300 mg CAPSULES DosageNameRegistration of form: medicine: number: CONCENTRATEMYLAN43/26/0348 IRINOTECAN FOR 100SOLUTION mg/5 ml FOR DosageNameRegistration of form: medicine: number: 43/26/0349CONCENTRATEMYLAN IRINOTECAN FOR 40SOLUTION mg/2 ml Active ingredients: GABAPENTINEACH CAPSULE CONTAINS: 300,0 mg Active ingredients: equivalentEACHINFUSIONIrinotecan VIAL to CONTAINS: Hydrochloride Trihydrate Active ingredients: equivalentIrinotecanEACHFOR INFUSION VIAL Hydrochlorideto CONTAINS: Trihydrate ApplicantConditions of registration: AUROBINDO1, 2, 3, 4, 5,PHARMA 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: XIXIA1,Irinotecan 2,PHARMACEUTICALS 3, 4, 5, 6, 7 (PTY) LTD 100,0 mg Applicant:Conditions of registration: XIXIA1,Irinotecan 2, 3, PHARMACEUTICALS 4, 5, 6, 7 (PTY) 40,0 mg Manufacturer. QUTHUBULLAPURAUROBINDOHYDERABAD, PHARMA ANDHRA MANDAL, LTD, PRADESH, UNIT III, INDIA Manufacturer: MEDIONA,GP PHARM, BARCELONA, S.A., SANT QUINTI SPAIN DE Manufacturer: MEDIONA,GPLTD PHARM, BARCELONA, S.A., SANT QUINTI SPAIN DE Packer: AUROBINDOHYDERABAD,QUTHUBULLAPUR PHARMA ANDHRA MANDAL,LTD, PRADESH, UNIT III, INDIA Packer: JOHANNESBURG,MEDIONA,PACKAGINGDIVPHARMGP PHARM, BARCELONA, MANUFACTURING S.A., (PTY) RSA SANT LTD, SPAIN QUINTIINDUSTRIA AND DE Packer: JOHANNESBURG,PACKAGINGDIVPHARMMEDIONA,GP PHARM, BARCELONA, MANUFACTURING S.A., (PTY) SANT RSALTD, QUINTIINDUSTRIA SPAIN AND DE Laboratory: FPRC: AUROBINDOM&LHYDERABAD,QUTHUBULLAPUR LABORATORY PHARMA ANDHRA MANDAL, LTD,SERVICES, PRADESH, UNIT III, LIMBRO INDIA Laboratory: FPRC: LABORATORIES,CONSULTINGMEDIONA,GP PHARM, BARCELONA, S.A., CHEMICAL ATLASVILLE,SANT QUINTI SPAIN DE Laboratory: FPRC LABORATORIES,CONSULTINGMEDIONA,GP PHARM, BARCELONA, S.A., CHEMICAL ATLASVILLE,SANT QUINTI SPAIN DE JOHANNESBURG,MIDRAND,KHULULEKANIBUSINESS RSAPARK, RSALABORATORY SANDTON, SERVICES, SABSPOTCHEFSTROOM,PHARMACY,RESEARCHBOKSBURG, COMMERCIAL INSTITUTE RSANORTH-WEST RSA(PTY) FOR LTD, UNIVERSITY, INDUSTRIAL POTCHEFSTROOM,WESTRESEARCHBOKSBURG,INDUSTRIAL UNIVERSITY, INSTITUTE RSA PHARMACY, RSA FOR NORTH- MANUFACTURINGMERCKPRETORIA,DEPARTMENT,PHARMACEUTICAL PHARMACEUTICAL RSA GROENKLOOF, (PTY) CHEMISTRY LTD, MERCKSABSPRETORIA,DEPARTMENT,PHARMACEUTICAL COMMERCIAL PHARMACEUTICAL RSA GROENKLOOF, (PTY) CHEMISTRY LTD, FPRR: AUROBINDOROSEBANK, PHARMA JOHANNESBURG, (PTY) LTD, RSA FPRR: XIXIALTD,MODDERFONTEIN,WADEVILLE, PHARMACEUTICALS GERMISTON, (PTY)RSA RSA FPRR: XIXIAWADEVILLE,LTD,MODDERFONTEIN,MANUFACTURING PHARMACEUTICALS GERMISTON, (PTY) RSA (PTY)RSA LTD, Shelf-life: 24 months (Provisional) Shelf-life: OulumanufacturedGP36 months Pharm Plant FinlandSpainif manufactured by Fermionwith API Oy by Shelf-life: API Fermionby36manufactured GPmonths Pharm Oy if Oulumanufactured Spain by Plant with Date of registration: 25 NOVEMBER 2011 Date of registration: 25246 hours NOVEMBERhours stored stored at at2011 25 2-8 °C °C Date of registration: 25246Finland hours NOVEMBERhours stored stored at at2011 25 2-8 °C °C NameRegistrationMRF of15 medicine: number: CAPSULES43/2.5/0452BINRONTIN 400 mg NameRegistrationMRF15 of medicine: number: ONGLYZA43/21.2/0608 2,5 MRF 15 NameRegistration of medicine: number: ONGLYZA43/21.2/0609 5 ActiveDosage ingredients: form: CONTAINS:CAPSULEEACH CAPSULE ActiveDosage ingredients: form: SAXAGLIPTINEACHTABLET TABLET CONTAINS: 2,5 mg ActiveDosage ingredients: form: TABLETSAXAGLIPTINEACH TABLET CONTAINS: 5,0 mg Applicant:Conditions of registration: AUROBINDOGABAPENTIN1, 2, 3, 4, 5, PHARMA 400,06, 7, 8 mg Applicant:Conditions of registration: BRISTOL-MYERS1, 2, 3, 4, 5, 6, 7, 8 SQUIBB (PTY) Applicant:Conditions of registration: BRISTOL-MYERS1, 2, 3, 4, 5, 6, 7, 8 SQUIBB (PTY) LTD LTD (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: ANDHRAMANDAL,AUROBINDOUNIT III, PRADESH,HYDERABAD, QUTHUBULLAPUR PHARMA INDIA LTD, Manufacturer: INDIANA,COMPANY,BRISTOL-MYERS USA MOUNT SQUIBB VERNON, Manufacturer: VERNON,COMPANY,BRISTOL-MYERS INDIANA, MOUNT USASQUIBB Packer: ANDHRAMANDAL,AUROBINDOUNIT III, PRADESH,HYDERABAD, QUTHUBULLAPUR PHARMA INDIA LTD, Packer: ANAGNI,BRISTOL-MYERS ITALY SQUIBB S.r.I., Packer: S.r.I.,BRISTOL-MYERS ANAGNI, ITALY SQUIBB Laboratory: FPRC: ANDHRAMANDAL,UNITAUROBINDO III, QUTHUBULLAPUR PRADESH,HYDERABAD, PHARMA INDIA LTD, Laboratory: FPRC: BRISTOL-MYERSINDIANA,COMPANY, USA MOUNT SQUIBB VERNON, S.r.I., Laboratory: FPRC VERNON,BRISTOL-MYERSCOMPANY, INDIANA, MOUNT USASQUIBB JOHANNESBURG,SANDTON,BUSINESSSERVICES,M&L LABORATORY PARK, LIMBRO RSA ANAGNI,BOKSBURGLABORATORIES,CONSULTING ITALY CHEMICAL ATLASVILLE, ATLASVILLE,LABORATORIES,CONSULTINGS.r.I., ANAGNI, BOKSBURG CHEMICALITALY FPRR: MIDRAND,LABORATORYKHULULEKANI RSA SERVICES, FPRR: FPRR: Shelf-life: AUROBINDOJOHANNESBURG,(PTY) LTD, PHARMAROSEBANK, RSA Shelf-life: JOHANNESBURG,LTD,BRISTOL-MYERS BEDFORDVIEW, SQUIBB RSA (PTY) Shelf-life: JOHANNESBURG,(PTY)BRISTOL-MYERS LTD, BEDFORDVIEW, SQUIBB RSA Date of registration: 25(Provisional)24 NOVEMBERmonths 2011 Date of registration: 2524 NOVEMBERmonths (Provisional) 2011 Date of registration: 2524 NOVEMBERmonths (Provisional) 2011 19 20 o 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 RegistrationMRF 15 number: 43/20.1.1/0656 RegistrationMRF15 number: 43/20.1.1/0657 MRF 15 Registration number: 43/31/0745 DosageName of form: medicine: TABLETARROW NORFLOXACIN 400 DosageName of form: medicine: TABLETUTIFLOXA 400 DosageName of form: medicine: MYOZYMEINJECTIONLYOPHILIZED POWDER FOR Active ingredients: NORFLOXACINEACH TABLET CONTAINS: 400,0 mg Active ingredients: NORFLOXACINEACH TABLET CONTAINS: 400,0 mg Active ingredients: ALPHA-GLUCOSIDASEmgRECOMBINANTEACH VIAL CONTAINS: HUMAN (rhGAA) ACID 50,0 Applicant:Conditions of registration: (PTY)ARROW1, 2, 3, LTD 4, PHARMA5, 6, 7 SOUTH AFRICA Applicant:Conditions of registration: ARROWLTD PHARMA SOUTH2, AFRICA 3, 4, 5, 6, (PTY) 7 Applicant:Conditions of registration: SAGENZYME1, 2, (PTY) 3, 4, 5,LTD BIOPHARMACEUTICALS 6, 7 Manufacturer. MISSISSAUGA,COBALT PHARMACEUTICALS ONTARIO, CANADA INC, Manufacturer MISSISSAUGA,COBALT PHARMACEUTICALS ONTARIO, CANADA INC, Manufacturer WATERFORD,ALLSTON,IDAGENZYME INDUSTRIAL MASSACHUSETTS, CORPORATION,IRELAND PARK, USA Packer: DIVPHARMROBERTVILLE,TECHNIKONMISSISSAUGA,COBALT PHARMACEUTICALS MANUFACTURING LABORATORIES, FLORIDA,ONTARIO, RSACANADA INC, AND Packer: DIVPHARMROBERTVILLE,TECHNIKONMISSISSAUGA,COBALT PHARMACEUTICALS MANUFACTURING LABORATORIES, ONTARIO,FLORIDA, RSACANADA INC,AND Packer: ALLSTON,WATERFORD,IDAGENZYME INDUSTRIAL MASSACHUSETTS, CORPORATION, IRELAND PARK, USA Laboratory: FPRC: MISSISSAUGA,COBALTJOHANNESBURG,PACKAGING, PHARMACEUTICALS LONGDALE, ONTARIO, RSA INDUSTRIA,CANADA INC, Laboratory: FPRC: MISSISSAUGA,COBALTJOHANNESBURG,PACKAGING, PHARMACEUTICALS LONGDALE, ONTARIO, RSA INDUSTRIA,CANADA INC, Laboratory: FPRC ALLSTON,GENZYME MASSACHUSETTS, CORPORATION, USA EAST,SEDEKROBERTVILLE,TECHNIKON PRETORIA, AGRICHEM, LABORATORIES, FLORIDA, RSA KAMEELDRIFT- RSA TECHNIKONEAST,SEDEKROBERTVILLE, PRETORIA, AGRICHEM, LABORATORIES, FLORIDA, RSA KAMEELDRIFT- RSA MASSACHUSETTS,NEWGENZYMEWATERFORD,IDA INDUSTRIAL YORK CORPORATION, AVENUE, IRELAND PARK, USA FRAMINGHAM, 45 & 76 LABORATORIES,CONSULTINGDERBYSHIRE,SERVICES,INTERNATIONAL SHARDLOW, CHEMICALUNITED ATLASVILLE,LABORATORY KINGDOM FPRR: ARROW(PTY) PHARMA LTD WOODMEAD, SOUTH AFRICA, RSA FPRR: ARROWLTD WOODMEAD, PHARMA SOUTH RSA AFRICA, (PTY) FPRR: GAUTENG,SAGENZYMEBOKSBURG, (PTY) LTD, BIOPHARMACEUTICALSRSA RSA BRYANSTON, DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 MRF 15 MRF15 IF 15 DosageNameRegistration of form: medicine: number: TABLETTEVA43/21.12/0764 BICALUTAMIDE 50 DosageNameRegistration of form: medicine: number: TABLETTEVA43/21.12/0765 BICALUTAMIDE 150 DosageNameRegistration of form: medicine: number: SOLUTIONVICTOZA43/21.13/0781 FOR INJECTION ConditionsActive ingredients: of registration: 1,BICALUTAMIDEEACH 2, 3, TABLET4, 5, 6, 7 CONTAINS: 50,0 mg ConditionsActive ingredients: of registration: 1,BICALUTAMIDEEACH 2, 3, TABLET CONTAINS: 5, 6, 7 150,0 mg ConditionsActive ingredients: of registration: 1,LIRAGLUTIDEEACH 2, 3, 1,0 4, 5,ml 6, CONTAINS: 7 6,0 mg Applicant:Manufacturer: LTD,TEVA KFAR PHARMACEUTICALPHARMACEUTICALS SAVA, ISRAEL INDUSTRIES (PTY) LTD Manufacturer.Applicant: TEVA PHARMACEUTICALPHARMACEUTICALS INDUSTRIES (PTY) LTD Manufacturer.Applicant: NOVO NORDISK (PTY)A/S, BAGSVAERD, LTD DENMARK No.35409 STAATSKOERANT, 8JUNIE2012 Packer: TEVALTD, PHARMACEUTICAL KFAR SAVA, ISRAEL WORKSINDUSTRIES Plc., Packer: TEVATEVALTD, PHARMACEUTICAL KFAR PHARMACEUTICAL SAVA, ISRAEL INDUSTRIES WORKS Plc., Packer: NOVO NORDISK PHARMACEUTICALA/S,NS, BAGSVAERD,KALUNDBORG, DENMARK INDUSTRY, DENMARK Laboratory: FPRC: CONSULTINGLTD,TEVATANCSICS KFAR PHARMACEUTICAL SAVA,MIHALY, CHEMICAL ISRAEL HUNGARY INDUSTRIES Laboratory: FPRC: CONSULTINGLTD,TEVATANCSICS KFAR PHARMACEUTICAL MIHALY,SAVA, CHEMICAL ISRAEL HUNGARY INDUSTRIES Laboratory: FPRC DENMARKNOVOINC., CLAYTON, NORDISK NORTH NS, FREDERIKSBERG,BAGSVAERD, CAROLINA, DENMARKUSA RSASERVICES,INSTITUTEBOKSBURG,LABORATORIES, FORSIVERTONDALE, RSA PHARMACEUTICAL ATLASVILLE, PRETORIA, RSASERVICES,INSTITUTEBOKSBURG,LABORATORIES, FORSIVERTONDALE, RSA PHARMACEUTICAL ATLASVILLE, PRETORIA, NOVO NORDISK NS, HILLEROED, DENMARK PHARMACEUTICALSAGSPOTCHEFSTROOM,PHARMACY,RESEARCH COMMERCIAL INSTITUTE NORTH-WEST CHEMISTRYRSA (PTY) FOR LTDUNIVERSITY, INDUSTRIAL PHARMACEUTICALSASSPOTCHEFSTROOM,PHARMACY,RESEARCH COMMERCIAL INSTITUTE NORTH-WEST CHEMISTRYRSA (PTY) FOR LTD UNIVERSITY, INDUSTRIAL FPRR: ROODEPORT,TEVAPRETORIA,DEPARTMENT, PHARMACEUTICALS RSA GAUTENG, GROENKLOOF, RSA (PTY) LTD, FPRR: TEVAROODEPORT,PRETORIA,DEPARTMENT, PHARMACEUTICALS RSA GAUTENG, GROENKLOOF, (PTY) RSA LTD, FPRR: JOHANNESBURG,NOVO NORDISK (PTY) RSA LTD, SANDTON, DateShelf-life: of registration: 25 NOVEMBER24 months 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 DateShelf-life: of registration: 2530 NOVEMBERmonths (2 -8 2011 °C) 21 22 NameRegistrationMRF 15 of medicine: number: JARINA43/18.8/0782 NameRegistrationMRF15 of medicine: number: MYLAN43/11.4.3/0843 PANTOPRAZOLE 20 mg IF 15 NameRegistration of medicine: number: MYLAN43/11.4.3/0844 PANTOPRAZOLE 40 mg GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: DROSPIRENONEEACHTABLET TABLET (21) CONTAINS: ActiveDosage ingredients: form: TABLETEACH TABLET CONTAINS: ActiveDosage ingredients: form: TABLETEACH TABLET CONTAINS: Conditions of registration: 1,ETHINYLESTRADIOL 2, 3, 4, 5, 6, 7 0,03 mg 3,0 mg Conditions of registration: equivalent1,Pantoprazole20,0Pantoprazole 2, 3, to4, 5, 6, sodium 7 mg sesquihydrate Conditions of registration: 1,Pantoprazoleequivalent 2, 3, 4, 5, to 6, 40,0sodium 7 mg sesquihydrate Manufacturer.Applicant: SCHERINGBAYER (PTY) GmbH LTD und CO PRODUKTIONS Applicant: LTDXIXIA PHARMACEUTICALS (PTY) Applicant: LTDXIXIA PHARMACEUTICALS (MY) KG, WEIMAR, GERMANY Manufacturer. JOHANNESBURG,PHARMA-QBARCELONA,LABORATORIOS (PTY) SPAINLTD, RSA DR INDUSTRIA, ESTEVE S.A, Manufacturer. RSAPHARMA-QINDUSTRIA,BARCELONA,LABORATORIOS (PTY) JOHANNESBURG, SPAINLTD, DR ESTEVE S.A, Packer: GERMANYBAYERKG,SCHERING WEIMAR, SCHERING GmbH GERMANY und PHARMA CO PRODUKTIONS AG, BERLIN, Packer: JOHANNESBURG,PHARMA-QBARCELONA,LABORATORIOS (MY) SPAIN LTD, RSA DR INDUSTRIA, ESTEVE S.A, Packer: PHARMA-QBARCELONA,INDUSTRIA,LABORATORIOS (PTY) SPAIN JOHANNESBURG, LTD, DR ESTEVE S.A, DUBLIN,MC (T/ADERMOTT GERARD IRELAND LABORATORIES LABORATORIES), LTD LABORATORIES),LTDMC IRELANDRSADERMOTT (VA GERARD LABORATORIES DUBLIN, Laboratory: FPRC: SABSGERMANYBAYERKG,SCHERING WEIMAR, COMMERCIAL SCHERING GERMANY GmbH PHARMA (PTY) und CO LTD AG, PRODUKTIONS BERLIN, Laboratory: FPRC: JOHANNESBURG,PHARMA-QBARCELONA,LABORATORIOS (PTY) SPAIN DR LTD, RSA ESTEVE INDUSTRIA, S.A, Laboratory: FPRC INDUSTRIA,PHARMA-QBARCELONA,LABORATORIOS (PTY)JOHANNESBURG, SPAIN DR LTD, ESTEVE S.A, RESEARCHPRETORIA,DEPARTMENT,PHARMACEUTICAL RSAINSTITUTE GROENKLOOF, CHEMISTRYFOR INDUSTRIAL LABORATORIES,CONSULTINGDUBLIN,(T/AMC DERMOTT GERARD IRELAND LABORATORIES), CHEMICALLABORATORIES ATLASVILLE, LTD IRELANDLABORATORIES),LTDMCRSA DERMOTT (T/A GERARD LABORATORIES DUBLIN, NATAL,CONSULTANTSPOTCHEFSTROOM,PHARMACY,BIOCHEMICAL RSA NORTH-WEST Cc, AND HILTON,RSA SCIENTIFIC UNIVERSITY, KWA-ZULU PRETORIA,DEPARTMENT,PHARMACEUTICALSABSBOKSBURG COMMERCIAL RSA GROENKLOOF, CHEMISTRY (PTY) LTD PHARMACEUTICALSABSBOKSBURGLABORATORIES,CONSULTING COMMERCIAL CHEMICAL ATLASVILLE, CHEMISTRY (PTY) LTD POTCHEFSTROOM,WESTINDUSTRIALRESEARCH UNIVERSITY, INSTITUTE PHARMACY, RSA FOR NORTH- NORTH-WESTINDUSTRIALRESEARCHPRETORIA,DEPARTMENT, RSAINSTITUTE PHARMACY, UNIVERSITY, GROENKLOOF, FOR FPRR: RSABAYER (PTY) LTD, ISANDO, GAUTENG, FPRR: RSALTD,XIXIA MODDERFONTEIN, PHARMACEUTICALS GAUTENG, (PTY) FPRR: GAUTENG,LTD,XIXIAPOTCHEFSTROOM, MODDERFONTEIN, PHARMACEUTICALS RSA RSA (PTY) DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths 2011 Shelf-life:Date of registration: 24 months25 NOVEMBER 2011 MRF 15 MRF15 MRF 15 DosageNameRegistration of form: medicine: number: TABLETAVIGRA43/7.1.5/0886 25 DosageNameRegistration of form: medicine: number: TABLETAVIGRA43/7.1.5/0887 50 DosageNameRegistration of form: medicine: number: TABLETAVIGRA43/7.1.5/0888 100 Active ingredients: SILDENAFILEACH TABLET 25,0CITRATE CONTAINS: mg EQUIVALENT TO Active ingredients: SILDENAFILEACH TABLET 50,0CITRATE CONTAINS: mg EQUIVALENT TO Active ingredients: TOSILDENAFILSILDENAFILEACH TABLET CITRATE 100,0 CONTAINS: mgEQUIVALENT Applicant:Conditions of registration: PHARMACIA1, 2, 3, 4, 5,SOUTH 6, 7 AFRICA (PTY) LTD Applicant:Conditions of registration: PHARMACIA1, 2, 3, 4, 5, 6, SOUTH 7 AFRICA (PTY) LTD Applicant:Conditions of registration: LTDPHARMACIA1, 2, 3, 4, 5, 6, SOUTH 7 AFRICA (PTY) Manufacturer: DEUTSCHLANDPFIZERFRANCE MANUFACTURINGPGM AMBOISE, GmbH, ILLERTISSEN, POCE sur CISSE, Manufacturer: DEUTSCHLANDPFIZERFRANCE MANUFACTURINGPGM AMBOISE, GmbH, ILLERTISSEN, POCE sur CISSE, Manufacturer: DEUTSCHLANDPFIZERCISSE, FRANCE MANUFACTURINGPGM AMBOISE, GmbH, POCE sur CHINAPFIZERGERMANY PGM DALIAN, DETDZ, DALIAN, CHINAPFIZERGERMANY PGM DALIAN, DETDZ, DALIAN, DALIAN,PFIZERILLERTISSEN, PGM CHINA DALIAN, GERMANY DETDZ, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: DEUTSCHLANDPFIZERFRANCE MANUFACTURINGPGM AMBOISE, GmbH, ILLERTISSEN, POCE sur CISSE, Packer: DEUTSCHLANDPFIZERFRANCE MANUFACTURINGPGM AMBOISE, GmbH, ILLERTISSEN,POCE sur CISSE, Packer: DEUTSCHLANDPFIZERCISSE, FRANCE MANUFACTURINGPGM AMBOISE, GmbH, POCE sur Laboratory: FPRC: PFIZERCHINAGERMANY PGM AMBOISE,DALIAN, DETDZ, POCE DALIAN,sur CISSE, Laboratory: FPRC: PFIZERCHINAGERMANY PGM AMBOISE,DALIAN, DETDZ, POCE DALIAN,sur CISSE, Laboratory: FPRC PFIZERDALIAN,ILLERTISSEN, PGM CHINA DALIAN,AMBOISE, GERMANY DETDZ, POCE sur PFIZERGERMANYDEUTSCHLANDFRANCE PGMMANUFACTURING DALIAN, GmbH, DETDZ, ILLERTISSEN, DALIAN, PFIZERGERMANYDEUTSCHLANDFRANCE PGMMANUFACTURING DALIAN, GmbH, DETDZ, ILLERTISSEN, DALIAN, PFIZERILLERTISSEN,DEUTSCHLANDCISSE, FRANCE PGMMANUFACTURING DALIAN, GERMANY GmbH, DETDZ, CONSULTINGRETREAT,(DivisionPFIZERCHINA GLOBALof PfizerCAPE CHEMICAL Laboratories) MANUFACTURINGTOWN, RSA (PTYO LTD, CONSULTINGRETREAT,(DivisionPFIZERCHINA GLOBALof PfizerCAPE CHEMICAL Laboratories)MANUFACTURINGTOWN, RSA (PTYO LTD, CONSULTINGLTD,(DivisionPFIZERDALIAN, RETREAT, GLOBALofCHINA Pfizer CHEMICAL CAPE Laboratories)MANUFACTURING TOWN, (PTYO RSA DEPARTMENT,PHARMACEUTICALSABSBOKSBURG,LABORATORIES, COMMERCIAL RSA GROENKLOOF, ATLASVILLE, CHEMISTRY (PTY) LTD, DEPARTMENT,PHARMACEUTICALSABSBOKSBURG,LABORATORIES, COMMERCIAL RSA GROENKLOOF, ATLASVILLE, CHEMISTRY (PTY) LTD, DEPARTMENT,PHARMACEUTICALSABSBOKSBURG,LABORATORIES, COMMERCIAL RSA GROENKLOOF, ATLASVILLE, CHEMISTRY (Ti) LTD, LABJOHANNESBURG,BUSINESSM&LPRETORIA, &LABORATORY BIOLOGICAL PARK, RSA SANDTON, RSA SERVICESSERVICES, (PTY) LIMBRO LTD, LABJOHANNESBURG,BUSINESSM&LPRETORIA, &LABORATORY BIOLOGICAL PARK, RSA SANDTON,RSA SERVICES,SERVICES (PTY)LIMBRO LABSANDTON,LIMBROM&LPRETORIA, &LABORATORY BIOLOGICAL BUSINESS JOHANNESBURG,RSA PARK,SERVICES,SERVICES RSA (PTY) FPRR: SANDTON,PHARMACIABRACKENHURST, GAUTENG, SOUTH ALBERTON, AFRICA RSA (PTY) RSA LTD, FPRR: PHARMACIALTD, BRACKENHURST, SOUTH AFRICA ALBERTON, (PTY) LTD, RSA FPRR: PHARMACIARSALTD, BRACKENHURST, SOUTH AFRICA ALBERTON, (PTY)

SANDTON, GAUTENG, RSA LTD, SANDTON, GAUTENG, RSA 23 DateShelf-life: of registration: 2560 NOVEMBERmonths 2011 DateShelf-life: of registration: 2560 NOVEMBERmonths 2011 DateShelf-life: of registration: 2560 NOVEMBERmonths 2011 24 NameRegistrationMRF of15 medicine: number: 43/8.3/0941MIRCERA 30 pg/0,3 ml NameRegistrationMRF15 of medicine: number: 43/8.3/0942MIRCERA 120 pg/0,3 ml MRF 15 NameRegistration of medicine: number: 43/8.3/0943MIRCERA 360 pg/0,6 ml GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: METHOXYEACHINJECTION SYRINGE CONTAINS: ActiveDosage ingredients: form: METHOXYEACHINJECTION SYRINGE CONTAINS: ActiveDosage ingredients: form: METHOXYEACHINJECTION SYRINGE CONTAINS: Conditions of registration: 1,EPOETINPOLYETHYTHYLENE 2, 3, 4, 5, BETA 6, 7 30,0 pgGLYCOL Conditions of registration: 1,EPOETINPOLYETHYTHYLENE 2, 3, 4, 5, BETA 6, 7 IN 120,0 GLYCOL pg Conditions of registration: 1,360,0GLYCOLPOLYETHYTHYLENE 2, 3, pg 4, EPOETIN5, 6, 7 BETA IN Manufacturer:Applicant: MANNHEIM,ROCHE DIAGNOSTICS,PRODUCTS GERMANY (PTY) LTD Manufacturer:Applicant: MANNHEIM,ROCHE DIAGNOSTICS,PRODUCTS GERMANY (PTY) LTD Applicant:Manufacturer: MANNHEIM,ROCHELTD DIAGNOSTICS,PRODUCTS GERMANY (PTY) Packer: GmbHVETTERRAVENSBURG,MANNHEIM,ROCHE & Co.PHARM-FERTIGUNG DIAGNOSTICS, KG, GERMANY GERMANY Packer: GERMANYGmbHVETTERMANNHEIM,ROCHE & DIAGNOSTICS,Co,PHARM-FERTIGUNG RAVENSBURG,GERMANY Packer: FERTIGUNGVETTERMANNHEIM,ROCHERAVENSBURG, DIAGNOSTICS, PHARM- GERMANYGmbH GERMANY & Co, Laboratory: FPRC: MANNHEIM,AKACIAROCHEISANDO HEALTH DIAGNOSTICS,GAUTENG, GERMANY CARE, RSA Laboratory: FPRC: AKACIAMANNHEIM,ROCHEISANDO HEALTH DIAGNOSTICS,GAUTENG, GERMANY CARE, RSA Laboratory: FPRC MANNHEIM,AKACIAROCHEISANDO HEALTH DIAGNOSTICS,GAUTENG, GERMANY CARE, RSA FPRR: ROCHEAKACIAILLOVOISANDO PRODUCTSHEALTH GAUTENG,GAUTENG, CARE, (PTY) RSARSA LTD, FPRR: AKACIALTD,ROCHEISANDO ILLOVOHEALTH PRODUCTSGAUTENG, GAUTENG, CARE, RSA(PTY) RSA FPRR: AKACIALTD,ROCHEISANDO ILLOVO HEALTH PRODUCTSGAUTENG, GAUTENG, CARE, RSA(PTY) DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 DateShelf-life: of registration: 2536 NOVEMBERmonths 2011 DateShelf-life: of registration: 2536RSA NOVEMBERmonths 2011 RegistrationMRF 5 number: 44/20.2.8/0385 MRF15Registration number: 44/32.2/0393 IF 15 Registration number: 44/32.2/0394 DosageName of form: medicine: TABLETASPEN EFAVIRENZ 200 mg DosageName of form: medicine: 20SOLVENTINJECTION FOR CIPLA DOCETAXEL DosageName of form: medicine: SOLVENTINJECTIONDOCETAXEL FOR CIPLA 80 ConditionsActive ingredients: of registration: EFAVIRENZEACH1, 2, TABLET 3, 4, 5, 200,0 6,CONTAINS: 7 *mg ConditionsActive ingredients: of registration: 1,ETHANOLEACH 2, 3, VIAL4, 5, 13,0 6,CONTAINS: 7 % m/v ConditionsActive ingredients: of registration: 1,ETHANOLEACH 2, 3, VIAL 4, 5, 13,0CONTAINS:6, 7 % m/v Manufacturer:Applicant: STRIDESPHARMACARE ARCOLAB LIMITED LIMITED, Manufacturer:Applicant: CIPLA LTD,LIFE SCIENCESUNIT V, VERNA, (PTY) LTD Manufacturer:Applicant: CIPLALTD LTD,LIFE SCIENCESUNIT V, VERNA, (PTY) ASPENELIZABETHROAD,INDIAANEKAL PORT KORSTEN, TALUK, ELIZABETH, BANGALORE, PORT GIBAUD SALCETTE, GOA, INDIA SALCETTE, GOA, INDIA No.35409 STAATSKOERANT, 8JUNIE2012 Packer: ASPENANEKALINDIASTRIDES PORT TALUK, ARCOLAB ELIZABETH, BANGALORE, LIMITED, GIBAUD Packer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Packer: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Laboratory: FPRC: ANEKALSTRIDESELIZABETHROAD, TALUK, KORSTEN, ARCOLAB BANGALORE, PORT LIMITED, Laboratory: FPRC: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Laboratory: FPRC SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, PRETORIADEPARTMENT,PHARMACEUTICALSABSINDIA COMMERCIAL GROENKLOOF, CHEMISTRY (PTY) LTD, M&LPOTCHEFSTROOMWESTINDUSTRIALRESEARCH LABORATORY UNIVERSITY, INSTITUTE PHARMACY, SERVICES, FOR NORTH- FPRC/FPRR: ASPENSANDTON,LIMBRO PORT BUSINESS JOHANNESBURG, ELIZABETH, PARK, GIBAUD RSA FPRR: CIPLA LIFE SCIENCES (PTY) LTD, FPRR: CIPLA LIFE SCIENCES (PTY) FPRR: PHARMACAREELIZABETHROAD, KORSTEN, LTD, PORT WOODMEAD, Shelf-life: 24TOWN,ROSENPARK, months RSA (2- 8 BELLVILLE, °C) CAPE CAPELTD, TOWN, ROSENPARK, RSA BELLVILLE, Shelf-life: 24SANDTON, months RSA Date of registration: 25 NOVEMBER 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths (2 -8 2011 °C) 25 *SEEDate of AT registration: END OF BOOK FOR ADDITIONAL CONDITIONS 25 NOVEMBER 2011 26 o 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 MRFNameRegistration 15 of medicine: number: ZYDUS44/7.1.3/0504 PERINDOPRIL 4 mg TABLETS NameRegistrationMRF15 of medicine: number: BACATAC44/20.2.8/0919 ARF 15 NameRegistration of medicine: number: TRIBUSS44/20.2.8/0980 ActiveDosage ingredients: form: PERINDOPRILEACHTABLET TABLET ERBUMINECONTAINS: 4,0 mg ActiveDosage ingredients: form: AbacavirEACHTABLET TABLET sulfate CONTAINS: equivalent to ActiveDosage ingredients: form: TenofovirEACHTABLET TABLET disoproxil CONTAINS: fumarate Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,ZidovudineLamivudineAbacavir 2, 3, 4, 5, 300,0150,06, 7 mg 300,0 mg Conditions of registration: 1,EmtricitabineEfavirenz300,0 2, 3, mg 4, 5, 6, 200,0 7, 8 mg 600,0 mg Manufacturer:Applicant: SANAND,ZYDUS CADILAHEALTHCARE AHMEDABAD, HEALTHCARE SA INDIA (PTY) LIMITED, LTD Manufacturer:Applicant: PRADESH,VZIANAGARAMMATRIXPHARMACARE LABORATORIES INDIA LIMITED DISTRICT, LIMITED, ANDHRA Manufacturer:Applicant: STATE,SINNAR,MATRIXPHARMACARE INDIALABORATORIES NASHIK, LIMITED MAHARASHTRA LIMITED, Packer: ZYDUS CADILA HEALTHCARE LIMITED, ASPENKORSTEN,FAIRCLOUGH PORT ELIZABETH, PORT AND ELIZABETH, GIVAUD CNR ROADS, RSA SANAND, AHMEDABAD, INDIA Packer: KORSTEN,ASPENPRADESH,VZIANAGARAMMATRIX PORT LABORATORIES INDIAPORT ELIZABETH DISTRICT, ELIZABETH, LIMITED, (PTY)ANDHRA RSA LTD, Packer: FAIRCLOUGHASPENSTATE,SINNAR,MATRIX PORT INDIALABORATORIES NASHIK, ANDELIZABETH, MAHARASHTRA GIVAUD LIMITED, CNR ROADS, Laboratory: FPRC: INSTITUTESANAND,ZYDUS CADILA AHMEDABAD, FOR HEALTHCAREPHARMACEUTICAL INDIA LIMITED, Laboratory: FPRC: VZIANAGARAMPRADESH,MATRIX LABORATORIES INDIA DISTRICT, ANDHRA LIMITED, Laboratory: FPRC MATRIXINDIASINNAR,KORSTEN, LABORATORIES NASHIK, PORT ELIZABETH,MAHARASHTRA, LIMITED, RSA POTCHEFSTROOM,PHARMACY,RESEARCHRSASERVICES, SILVERTONDALE, INSTITUTE NORTH-WEST RSA FOR UNIVERSITY, INDUSTRIAL PRETORIA, ASPENJOHANNESBURG,BUSINESSM&LKORSTEN, PORT LABORATORY ELIZABETH PARK,PORT ELIZABETH,SANDTON, RSA SERVICES, (PTY) LTD, RSA LIMBRO RESEARCHPRETORIA,DEPARTMENT,PHARMACEUTICALSABS COMMERCIAL RSAINSTITUTE GROENKLOOF, CHEMISTRY (PTY) FOR LTD RESEARCHPRETORIA,DEPARTMENT,PHARMACEUTICALSASS COMMERCIAL RSAINSTITUTE GROENKLOOF, CHEMISTRY (PTY) FOR LTD INDUSTRIAL M&LPOTCHEFSTROOM,WESTLIMBROINDUSTRIAL LABORATORY UNIVERSITY, BUSINESS PHARMACY, SERVICES, RSA PARK, NORTH- FPRR: ZYDUSPOTCHEFSTROOM, HEALTHCARE SA RSA (PTY) LTD, FPRR: KORSTEN,ASPENPOTCHEFSTROOM,PHARMACY, PORT PORT ELIZABETH NORTH-WEST ELIZABETH, RSA (PTY) RSA UNIVERSITY, LTD, FPRC/FPRR: FAIRCLOUGHASPENSANDTON, PORT ANDELIZABETH, JOHANNESBURG, GIVAUD CNR RSA Shelf-life: 24 months (Provisional) Shelf-life: 24JOHANNESBURG,PHARMACARE months LIMITED, RSA WOODMEAD, FPRR: SANDTON,PHARMACAREELIZABETH,ROADS,KORSTEN, RSA RSA LTD, PORT WOODMEAD, Date of registration: 25 NOVEMBER 2011 Date of registration: 25 NOVEMBER 2011 DateShelf-life: of registration: 2524 NOVEMBERmonths (Provisional) 2011 MRFNameRegistration 15 of medicine: number: KULAIR44/10.2.2/0847 4 MRF15NameRegistration of medicine: number: 44/10.2.2/0848KULAIR 5 IF 15 NameRegistration of medicine: number: 44/10.2.2/0849KULAIR 10 ActiveDosage ingredients: form: EQUIVALENTMONTELUKASTEACHTABLET TABLET TO CONTAINS: SODIUM ActiveDosage ingredients: form: TABLETEQUIVALENTMONTELUKASTEACH TABLET TO CONTAINS: SODIUM ActiveDosage ingredients: form: TABLETEQUIVALENTMONTELUKASTEACH TABLET TO CONTAINS: SODIUM Applicant:Conditions of registration: BRIMPHARM1,MONTELUKAST 2, 3, 4, 5, 6, SA7, 8 (PTY) LTD 4,0 mg Applicant:Conditions of registration: BRIMPHARM1,MONTELUKAST 2, 3, 4, 5, 6, SA7, 8 (PTY) LTD 5,0 mg Applicant:Conditions of registration: 1,MONTELUKAST 2, 3, 4, 5, 6, 7, 810,0 mg

BRIMPHARM SA (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Packer:Manufacturer. SIEGFRIEDSWITZERLAND LTD, ZOFINGEN, Packer:Manufacturer: SIEGFRIEDSWITZERLAND LTD, ZOFINGEN, Packer:Manufacturer: SIEGFRIEDZOFINGEN, LTD,SWITZERLAND RSAINDUSTRIA,&DIVPHARMSWITZERLAND PACKAGING, MANUFACTURING JOHANNESBURG, LONGDALE, RSAINDUSTRIA,&DIVPHARMSWITZERLAND PACKAGING, MANUFACTURING JOHANNESBURG, LONGDALE, ZOFINGEN,INDUSTRIA,PACKAGING,MANUFACTURINGDIVPHARM SWITZERLAND LONGDALE, & Laboratory: FPRC: CONFARMASWITZERLANDSIEGFRIED LTD, FRANCE ZOFINGEN, S.A.R.L., Laboratory: FPRC: CONFARMASWITZERLANDSIEGFRIED LTD, FRANCE ZOFINGEN, S.A.R.L., Laboratory: FPRC CONFARMAZOFINGEN,SIEGFRIEDJOHANNESBURG, LTD, SWITZERLANDFRANCE RSA BOKSBURG,LABORATORIES,CONSULTINGHOMBOURG, RSA FRANCE CHEMICAL ATLASVILLE, BOKSBURG,LABORATORIES,CONSULTINGHOMBOURG, RSA FRANCE CHEMICAL ATLASVILLE, ATLASVILLE,LABORATORIES,CONSULTINGFRANCES.A.R.L., HOMBOURG, BOKSBURG, CHEMICAL FPRR: CAPEBRIMPHARM TOWN, SA, RSA CLAREMONT, FPRR: RSACLAREMONT,BRIMPHARM SA, CAPE TOWN, FPRR: RSACLAREMONT,BRIMPHARM SA, CAPE TOWN, DateShelf-life: of registration: 24 months (Provisional) DateShelf-life: of registration: 24 months (Provisional) Shelf-life:Date of registration: (Provisional)24 months 25 NOVEMBER 2011 25 NOVEMBER 2011 201125 NOVEMBER 27 28

MRF 15 MRF15 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: SOLUTIONDANOVET07/21.9/02 2,5 FOR % INJECTION DosageNameRegistration of form: medicine: number: TABLETCERENIA09/11.2/03 16 mg DosageNameRegistration of form: medicine: number: TABLETCERENIA09/11.2/04 24 mg Active ingredients: DANOFLOXACINEQUIVALENTCONTAINS:EACH 1,0 ml SOLUTION TO MESYLATE 25,0 mg Active ingredients: MAROPITANTEQUIVALENTEACH TABLET TOCITRATE CONTAINS: 16,0 mg Active ingredients: MAROPITANTEQUIVALENTEACH TABLET TOCITRATE CONTAINS: 24,0 mg Applicant:Conditions of registration: CIPLA1, 2, 3, MEDPRO4, 5, 6, 7, 8(PTY) LTD Applicant:Conditions of registration: LTDPFIZER1, 2, 3, 4, LABORATORIES 5, 6, 7 (PTY) Applicant:Conditions of registration: LTDPFIZER1, 2, 3, 4, LABORATORIES 5, 6, 7 (PTY) Manufacturer: NADU,CIPLA LTD,INDIA HOSUR, TAMIL Manufacturer: PFIZERSUREMANUFACTURING, CISSE, GLOBAL FRANCE POCE Manufacturer: CISSE,MANUFACTURING,PFIZER FRANCEGLOBAL POCE SURE Packer: CIPLA LTD, HOSUR, TAMIL Packer: PFIZERNEBRASKA,MANUFACTURING, GLOBAL USA LINCOLN, Packer: PFIZERNEBRASKA,MANUFACTURING, GLOBAL USA LINCOLN, Laboratory: FPRC: NADU,CIPLANADU, LTD,INDIA INDIA HOSUR, TAMIL Laboratory: FPRC: MANUFACTURING,PFIZERSURE CISSE, GLOBAL FRANCE POCE Laboratory: FPRC: MANUFACTURING,PFIZERCISSE, FRANCEGLOBAL POCE SURE CONSULTINGPARK,SERVICES,MSURE &L LABORATORY CISSE,SANDTON, LIMBRO FRANCECHEMICAL RSA BUSINESS CONSULTINGSANDTON,LIMBROMCISSE, &L LABORATORY FRANCE BUSINESS RSA CHEMICAL PARK, SERVICES, ATLASVILLE,CHEMISTRYPHARMACEUTICALSABSLABORATORIES COMMERCIAL BOKSBURG, DEPARTMENT, (PTY) (PTY) LTD, RSA LTD ATLASVILLE,DEPARTMENT,PHARMACEUTICALSABSLABORATORIES COMMERCIAL BOKSBURG, GROENKLOOF, (PTY) CHEMISTRY (PTY) LTD, RSA LTD FPRR: ROSENPARK,CIPLA MEDPRO BELVILLE, (PTY) LTD, CAPE FPRR: GROENKLOOF,LTD,PFIZERRSA SANDTON, LABORATORIES PRETORIA, RSA (PTY) FPRR: LTD,PFIZERPRETORIA, SANDTON, LABORATORIES RSA RSA (PTY) DateShelf-life: of registration: 224TOWN, MARCH months RSA 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 March months 2012 RegistrationMRF 15 number: 09/11.2/05 RegistrationMRF15 number: 09/11.2/06 MRF 15 Registration number: 31/35/0528 ActiveDosageName ingredients: of form: medicine: EACHTABLETCERENIA TABLET 60 mg CONTAINS: ActiveDosageName ingredients: of form: medicine: EACHTABLETCERENIA TABLET 160 mg CONTAINS: ActiveDosageName ingredients: of form: medicine: EACHINJECTIONRENATEK VIAL CONTAINS: MAROPITANTEQUIVALENT TOCITRATE 60,0 mg MAROPITANTEQUIVALENT TOCITRATE 160,0 mg 0,27TINPENTETATECALCIUM DICHLORIDE-2 mg TRISODIUM HYDRATE 5,0 mg Applicant:Conditions of registration: LTDPFIZER1, 2, 3, 4, LABORATORIES 5, 6, 7 (PTY) Applicant:Conditions of registration: PFIZER1, 2, 3, LABORATORIES 4, 5, 6, 7 (PTY) LTD Applicant:registration:Conditions of NTP1, 2, 3,RADIOISOTOPES 4, 5, 6, 7 (PTY) LTD Manufacturer: PFIZERCISSE,MANUFACTURING, FRANCEGLOBAL POCE SURE Manufacturer: LINCOLN,PFIZERPOCE SURE GLOBAL NEBRASKA, CISSE, MANUFACTURING, FRANCE USA Manufacturer: RSALTD,NTP RADIOISOTOPESPELINDABA, PRETORIA, (PTY) No.35409 STAATSKOERANT, 8JUNIE2012 Packer: MANUFACTURING,PFIZERNEBRASKA, GLOBAL USA POCELINCOLN, SURE Packer: POCEPFIZER SURE GLOBAL CISSE, MANUFACTURING, FRANCE Packer: LTD,NTP RADIOISOTOPESPELINDABA, PRETORIA, (PTY) Laboratory: FPRC: CISSE,MANUFACTURING,PFIZER FRANCE GLOBAL POCE SURE Laboratory: FPRC: MPOCEPFIZER &L LABORATORY SURE GLOBAL CISSE, MANUFACTURING, SERVICES,FRANCE Laboratory: FPRC: LTD,NTPRSA RADIOISOTOPESPELINDABA, PRETORIA, (PTY) CONSULTINGSANDTON,LIMBROM &L LABORATORY BUSINESSRSA CHEMICAL PARK, SERVICES, LABORATORIESCONSULTINGSANDTON,LIMBRO BUSINESS RSA CHEMICAL (PTY) PARK, LTD, PRETORIA,CENTRE,BIOMEDICALRSA UNIVERSITY RSAONDERSTEPOORT, RESEARCH OF SABSATLASVILLE,DEPARTMENT,PHARMACEUTICALLABORATORIES COMMERCIAL BOKSBURG, GROENKLOOF, (PTY) (PTY) CHEMISTRY LTD, RSALTD ATLASVILLE,PRETORIA,DEPARTMENT,PHARMACEUTICALSABS COMMERCIAL BOKSBURG, RSA GROENKLOOF, CHEMISTRY (PTY) RSA LTD FPRR: LTD,PFIZERPRETORIA, SANDTON, LABORATORIES RSA RSA (PTY) FPRR: SANDTON,PFIZER LABORATORIES RSA (PTY) LTD, FPRR: RSALTD,NTP RADIOISOTOPESPELINDABA, PRETORIA, (PTY) Shelf-life: 24 months Shelf-life: Shelf-life: 29 Date of registration: 2 MARCH 2012 Date of registration: 224 MARCH months 2012 Date of registration: 2stored6 MARCHhours12 months at reconstituted 25°C 2012 product 30

MRF 15 MRF15 VIRE 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: VAGINALGLENMARK32/20.2.2/0041 TABLET CLOTRIMAZOLE 6 RegistrationName of medicine:number: VAGINALGLENMARK32/20.2.2/0042 TABLET CLOTRIMAZOLE 1 NameRegistration of medicine: number: TAMBOCOR37/6.2/0198 CR 50 ActiveDosage ingredients: form: CLOTRIMAZOLEEACHTABLETS TABLET CONTAINS: 100,0 mg ActiveDosage ingredients: form: CLOTRIMAZOLEEACHTABLETS TABLET CONTAINS: 500,0 mg ActiveDosage ingredients: form: FLECAINIDEEACHCAPSULE CAPSULE ACETATE CONTAINS: 50,0 mg Applicant:Conditions of registration: MEDIVISION1, 2, 3, 4, 5, (PTY) 6, 7, LTD8 Applicant:Conditions of registration: MEDIVISION1, 2, 3, 4, 5, (PTY) 6, 7, LTD8 Applicant:registration:Conditions of 3M1, 2, PHARMACEUTICALS 3, 4, 5, 6, 7 SA Manufacturer: GLENMARKGLENMARKLTD, SATPUR, PHARMACEUTICALS PHARMACEUTICALS NASIK, INDIA Manufacturer: GLENMARKSATPUR,PHARMACEUTICALS NASIK, INDIA LTD, Manufacturer: LEICESTERSHIRE,LOUGHBOROUGH,3M(PTY) HEALTH LTD CARE LTD,ENGLAND, Packer: GLENMARKLTD, BARDEZ, PHARMACEUTICALS GOA, INDIA Packer: GLENMARKBARDEZ,PHARMACEUTICALS GOA, INDIA LTD, Packer: 3MUK HEALTH CARE LTD, LTD,GLENMARK BARDEZ,SATPUR, PHARMACEUTICALS GOA,NASIK, INDIA INDIA BARDEZ,PHARMACEUTICALSGLENMARKSATPUR, GOA,NASIK, INDIA INDIA LTD,LTD, UKLEICESTERSHIRE,LOUGHBOROUGH, ENGLAND, Laboratory: FPRC: GLENMARKLTD, BARDEZ,SATPUR, PHARMACEUTICALS GOA,NASIK, INDIA INDIA Laboratory: FPRC: SATPUR,GLENMARKPHARMACEUTICALS NASIK, INDIA LTD, Laboratory: FPRC: UKLEICESTERSHIRE,LOUGHBOROUGH,3M HEALTH CARE LTD,ENGLAND, CONSULTINGINDUSTRIALRESEARCHBOKSBURG,LABORATORIES,ATLASVILLE, CHEMICAL INSTITUTE PHARMACY,RSA FOR NORTH- BOKSBURG,LABORATORIESATLASVILLE,CONSULTINGBARDEZ,PHARMACEUTICALS GOA, RSA CHEMICAL INDIA LTD, MWSET &PARK,(PTY)POTCHEFSTROOM, L LABORATORYUNIVERSITY, LTD, SANDTON, LIMBRO SERVICESJOHANNESBURG, BUSINESSRSA MPOTCHEFSTROOM,NORTH-WSETINDUSTRIALRESEARCH & L LABORATORY INSTITUTE PHARMACY, UNIVERSITY, RSA FOR FPRR: MEDIVISIONRSA (PTY) LTD, SPARTAN, FPRR: MEDIVISIONJOHANNESBURG,BUSINESSSERVICES PARK,(PTY) (PTY) LTD, SANDTON,RSALTD, LIMBRO Shelf-life: JOHANNESBURG,24 months (Provisional) RSA Shelf-life: 24RSASPARTAN, months (Provisional) JOHANNESBURG, FPRR: (PTY)3M PHARMACEUTICALS LTD, ELANDSFONTEIN, SA Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 DateShelf-life: of registration: 224RSA MARCH months 2012 RegistrationMRF 15 number: 37/6.2/0199 RegistrationMRF15 number: 37/6.2/0200 v1RF 15 Registration number: 37/6.2/0201 ActiveDosageName ingredients: of form: medicine: TAMBOCOREACHCAPSULE CAPSULE CR 100 CONTAINS: ActiveDosageName ingredients: of form: medicine: CAPSULETAMBOCOREACH CAPSULE CR 150 CONTAINS: ActiveDosageName ofingredients: form: medicine: EACHCAPSULETAMBOCOR CAPSULE CR 200CONTAINS: registration:Conditions of 1,100,0FLECAINIDE 2, 3, mg 4, 5, 6, ACETATE 7 Conditionsregistration: of 1,FLECAINIDE 2, 3, 4, 5, 6, ACETATE 7 150,0 mg registration:Conditions of 1,200,0FLECAINIDE 2, 3, mg 4, 5, 6, ACETATE 7 Applicant:Manufacturer: 3M(PTY)LOUGHBOROUGH, HEALTHPHARMACEUTICALS LTD CARE LTD, SA Manufacturer:Applicant: 3MLOUGHBOROUGH,LTD HEALTHPHARMACEUTICALS CARE LTD, SA (PTY) Applicant:Manufacturer: LOUGHBOROUGH,3M(PTY) HEALTHPHARMACEUTICALS LTD CARE LTD, SA No.35409 STAATSKOERANT, 8JUNIE2012 Packer: LOUGHBOROUGH,3MUKLEICESTERSHIRE, HEALTH CARE LTD, ENGLAND, Packer: LOUGHBOROUGH,3MLEICESTERSHIRE, HEALTH CARE LTD, ENGLAND, UK Packer: LOUGHBOROUGH,3MUKLEICESTERSHIRE, HEALTH CARE LTD,ENGLAND, Laboratory: FPRC: LOUGHBOROUGH,3MUKLEICESTERSHIRE, HEALTH CARE LTD, ENGLAND, Laboratory: FPRC: LOUGHBOROUGH,3MLEICESTERSHIRE, HEALTH CARE LTD, ENGLAND, UK Laboratory: FPRC: LOUGHBOROUGH,3MUKLEICESTERSHIRE, HEALTH CARE LTD,ENGLAND, FPRR: LTD,3MUKLEICESTERSHIRE, PHARMACEUTICALS ELANDSFONTEIN, ENGLAND, RSA SA (PTY) FPRR: LTD,3MLEICESTERSHIRE, PHARMACEUTICALS ELANDSFONTEIN, ENGLAND, RSA SA (PTY) UK FPRR 3M(PTY)UKLEICESTERSHIRE, PHARMACEUTICALS LTD, ELANDSFONTEIN, ENGLAND, SA DateShelf-life: of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 MARCH RSAmonths 2012 31 32 NameRegistrationMRF 15 of medicine: number: ADIPEN37/20.1.2/0452 S MRF15NameRegistration of medicine: number ADIPEN37/20.1.2/0453 SF F 15 NameRegistration of medicine: number PICOLAXA39/11.5/0058 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: CONTAINS:EACHSUSPENSIONPOWDER 5,0 FORml SUSPENSION ActiveDosage ingredients: form: CONTAINS:EACHPOWDER 5,0 mlFOR SUSPENSION SUSPENSION ActiveDosage ingredients: form: SODIUMEACHSOLUTIONPOWDER SACHET PICOSULPHATE FOR ORALCONTAINS: AMOXICILLINEQUIVALENTTRIHYDRATE TO 125,0 AMOXICILLINPOTASSIUMEQUIVALENT TRIHYDRATE CLAVULANATE TO 250,0 mg CITRIC12,0MAGNESIUM10,0 gmgACID (ANHYDROUS) OXIDE 3,5 g CLAVULANICEQUIVALENTCLAVULANATEPOTASSIUMmg TO ACID 31,25 CLAVULANICEQUIVALENT TOACID 62,5 mg Applicant:Conditions of registration: BIOTECH1,mg 2, 3, 4, 5,6,LABORATORIES 7 ApplicantConditions of registration: BIOTECH1, 2, 3, 4,LABORATORIES 5, 6, 7 Applicant:Conditions of registration: FERRING1, 2, 3, 4, 5, (PTY) 6, 7, LTD8 Manufacturer. PREVALJE,CHEMICALLEK(PTY) PHARMACEUTICAL LTD COMPANY SLOVENIA d.d, & Manufacturer: CHEMICALLEK(PTY)PREVALJE, PHARMACEUTICAL LTD COMPANY SLOVENIA d.d, & Manufacturer: UNITEDSWINTON,PHARMASERVE KINGDOM MANCHESTER, LTD, Packer: MANUFACTURINGDIVPHARMPREVALJE,CHEMICALLEK PHARMACEUTICAL COMPANY SLOVENIA & d.d, & Packer CHEMICALMANUFACTURINGDIVPHARMPREVALJE,LEK PHARMACEUTICAL COMPANY SLOVENIA & d.d, & Packer UNITEDSWINTON,PHARMASERVE KINGDOM MANCHESTER, LTD, Laboratory: FPRC : LEKINDUSTRIA,PACKAGING, PHARMACEUTICAL RSA LONGDALE, & Laboratory: FPRC: LEKINDUSTRIA,PACKAGING, PHARMACEUTICAL RSA LONGDALE, & Laboratory: FPRC PHARMASERVE LTD, SERVICES,PHARMACEUTICALINSTITUTEPREVALJE,CHEMICAL COMPANY FORSLOVENIA d.d, SERVICES,PHARMACEUTICALINSTITUTEPREVALJE,CHEMICAL FORCOMPANYSILVERTONDALE,SLOVENIA d.d, ATLASVILLE,CONSULTINGUNITEDSWINTON,LABORATORIES KINGDOM MANCHESTER, BOKSBURG, CHEMICAL (PTY) LTD, RSA FPRR: BIOTECHPRETORIA,SILVERTONDALE, LABORATORIES RSA FPRR BIOTECHPRETORIA, LABORATORIES RSA FPRR: FERRING (PTY) LTD, IRENE, RSA DateShelf-life: of registration: 224(PTY) MARCH months LTD, 2012 MIDRAND, RSA DateShelf-life: of registration: 224(PTY) MARCH months LTD, 2012 MIDRAND, RSA DateShelf-life: of registration: 224 MARCH months 2012(Provisional) RegistrationMRF 15 number: A40/20.1.1/0394 RegistrationMRF15 number: A40/20.1.1/0395 v1RF 15 Registration number: 41/2.2/0294 DosageName of form: medicine: INJECTIONSTRIDES CEFTRIAXONE 1 g DosageName of form: medicine: INJECTION500STRIDES mg CEFTRIAXONE DosageName of form: medicine: EMULSIONmg/mlB. BRAUN FOR ETOMIDATE INJECTION 2 Active ingredients: CEFTRIAXONEEQUIVALENTEACH VIAL TO CONTAINS: SODIUM 1,0 g Active ingredients: CEFTRIAXONEEQUIVALENTEACH VIAL CONTAINS: TO SODIUM500,0 mg Active ingredients: ETOMIDATEEACH 1,0 ml CONTAINS: 2,0 mg Applicant:Conditions of registration: (PTY)STRIDES1, 2, LTD 3, SA4, 5, PHARMACEUTICALS 6, 7, 8 Applicant:Conditions of registration: PHARMACEUTICALSSTRIDES1, 2, 3, 4, 5,SA 6, 7, 8 (PTY) Applicant:Conditions of registration: B BRAUN1, 2, 3, MEDICAL4, 5, 6, 7, 8 (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: BILEKAHALLI,STRIDES ARCOLAB BANGALORE, LTD, INDIA Manufacturer: STRIDESINDIABILEKAHALLI,LTD ARCOLAB BANGALORE, LTD, Manufacturer: B.MELSUNGEN, BRAUN MELSUNGEN GERMANY AG, Packer: BILEKAHALLI,STRIDES ARCQLAB 8ANGALORE, LTD, INDIA Packer: INDIABILEKAHALLI,STRIDES ARCOLAB BANGALORE, LTD, Packer: B.MELSUNGEN,BERLIN, BRAUN GERMANY MELSUNGEN GERMANY AG, Laboratory: FPRC: COLUMBIASTRIDESBILEKAHALLI, ARCOLAB PHARMACEUTICALS, BANGALORE, LTD, INDIA Laboratory: FPRC: INDIABILEKAHALLI,STRIDES ARCOLAB BANGALORE, LTD, Laboratory::FPRC MMELSUNGEN,B.BERLIN, &BRAUN L LABORATORY GERMANY MELSUNGEN GERMANY AG, RSASILVERTONDALE,PHARMACEUTICALINSTITUTEBARDENE, BOKSBURG,FOR PRETORIA, SERVICES, RSA INSTITUTEBARDENE,PHARMACEUTICALS,COLUMBIA FORBOKSBURG, RSA COSYRSABUSINESSSERVICES PHARMACEUTICALS, PARK,(PTY) LTD, SANDTON, LIMBRO PARK,NOVARTIS, RSA SPARTAN, KEMPTON KEMPTONNOVARTIS,PRETORIA,SERVICES,PHARMACEUTICAL PARK, SPARTAN,RSASILVERTONDALE, RSA ATLASVILLE,CONSULTINGJOHANNESBURG,LABORATORIESINDUSTRIA BOKSBURG, CHEMICALWEST, RSA (PTY) LTD, FPRR: PRETORIA,PHARMACEUTICALS,STRIDES S.A. RSA ARCADIA, FPRR: ARCADIA,PHARMACEUTICALS,STRIDES PRETORIA, S.A. RSA FPRR GAUTENG,LASERRSAB BRAUN PARK, RSA MEDICAL HONEYDEW, (PTY) LTD, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 33 34 RegistrationMRF 15 number: 41/21.12/0703 RegistrationMRF15 number: 41/21.12/0745 F 15 Registration number: 41/11.4.3/0761 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosageName ofingredients: form: medicine: TABLETEACHMYLAN TABLET BICALUTAMIDE CONTAINS: 50 ActiveDosageName ofingredients: form: medicine: TABLETXIXIAEACH BICALUTAMIDE TABLET CONTAINS: 50 ActiveDosageName ingredients: of form: medicine: EACHPEPLOCINJECTION VIAL IV CONTAINS: registration:Conditions of 1,BICALUTAMIDE 2, 3, 4, 5, 6, 7 50,0 mg Conditions of registration: 1,BICALUTAMIDE 2, 3, 4, 5, 6, 7 50,0 mg registration:Conditions of 1,PANTOPRAZOLE 2, 3, 4, 5, 6, 7 SODIUM EQUIVALENT TO 40,0 mg Manufacturer.Applicant: XIXIAMISSISSAUGA,GENPHARM PHARMACEUTICALS INC., ONTARIO, ONCOLOGY (PTY) CANADA LTDUNIT, Manufacturer:Applicant XIXIAMISSISSAUGA,GENPHARM PHARMACEUTICALS INC., ONTARIO, ONCOLOGY (PTY) CANADA LTD UNIT, Applicant:Manufacturer. PORTUGALFARMACEUTICA,SOFARIMEX,PHARMA DYNAMICS INDUSTRIA AGUALVA, (PTY) QUIMICA LTD CACEM, e Packer. GENERICSMISSISSAUGA,GENPHARMBAR, HERTFORDSHIRE, UK INC., LIMITED, ONTARIO, ONCOLOGY POTTERS CANADA UNITED UNIT, Packer: BAR,GENERICSMISSISSAUGA,GENPHARM HERTFORDSHIRE, UK INC., LIMITED, ONTARIO, ONCOLOGY POTTERSUNITED CANADA UNIT, Packer: TECHNIKONSOFARIMEX,PORTUGALFARMACEUTICA, LABORATORIES, INDUSTRIA AGUALVA, QUIMICA CACEM, e MERCKMCDERMOTTIRELANDGERARDKINGDOM PHARMACEUTICAL' LABORATORIES, LABORATORIES DUBLIN, T/A MERCKIRELANDGERARDMCDERMOTTKINGDOM PHARMACEUTICAL LABORATORIES, LABORATORIES DUBLIN, T/A PACKAGING,DIVPHARMN'DABENIPHARMACEUTICALROBERTVILLE, MANUFACTURING LONGDALE, FLORIDA ENTERPRISES JOHANNESBURG & Laboratory: FPRC: MISSISSAUGA,GENPHARMWADEVILLE,MANUFACTURING INC., GERMISTON, ONTARIO, ONCOLOGY (PTY) LTD, CANADA RSA UNIT, Laboratory: FPRC: MISSISSAUGA,GENPHARMWADEVILLE,MANUFACTURING INC., GERMISTON, ONTARIO, ONCOLOGY (PTY) LTD, CANADA RSA UNIT, Laboratory: FPRC: FARMACEUTICA,SOFARIMEX, INDUSTRIA AGUALVA, QUIMICA CACEM, e GERARDMCDERMOTTKINGDOMBAR,GENERICS HERTFORDSHIRE, LABORATORIES, UK LABORATORIESLIMITED, POTTERSUNITED DUBLIN, T/A GERARDMCDERMOTTGENERICSKINGDOMBAR, HERTFORDSHIRE,LABORATORIES, UK LABORATORIESLIMITED, POTTERS DUBLIN, UNITED T/A ATLASVILLE,CONSULTINGTECHNIKONPORTUGALROBERTVILLE, LABORATORIES, BOKSBURG,CHEMICAL FLORIDA, LABORATORIES, RSA RSA RESEARCHWADEVILLE,MANUFACTURINGMERCKIRELAND PHARMACEUTICAL INSTITUTE GERMISTON, (PTY) FOR LTD, RSA WADEVILLE,MANUFACTURINGMERCKRESEARCHIRELAND PHARMACEUTICAL GERMISTON, INSTITUTE (PTY) LTD, FORRSA QUEBEC,PHARMASCIENCE CANADA INC, MONTREAL, PHARMACEUTICALSABSPOTCHEFSTROOM,WESTINDUSTRIAL COMMERCIALUNIVERSITY, PHARMACY, CHEMISTRYRSA (PTY) NORTH-LTD SABSPOTCHEFSTROOM,WESTINDUSTRIAL COMMERCIALUNIVERSITY, PHARMACY, RSA (PTY) LTD NORTH- FPRR: XIXIAPRETORIA,DEPARTMENT PHARMACEUTICALS RSA GROENKLOOF, (PTY) FPRR: XIXIAPRETORIA,DEPARTMENTPHARMACEUTICAL PHARMACEUTICALS RSA GROENKLOOF, CHEMISTRY (PTY) LTD, FPRR: PHARMA DYNAMICS, WESTLAKE, CAPE DateShelf-life: of registration: 224LTD,MODDERFONTEIN, MARCH months 2012 RSA Shelf-life:Date of registration: 224MODDERFONTEIN, MARCH months 2012 RSA DateShelf-life: of registration: 224TOWN, MARCH months RSA 2012 MRF 15 NameRegistration of medicine: number: ALFATAM41/18.10/0828 SR 0,4 mg NameMRF15Registration of medicine: number: AURO42/1.2/0208 PAROXETINE 20 mg F 15 NameRegistration of medicine: number: AURO42/1.2/0209 PAROXETINE 30 mg ActiveDosage ingredients: form: CAPSULECAPSULESEACH CAPSULE CONTAINS: ActiveDosage ingredients: form: EACHTABLET TABLET CONTAINS: ActiveDosage ingredients: form: TABLET HYDROCHLORIDETAMSULOSIN 0,4 mg TOEQUIVALENTHYDROCHLORIDEPAROXETINE PAROXETINE 20,0 TOEQUIVALENTHYDROCHLORIDEPAROXETINEEACH PAROXETINE TABLET CONTAINS: 30,0 mg Applicant:Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Applicant:Conditions of registration: mg1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Manufacturer. HEALTHCAREZYDUS(PTY) LTD CADILAHEALTHCARE LIMITED, SA Manufacturer: AUROBINDOLTD,(PTY)AUROBINDO QUTHUBULLAPUR LTD PHARMA PHARMA Manufacturer.Applicant: LTD,AUROBINDO(PTY) QUTHUBULLAPUR LTD PHARMA No.35409 STAATSKOERANT, 8JUNIE2012 Packer: AHMEDABAD,HEALTHCAREZYDUSMORAIYA, CADILA SANAND, INDIA LIMITED, Packer: LTD,AUROBINDOANDHRAMANDAL, QUTHUBULLAPUR PRADESH,RANGA PHARMA REDDY, INDIA Packer: AUROBINDOLTD,ANDHRAMANDAL, QUTHUBULLAPUR PRADESH,RANGA PHARMA REDDY, INDIA Laboratory: FPRC: AHMEDABAD,HEALTHCAREZYDUSMORAIYA, CADILA SANAND, INDIA LIMITED, Laboratory: FPRC: AUROBINDOANDHRALTD,MANDAL, QUTHUBULLAPUR PRADESH, RANGA PHARMA REDDY,INDIA Laboratory: FPRC: AUROBINDOANDHRALTD,MANDAL, QUTHUBULLAPUR PRADESH, RANGA PHARMA REDDY,INDIA AHMEDABAD,SERVICES,PHARMACEUTICALINSTITUTEMORAIYA, SANAND, FORINDIA ANDHRAMANDAL, PRADESH, RANGA REDDY,INDIA ANDHRAMANDAL, PRADESH, RANGA REDDY,INDIA SILVERTONDALE,NORTH-WESTINDUSTRIALRESEARCHPRETORIA, RSAINSTITUTE PHARMACY, UNIVERSITY, FOR FPRR: (PTY)ZYDUSPOTCHEFSTROOM, LTD, HEALTHCARE VAN DER HOFF SA RSA FPRR: MEYERSDAL,AUROBINDO PHARMA, FPRR: MEYERSDAL,AUROBINDO PHARMA, PARK,RSA POTCHEFSTROOM, JOHANNESBURG, RSA JOHANNESBURG, RSA 35 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 36 RegistrationMRF 15 number: 42/1.2/0210 RegistrationMRF15 number: 42/1.2/0211 vIRF 15 Registration number: 42/2.5/0354 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosageName ingredients: of form: medicine: EACHTABLETTEXINE TABLET 20 mg CONTAINS: DosageName of form: medicine: TABLETTEXINE 30 mg DosageName of form: medicine: TABLETMYLAN OXCARBAZEPINE 150 20,0EQUIVALENTPAROXETINE mg TOHYDROCHLORIDE PAROXETINE Active ingredients: 30,0EQUIVALENTHYDROCHLORIDEPAROXETINEEACH mg TABLET TO CONTAINS: PAROXETINE Active ingredients: OXCARBAZEPINEEACH TABLET CONTAINS: 150,0 mg Applicant:registration:Conditions of AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: AUROBINDOLTD1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) Applicant:registration:Conditions of XIXIA1, 2, PHARMACEUTICALS 3, 4, 5, 6, 7, 8 (PTY) LTD Manufacturer: PRADESH,RANGAQUTHUBULLAPURAUROBINDO REDDY, INDIA PHARMA ANDHRA MANDAL, LTD, Manufacturer: AUROBINDOPRADESH,RANGAQUTHUBULLAPUR REDDY, PHARMA INDIA ANDHRA MANDAL, LTD, Manufacturer: ALPHAPHARMQUEENSLAND, (PTY) AUSTRALIA LTD, CAROLE PARK, Packer: PRADESH,RANGAQUTHUBULLAPURAUROBINDO REDDY, INDIA PHARMA ANDHRA hi1ANDAL, LTD, Packer: PRADESH,RANGAQUTHUBULLAPURAUROBINDO REDDY, INDIA PHARMA ANDHRA MANDAL, LTD, Packer: MCDERMOTTHERTFORDSHIRE,GENERICSQUEENSLAND,ALPHAPHARM UK LABORATORIES LIMITED,(PTY) AUSTRALIA UK LTD, POTTERS CAROLE T/A BAR,PARK, GERMISTON,MANUFACTURINGMERCKIRELANDGERARD PHARMACEUTICALS LABORATORIES, RSA (PTY) LTD, DUBLIN, WADEVILLE, Laboratory: FPRC QUTHUBULLAPURAUROBINDOPRADESH,RANGA REDDY, PHARMA INDIA MANDAL, ANDHRA LTD, Laboratory: FPRC: AUROBINDOPRADESH,RANGAQUTHUBULLAPUR REDDY, PHARMA INDIA ANDHRA MANDAL, LTD, Laboratory: FPRC: ALPHAPHARMMCDERMOTTHERTFORDSHIRE,GENERICSQUEENSLAND, UK(PTY) LABORATORIES LIMITED, AUSTRALIA LTD, UK CAROLE POTTERS T/A PARK, BAR, GERMISTON,MANUFACTURINGMERCKIRELANDGERARD PHARMACEUTICALS LABORATORIES, RSA (PTY) LTD, DUBLIN, WADEVILLE, SABSPHARMACEUTICALPOTCHEFSTROOM,PHARMACY,RESEARCH COMMERCIAL INSTITUTE NORTH-WEST (PTY) CHEMISTRYRSA FORLTD UNIVERSITY, INDUSTRIAL FPRR: AUROBINDOMEYERSDAL, PHARMA, JOHANNESBURG, FPRR: MEYERSDAL,AUROBINDO PHARMA, FPRR: MODDERFONTEIN,XIXIARSADEPARTMENT, PHARMACEUTICALS GROENKLOOF, GAUTENG, (PTY) RSA LTD, PRETORIA, DateShelf-life: of registration: 224RSA MARCH months 2012(Provisional) DateShelf-life: of registration: 224JOHANNESBURG, MARCH months 2012(Provisional) RSA Shelf-life:Date of registration: 224 MARCH months 2012(Provisional) RegistrationMRF 15 number: 42/2.5/0355 RegistrationMRF15 number: 42/11.4.1/0390 IF 15 Registration number: 42/2.6.5/0456 ActiveDosageName ofingredients: form: medicine: EACHTABLETMYLAN TABLET OXCARBAZEPINE CONTAINS: 300 DosageName of form: medicine: SUSPENSIONMAALOXEACH POCKET SACHET PACK CONTAINS: DosageName of form: medicine: TABLETZYDUSEACH RISPERIDONE TABLET CONTAINS: 1 TABLETS OXCARBAZEPINE 300,0 mg Active ingredients: MAGNESIUMmgEQUIVALENTALUMINIUM OXIDE HYDROXIDE TO ALUMINIUM HYDRATED 400,0 OXIDE mg 230,0 Active ingredients: RISPERIDONE 1,0 mg Manufacturer:Applicant:Conditions of registration: ALPHAPHARMXIXIA1, 2, 3, PHARMACEUTICALS 4, 5, 6, 7, (PTY) 8 LTD, CAROLE (PTY) LTD Manufacturer:Applicant:Conditions of registration: WINTHROPBK1, 2, GIULINI 3, 4, PHARMACEUTICALS 5, GmbH,6, 7 LUDWIGSHAFEN, (PTY) LTD Manufacturer:Applicant:Conditions of registration: ZYDUS1, 2, 3, 4, CADILAHEALTHCARE 5, 6, 7, HEALTHCARE8 S.A. (PTY) LTD, LTD SANAND, PARK, QUEENSLAND, AUSTRALIA SANOFI-AVENTISGERMANY S.p.A., ORIGGIO, ITALY AHMEDABAD, INDIA No.35409 STAATSKOERANT, 8JUNIE2012 Packer: MCDERMOTTHERTFORDSHIRE,GENERICSPARK,ALPHAPHARM QUEENSLAND, UK LABORATORIESLIMITED,(PTY) UK LTD, AUSTRALIA POTTERS CAROLE T/A BAR, Packer: WALTLOO,WINTHROPVARIOPACKSANOFI-AVENTISNIDDA-HARB, PRETORIA,PHARMACEUTICALS LOHNFERTIGUNGEN GERMANY S.p.A., RSA ORIGGIO, (PTY) GmbH, LTD,ITALY Packer: AHMEDABAD,ZYDUS CADILA INDIA HEALTHCARE LTD, SANAND, WADEVILLE,MANUFACTURINGMERCKIRELANDGERARD PHARMACEUTICALS LABORATORIES, GERMISTON, (PTY) LTD, RSADUBLIN, Laboratory: FPRC: MCDERMOTTHERTFORDSHIRE,GENERICSPARK,ALPHAPHARM QUEENSLAND, UK LABORATORIESLIMITED,(PTY) UK LTD, AUSTRALIA POTTERS CAROLE T/A BAR, Laboratory: FPRC: WALTLOO,WINTHROPA NATTERMANNSANOFI-AVENTISGERMANY PRETORIA,PHARMACEUTICALS & CIE S.p.A., GmbH,RSA ORIGGIO, COLOGNE, (PTY) ITALYLTD, Laboratory: FPRC: POTCHEFSTROOMPHARMACY,RESEARCHAHMEDABAD,ZYDUS CADILA INSTITUTE NORTH-WEST INDIA HEALTHCARE FOR UNIVERSITY, INDUSTRIAL LTD, SANAND, WADEVILLE,MANUFACTURINGMERCKIRELANDGERARD PHARMACEUTICALS LABORATORIES, GERMISTON, (PTY) LTD, RSADUBLIN, PHARMACEUTICALSABSUNIVERSITY,INDUSTRIALRESEARCH COMMERCIAL INSTITUTE PHARMACY, POTCHEFSTROOM, CHEMISTRY (PTY) FOR NORTH-WEST LTD RSA FPRR: XIXIAMODDERFONTEIN,PRETORIA,DEPARTMENT, PHARMACEUTICALS RSA GROENKLOOF, GAUTENG, (PTY) LTD, RSA FPRR: WINTHROPMIDRAND, PHARMACEUTICALS RSA (PTY) LTD, FPRR: ZYDUSPOTCHEFSTROOM HEALTHCARE, VAN DER HOFF PARK, Shelf-life: 24 months (Provisional) Shelf-life: WALTLOO,WINTHROP PRETORIA,PHARMACEUTICALS RSA (PTY) LTD, Shelf -life: Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH36 months 2012 Date of registration: 224 MARCH months 2012(Provisional) 37 38 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: TABLETSZYDUS42/2.6.5/0457 RISPERIDONE 2 MRF15NameRegistration of medicine: number: TABLETSZYDUS42/2.6.5/0458 RISPERIDONE 3 MRF 15 NameRegistration of medicine: number: TABLETSZYDUS42/2.6.5/0459 RISPERIDONE 4 ActiveDosage ingredients: form: RISPERIDONEEACHTABLET TABLET CONTAINS: 2,0 mg ActiveDosage ingredients: form: TABLETRISPERIDONEEACH TABLET CONTAINS: 3,0 mg ActiveDosage ingredients: form: RISPERIDONEEACHTABLET TABLET CONTAINS: 4,0 mg Applicant:Conditions of registration: (PTY)ZYDUS1, 2, LTD 3,HEALTHCARE 4, 5, 6, 7, 8 S.A. Applicant:Conditions of registration: ZYDUS(PTY)1, 2, 3,HEALTHCARE LTD 4, 5, 6, 7, 8 S.A. Applicant:Conditions of registration: (PTY)ZYDUS1, 2, LTD 3,HEALTHCARE 4, 5, 6, 7, 8 S.A. Manufacturer: ZYDUSINDIALTD, CADILASANAND, HEALTHCARE AHMEDABAD, Manufacturer: ZYDUSINDIALTD, CADILASANAND, HEALTHCARE AHMEDABAD, Manufacturer: ZYDUSINDIASANAND,HEALTHCARE CADILA AHMEDABAD, LTD, Packer: INDIALTD,ZYDUS SANAND, CADILA AHMEDABAD, HEALTHCARE Packer: INDIAZYDUSLTD, CADILASANAND, HEALTHCARE AHMEDABAD, Packer: INDIASANAND,HEALTHCAREZYDUS CADILA AHMEDABAD, LTD, Laboratory: FPRC: ZYDUSRESEARCHINDIALTD, CADILASANAND, INSTITUTE HEALTHCARE AHMEDABAD, FOR Laboratory: FPRC: RESEARCHLTD,ZYDUSINDIA SANAND, CADILA INSTITUTE AHMEDABAD, HEALTHCARE FOR Laboratory: FPRC ZYDUSSANAND,HEALTHCARE CADILA AHMEDABAD, LTD, POTCHEFSTROOMNORTH-WESTINDUSTRIAL PHARMACY, UNIVERSITY, POTCHEFSTROOMNORTH-WESTINDUSTRIAL UNIVERSITY, PHARMACY, UNIVERSITY,PHARMACY,FORRESEARCHINDIA INDUSTRIAL NORTH-WEST INSTITUTE FPRR: POTCHEFSTROOMDERZYDUS HOFF HEALTHCARE, PARK, VAN FPRR: DERZYDUS HOFF HEALTHCARE, PARK, VAN FPRR: ZYDUSDERPOTCHEFSTROOM HOFFHEALTHCARE, PARK, VAN DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 2 MARCH24POTCHEFSTROOM months 2012 (Provisional) DateShelf-life: of registration: 224 MARCH POTCHEFSTROOMmonths 2012(Provisional) RegistrationMRF 15 number: MRFRegistration 15 number: 42/20.2.20566 Registration number: 42/20.220684 DosageName of form: medicine: CAPSULE42/34/0496IMAVEC DosageName form: of medicine: TABLETBIO FLUCONAZOLE 50 mg DosageName of form: medicine: TABLETBIO FLUCONAZOLE 150 mg Active ingredients: IMATINIBEQUIVALENTEACH CAPSULE MESYLATE TO CONTAINS: 100,0 mg Active ingredients: FLUCONAZOLEEACH TABLET CONTAINS: 50,0 mg Active ingredients: FLUCONAZOLEEACH TABLET CONTAINS: 150,0 mg Applicant:Conditions of registration: CIPLA1, 2, 3, MEDPRO4, 5, 6, 7 (PTY) LTD Applicant:Conditions of registration: LTDBIOTECH1, 2, 3, 4, 5, LABORATORIES 6, 7 (PTY) Applicant:Conditions of registration: BIOTECH1, 2, 3, 4, 5,LABORATORIES 6, 7 (PTY) LTD Manufacturer: GOA,CIPLA INDIA LTD, UNIT VI, VERNA, Manufacturer: J.B.CHEMICALSLABORATORIESUNIQUE PHARMACEUTICAL &(DIVISION OF Manufacturer: J.B.CHEMICALSLABORATORIESUNIQUE PHARMACEUTICAL &(DIVISION PHARMACEUTICALS), OF No.35409 STAATSKOERANT, 8JUNIE2012 Packer: CIPLA LTD, UNIT VI, VERNA, Packer: LABORATORIESUNIQUEGUJARAT,PHARMACEUTICALS), PHARMACEUTICAL INDIA (DIVISION PANOLI, OF Packer: LABORATORIESUNIQUEPANOLI, PHARMACEUTICALGUJARAT, (DIVISION INDIA OF Laboratory: FPRC: CIPLAGOA, INDIA LTD, UNIT VI, VERNA, Laboratory: FPRC: UNIQUEGUJARAT,PHARMACEUTICALS),J. B. CHEMICALS PHARMACEUTICAL INDIA & PANOLI, Laboratory: FPRC: UNIQUEPANOLI,J.B.CHEMICALS PHARMACEUTICALGUJARAT, & PHARMACEUTICALS), INDIA GOA, INDIA INSTITUTEGUJARAT,PHARMACEUTICALS),J.B.CHEMICALSLABORATORIES INDIAFOR &(DIVISION PANOLI, OF SERVICES,INSTITUTEPANOLI,J.B.CHEMICALSLABORATORIES GUJARAT, FORSILVERTONDALE, PHARMACEUTICAL&(DIVISION PHARMACEUTICALS), INDIA OF PRETORIA, (PTY)MRSASILVERTONDALE,PHARMACEUTICAL & L LTD,LABORATORY LIMBRO PRETORIA, BUSINESSSERVICES, SERVICES CONSULTINGSANDTON,LTD,MRSA & L LIMBRO LABORATORY RSA BUSINESSCHEMICAL SERVICES PARK, LABORATORIES (PTY) RESEARCHATLASVILLE,LABORATORIESCONSULTINGPARK, SANDTON, INSTITUTE BOKSBURG, CHEMICAL (PTY) RSA LTD, FOR RSA POTCHEFSTROOM,PHARMACY,RESEARCH(PTY) LTD, ATLASVILLE, INSTITUTE NORTH-WEST RSA FOR BOKSBURG, UNIVERSITY, INDUSTRIAL RSA FPRR: FPRR: BIOTECHPOTCHEFSTROOM,NORTH-WESTINDUSTRIAL LABORATORIES PHARMACY, UNIVERSITY, RSA (PTY) FPRR: BIOTECH LABORATORIES (PTY) LTD, Shelf-life: RSAROSENPARK,CIPLA MEDPRO, BELLVILLE, Shelf-life: 36LTD, months MIDRAND, RSA Shelf-life: 36MIDRAND, months RSA Date of registration: 224 MARCH months 2012 Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 39 40 o 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistrationMRF 15 of medicine: number: ULTRA-TECHNEKOW42/35/0689 FM RegistrationNameMRF15 of number:medicine: 81042/20.2.2/0690 FLUCONAZOLE 200 mg IF 15 NameRegistration of medicine: number: TYSABRI42/30.1/0765 ActiveDosage ingredients: form: SODIUMEACHRADIONUCLIDE GENERATOR MOLYBDATE GENERATOR CONTAINS: 2,15 GBq ActiveDosage ingredients: form: FLUCONAZOLEEACHTABLET TABLET CONTAINS: 200,0 mg ActiveDosage ingredients: form: NATALIZUMABEACHINFUSION 1,0 ml CONCENTRATE CONTAINS: 20,0 mg Applicant:Conditions of registration: COVIDIEN1,SODIUM 2, 3, 4, PERTECHNETATE5, (PTY) 6, 7, 8LTD 2,08 GBq Applicant:Conditions of registration: BIOTECH1, 2, 3, 4, 5, LABORATORIES 6, 7 (PTY) Applicant:Conditions of registration: PHARMAPLAN1, 2, 3, 4, 5, 6, 7, (PTY) 8 LTD Manufacturer: PETTEN,MALLINCKRODT NETHERLANDS MEDICAL B.V., Manufacturer. J.B.CHEMICALSLABORATORIESUNIQUELTD PHARMACEUTICAL &(DIVISION OF Manufacturer: HOSPIRACALIFORNIA,TEVA PARENTERAL INC, USA MCPHERSON, MEDICINES KANSAS, INC, IRVINE, USA Packer: PETTEN,MALLINCKRODT NETHERLANDS MEDICAL B.V., Packer: LABORATORIESUNIQUEGUJARAT,PHARMACEUTICALS), PHARMACEUTICAL INDIA (DIVISION PANOLI, OF Packer: TEVAMOOSWIESEN,VETTERCALIFORNIA, PARENTERAL PHARMA-FERTIGUNG RAVENSBURG, USA MEDICINES GmbHGERMANY INC, IRVINE, & Co, GUJARAT,PHARMACEUTICALS),J.B.CHEMICALS INDIA & PANOLI, MOOSWIESEN,VETTERHOSPIRAHILLEROD,BIOGEN PHARMA-FERTIGUNG INC, IDEC MCPHERSON,DENMARK RAVENSBURG, DENMARK MANUFACTURING, KANSAS, GmbH GERMANY & USACo, Laboratory: FPRC: PETTEN,MALLINCKRODT NETHERLANDS MEDICAL B.V., Laboratory: FPRC: LABORATORIESUNIQUE PHARMACEUTICAL (DIVISION OF Laboratory: FPRC MOOSWIESEN,VETTERATHLONE,ELAN PHARMA-FERTIGUNG PHARMA WESTMEATH, RAVENSBURG, INTERNATIONAL IRELAND GmbH GERMANY LTD, & Co, LTD,PET LABSGROENKLOOF, PHARMACEUTICAL PRETORIA, (PTY) RSA SERVICES,INSTITUTEGUJARAT,PHARMACEUTICALS),J.B.CHEMICALS INDIA FORSILVERTONDALE, PHARMACEUTICAL& PANOLI, ELANNETHERLANDSBIOGENHILLEROD, PHARMA IDEC DENMARK B.V.,DENMARK INTERNATIONAL HOOFDDORP, MANUFACTURING, LTD, THE CONSULTINGPARK,(PTY)MPRETORIA, & L LTD,LABORATORY SANDTON, LIMBRORSA CHEMICAL RSA BUSINESS SERVICES VETTERGERMANYSCHUETZENSTRASSE,ATHLONE, PHARMA-FERTIGUNG WESTMEATH, RAVENSBURG, IRELAND GmbHGmbH & & Co, Co, WESTINDUSTRIALRESEARCHATLASVILLE,LABORATORIES UNIVERSITY, INSTITUTE PHARMACY,BOKSBURG, (PTY) LTD, FOR NORTH-RSA LANGENARGEN,VETTERHOLBEINSTRASSE, PHARMA-FERTIGUNG GERMANY RAVENSBURG, GmbH GERMANY & Co, FPRR: COVIDIENLTD,PET LABSGROENKLOOF, (PTY)PHARMACEUTICAL LTD, PRETORIA, MIDRAND, (Pry) RSA FPRR: LTD,BIOTECHPOTCHEFSTROOM, MIDRAND, LABORATORIES RSA RSA (PTY) FPRR: PHARMAPLAN, MIDRAND, RSA DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 236 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) RegistrationMRF 15 number: 42/20.1.1/0915 RegistrationMRF15 number: 42/20.2.8/0943 MRF 15 Registration number: 42/5.7.1/0985 DosageName of form: medicine: INJECTIONVANCOMYCIN 500 SAFELINE mg DosageName of form: medicine: TABLETDEZZO TRIVIR DosageName of form: medicine: TABLETDYNA DESLORATADINE 5 mg Active ingredients: 500,0EQUIVALENTHYDROCHLORIDEVANCOMYCINEACH mgVIAL CONTAINS: TO VANCOMYCIN Active ingredients: NEVIRAPINELAMIVUDINESTAVUDINEEACH TABLETS CONTAINS: 200,0150,030,0 mg mg Active ingredients: DESLORATADINEEACH TABLET CONTAINS: 5,0 mg Applicant:Conditions of registration: SAFELINE1, 2, 3, 4, PHARMACEUTICALS 5, 6, 7 Applicant:Conditions of registration: DEZZO1, 2, 3,TRADING 4, 5, 6, 7, 392 8 (PTY) ApplicantConditions of registration: PHARMA1, 2, 3, DYNAMICS 4, 5, 6, 7 (PTY) LTD No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: GREECEVIANEX(PTY) LTD S.A., PALINI ATTICI, Manufacturer: INDIALIMITED,EMCURELTD, T/A HINJWADI,PHARMACEUTICALS INDO PHARMA PUNE, Manufacturer. QUEBEC,PHARMASCIENCE CANADA INC, MONTREAL, Packer: GREECEVIANEX S.A., PALINI ATTICI, Packer: LIMITED,EMCUREINDIA HINJWADI,PHARMACEUTICALS PUNE, Packer: TECHNIKONCANADAROPACKQUEBEC,PENDOPHARM INC, CANADA LABORATORIES, MONTREAL, INC, MONTREAL, QUEBEC, PACKAGING,DIVPHARMN'DABENIPHARMACEUTICALROBERTVILLE, MANUFACTURING LONGDALE, FLORIDA ENTERPRISES & Laboratory: FPRC: GREECEVIANEX S.A., PALINI ATTICI, Laboratory: FPRC: LIMITED,EMCURE HINJWADI,PHARMACEUTICALS PUNE, Laboratory: FPRC PENDOPHARMQUEBEC,PHARMASCIENCEJOHANNESBURG CANADA INC, INC, MONTREAL, MONTREAL, RSASILVERTONDALE,PHARMACEUTICALINSTITUTE FOR PRETORIA, SERVICES, ATLASVILLE,CONSULTINGLABORATORIESINDIA BOKSBURG, CHEMICAL (PTY) LTD, BOKSBURG,LABORATORIES,CONSULTINGQUEBEC, CANADA RSA CHEMICAL ATLASVILLE, FPRR: JOHANNESBURG,(PTY)SAFELINE LTD, PHARMACEUTICALSFLORIDA, RSA FPRR: ANCHORVILLE,LTD,DEZZORSA T/A TRADING INDO LENASIA, PHARMA, 392 (PTY) RSA FPRR: CAPEPHARMA TOWN, DYNAMICS, RSA WESTLAKE, Shelf-life:Date of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 41 42 RegistrationMRF 15 number: 42/32.2/0988 MRF15Registration number: 42/34/0996 2F 15 Registration number: 43/3.2/0266 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageName of medicine: form: CAPSULEASPENCEPT 250 mg DosageName form: of medicine: INJECTIONASPEN WATER FOR INJECTION DosageName form: of medicine: TABLETDYNA ALENDRONATE 70 mg Active ingredients: 250,0MYCOPHENOLATEEACH mg CAPSULE CONTAINS: MOFETIL Active ingredients: WATEREACH AMPOULE FOR INJECTIONS CONTAINS: 2,0 ml Active ingredients: TRIHYDRATEALENDRONATEEACHEQUIVALENT TABLET MONOSODIUM CONTAINS: TO Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6,LTD 7, 8 Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6, 7 LIMITED Applicant:Conditions of registration: PHARMAALENDRONIC1, 2, 3, DYNAMICS4, 5, 6,ACID 7 70,0 (PTY) mg Manufacturer. ANEKALSTRIDESPORTPHARMACARE TALUK, ARCOLABELIZABETH, BANGALORE, LTD, LIMITED, RSA KORSTEN, INDIA Manufacturer. WARSZAWA,STRIDES ARCOLAB POLAND POLSKA SP, Manufacturer. S.A.,LABORATORIOSLTD ZARAGOZA, BELMAC, SPAIN Packer: PORTPHARMACAREANEKALSTRIDES ELIZABETH, TALUK, ARCOLAB LTD, BANGALORE, RSA KORSTEN, LIMITED, INDIA Packer: ELIZABETH,PHARMACAREWARSZAWA,STRIDES ARCOLAB RSA POLAND LTD, POLSKAKORSTEN, SP, PORT Packer: S.A.,LABORATORIOS ZARAGOZA, SPAIN BELMAC, Laboratory: FPRC: PORTPHARMACAREANEKALSTRIDES ELIZABETH, TALUK, ARCOLAB LTD, BANGALORE, RSA LIMITED,KORSTEN, INDIA Laboratory: FPRC: WARSZAWA,PHARMACY,RESEARCHSTRIDES ARCOLABPOLAND INSTITUTE NORTH-WEST POLSKA FOR UNIVERSITY, INDUSTRIAL SP, Laboratory: FPRC S.A.,LABORATORIOS ZARAGOZA, BELMAC, SPAIN SABSPOTCHEFSTROOM,WESTINDUSTRIALRESEARCH COMMERCIALUNIVERSITY, INSTITUTE PHARMACY, RSA (PTY) FOR NORTH- LTD PHARMACEUTICALSABSBUSINESSM&LPOTCHEFSTROOM, LABORATORY COMMERCIAL PARK, SANDTON, SERVICES,CHEMISTRYRSA (PTY) LTD RSA LIMBRO RSAATLASVILLE,LABORATORIES,CONSULTING BOKSBURG, CHEMICAL (PTY)MPRETORIA,DEPARTMENT,PHARMACEUTICAL & L LTD,LABORATORY LIMBRO RSA GROENKLOOF, BUSINESSCHEMISTRY SERVICES PARK, PRETORIA,DEPARTMENT RSA GROENKLOOF, FLORIDA,(PTY)TECHNIKON LTD, RSA ROBERTVILLE, LABORATORIES FPRR: PHARMACAREELIZABETH,SANDTON, RSA RSA LTD, WOODMEAD,KORSTEN PORT FPRR: PHARMACAREELIZABETH, LTD, RSA KORSTEN, PORT FPRR: PHARMA DYNAMICS (PTY) Shelf-life: 24SANDTON, months (Provisional) RSA Shelf -life: SANDTON,PHARMACARE RSA LTD, WOODMEAD, Shelf-life: 24TOWN, LTD,months RSAWESTLAKE, CAPE Date of registration: 2 MARCH 2012 Date of registration: 224 MARCH months 2012 Date of registration: 2 MARCH 2012 RegistrationMRFName 15 of medicine:number: VIAPAN43/11.4.3/0439 NameRegistrationMRF15 of medicine: number: ZOMEDRON43/34/0613 MRF 15 NameRegistration of medicine: number: AURO43/5.7.1/0643 CETIRIZINE TABLETS ActiveDosage ingredients: form: EACHPOWDER VIAL FOR CONTAINS: INJECTION ActiveDosage ingredients: form: EACHINJECTION VIAL CONTAINS: ActiveDosage ingredients: form: TABLET5 mgEACH TABLET CONTAINS: Conditions of registration: 1,PANTOPRAZOLEEQUIVALENT 2, 3, 4, 5, 6, TO7, 8 SODIUM 40,0 mg Conditions of registration: ZOLEDRONIC1, 2, 3, 4, 5, ACID6, 7, 8 4,0 mg Conditions of registration: CETIRIZINE1,DIHYDROCHLORIDE 2, 3, 4, 5, 6, 7, 8 5,0 mg

Applicant: (PTY)SAFELINE LTD PHARMACEUTICALS Applicant: CIPLA MEDPRO (PTY) LTD Applicant: AUROBINDOLTD PHARMA (PTY) No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: GREECEVIANEX S.A., PALINI ATTICI, Manufacturer: INDIACIPLA LTD, UNIT IX, VERNA, GOA, Manufacturer: ANDHRAAUROBINDODISTRICT,MANDAL,UNIT III, PRADESH QUTHUBULLAPUR RANGAPHARMA HYDERABAD, INDIAREDDY LIMITED, Packer: GREECEVIANEX S.A., PALINI ATTICI, Packer: INDIACIPLA LTD, UNIT IX, VERNA, GOA, Packer: AUROBINDODISTRICT,MANDAL,UNIT III, QUTHUBULLAPUR RANGAPHARMA HYDERABAD, REDDY LIMITED, Laboratory: FPRC: GREECEVIANEXINSTITUTE S.A., PALINI FOR ATTICI, Laboratory: FPRC: INDIACIPLA LTD, UNIT IX, VERNA, GOA, Laboratory: FPRC AUROBINDOANDHRAMANDAL,UNIT III, PRADESH QUTHUBULLAPUR RANGAPHARMA INDIAREDDY LIMITED, SILVERTONDALE,RSAPHARMACEUTICAL PRETORIA, SERVICES, SANDTON,LIMBROMANDHRADISTRICT, &L LABORATORY BUSINESS PRADESH HYDERABAD,RSA PARK, SERVICES,INDIA FPRR: SAFELINE PHARMACEUTICALS FPRR: CIPLA LTD, UNIT IX, VERNA, GOA, FPRR: AUROBINDOPARK,SERVICESKHULULEKANI MIDRAND, cc, PHARMA COVENTRY LABORATORY RSA (PTY) Shelf-life: 24JOHANNESBURG,(PTY) months LTD, (Provisional) FLORIDA, RSA Shelf-life: 24INDIA months (Provisional) Shelf-life: 24JOHANNESBURG,LTD, months MEYERSDAL, (Provisional) RSA

Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 43 44

MRF 15 MRF15 2F 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: AURO43/5.7.1/064410 mg CETIRIZINE TABLETS RegistrationName of number:medicine: TRANTRIN43/5.7.1/0645 TABLETS 5 mg NameRegistration of medicine: number: TRANTRIN43/5.7.1/0646 TABLETS 10 mg ActiveDosage ingredients: form: CETIRIZINETABLETDIHYDROCHLORIDEEACH TABLET CONTAINS: 10,0 mg ActiveDosage ingredients: form: DIHYDROCHLORIDECETIRIZINEEACHTABLET TABLET CONTAINS: 5,0 mg ActiveDosage ingredients: form: CETIRIZINETABLET10,0EACH mg TABLET DIHYDROCHLORIDE CONTAINS: Applicant:Conditions of registration: LTDAUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) Applicant:Conditions of registration: LTDAUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) LTD Manufacturer: RANGAQUTHUBULLAPURLIMITED,AUROBINDO REDDY UNIT PHARMA III, DISTRICT, MANDAL, Manufacturer: RANGAQUTHUBULLAPURLIMITED,AUROBINDO REDDY UNIT PHARMA III, DISTRICT, MANDAL, Manufacturer: MANDAL,AUROBINDOHYDERABAD,UNIT III, RANGA QUTHUBULLAPUR PHARMA ANDHRA REDDY LIMITED, DISTRICT,PRADESH Packer: AUROBINDOPRADESHHYDERABAD, PHARMAINDIA ANDHRA Packer: PRADESHHYDERABAD, INDIA ANDHRA Packer: INDIA HYDERABAD,RANGAQUTHUBULLAPURLIMITED, REDDY UNIT ANDHRAIII, DISTRICT, MANDAL, HYDERABAD,RANGAQUTHUBULLAPURLIMITED,AUROBINDO REDDY UNIT PHARMA ANDHRAIII, DISTRICT, MANDAL, HYDERABAD,MANDAL,AUROBINDOINDIAUNIT III, RANGA QUTHUBULLAPUR PHARMA ANDHRA REDDY LIMITED, PRADESH DISTRICT, Laboratory: FPRC: AUROBINDOQUTHUBULLAPURLIMITED,PRADESH UNIT PHARMAINDIA III, MANDAL, Laboratory: FPRC: AUROBINDOQUTHUBULLAPURLIMITED,PRADESH UNIT PHARMAINDIA III, MANDAL, Laboratory: FPRC MANDAL,UNITAUROBINDO III, QUTHUBULLAPUR RANGA PHARMA REDDY LIMITED, DISTRICT, LIMBROMPRADESHHYDERABAD,RANGA &L LABORATORY REDDYBUSINESS INDIA ANDHRA DISTRICT, PARK, SERVICES, MPRADESHHYDERABAD,RANGA &L LABORATORY REDDY INDIA ANDHRA DISTRICT, M &LLIMBROINDIAHYDERABAD, LABORATORY BUSINESS ANDHRA SERVICES, PARK, PRADESH PARK,SERVICESKHULULEKANISANDTON, MIDRAND, cc,RSA COVENTRY LABORATORY RSA SERVICESKHULULEKANIRSABUSINESSSERVICES, PARK,cc, LIMBRO COVENTRY LABORATORY SANDTON, MIDRAND,SERVICESKHULULEKANISANDTON, RSAcc, RSACOVENTRY LABORATORY PARK, FPRR: AUROBINDOJOHANNESBURG,LTD, MEYERSDAL, PHARMA RSA (PTY) FPRR: AUROBINDOJOHANNESBURG,LTD,PARK, MEYERSDAL, MIDRAND, PHARMA RSA RSA (PTY) FPRR: MEYERSDAL,AUROBINDORSA PHARMA JOHANNESBURG, (PTY) LTD, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) RegistrationMRF 15 number: 43/34/0731 MRF15Registration number: 43/20.2.8/0831 IIRF 15 Registration number: 43/26/0913 DosageName of form: medicine: INJECTIONCIPLA ZOLEDRONIC ACID DosageName form: of medicine: TABLETHETLAM DosageName of form: medicine: SOLUTIONPOWDERIXEMPRA AND FOR 15 DILUENT INFUSIONmg FOR ConditionsActive ingredients: of registration: ZOLEDRONICEACH VIAL CONTAINS:ACID 4,0 mg ConditionsActive ingredients: of registration: LAMIVUDINEEACH TABLET 150,0 CONTAINS: mg Active ingredients: IXABEPILONEEACH VIAL CONTAINS: 15,0 mg Applicant: CIPLA1, 2, 3, LIFE4, 5, SCIENCES6, 7, 8 (PTY) Applicant: BLISS1, 2, 3, 4, 5, 6, 7, 8 Applicant:Conditions of registration: BRISTOL-MYERS1, 2, 3, 4, 5, 6, 7, 8 SQUIBB (PTY) No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: GOA,CIPLALTD INDIA LTD, UNIT IX, VERNA, Manufacturer. HYDERABAD,JEEDIMETLAHETEROPHARMACEUTICALS DRUG INDIA LTD, cc Manufacturer. HALLE/WESTFALEN,BAXTERLTD ONCOLOGY GERMANYGmbH, Packer: GOA,CIPLA INDIA LTD, UNIT IX, VERNA, Packer: HYDERABAD,JEEDIMETLAHETERO DRUG INDIA LTD, Packer: SERMONETA,BRISTOL-MYERSHALLE/WESTFALEN,BAXTER ONCOLOGY LATINA, SQUIBB GERMANYGmbH, ITALY S.r.I., Laboratory: FPRC: GOA,CIPLA INDIA LTD, UNIT IX, VERNA, Laboratory: FPRC: JEEDIMETLAHYDERABAD,HETERO DRUG INDIA LTD, Laboratory: FPRC SERMONETA,BRISTOL-MYERSHALLE/WESTFALEN,BAXTER ONCOLOGY LATINA, SQUIBB GERMANYGmbH, ITALY S.r.I., MANUFACTURERMERCKATLASVILLE,LABORATORIESCONSULTING PHARMACEUTICAL BOKSBURG, CHEMICAL (PTY) (PTY) LTD, LTD, RSA FPRR: ROSENPARK,CIPLA LIFE SCIENCES, BELLVILLE FPRR: WOODMEAD,PHARMACEUTICALS,BLISS SANDTON FPRR: JOHANNESBURG,LTD,BRISTOL-MYERSWADEVILLE, BEDFORDVIEW, GERMISTON, SQUIBB RSA (PTY) RSA DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 2(Provisional)24 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 45 46 o 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistrationMRF 15 of medicine: number: 43/26/0914IXEMPRA 45 mg NameRegistrationMRF15 of medicine: number: 43/7.1.3/1094CO-TEKTURNA 150 mg/12,5 mg ARF 15 NameRegistration of medicine: number: 43/7.1.3/1095CO=TEKTURNA 150 mg/25 mg ActiveDosage ingredients: form: EACHFORPOWDER INFUSION VIAL AND CONTAINS: DILUENT FOR SOLUTION ActiveDosage ingredients: form: TABLET Dosage form: TABLE IXABEPILONE 45,0 mg ALISKIRENHYDROCHLOROTHIAZIDEEQUIVALENTEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 12,5 150,0 mg mg Active ingredients: ALISKIRENHYDROCHLOROTHIAZIDEEQUIVALENTEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 25,0 mg 150,0 mg Manufacturer.Applicant:Conditions of registration: BAXTERBRISTOL-MYERS1, 2, 3, ONCOLOGY 4, 5, 6, 7,SQUIBB 8 GmbH, (PTY) LTD Manufacturer:Applicant:Conditions of registration: NOVARTISNOVARTIS1, 2, 3, 4, SA 5, (PTY)PHARMA6, 7, 8 LTD PRODUKTIONS Applicant:Manufacturer.Conditions of registration: NOVARTIS1, 2, 3, 4, PHARMASA 5, (PTY)6, 7, 8 LTDPRODUKTIONS Packer: BAXTERHALLENVESTFALEN, ONCOLOGY GERMANYGmbH, Packer: ANNUNZIATA,GmbH,NOVARTIS WEHR, GERMANYITALYFARMA S.p.A., TORRE ANNUNZIATA,GmbH,NOVARTIS WEHR, ITALYFARMAGERMANY S.p.A., TORRE SERMONETA,BRISTOL-MYERSHALLEANESTFALEN, LATINA, SQUIBB GERMANY ITALY S.r.I., ALLPACKANNUNZIATA,NOVARTISGmbH, WEHR, GROUP FARMAPHARMA ITALYGERMANY AG, S.p.A., PRODUKTIONS REINACH, TORRE Packer: ALLPACKANNUNZIATA,NOVARTISGmbH, WEHR, GROUP FARMAPHARMA GERMANYITALY AG, S.p.A., PRODUKTIONS REINACH, TORRE SWITZERLANDIVERS-LEEKONAPHARMASWITZERLAND AG, BURGDORF, AG, PRATTELN, SWITZERLANDIVERS-LEEKONAPHARMASWITZERLAND AG, BURGDORF, AG, PRATTELN, KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A., PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A.,PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN Laboratory: FPRC: CONSULTINGSERMONETA,BRISTOL-MYERSHALLE/WESTFALEN,BAXTER ONCOLOGY CHEMICALLATINA, SQUIBB GERMANYGmbH, ITALY LABORATORIESS.r.I., Laboratory: FPRC: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE Laboratory: FPRC ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA GERMANYITALY S.p.A., PRODUKTIONS TORRE GERMISTON,MANUFACTURERMERCK(PTY) LTD, PHARMACEUTICAL ATLASVILLE, RSA (PTY) LTD,BOKSBURG, WADEVILLE, RSA MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., LIMBRO MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., FPRR: BEDFORDVIEW,BRISTOL-MYERS JOHANNESBURG, SQUIBB (PTY) LTD, RSA FPRR: KEMPTONNOVARTISBUSINESS PARK,SA (PTY) RSASANDTON, LTD, SPARTAN, RSA FPRR: KEMPTONNOVARTISSANDTON,LIMBRO BUSINESS PARK,SARSA (PTY) RSA PARK, LTD, SPARTAN, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) MRF 15 43/7.1.3/1096 MRF15 MRF 15 DosageNameRegistration of form: medicine: number: TABLETCO-TEKTURNA 300 mg/12,5 mg DosageNameRegistration of form: medicine: number: TABLETCO-TEKTURNA43/7.1.3/1097 300 mg/25 mg DosageNameRegistration of form: medicine: number: TABLETCO-RASILEZ43/7.1.3/1098 150 mg/12,5 mg Active ingredients: ALISKIRENHYDROCHLOROTHIAZIDETOEACH ALISKIREN TABLET HEMIFUMARATE CONTAINS:300,0 mg EQUIVALENT 12,50 mg Active ingredients: HYDROCHLOROTHIAZIDEEQUIVALENTALISKIRENEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 25,0 300,0 mg m Active ingredients: ALISKIRENEQUIVALENTEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 150,0 mg Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, 5, SA6, 7, (PTY) 8 LTD Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, 5, SA6, 7, (PTY) 8 LTD ApplicantConditions of registration: NOVARTIS1,HYDROCHLOROTHIAZIDE 2, 3, 4, 5, SA6, 7, (PTY) 8 LTD 12,5 mg Manufacturer: NOVARTIS PHARMA PRODUKTIONS Manufacturer: NOVARTIS PHARMA PRODUKTIONS Manufacturer: NOVARTIS PHARMA PRODUKTIONS No.35409 STAATSKOERANT, 8JUNIE2012 Packer: ANNUNZIATA,NOVARTISGmbH, WEHR, ITALYPHARMAFARMA GERMANY S.p.A., PRODUKTIONS TORRE Packer: ANNUNZIATA,NOVARTISGmbH, WEHR, ITALYPHARMAFARMA GERMANY S.p.A., PRODUKTIONS TORRE Packer: ANNUNZIATA,NOVARTISGmbH, WEHR, ITALYPHARMAFARMA GERMANY S.p.A., PRODUKTIONS TORRE SWITZERLANDALLPACKANNUNZIATA,NOVARTISGmbH, GROUP WEHR, ITALYFARMA PG,GERMANY REINACH,S.p.A., TORRE ALLPACKANNUNZIATA,NOVARTISGmbH, GROUP WEHR, ITALYFARMA AG,GERMANY REINACH,S.p.A., TORRE ALLPACKANNUNZIATA,NOVARTISGmbH, GROUP WEHR, ITALYFARMA AG,GERMANY REINACH, S.p.A., TORRE SWITZERLANDIVERS-LEEKONAPHARMA AG, AG,BURGDORF, PRATTELN, SWITZERLANDIVERS-LEEKONAPHARMASWITZERLAND AG, AG,BURGDORF, PRATTELN, SWITZERLANDIVERS-LEEKONAPHARMASWITZERLAND AG, BURGDORF, AG, PRATTELN, KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A.,PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN MIPHARMKEMPTONSANDOZPROSPERO,LAMP SAN S.p.A., SA PARK,PROSPERO (PTY)ITALY MILANO, RSA LTD, ITALYS.p.A.,SPARTAN, SAN MIPHARMPROSPERO,LAMPKEMPTONSANDOZ SAN S.p.A., PROSPERO SAITALY PARK, (PTY) MILANO, RSA LTD, S.p.A., ITALYSPARTAN, SAN Laboratory: FPRC: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA GERMANYITALY S.p.A., PRODUKTIONS TORRE Laboratory: FPRC: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE Laboratory: FPRC ANNUNZIATA,NOVARTISGmbH, WEHR, PHARMAFARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., LIMBRO MSANDOZLOCARNO,NOVARTIS &LKEMPTON LABORATORY SA PHARMANALYTICASWITZERLAND (PTY) PARK, LTD, SERVICES, RSA SPARTAN, S.A., LIMBRO MSANDOZLOCARNO,NOVARTIS &LKEMPTON LABORATORY SA PHARMANALYTICASWITZERLAND (PTY) PARK, LTD, SERVICES, RSA SPARTAN, S.A., FPRR: KEMPTONNOVARTISBUSINESS PARK,SAPARK, (PTY) RSASANDTON, LTD, SPARTAN, RSA FPRR: KEMPTONNOVARTISBUSINESS PARK,SAPARK, (PTY) RSASANDTON, LTD, SPARTAN, RSA FPRR: KEMPTONNOVARTISSANDTON,LIMBRO BUSINESS PARK,SARSA (PTY) RSA PARK, LTD, SPARTAN, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 47 48 MRF 15 MRF15 F 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: TABLETCO-RASILEZ43/7.1.3/1099 150 mg/25 mg RegistrationDosageName of form: medicine:number: TABLETCO-RASILEZ43/7.1.3/1100 300 mg/12,5 mg DosageNameRegistration of form: medicine: number: TABLETCO-RASILEZ43/7.1.3/1101 300 mg/25 mg Active ingredients: HYDROCHLOROTHIAZIDETOALISKIRENEACH ALISKIREN TABLET HEMIFUMARATE CONTAINS:150,0 mg 25,0 EQUIVALENT mg Active ingredients: HYDROCHLOROTHIAZIDEEQUIVALENTALISKIRENEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 12,5 300,0 mg mg Active ingredients: ALISKIRENEQUIVALENTEACH TABLET HEMIFUMARATE TO CONTAINS: ALISKIREN 300,0 mg Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, SA 5, (PTY)6, 7, 8 LTD Applicant:Conditions of registration: NOVARTIS1, 2, 3, 4, 5, SA6, 7, (PTY) 8 LTD Applicant:Conditions of registration: NOVARTIS1,HYDROCHLOROTHIAZIDE 2, 3, 4, 5, SA6, 7, (PTY) 8 LTD 25,0 mg Manufacturer: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE Manufacturer: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE Manufacturer: ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE Packer: ALLPACKANNUNZIATA,NOVARTISGmbH, WEHR, GROUP FARMAPHARMA ITALYGERMANY AG, S.p.A., PRODUKTIONS REINACH, TORRE Packer: ALLPACKANNUNZIATA,NOVARTISGmbH, WEHR, GROUP FARMAPHARMA ITALYGERMANY AG, S.p.A., PRODUKTIONS REINACH, TORRE Packer: ALLPACKANNUNZIATA,NOVARTISGmbH, WEHR, GROUP FARMAPHARMA ITALYGERMANY AG, S.p.A., PRODUKTIONS REINACH, TORRE SWITZERLANDIVERS-LEEKONAPHARMA AG, AG,BURGDORF, PRATTELN, SWITZERLANDIVERS-LEEKONAPHARMA AG, AG,BURGDORF, PRATTELN, SWITZERLANDIVERS-LEEKONAPHARMA AG, AG,BURGDORF, PRATTELN, KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A., PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A., PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN KEMPTONSANDOZMIPHARMPROSPERO,LAMP SAN SA S.p.A., PARK,PROSPERO (PTY)ITALY MILANO,RSA LTD, S.p.A.,SPARTAN, ITALY SAN Laboratory: FPRC: ANNUNZIATA,NOVARTISGmbH, WEHR, ITALYFARMAPHARMA GERMANY S.p.A., PRODUKTIONS TORRE Laboratory: FPRC: ANNUNZIATA,NOVARTISGmbH, WEHR, ITALYFARMAPHARMA GERMANY S.p.A., PRODUKTIONS TORRE Laboratory: FPRC ANNUNZIATA,NOVARTISGmbH, WEHR, FARMAPHARMA ITALYGERMANY S.p.A., PRODUKTIONS TORRE MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., LIMBRO MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., LIMBRO MKEMPTONSANDOZLOCARNO,NOVARTIS &L LABORATORY SA PARK,PHARMANALYTICASWITZERLAND (PTY) RSA LTD, SERVICES, SPARTAN, S.A., FPRR: KEMPTONNOVARTISBUSINESS PARK,SA (PTY)PARK, RSA LTD, SANDTON, SPARTAN, RSA FPRR: KEMPTONNOVARTISBUSINESS PARK,SA (PTY) RSASANDTON, LTD, SPARTAN, RSA FPRR: KEMPTONNOVARTISSANDTON,LIMBRO BUSINESS PARK,SARSA (PTY) RSA PARK, LTD, SPARTAN, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224 MARCH months 2012(Provisional) RegistrationMRF 15 number: 43/20.1.6/1103 RegistrationMRF15 number: 43/13.1/1104 ARF 15 Registration number: 43/13.1/1105 DosageName of form: medicine: OINTMENTALTARGO DosageName of form: medicine: ORALGAVISCON POWDER TROPICAL GRANULES DosageName of form: medicine: ORALGRANULESGAVISCON POWDER PEPPERMINT Active ingredients: RETAPAMULINEACH 1,0 g OF OINTMENT CONTAINS: 10,0 mg Active ingredients: CALCIUMSODIUMEACH SACHET BICARBONATEALGINATE CARBONATE CONTAINS: 500,0 160,0 267,0 mg mg mg Active ingredients: CALCIUMSODIUMEACH SACHET BICARBONATEALGINATE CARBONATE CONTAINS: 500,0 160,0 267,0 mg mg mg Applicant:Conditions of registration: GLAXOSMITHKLINE1, 2, 3, 4, 5, 6, 7 SA (PTY) LTD Applicant:Conditions of registration: PHARMACEUTICALSRECKITT1, 2, 3, 4, 5,BENCKISER 6, 8 (PTY) LTD Applicant:Conditions of registration: PHARMACEUTICALSRECKITT1, 2, 3, 4, 5,BENCKISER 6, 8 (PTY) LTD Manufacturer. KINGDOMBARNARDGLAXO OPERATIONS CASTLE, DURHAM, UK LIMITED, UNITED Manufacturer. RECKITTUNITED(UK) LTD, KINGDOM BENCKISERHULL, EAST HEALTHCAREYORKSHIRE, Manufacturer: RECKITTUNITED(UK) LTD, KINGDOM BENCKISERHULL, EAST HEALTHCAREYORKSHIRE, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: GLAXO OPERATIONS UK LIMITED, Packer: KINGDOMUNITEDINTERNATIONAL LTD, NOTTINGHAM, UNITEDINTERNATIONAL KINGDOM LTD, NOTTINGHAM, EPPING,GLAXOSMITHKLINEiSAKINGDOMBARNARD CAPE CASTLE, TOWN, DURHAM, RSA (PTY) LTD, UNITED INTERNATIONALRECKITTUNITED(UK) LTD, KINGDOM BENCKISERHULL, EAST LTD, HEALTHCARENOTTINGHAM,YORKSHIRE, Packer INTERNATIONALRECKITTUNITED(UK) LTD, KINGDOM BENCKISER HULL EAST LTD, HEALTHCAREYORKSHIRE,NOTTINGHAM, (PTY)PHARMACEUTICALSCHORNDORF,CARDINALUNITED LTD, KINGDOM ISANDO,HEALTH GERMANY CONTRACTORSGERMANYRSA GmbH, (PTY)PHARMACEUTICALGmbH,CARDINALUNITED LTD, SCHORNDORF, KINGDOM ISANDO,HEALTH CONTRACTORSGERMANYRSA GERMANY Laboratory: FPRC: GLAXOSMITHKLINEKINGDOMBARNARDGLAXO OPERATIONS CASTLE, DURHAM,SA UK (PTY) LIMITED, LTD, UNITED Laboratory: FPRC: RECKITTUNITED(UK)RECKITT LTD, BENCKISER KINGDOM BENCKISERHULL, EAST HEALTHCARE HEALTHCAREYORKSHIRE, Laboratory: FPRC RECKITTUNITED(UK) LTD, KINGDOM BENCKISERHULL, EAST HEALTHCAREYORKSHIRE, EPPING, CAPE TOWN, RSA SCHORNDORF,CARDINALKINGDOMUNITEDINTERNATIONAL HEALTH GERMANY GERMANY LTD, NOTTINGHAM, GmbH, PHARMACEUTICALGmbH,CARDINALUNITEDINTERNATIONAL SCHORNDORF, KINGDOM HEALTH LTD, CONTRACTORSGERMANY NOTTINGHAM, GERMANY FPRR: EPPING,GLAXOSMITHKLINE CAPE TOWN, SA RSA (PTY) LTD, FPRR: (PTY)RECKITTPHARMACEUTICAL LTD, ISANDO, BENCKISER RSA CONTRACTORS FPRC/FPRR: RECKITT(PTY) LTD, BENCKISER ISANDO, RSA Shelf-life: 24GLAXOSMITHKLINE monthsBRYANSTON, JOHANNESBURG, SA (PTY) LTD, RSA Shelf-life: 24ELANDSFONTEIN, monthsPHARMACEUTICALS (Provisional) RSA (PTY) LTD, ELANDSFONTEIN,PHARMACEUTICALS RSA (PTY) LTD, Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 49 50 MRF 15 MRF15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: AZARGA44/15.4/0046 NameRegistration of medicine: number: LETROZOLE44/21.12/0260 BRIMPHARM IF 15 NameRegistration of medicine: number: TROZOLT44/21.12/0261 ActiveDosage ingredients: form: BRINZOLAMIDEEACHEYE DROP 1,0 ml SUSPENSION SUSPENSION CONTAINS: 10,0 mg. ActiveDosage ingredients: form: EACHTABLET TABLET CONTAINS: ActiveDosage ingredients: form: EACHTABLET TABLET CONTAINS: Conditions of registration: TIMOLOL1, 2, 3, MALEATE 4, 5, 6, 7, 8EQUIVALENT TO 5,0 mg Conditions of registration: 1,LETROZOLE2,5 2, 3, 4, 5, 6, 7, mg8 Conditions of registration: LETROZOLE1, 2, 3, 4, 5, 6, 7, 8 2,5 mg Manufacturer.Applicant: BELGIUMS.A.ALCON ALCON-COUVREUR LABORATORIES N.V,SA (PTY) PUURS, LTD Manufacturer.Applicant: BARCELONA,KERNBRIMPHARM PHARMA SPAIN S.L, SA TERRASSA(PTY) LTD Manufacturer:Applicant: KERNBRIMPHARM PHARMA SA S.L, (PTY) LTD Packer: BELGIUMS.A. ALCON-COUVREUR N.V, PUURS, Packer: KERNBARCELONA, PHARMA S.L, SPAIN TERRASSA Packer: KERNSPAINTERRASSA PHARMA BARCELONA, S.L, Laboratory: FPRC: RESEARCHBELGIUMS.A. ALCON-COUVREUR INSTITUTE FOR N.V, INDUSTRIAL PUURS, Laboratory: FPRC: BARCELONA,KERN PHARMA SPAIN S.L, TERRASSA Laboratory: FPRC KERNSPAINTERRASSA PHARMA BARCELONA, S.L, POTCHEFSTROOM,PHARMACY, NORTH-WEST RSA UNIVERSITY, LABORATORIESCONSULTINGINDUSTRIA,PACKAGINGDIVPHARM MANUFACTURINGRSA (PTY) CHEMICAL (PTY) LTD, LTD, LONGDALE, ATLASVILLE, & TERRASSAMANUFACTURINGDIVPHARMSPAIN BARCELONA, & BOKSBURG, RSA (PTY)CHEMICALRSALONGDALE,PACKAGING CONSULTING LTD, ATLASVILLE,LABORATORIES INDUSTRIA,(PTY) LTD, FPRC/FPRR: ALCONBRYANSTON, LABORATORIES JOHANNESBURG, SA (PTY) LTD, RSA FPRR: CAPEBRIMPHARM TOWN, SARSA (PTY) LTD, ATHLONE, FPRR: ATHLONE,RSABRIMPHARMBOKSBURG, CAPE RSASA TOWN, (PTY) LTD, DateShelf-life: of registration: 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 20 MARCH24 months 2012 (Provisional) DateShelf-life: of registration: 2 MARCH24 months 2012 (Provisional) MRF 15 MRF15 IF 15 NameRegistration of medicine: number: 44/26/0374PAXITAS 30 RegistrationName of number:medicine: 44/26/0375PAXITAS 100 NameRegistration of medicine: number: PAXITAS44/26/0376 300 ActiveDosage ingredients: form: PACLITAXELEACHCONCENTRATE 5,0 ml CONTAINS: FOR INFUSION 30,0 mg ActiveDosage ingredients: form: EACHCONCENTRATEINFUSION 16,7 ml CONTAINS: FOR ActiveDosage ingredients: form: EACHINFUSIONCONCENTRATE 50,0 ml CONTAINS: FOR Applicant:Conditions of registration: ACCORD1, 2, 3, 4,HEALTHCARE 5, 6, 7 (PTY) Applicant:Conditions of registration: ACCORD1,PACLITAXEL 2, 3, 4,HEALTHCARE 5, 6, 7100,0 mg (PTY) Applicant:Conditions of registration: ACCORD1,PACLITAXEL 2, 3, 4, 5,HEALTHCARE 6, 7 300,0 mg Manufacturer: AHMEDABAD,LTD,INTASLTD MATODA, PHARMACEUTICALS GUJARAT, SANAND, INDIA Manufacturer: AHMEDABAD,LTD,INTASLTD MATODA, PHARMACEUTICALS GUJARAT, SANAND, Manufacturer. AHMEDABAD,LTD,INTAS(PTY) MATODA, LTD PHARMACEUTICALS GUJARAT, SANAND, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: AHMEDABAD,LTD,INTAS MATODA, PHARMACEUTICALS 'GUJARAT, SANAND, INDIA Packer: AHMEDABAD,LTD,INDIAINTAS MATODA, PHARMACEUTICALS GUJARAT, SANAND, Packer: AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, Laboratory: FPRC: AHMEDABAD,LTD,INTAS MATODA, PHARMACEUTICALS GUJARAT, SANAND, INDIA Laboratory: FPRC: AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, Laboratory: FPRC AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, CONSULTINGRSARANDBURG,LABORATORIES,PHARMASPEC JOHANNESBURG, CHEMICAL CONSULTING FERNDALE, RANDBURG,LABORATORIES,PHARMASPECINDIA CONSULTING FERNDALE, LABORATORIES,CONSULTINGPHARMASPECINDIA BOKSBURG,LABORATORIES, RSA ATLASVILLE, BOKSBURG,LABORATORIES,CONSULTINGJOHANNESBURG, RSA CHEMICAL ATLASVILLE, RSA ATLASVILLE,LABORATORIES,CONSULTINGJOHANNESBURG,FERNDALE, RANDBURG, BOKSBURG, CHEMICAL RSA FPRR: ACCORDLTD, RIVONIA, HEALTHCARE GAUTENG, (PTY) RSA FPRR: ACCORDLTD, RIVONIA, HEALTHCARE GAUTENG, (PTY) RSA FPRR: ACCORDGAUTENG,(PTY)RSA LTD, HEALTHCARE RIVONIA,RSA DateShelf-life: of registration: 24 2months MARCH 2012 DateShelf-life: of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012 51 52 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 RegistrationName of number:medicine: ACCORD44/26/0377 PACLITAXEL 30 MRF15NameRegistration of medicine: number: ACCORD44/26/0378 PACLITAXEL 100 2F 15 NameRegistration of medicine: number: ACCORD44/26/0379 PACLITAXEL 300 ActiveDosage ingredients: form: PACLITAXELEACHCONCENTRATE 5,0 ml CONTAINS: FOR INFUSION 30,0 mg ActiveDosage ingredients: form: PACLITAXELEACHINFUSIONCONCENTRATE 16,7 ml CONTAINS: FOR ActiveDosage ingredients: form: EACHINFUSIONCONCENTRATE 50,0 ml CONTAINS: FOR Applicant:Conditions of registration: ACCORD1, 2, 3, HEALTHCARE4, 5, 6, 7 (PTY) Applicant:Conditions of registration: ACCORD1, 2, 3, HEALTHCARE4, 5, 6, 7 (PTY) 100,0 mg Applicant:Conditions of registration: ACCORD1,PACLITAXEL 2, 3, 4,HEALTHCARE 5, 6, 7 300,0 mg Manufacturer: AHMEDABAD,LTD,LTDINTAS MATODA, PHARMACEUTICALS GUJARAT, SANAND, INDIA Manufacturer: AHMEDABAD,LTD,INTASLTD MATODA, PHARMACEUTICALS GUJARAT, SANAND, Manufacturer: AHMEDABAD,LTD,INTAS(PTY) MATODA, LTD PHARMACEUTICALS GUJARAT, SANAND, Packer: AHMEDABAD,LTD,INTAS MATODA, PHARMACEUTICALS GUJARAT, SANAND, INDIA Packer: AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, Packer: AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, Laboratory: FPRC: AHMEDABAD,LTD,INTAS MATODA, PHARMACEUTICALS GUJARAT, SANAND, INDIA Laboratory: FPRC: AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, Laboratory: FPRC AHMEDABAD,LTD,INTASINDIA MATODA, PHARMACEUTICALS GUJARAT, SANAND, CONSULTINGRSARANDBURG,LABORATORIES,PHARMASPEC JOHANNESBURG, CHEMICAL CONSULTING FERNDALE, RANDBURG,LABORATORIES,PHARMASPECINDIA CONSULTING FERNDALE, LABORATORIES,CONSULTINGPHARMASPECINDIA BOKSBURG,LABORATORIES, RSA ATLASVILLE, CONSULTINGJOHANNESBURG,BOKSBURG,LABORATORIES, CHEMICAL RSA RSA ATLASVILLE, ATLASVILLE,JOHANNESBURG,LABORATORIES,CONSULTINGFERNDALE, BOKSBURG, RANDBURG, CHEMICAL RSA FPRR: LTD,ACCORD RIVONIA, HEALTHCARE GAUTENG, (PTY) RSA FPRR: LTD,ACCORD RIVONIA, HEALTHCARE GAUTENG, (PTY) RSA FPRR: GAUTENG,(PTY)ACCORDRSA LTD, HEALTHCARE RIVONIA,RSA DateShelf-life: of registration: 224 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012 Shelf-life:Date of registration: 224 MARCH months 2012 MRF 15 MRF15 2F 15 NameRegistration of medicine: number: ACROVIC44/21.12/0439 1 NameRegistration of medicine: number: DRL44/21.12/0440 ANASTROZOLE 1 NameRegistration of medicine: number: TABLETSZYDUS44/7.1.3/0503 PERINDOPRIL CO ActiveDosage ingredients: form: ANASTROZOLETABLETEACH TABLET CONTAINS: 1,0 mg ActiveDosage ingredients: form: ANASTROZOLETABLETEACH TABLET CONTAINS: 1,0 mg ActiveDosage ingredients: form: BUTYLAMINEPERINDOPRILEACHTABLET TABLET 4,0 TERT-CONTAINS: mg Applicant:Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,INDAPAMIDE 2, 3, 4, 5, 6, 7, 8 1,25 mg DR REDDY'S LABORATORIES Applicant: DR REDDY'S LABORATORIES Applicant: ZYDUS HEALTHCARE SA (PTY) No.35409 STAATSKOERANT, 8JUNIE2012 Manufacturer: VISHAKAPATNAM,LIMITED,DR(PTY) REDDY'S LTD UNIT LABORATORIES VII, ANDHRA Manufacturer. VISHAKAPATNAM,(PTY)LIMITED,DR LTDREDDY'S UNIT LABORATORIES VII, ANDHRA Manufacturer: AHMEDABAD,LIMITED,ZYDUSLTD CADILA MORAIYA, INDIA HEALTHCARE SANAND, Packer: LIMITED,DRPRADESH, REDDY'S UNIT INDIA LABORATORIES VII, Packer: LIMITED,DRPRADESH, REDDY'S UNIT INDIA VII, LABORATORIES Packer: AHMEDABAD,LIMITED,ZYDUS CADILA MORAIYA, INDIA HEALTHCARE SANAND, Laboratory: FPRC: LIMITED,DRPRADESH,VISHAKAPATNAM, REDDY'S UNIT INDIA LABORATORIES VII, ANDHRA Laboratory: FPRC: LIMITED,DRPRADESH,VISHAKAPATNAM, REDDY'S UNIT INDIA LABORATORIES VII, ANDHRA Laboratory: FPRC ZYDUSLIMITED, CADILA MORAIYA, HEALTHCARE SANAND, PHARMACEUTICALINSTITUTEPRADESH,VISHAKAPATNAM, INDIAFOR ANDHRA SERVICES, PHARMACEUTICALINSTITUTEPRADESH,VISHAKAPATNAM, INDIAFOR ANDHRA AHMEDABAD,RSASILVERTONDALE,PHARMACEUTICALINSTITUTE FORINDIA PRETORIA, SERVICES, NORTH-WESTINDUSTRIALRESEARCHRSASILVERTONDALE, INSTITUTE PHARMACY, UNIVERSITY, PRETORIA, FOR NORTH-WESTINDUSTRIALRESEARCHPRETORIA,SERVICES, SILVERTONDALE,RSAINSTITUTE PHARMACY, UNIVERSITY, FOR INDUSTRIALRESEARCHPOTCHEFSTROOM,NORTH-WEST INSTITUTE PHARMACY, UNIVERSITY, RSAFOR FPRR: PRETORIA,(PTY)DRPOTCHEFSTROOM, REDDY'S LTD, MURRAYFIELD, RSA LABORATORIES RSA FPRR: PRETORIA,(PTY)DRPOTCHEFSTROOM, REDDY'S LTD, MURRAYFIELD, RSA LABORATORIES RSA FPRR: POTCHEFSTROOM,LTD,ZYDUS VAN HEALTHCARE DER HOFF RSA PARK, SA (PTY) DateShelf-life: of registration: 236 MARCH months 2012 DateShelf-life: of registration: 236 MARCH months 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) 53 54 MRF 15 MRF15 MMRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: *ODIMUNE44/20.2,8/0779 NameRegistration of medicine: number: 44/20.2.8/0780 mg/EMTRICITABINE 200 mg EFAVIRENZ 600 mg/TENOFOVIR NameRegistration of medicine: number: PERGOVERIS44/21.10/0781 150 I.0 /75 I.0 ActiveDosage ingredients: form: EFAVIRENZEACHTAB; ET TABLET CONTAINS: 600,0 mg ActiveDosage ingredients: form: TABLET TABLET CONTAINS: 600,0 mg ActiveDosage ingredients: form: FOLLITROPINEACHPOWDER VIAL FOR CONTAINS: ALFA SOLUTION (r-hFSH) Conditions of registration: 1,2,3,4,5,6,7,8,9,10**300,0TENOFOVIREMTRICITABINE mg DISOPROXIL FUMARATE 200,0 mg TENOFOVIR1,2,3,4,5,6,7,8,9,10** DISOPROXIL FUMARATE mg 200,0 mg LUTROPIN150,0 I.0 ALFA (r-hLH) 75,0 I.0 Applicant:Manufacturer: CIPLA LTD,MEDPRO UNIT (PTY) VII, VERNA, LTD GOA, INDIA Manufacturer:Applicant:Conditions of registration: LTD,LIFE SCIENCESUNIT VII, VERNA, (PTY) LTDGOA, INDIA Manufacturer:Applicant:Conditions of registration: MERCK1, 2, 3,SERONO(PTY) 4, 5, LTD6, 7, S.A., 8 Packer: CIPLA LTD, UNIT VII, VERNA, GOA, INDIA Packer: LTD, UNIT VII, VERNA, GOA, INDIA Packer: MERCKAUBONNE, SERONO SWITZERLAND S.A., Laboratory: FPRC: CIPLA LTD, UNIT WI, VERNA, GOA, INDIA Laboratory: FPRC: LTD, UNIT VII, VERNA, GOA, INDIA Laboratory: FPRC MERCKAUBONNE,COINSINS, SERONO SWITZERLAND S.p.A.,S.A., FPRR: BELLVILLE,CIPLA MEDPRO, RSA ROSENPARK, FPRR: LIFE SCIENCES, ROSENPARK, RSA FPRR: MODDERFONTEIN,MERCKGUIDONIARSA (PTY) MONTECELIO, LTD, GAUTENG, ITALY DateShelf -life:of registration: 0924 Februarymonths (Provisional) 2012 DateShelf-life: of registration: 0924 Februarymonths (Provisional) 2012 DateShelf-life: of registration: 224 MARCH months 2012(Provisional) NameRegistrationMRF 15 of medicine: number: SEROQUEL44/2.6.5/0973 XR 150 MRF15NameRegistration of medicine: number: RAOLIN45/20.2.8/0078 100/25 mg TABLETS MRF 15 NameRegistration of medicine: number: RAOLIN45/20.2.8/0079 200/50 mg TABLETS ActiveDosage ingredients: form: QUETIAPINEEACHTABLET TABLET FUMARATE CONTAINS: 150,0 mg ActiveDosage ingredients: form: RITONAVIRLOPINAVIREACHTABLET TABLET CONTAINS: 25,0100,0 mg mg ActiveDosage ingredients: form: RITONAVIRLOPINAVIREACHTABLET TABLET CONTAINS: 200,0 mg50,0 mg Applicant:Conditions of registration: ASTRAZENECAPHARMACEUTICALS1, 2, 3, 4, 5, 6, 7 (PTY) LIMITED Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: AUROBINDOLTD1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) Manufacturer: ASTRAZENECASWEDEN UKAB, LIMITED,SODERTALJE, Manufacturer: MANDAL,AUROBINDOUNIT III, RANGA QUTHUBULLAPUR PHARMA REDDY LIMITED, Manufacturer: MANDAL,AUROBINDOUNIT III, RANGA QUTHUBULLAPUR PHARMA REDDY LIMITED, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: ASTRAZENECAMACCLESFIELD,SWEDEN AB, CHESHIRE, SODERTALJE, UK Packer: AUROBINDOUNITPRADESHDISTRICT, III, QUTHUBULLAPUR PHARMAINDIAHYDERABAD, LIMITED, ANDHRA Packer: AUROBINDOANDHRAUNITDISTRICT, III, PRADESH QUTHUBULLAPUR PHARMAHYDERABAD, INDIA LIMITED, ALBERTON,MANUFACTURINGAFRIKACHESHIRE,ASTRAZENECA BIOPHARMA UKSOUTH UK (PTY) LIMITED, AFRICA LTD, PRADESHDISTRICT,MANDAL, INDIA RANGA HYDERABAD, REDDY ANDHRA ANDHRADISTRICT,MANDAL, PRADESH RANGA HYDERABAD, INDIA REDDY Laboratory: FPRC: CHESHIRE,ASTRAZENECASWEDEN UK UKAB, LIMITED,SODERTALJE, Laboratory: FPRC: MANDAL,AUROBINDOUNIT III, RANGA QUTHUBULLAPUR PHARMA REDDY LIMITED, Laboratory: FPRC AUROBINDOMANDAL,UNIT III, QUTHUBULLAPUR RANGAPHARMA REDDY LIMITED, BOKSBURG,LABORATORIES,CONSULTING RSA CHEMICAL ATLASVILLE, SANDTON,LIMBROM &LPRADESHDISTRICT, LABORATORY BUSINESS RSA INDIAHYDERABAD, PARK, SERVICES, ANDHRA SANDTON,LIMBROMANDHRA &LDISTRICT, LABORATORY BUSINESS PRADESH RSA HYDERABAD, PARK, INDIASERVICES, FPRR: ASTRAZENECA FPRR: AUROBINDOMIDRAND,SERVICESKHULULEKANI RSAcc, PHARMA COVENTRY LABORATORY (PTY) PARK, LTD, FPRR: AUROBINDOSERVICESPARK,KHULULEKANI MIDRAND, cc, PHARMA COVENTRY LABORATORY RSA (PTY) Shelf-life: 36 monthsLIMITED,PHARMACEUTICALS SUNNINGHILL, (PTY) RSA Shelf-life: 24RSAMEYERSDAL, months (Provisional) JOHANNESBURG, Shelf-life: 24JOHANNESBURG, monthsLTD, MEYERSDAL, (Provisional) RSA Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 Date of registration: 2 MARCH 2012 55 56 MRF 15 MECOTRIL45/20.2.8/0080 100/25 mg TABLETS NameRegistrationMRF 15 of medicine: number: MECOTRIL45/20.2.8/0081 200/50 mg GOVERNMENT GAZETTE,8JUNE2012 No. 35409 EACHTABLET TABLET CONTAINS: Dosage form: TABLETTABLETS 1,RITONAVIRLOPINAVIR 2, 3, 4, 5, 6, 7, 8 100,0 mg25,0 mg ActiveConditions ingredients: of registration: RITONAVIRLOPINAVIREACH1, 2, TABLET 3, 4, 5, 6, CONTAINS: 7, 8 50,0200,0 mg mg AUROBINDOAUROBINDO PHARMA PHARMA (PTY) LIMITED, LTD Applicant:Manufacturer: AUROBINDOAUROBINDOLTD PHARMA PHARMA (PTY) INDIAHYDERABAD,MANDAL,UNIT III, QUTHUBULLAPUR RANGA ANDHRA REDDY PRADESH DISTRICT, PRADESHHYDERABAD,RANGAQUTHUBULLAPURLIMITED, REDDY UNIT INDIA ANDHRA III, DISTRICT, MANDAL, AUROBINDOINDIAHYDERABAD,MANDAL,UNIT III, QUTHUBULLAPUR RANGAPHARMA ANDHRA REDDY LIMITED, PRADESH DISTRICT, Packer: AUROBINDOHYDERABAD,RANGAQUTHUBULLAPURLIMITED, REDDY UNIT PHARMA ANDHRAIII, DISTRICT, MANDAL, MANDAL,AUROBINDOUNIT III, RANGA QUTHUBULLAPUR PHARMA REDDY LIMITED, DISTRICT, Laboratory: FPRC: QUTHUBULLAPURAUROBINDOLIMITED,PRADESH UNIT INDIAPHARMA III, MANDAL, SANDTON,LIMBROM &LINDIAHYDERABAD, LABORATORY BUSINESS RSA ANDHRA PARK, SERVICES, PRADESH M &LPRADESHHYDERABAD,RANGA LABORATORY REDDY INDIA ANDHRA DISTRICT, MIDRAND,SERVICESKHULULEKANI RSAcc, COVENTRY LABORATORY PARK, SERVICESKHULULEKANIRSABUSINESSSERVICES, cc,PARK, LIMBRO COVENTRY LABORATORY SANDTON, AUROBINDORSAMEYERSDAL, PHARMA JOHANNESBURG, (PTY) LTD, FPRR: LTD,AUROBINDOPARK, MEYERSDAL, MIDRAND, PHARMA RSA (PTY) 224 MARCH months 2012(Provisional) DateShelf-life: of registration: 224JOHANNESBURG, MARCH months 2012(Provisional) RSA MRF 15 MRF15 MRF 15 NameRegistration of medicine: number: METACAM08/3.1.2/14PIGS AND 20 HORSESmg/ml FOR CATTLE, NameRegistration of medicine: number: A39/34/0605COATEDNICOTINELL CHEWING FRUIT 2GUM mg NameRegistration of medicine: number: A39/34/0606COATEDNICOTINELL CHEWING FRUIT 4 GUM mg ActiveDosage ingredients: form: MELOXICAMCONTAINS:EACHSOLUTION 1,0 mlFOR SOLUTION INJECTION 20,0 mg ActiveDosage ingredients: form: CONTAINS:NICOTINEEACHCHEWING CHEWING GUM GUM 2,0 mg ActiveDosage ingredients: form: NICOTINECONTAINS:EACHCHEWING CHEWING GUM GUM 4,0 mg Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 No.35409 STAATSKOERANT, 8JUNIE2012 Applicant:Manufacturer: LES(PTY)LABIANAINGELHEIM FONTS LTD LIFEDE PHARMACEUTICALS TERRASSA, SCIENCES S.A., Applicant:Manufacturer: VEJLE,FERTIN(PTY)NOVARTIS DENMARK LTD A/S, SOUTH DANDYVEJ, AFRICA Applicant:Manufacturer: DENMARKFERTIN(PTY)NOVARTIS LTD A/S, SOUTH DANDYVEJ, AFRICA VEJLE, Packer: BARCELONA,LESLABIANA FONTS LIFE DE SPAINSCIENCES TERRASSA, S.A., Packer: SANDOZVEJLE,FERTIN DENMARK SA, A/S, SPARTAN, DANDYVEJ, Packer: SANDOZDENMARKFERTIN NS, SA, DANDYVEJ, SPARTAN, VEJLE, Laboratory: FPRC: BARCELONA,LESLABIANA FONTS LIFE DE SPAINSCIENCES TERRASSA, S.A., Laboratory: FPRC: SANDOZVEJLE,FERTINKEMPTON DENMARKNS, SA, PARK DANDYVEJ, SPARTAN, Laboratory: FPRC: SANDOZDENMARKFERTINKEMPTON A/S, SA, PARK DANDYVEJ,SPARTAN, VEJLE, FPRR: PHARMACEUTICALS,INGELHEIMWALTLOO,WINTHROP PRETORIAPHARMACEUTICALS, FPRR: KEMPTONNOVARTIS PARKSA, SPARTAN, FPRR: KEMPTONNOVARTIS PARKSA, SPARTAN, DateShelf-life: of registration: 2036FERNDALE, APRILmonths 2012 RANDBURG DateShelf-life: of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 24 20months APRIL 2012 57 58 NameRegistrationMRF of15 medicine: number: A39/34/0607NICOTINELL MINT 2 mg NameRegistrationMRF15 of medicine: number: NICOTINELLA39/34/0608 MINT 4 mg COATED MRF 15 NameRegistration of medicine: number: GAVISCON41/11.10/0215 LIQUISHOT GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: EACHCHEWINGCOATED CHEWING CHEWING GUM GUM GUM ActiveDosage ingredients: form: CHEWINGEACH CHEWING GUM GUM CONTAINS: ActiveDosage ingredients: form: EACHSUSPENSION SACHET CONTAINS: Conditions of registration: 1,NICOTINECONTAINS: 2, 3, 4, 5, 6, 7 2,0 mg Conditions of registration: 1,NICOTINE 2, 3, 4, 5, 6, 7 4,0 mg registration:Conditions of SODIUM1, 2, 3, ALGINATE 4, 5, 6, 8 500,0 mg Manufacturer:Applicant: DENMARKFERTIN(PTY)NOVARTIS LTD A/S, SOUTH DANDYVEJ, AFRICA VEJLE, ApplicantManufacturer: DENMARKFERTINLTDNOVARTIS A/S, SOUTH DANDYVEJ, AFRICA VEJLE, (PTY) Manufacturer:Applicant: HEALTHCARERECKITTPHARMACEUTICALS BENCKISER (UK) LTD, (PTY) HULL, LTD Packer: DENMARKFERTIN A/S, DANDYVEJ, VEJLE, Packer: DENMARKFERTIN NS, DANDYVEJ, VEJLE, Packer: HEALTHCARERECKITTKINGDOMEAST YORKSHIRE, BENCKISER (UK) LTD,UNITED HULL, Laboratory: FPRC: DENMARKFERTINKEMPTONSANDOZ NS, SA, PARK DANDYVEJ, SPARTAN, VEJLE, Laboratory: FPRC: DENMARKFERTINPARKSANDOZ NS, SA, DANDYVEJ, SPARTAN, KEMPTONVEJLE, Laboratory: FPRC: HEALTHCARERECKITTKINGDOMEAST YORKSHIRE, BENCKISER (UK) LTD,UNITED HULL, KEMPTONSANDOZ SA, PARK SPARTAN, PARKSANDOZ SA, SPARTAN, KEMPTON ELANDSFONTEIN,PHARMACEUTICALSRECKITTKINGDOMEAST YORKSHIRE, BENCKISER RSA UNITED (PTY) LTD, PHARMACEUTICALSABSATLASVILLE,LABORATORIESCONSULTING COMMERCIAL BOKSBURG, CHEMICAL (PTY) CHEMISTRY (PTY) LTD, RSALTD FPRR: KEMPTONNOVARTIS PARKSA, SPARTAN, FPRR: KEMPTONNOVARTIS PARKSA, SPARTAN, FPRR: PHARMACEUTICALSRECKITTPRETORIA,DEPARTMENT, BENCKISER RSA GROENKLOOF, (PTY) LTD, DateShelf-life: of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 2024 APRILELANDSFONTEIN,months 2012 (Provisional) RSA MRF 15 MRF15 :F 15 DosageNameRegistration of form: medicine: number: INJECTIONOVITRELLE41/21.10/0523 250 pg/0,5 ml Registration number: Name of medicine: 41/26/0608 ASPEN CARBOPLATIN 50 mg Registration number:Name of medicine: 41/26/0609ASPEN CARBOPLATIN 150 mg Active ingredients: ChoriogonadotropinEACH 0,5 ml SOLUTION alfa 250,0 CONTAINS: pg ActiveDosage ingredients: form: CARBOPLATINEACHFORCONCENTRATE INFUSION 5,0 ml VIAL FOR CONTAINS: SOLUTION 50,0 mg ActiveDosage ingredients: form: CARBOPLATINEACHCONCENTRATE 15,0 ml VIAL FOR CONTAINS: SOLUTION FOR INFUSION 150,0 mg Applicant:registration:Conditions of SERONO1, 2, 3, 4, 5,SA 6, (PTY) 7 LTD Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6, 7, LIMITED 8 Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6, 7, LIMITED 8 Packer:Manufacturer: SpA,INDUSTRIA BARI, ITALY FARMACEUTICAFARMACEUTICA SERONOSERONO Packer:Manufacturer. S.C.BUCHAREST,BUCHAREST,S.C. SINDAN-PHARMA SINDAN-PHARMA ROMANIA ROMANIA S.R.L, S.R.L, Packer:Manufacturer. ROMANIAS.C. SINDAN-PHARMA S.R.L, BUCHAREST, No.35409 STAATSKOERANT, 8JUNIE2012 COINSINS,LABORATOIRES SWITZERLAND SERONO SA, ASPENLONDON,PORTPHARMACARE PHARMACARE ELIZABETH, RSAWILSONIA, LTD, RSA EAST KORTSEN, EAST WILSONIA,ASPENELIZABETH,PHARMACARE PHARMACARE EAST RSA LTD, LONDON, KORTSEN, EAST RSA LONDON, PORT Laboratory: FPRC: COINSINS,SpA,LABORATOIRESINDUSTRIA BARI, ITALYSWITZERLAND FARMACEUTICA SERONO SA, SERONO Laboratory: FPRC: DEPARTMENTPHARMACEUTICALSABSBUCHAREST,S.C. COMMERCIAL SINDAN-PHARMA ROMANIA GROENKLOOF, CHEMISTRY (PTY) S.R.L, LTD Laboratory: FPRC: GROENKLOOF,PHARMACEUTICALSABSROMANIAS.C. SINDAN-PHARMA COMMERCIAL PRETORIA, CHEMISTRY (PTY) S.R.L, LTD RSA BUCHAREST, DEPARTMENT POTCHEFSTROOM,NORTH-WESTINDUSTRIALRESEARCHPRETORIA, RSAINSTITUTE PHARMACY, UNIVERSITY, RSA FOR BUSINESSM&LPOTCHEFSTROOM,PHARMACY,RESEARCH LABORATORY PARK, INSTITUTE NORTH-WEST SANDTON, SERVICES, RSA FOR UNIVERSITY, INDUSTRIAL RSA LIMBRO FPRR: SERONO SA (PTY) LTD, FOURWAYS, FPRC/FPRR: PHARMACARESANDTON,LIMBROM&L LABORATORY BUSINESS RSA LTD, PARK,SERVICES, KORTSEN, FPRC/FPRR: PHARMACARE LTD, SANDTON, RSA LONDON,ASPENPORT ELIZABETH, PHARMACARE RSAWILSONIA, RSA EAST EAST EASTASPENELIZABETH,KORTSEN, LONDON, PHARMACARE PORT RSA WILSONIA,RSA DateShelf-life: of registration: 2024 APRILmonths 2012 at 2-8 °C Shelf-life: FPRR: 24WOODMEAD,PHARMACARE months (Provisional) SANDTON, LTD, at 2-8 RSA °C Shelf-life: FPRR: 24RSAPHARMACARE months (Provisional) LTD, WOODMEAD, at 2-8 °C SANDTON,

Date of registration: 20 APRIL 2012 Date of registration: 20 APRIL 2012 59 60 NameRegistrationMRF 15 of medicine: number: ASPEN41/26/0610 CARBOPLATIN 450 mg NameRegistrationMRF15 of medicine: number: ASPEN42/20.1.1/0247 AZITHROMYCIN IV .F 15 NameRegistration of medicine: number: MYLAN-METHYLPREDNISOLONE42/21.5.1/0310 120 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: CARBOPLATINEACHINFUSIONCONCENTRATE 45,0 ml VIAL FOR CONTAINS: SOLUTION FOR 450,0 mg ActiveDosage ingredients: form: AZITHROMYCINEACHINFUSIONPOWDER VIAL FORSOLUTION CONTAINS: MONOHYDRATE FOR ActiveDosage ingredients: form: MethylprednisoloneEACHINJECTION VIAL CONTAINS: hemisuccinate equivalent to registration:Conditions of 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,TOEQUIVALENT 2, AZITHROMYCIN 3, 4, 5, 6, 7 500,0 mg registration:Conditions of Methylprednisolone1, 2, 3, 4, 5, 6, 7 120,0 mg Manufacturer:Applicant: ROMANIAS.C.PHARMACARE SINDAN-PHARMA LIMITED S.R.L, BUCHAREST, Applicant:Manufacturer: BANNERGHATTA(STERILESTRIDESPHARMACARE ARCOLABPRODUCTS LTD ROAD, LIMITED DIVISION), Manufacturer:Applicant: VIANEXMASATEXIXIABIOLOGICI PHARMACEUTICALS SA (MILANO), - PLANT ITALIA ITALYC, LABORATORIES PALLINI-ATTICA, (PTY) LTD S.R.L., Packer: PHARMACAREROMANIAS.C. SINDAN-PHARMA LTD, KORTSEN, S.R.L, BUCHAREST, PORT Packer: INDIAANEKALSTRIDESBANGALORE, TALUK, ARCOLAB INDIA BANGALORE, LIMITED, Packer: VIANEXMASATEBIOLOGICIGREECE SA (MILANO), ITALIA- PLANT LABORATORIES ITALYC, PALLINI-ATTICA, S.R.L., ASPENWILSONIA,ELIZABETH, PHARMACARE EAST RSA LONDON, EAST LONDON, RSA LONDON,ASPENPORTPHARMACARE ELIZABETH, PHARMACARE RSAWILSONIA, LTD, RSA KORSTEN, EAST EAST GREECERSAPHARMA-Q, INDUSTRIA, JOHANNESBURG, Laboratory: FPRC: SABSPHARMACEUTICALROMANIAS.C. COMMERCIAL SINDAN-PHARMA (PTY) CHEMISTRY S.R.L, LTD BUCHAREST, Laboratory: FPRC: ANEKALPHARMACAREINDIASTRIDES TALUK, ARCOLAB BANGALORE, LTD, LIMITED,KORSTEN, Laboratory: FPRC: PHARMA-Q,GERMISTON,MANUFACTURINGMERCK PHARMACEUTICALS INDUSTRIA, RSA (PTY) JOHANNESBURG,LTD, WADEVILLE, POTCHEFSTROOM,PHARMACY,RESEARCHRSADEPARTMENT INSTITUTE NORTH-WEST GROENKLOOF, RSA FOR UNIVERSITY, INDUSTRIAL PRETORIA, ASPENRESEARCHLONDON,PORT PHARMACARE ELIZABETH, RSAWILSONIA, INSTITUTE RSA EAST EAST FOR SASSPOTCHEFSTROOM,PHARMACY,RESEARCHRSA COMMERCIAL INSTITUTE NORTH-WEST RSA (PTY) FOR LTD UNIVERSITY, INDUSTRIAL M&LBUSINESS LABORATORY PARK, SERVICES, SANDTON, LIMBRO RSA PHARMACEUTICALSABSPOTCHEFSTROOM,WESTINDUSTRIAL COMMERCIALUNIVERSITY, PHARMACY, CHEMISTRYRSA (PTY) NORTH-LTD MASATEBIOLOGICIRSADEPARTMENT,PHARMACEUTICAL (MILANO), ITALIA LABORATORIES GROENKLOOF, ITALY CHEMISTRY PRETORIA,S.R.L., PARK,(PTY)MPRETORIA,DEPARTMENT, & L LTD,LABORATORY SANDTON, LIMBRO RSA GROENKLOOF, RSA BUSINESS SERVICES GREECEVIANEX SA- PLANT C, PALLINI-ATTICA, FPRC/FPRR: WILSONIA,ASPENELIZABETH,PHARMACARE PHARMACARE EAST RSA LTD, LONDON, KORTSEN, EAST RSA LONDON, PORT FPRR: ASPENLONDON,PORTPHARMACARE PHARMACARE ELIZABETH, RSAWILSONIA, LTD, RSA EAST KORSTEN, EAST FPRR MODDERFONTEIN,XIXIA PHARMACEUTICALS, GAUTENG, RSA FPRR: RSAPHARMACARE LTD, WOODMEAD, SANDTON, Shelf-life: 24SANDTON,PHARMACARE months RSA LTD, WOODMEAD, Shelf-life: 24 months DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) at 2-8 °C Date of registration: 20 APRIL 2012 Date of registration: 20 APRIL 2012 NameRegistrationMRF 15 of medicine: number: MYLAN42/21.5.1/0311 METHYLPREDNISOLONE NameRegistrationMRF15 of medicine: number: 42/21.5.1/0312MYLAN-METHYLPREDNISOLONE F 15 NameRegistration of medicine: number TRANDOPRESS42/7.1.3/0352 0,5 mg ActiveDosage ingredients: form: EACHINJECTION500 VIAL CONTAINS: ActiveDosage ingredients: form: EACHINJECTION1 000 VIAL CONTAINS: ActiveDosage ingredients: form: EACHCAPSULE CAPSULE CONTAINS: Conditions of registration: 500,0equivalentMethylprednisolone mg to Methylprednisolone hemisuccinate equivalentMethylprednisolone1 000,0 to mg Methylprednisolone hemisuccinate TRANDOLAPRIL 0,5 mg Applicant: LTDXIXIA1, 2,PHARMACEUTICALS 3, 4, 5, 6, 7 (PTY) Applicant:registration:Conditions of LTDXIXIA1, 2,PHARMACEUTICALS 3, 4, 5, 6, 7 (PTY) Applicant:registration:Conditions of PHARMACARE1, 2, 3, 4, 5, 6, 7, LIMITED 8 Manufacturer. VIANEXS.R.L.,BIOLOGICI MASATE SA - PLANT ITALIA (MILANO), C, LABORATORIES PALLINI- ITALY Manufacturer. VIANEXS.R.L.,BIOLOGICI MASATE SA ITALIA- PLANT (MILANO), LABORATORIES C, PALLINI- ITALY Manufacturer. GREECEPHARMATEN S.A, PALLINI, ATTIKIS, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: VIANEXS.R.L.,ATTICA,BIOLOGICI MASATE GREECESA- PLANT ITALIA (MILANO), C, LABORATORIES PALLINI- ITALY Packer: VIANEXS.R.L.,BIOLOGICIATTICA, MASATE GREECESA- ITALIA PLANT (MILANO), LABORATORIES C, PALLINI- ITALY Packer: PHARMACAREGREECEPHARMATEN S.A, LIMITED, PALLINI, KORSTEN, ATTIKIS, PORT Laboratory: FPRC : MERCKJOHANNESBURG,PHARMA-Q,ATTICA, PHARMACEUTICALSGREECE INDUSTRIA; RSA Laboratory: FPRC: MERCKJOHANNESBURG,PHARMA-Q,ATTICA, PHARMACEUTICALSGREECE INDUSTRIA, RSA Laboratory: FPRC WILSONIA,ASPENPHARMATENELIZABETH, PHARMACARE EAST RSA S.A,LONDON, PALLINI, ESAT RSA LONDON, ATTIKIS, RESEARCHJOHANNESBURG,PHARMA-Q,WADEVILLE,MANUFACTURING INSTITUTEINDUSTRIA, GERMISTON, RSA(PTY) FOR LTD, RSA RESEARCHJOHANNESBURG,PHARMA-Q,WADEVILLE,MANUFACTURING INSTITUTEINDUSTRIA, GERMISTON, RSA(PTY) FOR LTD, RSA WILSONIA,ASPENELIZABETH,PHARMACAREGREECE PHARMACARE ESAT RSA LONDON, LIMITED, EAST RSA KORSTEN, LONDON, PORT PHARMACEUTICALSABSPOTCHEFSTROOM,WESTINDUSTRIAL COMMERCIALUNIVERSITY, PHARMACY, CHEMISTRYRSA (PTY) NORTH- LTD SABSPOTCHEFSTROOM,WESTINDUSTRIAL COMMERCIALUNIVERSITY, PHARMACY, RSA (PTY) NORTH- LTD DEPARTMENT,PRETORIA,PHARMACEUTICALSABS COMMERCIAL RSAGROENKLOOF, CHEMISTRY (PTY) LTD S.R.L.,BIOLOGICIPRETORIA,DEPARTMENT, MASATE ITALIARSA GROENKLOOF, (MILANO), LABORATORIES ITALY S.R.L.,BIOLOGICIPRETORIA,DEPARTMENT,PHARMACEUTICAL MASATE ITALIARSA GROENKLOOF, (MILANO), LABORATORIES CHEMISTRY ITALY M&LRSALIMBROPHARMACY,RESEARCH LABORATORY BUSINESS INSTITUTE POTCHEFSTROOM, SERVICES PARK, FOR SANDTON, (PTY) INDUSTRIAL RSALTD, FPRR: MODDERFONTEIN,XIXIATTICA,VIANEX PHARMACEUTICALS, SA-GREECE PLANT GAUTENG,C, PALLINI- FPRR MODDERFONTEIN,XIXIATTICA,VIANEX PHARMACEUTICALS, SA-GREECE PLANT GAUTENG,C, PALLINI- RSA FPRC/FPRR: ELIZABETH,PHARMACARE RSA LIMITED, KORSTEN, PORT Shelf-life: 24RSA months Shelf-life: 24 months FPRR: SANDTON,PHARMACAREWILSONIA,ASPEN PHARMACARE RSAESAT LIMITED, LONDON, ESAT WOODMEAD, RSA LONDON, Date of registration: 20 APRIL 2012 Date of registration: 20 APRIL 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) 61 62 MRF 15 MRF15 F 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 NameRegistration of medicine: number: 42/20.1.1/0641INJECTIONGULF CEFOTAXIME 2 g NameRegistration of medicine: number: VATICOL42/7.5/0805 XL NameRegistration of medicine: number: IRBELO42/7.1.3/0947 75 ActiveDosage ingredients: form: EQUIVALENTCEFOTAXIMEEACH VIAL CONTAINS: TOSODIUM ActiveDosage ingredients: form: TABLETFLUVASTATINEACH TABLET CONTAINS:SODIUM EQUIVALENT TO 80,0 mg ActiveDosage ingredients: form: IRBESARTANEACHTABLET TABLET CONTAINS: 75,0 mg Applicant:Conditions of registration: GULF1,CEFOTAXIME 2, 3, DRUG 4, 5, 6, COMPANY 7 (PTY) 2,0 g Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6, 7, LIMITED 8 Applicant:Conditions of registration: RANBAXY1, 2, 3, 4,SA 5, (PTY) 6, 7, 8LTD Manufacturer: TOLEDO,LTDLABORATORIO SPAIN REIG JOFRE, Manufacturer. PHARMACAREPHARMATHENELIZABETH, S.A., LTD,RSA PALLINI,KORSTEN, ATTIKIS, PORT GREECE Manufacturer: PRADESH,LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIES INDIA Packer: TOLEDO,LABORATORIO SPAIN REIG JOFRE, Packer: PHARMACAREPHARMATHENWILSONIA,ASPEN PHARMACARE EAST S.A.,LTD, LONDON, PALLINI,KORSTEN, EAST RSA LONDON,ATTIKIS, PORT GREECE Packer: LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIES PHARMANELFAMARWILSONIA,ASPENELIZABETH, PHARMACARES.A., EAST RSA ANTHOUSA,PHARMACEUTICALS LONDON, EAST ATTIKIS, RSA LONDON, S.A.,GREECE PRADESH, INDIA Laboratory: FPRC: SABSTOLEDO,LABORATORIO PHARMACEUTICAL SPAIN REIG JOFRE, Laboratory: FPRC: PHARMACEUTICALSABSPHARMATHENSCHIMATARI, COMMERCIAL ATHENS, S.A., CHEMISTRY PALLINI,(PTY) GREECE LTD ATTIKIS, DEPARTMENT, GREECE Laboratory FPRC PRADESH,LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIES INDIA CONSULTINGORMONDE,M&LGROENKLOOF,CHEMISTRY LABORATORY JOHANNESBURG LABORATORY, CHEMICAL PRETORIA SERVICES, POTCHEFSTROOM,PHARMACY,RESEARCHGROENKLOOF, INSTITUTE NORTH-WEST PRETORIA, RSA FOR UNIVERSITY,RSA INDUSTRIAL CONSULTINGMIDRAND,SERVICES,KHULULEKANI RSA COVENTRY CHEMICAL LABORATORY PARK, JOHANNESBURGPHARMA-Q,BOKSBURGLABORATORIES, INDUSTRIA-WEST, ATLASVILLE, BUSINESSM&L LABORATORY PARK, SANDTON, SERVICES, RSA LIMBRO ROODEPOORT,(PTY)BE-TABSATLASVILLE,LABORATORIES LTD, PHARMACEUTICALS STORMHILL, BOKSBURG, RSA(PTY) LTD, RSA MICROBIOLOGICALCONSULTINGSILVERTONDALE,PHARMACEUTICALINSTITUTE FOR PRETORIA SERVICES, FPRR: EDGECOMBEGULFBOKSBURGLABORATORY, DRUG COMPANY, BEYERSPARK, MOUNT FPRC/FPRR: ELIZABETH,PHARMACARE RSA LTD, KORSTEN, PORT FPRR AVENUERANBAXY NORTH, SA (PTY)CENTURION, LTD, LENCHEN RSA Shelf-life: 24 months FPRR: WILSONIA,ASPENRSAPHARMACARE PHARMACARE EAST LONDON, LTD, EAST WOODMEAD, RSA LONDON, SANDTON, Shelf-life: 24 months (Provisional) Date of registration: 20 APRIL 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) Date of registration: 20 APRIL 2012 MRF 15 MRF15 MRF 15 medicine:Namenumber:Registration of 42/7.1.3/0948IRBELO 150 NameRegistration of medicine: number: 42/7.1.3/0949IRBELO 300 medicine:Namenumber:Registration of RAN42/7.1.3/0950 IRBESARTAN 75 ActiveDosage ingredients: form: TABLETIRBESARTANEACH TABLET CONTAINS: 150,0 mg ActiveDosage ingredients: form: TABLETIRBESARTANEACH TABLET CONTAINS: 300,0 mg ActiveDosage form: IRBESARTANEACHTABLET TABLET CONTAINS: Applicant:registration:Conditions of RANBAXY1, 2, 3, 4, 5, SA 6, 7,(Pm') 8 LTD Applicant:registration:Conditions of RANBAXY1, 2, 3, 4, SA 5, (PTY)6, 7, 8 LTD Applicant:registration:Conditionsingredients: of RANBAXY1, 2, 3, 4, 5, SA 6, 7,(P11') 8 LTD 75,0 mg Manufacturer: PRADESH,SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIES INDIA Manufacturer: PRADESH,SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIESINDIA Manufacturer: PRADESH,LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIES INDIA No.35409 STAATSKOERANT, 8JUNIE2012 Packer: PRADESH,SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIES INDIA Packer: PRADESH,SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIESINDIA Packer: PRADESH,LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIES INDIA FPRC:Laboratory: SIRMOUR,HIMACHALPRADESH,LIMITED,RANBAXY LABORATORIES INDIA Laboratory: FPRC: PRADESH,SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIESINDIA FPRC:Laboratory: KHULULEKANIPRADESH,LIMITED,RANBAXY SIRMOUR,HIMACHAL LABORATORIESINDIA LABORATORY CONSULTINGMIDRAND,COVENTRYLABORATORYKHULULEKANI RSA PARK, CHEMICAL SERVICES, CONSULTINGMIDRAND,COVENTRYLABORATORYKHULULEKANI RSA PARK, CHEMICALSERVICES, ATLASVILLE,LABORATORIESCONSULTINGMIDRAND,SERVICES, RSABOKSBURG, COVENTRY CHEMICAL (PTY) LTD, PARK,RSA BE-TABSATLASVILLE,PHARMACEUTICALSRSALABORATORIES BOKSBURG, (PTY) (PTY) LTD, ATLASVILLE,PHARMACEUTICALSBE-TABSRSALABORATORIES BOKSBURG, (PTY) (PTY) LTD, ROODEPOORT,(PTY)BE-TABS LTD, PHARMACEUTICALS STORMHILL, RSA FPRR: LENCHENRANBAXYROODEPOORT,LTD, STORMHILL, AVENUESA (PTY) RSA NORTH,LTD, FPRR: LENCHENRANBAXYROODEPOORT,LTD, STORMHILL, AVENUESA (PTY) RSA NORTH,LTD, FPRR: LENCHENRANBAXY AVENUE SA (Fr() NORTH, LTD, CENTURION, RSA CENTURION, RSA CENTURION, RSA 63 registration:DateShelf-life: of 2024 APRILmonths 2012 (Provisional) Shelf-life:Date of registration: 24 20months APRIL (Provisional) 2012 registration:DateShelf-life: of 2024 APRILmonths 2012 (Provisional) 64 MRF 15 MRF15 v1RF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: TABLETRAN42/7.1.3/0951 IRBESARTAN 150 RegistrationDosageName of form: medicine:number: TABLET42/7.1.3/0952 IRBESARTAN 300 RegistrationDosageName of form: medicine:number: SOLUTIONMYLAN42/26/0965 CARBOPLATIN FOR INJECTION 150 ConditionsActive ingredients: of 1,IRBESARTANEACH 2, 3, TABLET4, 5, 6, 7,150,0 CONTAINS: 8 mg ActiveConditions ingredients: of registration: IRBESARTANEACH TABLET 300,0 CONTAINS: mg2, 3, 4, 5, 6, 7, 8 ActiveConditions ingredients: of 1,CARBOPLATINEACH 2, 3, VIAL4, 5, 6,CONTAINS: 7, 8 150,0 mg Manufacturer:Applicant:registration: RANBAXY LABORATORIESSA (PTY) LTD Manufacturer:Applicant: LABORATORIESSA (PTY) LTD Manufacturer:Applicant:registration: VIANEXXIXIA PHARMACEUTICALS S.A., PALLINI, ATTICA, (PTY) GREECE LTD Packer: RANBAXYPRADESH,SIRMOUR,HIMACHALLIMITED, LABORATORIES INDIA Packer: SIRMOUR,HIMACHALLIMITED, LABORATORIESINDIA Packer: VIANEX S.A., PALLINI, ATTICA, GREECE Laboratory: FPRC: RANBAXYPRADESH,SIRMOUR,HIMACHALLIMITED, LABORATORIES INDIA SIRMOUR,HIMACHAL INDIA KHULULEKANIPRADESH,SIRMOUR,HIMACHALLIMITED, INDIA LABORATORY Laboratory: FPRC: SIRMOUR,HIMACHALLIMITED,RANBAXY LABORATORIES INDIA Laboratory: FPRC: GERARDMCDERMOTTVIANEXHERTFORDSHIRE,GENERICS S.A., LABORATORIES, PALLINI, LABORATORIESUK LIMITED, UNITEDATTICA, DUBLIN,POTTERS KINGDOM T/AGREECE BAR, ATLASVILLE,CONSULTINGSERVICES,LABORATORIESPARK, MIDRAND, COVENTRY BOKSBURG, CHEMICAL (PTY) RSA LTD, MIDRAND,COVENTRY RSA PARK, CHEMICALSERVICES, WADEVILLE,MANUFACTURINGMERCKIRELAND PHARMACEUTICAL GERMISTON, (PTY) LTD, RSA LTD,PHARMACEUTICALSBE-TABSRSA STORMHILL, (PTY) ATLASVILLE, BOKSBURG, (PTY) LTD, (PTY) PHARMACEUTICALSABSPOTCHEFSTROOM,PHARMACY,RESEARCH COMMERCIAL INSTITUTE NORTH-WEST CHEMISTRY (PTY) RSA LTDFOR UNIVERSITY, INDUSTRIAL FPRR: LENCHENRANBAXYROODEPOORT, SAAVENUE (PTY) RSA LTD,NORTH, FPRR: STORMHILL, AVENUESA (PTY) NORTH,LTD, RSA FPRR: XIXIAPRETORIA,DEPARTMENTLTD,MODDERFONTEIN, PHARMACEUTICALS RSA GROENKLOOF, (PTY)RSA DateShelf-life: of registration: 2024CENTURION, APRILmonths 2012 (Provisional) RSA DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) RSA DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) RegistrationMRF 15 number: MRF15Registration number: 42/2.9/0967 F 15 42/21.12/1096 DosageName of form: medicine: SOLUTIONMYLAN42/26/0965 CARBOPLATIN FOR INJECTION 450 DosageName of form: medicine: TRAMASPENCAPSULE 50 mg DosageNameRegistration of form: medicine: number: TABLETEVERDEX 1 mg ConditionsActive ingredients: of registration: 1,CARBOPLATINEACH 2, 3, VIAL4, 5, 6,CONTAINS: 7, 8 450,0 mg ActiveConditions ingredients: of registration: TramadolEACH1, 2,CAPSULE50,0 3, Hydrochloride 4, mg 5, 6, CONTAINS: 7 ConditionsActive ingredients: of registration: ANASTROZOLEEACH1, 2,TABLET 3, 4, 5, CONTAINS:6, 7 1,0 mg Manufacturer.Applicant: VIANEXLTDXIXIA S.A., PHARMACEUTICALS PALLINI, ATTICA, (PTY) Manufacturer.Applicant: FAMARPHARMACARE ITALIA S.p.A, LIMITED BARANZATE DI Manufacturer:Applicant ASTRAZENECA PHARMACEUTICALS,PHARMACEUTICALS (PTY)NEWARK, LTD Packer: VIANEXGREECE S.A., PALLINI, ATTICA, Packer: BOLLATE,FAMAR ITALIA ITALY S.p.A, BARANZATE DI Packer: ASTRAZENECADELAWARE, PHARMACEUTICALS,USA NEWARK, No.35409 STAATSKOERANT, 8JUNIE2012 ASPENLONDON,PORTPHARMACARE PHARMACARE ELIZABETH, RSAWILSONIA, LTD, RSA EAST KORTSEN, EAST ASTRAZENECACHESHIRE, UKUK LTD, MACCLESFIELD, Laboratory: FPRC GENERICSVIANEXKINGDOMBAR,GREECE HERTFORDSHIRE,S.A., UK PAWN!, LIMITED, ATTICA, POTTERS UNITED Laboratory: FPRC: DEPARTMENTPHARMACEUTICALSABSBOLLATE,FAMAR COMMERCIAL ITALIA ITALY GROENKLOOF, S.p.A, CHEMISTRY (PTY) BARANZATE LTD DI Laboratory: FPRC: CARDINALDELAWARE,ASTRAZENECACHESHIRE, HEALTH USA UK PHARMACEUTICALS,UK LTD,UK 417 MACCLESFIELD, LIMITED, STOCKPOT, NEWARK, MCDERMOTTMERCKIRELANDGERARD PHARMACEUTICAL. LABORATORIES, LABORATORIES DUBLIN, T/A WESTRESEARCHPRETORIA,POTCHEFSTROOM,INDUSTRIAL UNIVERSITY, RSAINSTITUTE PHARMACY, RSAFOR NORTH- ATLASVILLE,ALBERTON,AFRIKACHESHIRE,CONSULTING BIOPHARMA UKRSA BOKSBURG CHEMICAL (PTY) LTD, LABORATORIES, ALRODE, WESTWADEVILLE,MANUFACTURINGINDUSTRIALRESEARCH UNIVERSITY, GERMISTON, INSTITUTE PHARMACY, (PTY) LTD, FOR RSA NORTH- SANDTON,LIMBROM&L LABORATORY BUSINESS RSA PARK,SERVICES, PRETORIA,SABSDEPARTMENTPHARMACEUTICALPOTCHEFSTROOM, COMMERCIAL RSA GROENKLOOF, (PTY) CHEMISTRYRSA LTD FPRR: LTD,MODDERFONTEIN,XIXIA PHARMACEUTICALS RSA (PTY) FPRC/FPRR: LONDON,ASPENPORTPHARMACARE ELIZABETH, PHARMACARE WILSONIA, LTD, RSA KORTSEN, EAST EAST FPRR: SUNNINGHILL,ASTRAZENECA JOHANNESBURG PHARMACEUTICALS, Shelf-life: 24 months (Provisional) FPRR: PHARMACARELONDON, RSA LTD, WOODMEAD, Shelf-life: 60 months 65 Date of registration: 20 APRIL 2012 DateShelf-life: of registration: 2024SANDTON, monthsAPRIL 2012 RSA Date of registration: 20 APRIL 2012 66 MRF 15 MRF15 MRF 15 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageNameRegistration of form: medicine: number: TABLETRISPEVON43/2.6.5/0039 1 DosageNameRegistration of form: medicine: number: TABLET43/2.6.5/0040RISPEVON 2 DosageRegistrationName form: of medicine:number: TABLETRISPEVON43/2.6.5/0041 3 ConditionsActive ingredients: of registration: 1,RISPERIDONEEACH 2, 3, TABLET 4, 5, 6, 7, CONTAINS: 8 1,0 mg ConditionsActive ingredients: of registration: 1,RISPERIDONEEACH 2, 3, TABLET 4, 5, 6, 7, CONTAINS: 8 2,0 mg ConditionsActive ingredients: of 1,RISPERIDONEEACH 2, 3, TABLET 4, 5, 6, 7, CONTAINS: 8 3,0 mg Manufacturer:Applicant: TORRENTTRINITY PHARMA (PTY) LTD Manufacturer:Applicant: TORRENTTRINITY PHARMA PHARMACEUTICALS (PTY) LTD Manufacturer:Applicant:registration: TORRENTTRINITY PHARMACEUTICALS PHARMA (PTY) LTD LTD, Packer: TORRENTPHARMACEUTICALSINDRAD, MEHSANA, INDIALTD, Packer: TORRENTLTD,LTD,INDIA INDRAD, INDRAD, PHARMACEUTICALS MEHSANA, INDIA MEHSANA, Packer: INDRAD,TORRENT MEHSANA,MEHSANA, PHARMACEUTICALS INDIAINDIA LTD, Laboratory: FPRC: TORRENTINDRAD, MEHSANA, INDIA , Laboratory: FPRC: Laboratory: FPRC: PHARMACEUTICALINSTITUTEINDRAD,PHARMACEUTICALS MEHSANA, FOR INDIALTD, SILVERTONDALE,PHARMACEUTICALINSTITUTELTD,TORRENT INDRAD, PHARMACEUTICALSFOR MEHSANA, PRETORIA, SERVICES, INDIA PRETORIA,SERVICES,INSTITUTEINDRAD,TORRENT MEHSANA, PHARMACEUTICALS FORSILVERTONDALE,RSA PHARMACEUTICAL INDIA LTD, NORTH-WESTRESEARCHPRETORIA,SERVICES,INDUSTRIAL SILVERTONDALE,RSAINSTITUTE UNIVERSITY, PHARMACY, FOR POTCHEFSTROOM,NORTH-WESTRESEARCHRSAINDUSTRIAL INSTITUTE UNIVERSITY, PHARMACY, RSA FOR WESTPOTCHEFSTROOM,INDUSTRIALRESEARCH UNIVERSITY, INSTITUTE PHARMACY, RSA FOR NORTH- FPRR: RSAMURRAYFIELD,TRINITYPOTCHEFSTROOM, PHARMA PRETORIA, (PTY) RSA LTD, FPRR: MURRAYFIELD,TRINITY PHARMA PRETORIA, (PTY) LTD, RSA FPRR: TRINITYMURRAYFIELD, PHARMA (PTY) PRETORIA, LTD, RSA DateShelf-life: of registration: 20(Provisional)24 APRILmonths 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) MRF 15 MRF15 MRF 15 DosageNameRegistration of form: medicine: number: TABLET43/2.6.5/0042RISPEVON 4 DosageNameRegistration of form: medicine: number: 43/26/0046POWDERMYLAN GEMCITABINE FOR INJECTION 1 g DosageNameRegistration of form: medicine: number: TABLETORCHID43/20.1.1/0062 CEFUROXIME 250 mg Active ingredients: RISPERIDONEEACH TABLET CONTAINS: 4,0 mg Active ingredients: GEMCITABINEEACH VIAL CONTAINS: EQUIVALENT TO 1,0 g Active ingredients: CEFUROXIMEEQUIVALENTEACH TABLET TO AXETILCONTAINS: 250,0 mg Applicant:Conditions of registration: TRINITY1, 2, 3, 4, PHARMA5, 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: LTDXIXIA PHARMACEUTICALS2, 3, (PTY) 4, 5, 6, 7, 8 ApplicantConditions of registration: SAORCHID1, 2, (PTY) 3, 4, PHARMACEUTICALS5,LTD 6, 7 Manufacturer: TORRENTLTD, INDRAD, PHARMACEUTICALS MEHSANA, Manufacturer: SANAND,INTAS PHARMACEUTICALS DISTRICT AHMEDABAD, LTD, Manufacturer: SRIPERUMBUDUR,ORCHID HEALTHCARE, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: TORRENTLTD,INDIA INDRAD, PHARMACEUTICALS MEHSANA, INDIA Packer: GUJURAT,SANAND, DISTRICT INDIA AHMEDABAD, PHARMACEUTICALS LTD, Packer: SRIPERUMBUDUR,ORCHIDKANCHEEPURAM, HEALTHCARE, INDIA Laboratory: FPRC: SERVICES,PRETORIA,INSTITUTELTD,TORRENT INDRAD, SILVERTONDALE, PHARMACEUTICALS FORRSA MEHSANA, PHARMACEUTICAL INDIA Laboratory: FPRC: GENERICSGUJURAT,SANAND,INTAS PHARMACEUTICALS DISTRICT INDIAUK LIMITED, AHMEDABAD, POTTERS LTD, Laboratory: FPRC CONSULTINGKANCHEEPURAM,SRIPERUMBUDUR,ORCHID HEALTHCARE, CHEMICAL INDIA WESTPOTCHEFSTROOM,INDUSTRIALRESEARCH UNIVERSITY, INSTITUTE PHARMACY, RSA FOR NORTH- GERARDMCDERMOTTKINGDOMBAR, HERTFORDSHIRE, LABORATORIES, LABORATORIES UNITED T/A IRELAND NORTH-WESTINDUSTRIALRESEARCHBOKSBURG,LABORATORIES, INSTITUTE PHARMACY,RSA UNIVERSITY, ATLASVILLE, FOR INDUSTRIALRESEARCHWADEVILLE,MANUFACTURINGMERCK PHARMACEUTICAL INSTITUTE PHARMACY,GERMISTON, (PTY) FOR LTD, NORTH- RSA RSASILVERTONDALE,PHARMACEUTICALINSTITUTEPOTCHEFSTROOM, FOR PRETORIA, SERVICES, RSA PHARMACEUTICALSABSPOTCHEFSTROOM,WEST COMMERCIALUNIVERSITY, CHEMISTRYRSA (PTY) LTD GROENKLOOF, FPRR: MURRAYFIELD,TRINITY PHARMA PRETORIA, (PTY) LTD, RSA FPRR: LTD,MODDERFONTEIN,XIXIAPRETORIA, PHARMACEUTICALS RSA RSA (PTY) FPRR: POTCHEFSTROOM,SA,ORCHID NOORBRUG, PHARMACEUTICALS, RSA DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf -life:of registration: 2024 APRILmonths 2012 67 68 RegistrationMRF 15 number: 43/20.1.1/0063 RegistrationMRF 15 number: 43/26/0068 Registration number: GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageName of form: medicine: TABLETORCHID CEFUROXIME 500 mg DosageName of form: medicine: POWDERMYLAN GEMCITABINE FOR INJECTION 200 mg DosageName of form: medicine: TABLETZEEMIDE43/20.1.1/0221 500 mg Active ingredients: CEFUROXIMETOEACH TABLET AXETILCONTAINS:500,0 mg EQUIVALENT Active ingredients: GEMCITABINEEACH VIAL CONTAINS: 200,0EQUIVALENT mg TO Active ingredients: equivalentAzithromycinEACH TABLET to dehydrate CONTAINS: Applicant:Conditions of registration: ORCHID1, 2, 3, 4, PHARMACEUTICALS5, 6, 7 SA Applicant:Conditions of registration: XIXIA1, 2, 3, PHARMACEUTICALS 4, 5, 6, 7, 8 (PTY) Applicant:Conditions of registration: Azithromycin1, 2, 3, 4, 5, 6, 7 500,0 mg Manufacturer: INDIASRIPERUMBUDUR,ORCHID(PTY) LTD HEALTHCARE, KANCHEEPURAM, Manufacturer. AHMEDABAD,SANAND,INTASLTD PHARMACEUTICALS DISTRICT GUJURAT, INDIA LTD, Manufacturer. TERRASSA-BARCELONA,KERNBRIMPHARM PHARMA SA S.L., (PTY) VENUS, LTD Packer: INDIASRIPERUMBUDUR,ORCHID HEALTHCARE, KANCHEEPURAM, Packer: AHMEDABAD,SANAND,INTAS PHARMACEUTICALS DISTRICT GUJURAT, INDIA LTD, Packer: SPAINTERRASSA-BARCELONA,KERN PHARMA S.L., VENUS, Laboratory: FPRC: LABORATORIES,CONSULTINGINDIASRIPERUMBUDUR,ORCHID HEALTHCARE, CHEMICAL ATLASVILLE, KANCHEEPURAM, Laboratory: FPRC: AHMEDABAD,POTTERSGENERICSSANAND,INTAS PHARMACEUTICALS DISTRICTBAR, GUJURAT,UK LIMITED, INDIA LTD, Laboratory: FPRC: SPAINTERRASSA-BARCELONA,KERN PHARMA S.L., VENUS, POTCHEFSTROOM,WESTINDUSTRIALRESEARCHBOKSBURG, UNIVERSITY, INSTITUTE RSAPHARMACY, RSA FOR NORTH- DUBLIN,T/AMCDERMOTTKINGDOMHERTFORDSHIRE, GERARD IRELAND LABORATORIES, LABORATORIES UNITED BOKSBURG,LABORATORIES,CONSULTING RSA CHEMICAL ATLASVILLE, PRETORIA,SERVICES,INSTITUTE SILVERTONDALE,RSA FOR PHARMACEUTICAL WADEVILLE,INDUSTRIALRESEARCHMANUFACTURINGMERCK PHARMACEUTICAL GERMISTON, INSTITUTE PHARMACY, (PTY) FORRSA LTD, DEPARTMENTPHARMACEUTICALSABSPOTCHEFSTROOM,NORTH-WEST COMMERCIAL UNIVERSITY,GROENKLOOF, CHEMISTRYRSA (PTY) LTD FPRR: RSANOORBRUG,ORCHID PHARMACEUTICALS, POTCHEFSTROOM, SA, FPRR: LTD,XIXIAPRETORIA, MODDERFONTEIN, PHARMACEUTICALS RSA RSA (PTY) FPRR: CLAREMONT,BRIMPHARM SA CAPE (PTY) TOWN, LTD, DateShelf-life: of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf-life: of registration: 20 APRIL24RSA months 2012 MRF 15 MRF15 MRF 15 RegistrationDosageName of form: medicine:number: TABLETASPEN43/11.4.3/0545 PANTOPRAZOLE 20 DosageNameRegistration of form: medicine: number: TABLETASPEN43/11.4.3/0546 PANTOPRAZOLE 40 DosageNameRegistration of form: medicine: number: TABLETVUDERIT43/20.2.8/0570 30 mg Active ingredients: Pantoprazole20,0equivalentPantoprazofeEACH TABLETto Sodium mg CONTAINS: Sesquihydrate Active ingredients: SesquihydratePantoprazoleEACH TABLET Sodium equivalent CONTAINS: to Active ingredients: STAVUDINELAMIVUDINEEACH TABLET 150,0 CONTAINS: mg 30,0 mg Applicant:Conditions of registration: PHARMACARE1, 2, 3, 4, 5, 6, 7, LIMITED 8 Applicant:Conditions of registration: PHARMACARE1,Pantoprazole 2, 3, 4, 5, 6, 7, LIMITED 8 40,0 mg Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7 (PTY) LTD Manufacturer: ACTAVIS LTD.,Hf., ICELAND ZEJTUN, MALTA Manufacturer: ACTAVISMALTAACTAVIS Hf., LTD., ICELAND ZEJTUN, Manufacturer: AUROBINDOREDDYQUTHUBULLAPUR DISTRICT, PHARMA ANDHRAMANDAL, LTD, UNIT PRADESH, RANGA III, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: ACTAVIS LTD.,Hf., ICELAND ZEJTUN, MALTA Packer: ACTAVISMALTA LTD.,Hf., ICELAND ZEJTUN, Packer: AUROBINDOREDDYQUTHUBULLAPURINDIA DISTRICT, PHARMA ANDHRAMANDAL, LTD, UNIT PRADESH, RANGA III, Laboratory: FPRC: PHARMACEUTICALSABSACTAVIS COMMERCIAL LTD.,Hf., ICELAND ZEJTUN, CHEMISTRY (PTY) MALTA LTD Laboratory: FPRC: ACTAVISMALTA LTD.,Hf., ICELAND ZEJTUN, Laboratory: FPRC AUROBINDOQUTHUBULLAPURINDIA PHARMA MANDAL, LTD, UNIT RANGA III, POTCHEFSTROOM,INDUSTRIALRESEARCHPRETORIA,DEPARTMENT RSAINSTITUTE PHARMACY, GROENKLOOF, RSA FOR GROENKLOOF,CHEMISTRYPHARMACEUTICALSABS COMMERCIAL DEPARTMENT PRETORIA, (PTY) LTD M&LKHULULEKANIBUSINESSINDIAREDDY LABORATORY DISTRICT, PARK, LABORATORY SERVICES, SANDTON, ANDHRA PRADESH,LIMBRO RSA SANDTON,LTD,M&L LABORATORYLfMBRO RSA BUSINESS SERVICES PARK, (PTY) M&LPOTCHEFSTROOM,INDUSTRIALRESEARCHRSA LABORATORY INSTITUTE PHARMACY, SERVICESRSA FOR MIDRAND,SERVICES, RSA COVENTRY PARK, FPRR: WOODMEAD,PHARMACARE SANDTON, LIMITED, RSA FPRR: WOODMEAD,PHARMACAREPARK,(PTY) LTD, SANDTON, SANDTON,LIMBRO LIMITED, RSA BUSINESS RSA FPRR: JOHANNESBURGAUROBINDO PHARMA, MEYERSDAL, DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf-life: of registration: 24 months (Provisional) DateShelf-life: of registration: 2024 APRILmonths 2012 20 APRIL 2012 69 70 NameRegistrationMRF of 15 medicine: number: VUDERIT43/20.2.8/0571 40 mg RegistrationMRF15Name of number:medicine: EPIMATE43/2.5/0823 25 MRF 15 NameRegistration of medicine: number. EPIMATE43/2.5/0824 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: TABLETSTAVUDINELAMIVUDINEEACH TABLET 150,0 CONTAINS: mg 40,0 mg ActiveDosage ingredients: form: TOPIRAMATEEACHTABLET TABLET CONTAINS: 25,0 mg ActiveDosage ingredients: form: TABLETTOPIRAMATEEACH TABLET CONTAINS: 50,0 mg Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7 (PTY) LTD Applicant:Conditions of registration: TRINITY1, 2, 3, 4, PHARMA5, 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: TRINITY1, 2, 3, PHARMA 4, 5, 6, 7, (PTY)8 Manufacturer. QUTHUBULLAPURAUROBINDORANGA REDDY PHARMA DISTRICT,MANDAL, LTD, UNIT ANDHRA III, Manufacturer. TORRENTINDRAD,PHARMACEUTICALS DISTRICT MEHSANA, LTD, Manufacturer. TORRENTINDRAD,PHARMACEUTICALSLTD DISTRICT LTD, Packer: AUROBINDORANGAQUTHUBULLAPURPRADESH, REDDY PHARMA INDIA DISTRICT, MANDAL, LTD, UNIT ANDHRA III, Packer: INDRAD,PHARMACEUTICALSTORRENTINDIA DISTRICT MEHSANA, LTD, Packer: INDRAD,PHARMACEUTICALSTORRENTMEHSANA, DISTRICT INDIA LTD, Laboratory: FPRC: QUTHUBULLAPURAUROBINDORANGAPRADESH, REDDY PHARMA INDIA DISTRICT,MANDAL, LTD, UNIT ANDHRA III, Laboratory: FPRC: TORRENTINDRAD,PHARMACEUTICALSINDIA DISTRICT MEHSANA, LTD, Laboratory: FPRC TORRENTINDRAD,PHARMACEUTICALSMEHSANA, DISTRICT INDIA LTD, KHULULEKANISANDTON,M&LLIMBROPRADESH, LABORATORY RSABUSINESS INDIA LABORATORY SERVICES, PARK, SERVICES,PHARMACEUTICALINSTITUTEINDIA FORSILVERTONDALE, SERVICES,PHARMACEUTICALINSTITUTEMEHSANA, FORINDIA MIDRAND,SERVICES, RSA COVENTRY PARK, POTCHEFSTROOM,NORTH-WESTINDUSTRIALRESEARCHPRETORIA, RSAINSTITUTE PHARMACY, UNIVERSITY, RSA FOR PHARMACY,FORRESEARCHPRETORIA,SILVERTONDALE, INDUSTRIAL RSAINSTITUTE NORTH-WEST FPRR: MEYERSDAL,AUROBINDO PHARMA, JOHANNESBURG FPRR: MURRAYFEILD,TRINITY PHARMA PRETORIA, (PTY) LTD, FPRR: LTD,TRINITYPOTCHEFSTROOM,UNIVERSITY, MURRAYFEILD, PHARMA (PTY) RSA Shelf-life:Date of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 2024 APRIL RSAmonths 2012 (Provisional) Shelf-life:Date of registration: 2024 APRIL PRETORIA,months 2012 (Provisional) RSA RegistrationMRF 15 number: RegistrationMRF15 number: 2F 15 Registration number: DosageName of form: medicine: TABLETEPIMATE43/2.5/0825 100 DosageName form: of medicine: TABLETEPIMATE43/2.5/0826 200 DosageName of form: medicine: TABLET43/11.4.3/1001PANTOLOC OTC Active ingredients: TOPIRAMATEEACH TABLET CONTAINS: 100,0 mg Active ingredients: TOPIRAMATEEACH TABLET CONTAINS: 200,0 mg Active ingredients: EQUIVALENTSESQUIHYDRATEPANTOPRAZOLEEACH TABLET TO CONTAINS: SODIUM Applicant:Conditions of registration: TRINITY1, 2, 3, PHARMA 4, 5, 6, 7, (PTY)8 Applicant:Conditions of registration: TRINITY1, 2, 3, PHARMA 4, 5, 6, 7 (PTY) LTD Applicant:Conditions of registration: NYCOMED1,PANTOPRAZOLE 2, 3, 4, 5, (PTY)6, 7 LTD 20,0 mg Manufacturer: INDRAD,PHARMACEUTICALSTORRENTLTD DISTRICT LTD, Manufacturer: MEHSANA,LTD,TORRENT INDRAD, PHARMACEUTICALS INDIA DISTRICT Manufacturer. ADAVANCEORANIENBURG,NYCOMED PHARMA GmbH, GERMANY GmbH, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: TORRENTPHARMACEUTICALSMEHSANA, INDIA LTD, ' Packer: LTD,TORRENT INDRAD, PHARMACEUTICALS DISTRICT Packer. ORANIENBURG,NYCOMEDBERLIN, GERMANY GmbH, GERMANY Laboratory: FPRC: TORRENTPHARMACEUTICALSMEHSANA,INDRAD, DISTRICT INDIA LTD, Laboratory: FPRC: LTD,TORRENTMEHSANA, INDRAD, PHARMACEUTICALS INDIA DISTRICT Laboratory: FPRC ORANIENBURG,NYCOMED GmbH, GERMANY SERVICES,PHARMACEUTICALINSTITUTEMEHSANA,INDRAD, DISTRICT FORINDIA RSASILVERTONDALE,PHARMACEUTICALINSTITUTEMEHSANA, FORINDIA PRETORIA, SERVICES, PHARMACY,FORRESEARCHPRETORIA,SILVERTONDALE, INDUSTRIAL NORTH-WEST RSAINSTITUTE POTCHEFSTROOM,NORTH-WESTINDUSTRIALRESEARCH INSTITUTE PHARMACY, UNIVERSITY, RSA FOR FPRR: LTD,TRINITYPOTCHEFSTROOM,UNIVERSITY, MURRAYFEILD, PHARMA (PTY) RSA FPRR: TRINITYMURRAYFEILD, PHARMA (PTY)PRETORIA, LTD, FPRR: BRYANSTON,NYCOMED (PTY) RSA LTD, DateShelf-life: of registration: 2024PRETORIA, APRIL months 2012 (Provisional) RSA DateShelf-life: of registration: 20 APRIL24RSA months 2012 (Provisional) DateShelf -life:of registration: 2036 APRIL months 2012 71 72 MRFNameRegistration 15 of medicine: number: ZYDUS43/1.2/1 01ESCITALOPRAM 5 10 NameRegistrationMRF15 of medicine: number: BIQURETIC43/7.1.3/1044 10/12,5 mg MRF 15 NameRegistration of medicine: number: BIQURETIC43/7.1.3/1045 20/12,5 mg GOVERNMENT GAZETTE,8JUNE2012 No. 35409 ActiveDosage ingredients: form: TABLETmg ActiveDosage ingredients: form: TABLETEACH TABLET CONTAINS: ActiveDosage ingredients: form: TABLETEACH TABLET CONTAINS: EACHESCITALOPRAMEQUIVALENT TABLET CONTAINS: TO OXALATE 10,0 mg HydrochlorothiazideQuinapril Hydrochloride equivalent to 10,0 mg 12,5 mg HydrochlorothiazideQuinaprilequivalent Hydrochloride to 20,0 mg 12,5 mg Applicant:Conditions of registration: (PTY)ZYDUS1, 2, LTD 3,HEALTHCARE 4, 5, 6, 7 SA Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) LTD ApplicantConditions of registration: AUROBINDOLTD1, 2, 3, 4, 5, PHARMA 6, 7, 8 (PTY) Manufacturer: INDIASANAND,HEALTHCAREZYDUS CADILA AHMEDABAD, LIMITED, Manufacturer: MANDAL,AUROBINDODISTRICT,UNIT III, RANGA QUTHUBULLAPUR PHARMA HYDERABAD, REDDY LIMITED, ANDHRA Manufacturer: MANDAL,AUROBINDODISTRICT,UNIT III, RANGA QUTHUBULLAPUR PHARMA HYDERABAD, REDDY LIMITED, Packer: SANAND,HEALTHCAREZYDUS CADILA AHMEDABAD, LIMITED, Packer: MANDAL,AUROBINDOUNITPRADESH III, RANGA QUTHUBULLAPUR PHARMAINDIA REDDY LIMITED, Packer: MANDAL,AUROBINDOANDHRAUNIT III, PRADESHRANGA QUTHUBULLAPUR PHARMA REDDY INDIA LIMITED, Laboratory: FPRC: HEALTHCAREZYDUSINDIA CADILA LIMITED, Laboratory: FPRC: AUROBINDOPRADESHDISTRICT,UNIT III, INDIAHYDERABAD, QUTHUBULLAPUR PHARMA LIMITED, ANDHRA Laboratory: FPRC AUROBINDOANDHRADISTRICT,UNIT III, PRADESH HYDERABAD, QUTHUBULLAPUR PHARMA INDIA LIMITED, PHARMACEUTICALINSTITUTEINDIASANAND, AHMEDABAD, FOR LIMBROMPRADESHDISTRICT,MANDAL, &L LABORATORY BUSINESS RANGA INDIAHYDERABAD, REDDY PARK, SERVICES, ANDHRA LIMBROMANDHRADISTRICT,MANDAL, &L LABORATORY BUSINESS PRADESHRANGA HYDERABAD, REDDY PARK, SERVICES,INDIA SERVICES,NORTH-WESTINDUSTRIALRESEARCHPRETORIA, SILVERTONDALE, RSAINSTITUTE PHARMACY, UNIVERSITY, FOR MIDRAND,SERVICESKHULULEKANISANDTON, RSAcc,RSA COVENTRY LABORATORY PARK, PARK,SERVICESKHULULEKANISANDTON, MIDRAND, cc,RSA COVENTRY LABORATORY RSA FPRR: (PTY)ZYDUSPOTCHEFSTROOM, LTD, HEALTHCARE RSA SA FPRR: AUROBINDORSAMEYERSDAL, PHARMA JOHANNESBURG, (PTY) LTD, FPRR: JOHANNESBURG,LTD,AUROBINDO MEYERSDAL, PHARMA RSA (PTY) DateShelf-life: of registration: 2024POTCHEFSTROOM, APRIL months 2012 RSA DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) DateShelf-life: of registration: 2024 APRILmonths 2012 (Provisional) MRF 15 NameRegistration of medicine: number: 43/7.1.3/1046 NameRegistrationMRF15 of medicine: number: AURO4317.1.3/1047 QUINAPRIL CO 20/12,5 mg IF 15 NameRegistration of medicine: number: 44/20.1.1/0316 ActiveDosage ingredients: form: EACHTABLETAURO TABLETQUINAPRIL CONTAINS: CO 10/12,5 mg ActiveDosage ingredients: form: EACHTABLET TABLET CONTAINS: ActiveDosage ingredients: form: EACHINJECTIONKANAMYCIN AMPOULE 1 g BIOTECH CONTAINS: Conditions of registration: HydrochlorothiazideQuinapril Hydrochloride equivalent to 10,0 mg 12,5 mg QuinaprilHydrochlorothiazideQuinapril Hydrochloride equivalent to 20,0 mg 12,5 mg KANAMYCIN1000,0KANAMYCIN SULPHATE mg EQUIVALENT TO Applicant:Manufacturer. AUROBINDO1, 2, 3, 4, 5, 6, PHARMA7, 8 (PTY) LTD Applicant:Conditions of registration: AUROBINDO1, 2, 3, 4, 5,PHARMA 6, 7, 8 (PTY) LTD Applicant:Conditions of registration: 1, 2,BIOTECH 3, 4, 5, 6, LABORATORIES7, 8 (PTY) LTD AUROBINDOINDIAHYDERABAD,MANDAL,UNIT III, QUTHUBULLAPUR RANGAPHARMA ANDHRA REDDY LIMITED, PRADESH DISTRICT, Manufacturer: ANDHRAREDDYQUTHUBULLAPURAUROBINDO PRADESH PHARMA MANDAL, INDIA LIMITED, RANGA UNIT III, HYDERABAD, Manufacturer. PHARMACEUTICALSDIVISIONUNIQUE PHARMACEUTICAL OF JB CHEMICALS LIMITED), LABORATORIES& PANOLI, INDIA (A No.35409 STAATSKOERANT, 8JUNIE2012 Packer: AUROBINDOMANDAL,UNIT III, QUTHUBULLAPUR RANGAPHARMA REDDY LIMITED, DISTRICT, Packer: ANDHRAREDDYQUTHUBULLAPURAUROBINDO PRADESH PHARMA MANDAL, INDIA LIMITED, RANGA UNIT III, HYDERABAD, Packer: PHARMACEUTICALSDIVISIONUNIQUE PHARMACEUTICAL OF JB CHEMICALS LIMITED), LABORATORIES& PANOLI, INDIA (A INDIAHYDERABAD, ANDHRA PRADESH LTD,AFRIKAJOHANNESBURG,PHARMACEUTICALS,PHARMA-Q ALRODE, BIOPHARMA ALBERTON, (PTY) RSA MANUFACTURINGLTD INDUSTRIATRADING RSA AS WEST, COSI (PTY) Laboratory: FPRC: MANDAL,AUROBINDOUNIT III, RANGA QUTHUBULLAPUR PHARMA REDDY LIMITED, DISTRICT, Laboratory: FPRC: ANDHRAREDDYQUTHUBULLAPURAUROBINDO PRADESH PHARMA MANDAL, INDIA LIMITED, RANGA UNIT III, HYDERABAD, Laboratory: FPRC PHARMACEUTICALSDIVISIONUNIQUE PHARMACEUTICAL OF JB CHEMICALS LIMITED), LABORATORIES& PANOLI, INDIA (A LIMBROM &LINDIAHYDERABAD, LABORATORY BUSINESS ANDHRA PARK, SERVICES, PRADESH cc,KHULULEKANIBUSINESSM &L COVENTRY LABORATORY PARK, LABORATORYPARK, SANDTON, SERVICES, MIDRAND, RSASERVICES LIMBRO RSA LTD,AFRIKAJOHANNESBURG,PHARMACEUTICALS,PHARMA-Q ALRODE, BIOPHARMA (PTY) ALBERTON, LTD RSA MANUFACTURING INDUSTRIATRADING RSA AS WEST, COSI (PTY) MIDRAND,SERVICESKHULULEKANISANDTON, RSA cc,RSA COVENTRY LABORATORY PARK, ATLASVILLE,CONSULTINGGROENKLOOF,PHARMACEUTICALSABS COMMERCIAL BOKSBURG, CHEMICAL PRETORIA, CHEMISTRY (PTY) LABORATORIES, RSALTD RSA DEPARTMENT FPRR: AUROBINDO PHARMA (PTY) LTD, FPRR: AUROBINDOMEYERSDAL, PHARMA JOHANNESBURG, (PTY) LTD, RSA FPRR: BIOTECHSILVERTONDALE,INSTITUTE LABORATORIES FOR PHARMACEUTICAL PRETORIA, (PTY) RSA LTD, SERVICES, Shelf-life: RSAMEYERSDAL, JOHANNESBURG, Shelf-life: 24 months (Provisional) Shelf-life: RANDJESPARK, MIDRAND, RSA Date of registration: 2024 APRILmonths 2012 (Provisional) Date of registration: 20 APRIL 2012 Date of registration: 2024 APRILmonths 2012 (Provisional) 73 74 MRFRegistration 15 number: 44/34/0391 RegistrationMRF15 number: 44/34/0392 MRF 15 Registration number: 44/8.1/0550 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 DosageName of form: medicine: SOLVENTINJECTION FOR DOCELEX 20 DosageName of form: medicine: INJECTIONSOLVENT FOR DOCELEX 80 DosageName of form: medicine: INJECTIONFORPOWDERNOVOSEVEN SOLUTION AND 1 SOLVENTmg FOR Active ingredients: ETHANOLEACH VIAL CONTAINS: 13,0 % m/v Active ingredients: ETHANOLEACH VIAL CONTAINS: 13,0 % m/v Active ingredients: Activated(rFV11a)CoagulationEACH RecobinantVIAL 1,0 mg CONTAINS:Factor Vila Manufacturer:ApplicantConditions of registration: CIPLA1, 2, 3, LTD,MEDPRO4, 5, 6,UNIT 7 (PTY) V, VERNA, LTD SALCETTE, Applicant:Manufacturer:Conditions of registration: CIPLA1, 2, LTD,MEDPRO 3, 4, UNIT5, 6, (PTY) 7V, VERNA, LTD Applicant:Manufacturer:Conditions of registration: NOVO1, 2, 3, NORD1SKNORDISK4, 5, 6, 7 A/S,(PT?) LTD GOA, INDIA SALCETTE, GOA, INDIA HAGEDORNSVEJ,NOVOKALUNDBORG,BAGSVAERD, NORDISK DENMARK DENMARK A/S, Packer: CIPLA LTD, UNIT V, VERNA, SALCETTE, Packer: CIPLA LTD, UNIT V, VERNA, Packer: NOVOBROGAARDSVEJ,GENTOFTE, NORD1SKNORDISK DENMARK A/S, DENMARK GOA, INDIA SALCETTE, GOA, INDIA NOVOGENTOFTE,HAGEDORNSVEJ,BAGSVAERD, NORDISK DENMARK DENMARK A/S, Laboratory: FPRC: GOA,CIPLA INDIA LTD, UNIT V, VERNA, SALCETTE, Laboratory: FPRC: SALCETTE,CIPLA LTD, UNITGOA, V, INDIA VERNA, Laboratory: FPRC NOVOBAGSVAERD,BROGAARDSVEJ, NORDISK DENMARK A/S, DENMARK NOVOGENTOFTE,HAGEDORNSVEJ,KALUNDBORG, NORD1SKNORDISK DENMARK DENMARK A/S, FPRR: GOA,CIPLA INDIA LTD, UNIT V, VERNA, SALCETTE, FPRR: CAPEROSENPARK,CIPLA TOWN,MEDPRO RSABELLVILLE, (PTY) LTD, FPRR: SANDTON,NOVOBROGAARDSVEJ, NORDISK RSA (PTY) DENMARK LTD, DateShelf-life: of registration: 2024 APRILmonths 2012 DateShelf-life: of registration: 2024 monthsAPRIL 2012 DateShelf-life: of registration: 2024 APRILmonths 2012 NameRegistrationMRF 15 of medicine: number: 44/8.1/0551NOVOSEVEN 2 mg NameRegistrationMRF15 of medicine: number: NOVOSEVEN4418.1/0552 5 mg ARF 15 NameRegistration of medicine: number: XAMIOL44/13.9.1/0632 GEL ActiveDosage ingredients: form: ActivatedEACHFORPOWDER INJECTION Recobinant VIAL AND CONTAINS: SOLVENT Coagulation FOR Factor SOLUTION ActiveDosage ingredients: form: ActivatedEACHFORPOWDER INJECTION VIAL Recobinant AND CONTAINS: SOLVENT Coagulation FOR SOLUTION Factor ActiveDosage ingredients: form: EACHGEL GRAM CONTAINS: VI la (rFV11a) 2,0 mg Vila (rFV11a) 5,0 mg 0,5BetamethasonedipropionateCalcipotriol mg hydrate equivalent equivalent to to 50,0 ug Betamethasone

Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 No.35409 STAATSKOERANT, 8JUNIE2012 Applicant:Manufacturer. NOVODENMARKNOVO NORDISK NORDISK (PTY) AIS, LTD BAGSVAERD, Applicant:Manufacturer. NOVO NORDISK A/S,(PTY) BAGSVAERD, LTD ManufacturerApplicant: LEOADCOCK PHARMACEUTICAL INGRAM LIMITED PRODUCTS GENTOFTE,NOVODENMARKNOVO NORDISK NORDISK DENMARK A/S, NS, HAGEDORNSVEJ, KALUNDBORG, GENTOFTE,NOVODENMARK NORDISK DENMARK NS, HAGEDORNSVEJ,KALUNDBORG, LTD, BALLERUP, DENMARK Packer: DENMARKNOVO NORDISK A/S, BAGSVAERD,BROGAARDSVEJ, Packer NOVODENMARK NORDISK A/S,NS, BROGAARDSVEJ,BAGSVAERD, Packer: LEO PHARMACEUTICAL PRODUCTS DENMARKNOVOGENTOFTE, NORDISK DENMARK A/S,NS, BROGAARDSVEJ,HAGEDORNSVEJ, NOVOGENTOFTE,DENMARKNOVO NORDISK NORDISK DENMARK NS, NS,BROGAARDSVEJ, HAGEDORNSVEJ, LTD, BALLERUP, DENMARK Laboratory: FPRC: DENMARKNOVO NORDISK A/S, KALUNDBORG,BAGSVAERD, Laboratory: FPRC: NOVODENMARK NORDISK A/S,NS, KALUNDBORG,BAGSVAERD, Laboratory: FPRC ADCOCKLTD,LEO PHARMACEUTICALBALLERUP, INGRAM DENMARK HEALTHCARE, PRODUCTS DENMARKNOVOGENTOFTE, NORDISK DENMARK A/S, BROGAARDSVEJ,HAGEDORNSVEJ, GENTOFTE,NOVODENMARKDENMARKNOVO NORDISK NORDISK DENMARK NS, NS,HAGEDORNSVEJ, BROGAARDSVEJ, ADCOCKAEROTON,RESEARCHWADEVILLE, INGRAM JOHANNESBURG,& GERMISTON, DEVELOPMENT, LIMITED RSA RSA FPRR: RSANOVO NORDISK (PTY) LTD, SANDTON, FPRR: RSANOVO NORDISK (PTY) LTD, SANDTON, FPRR: ADCOCKWADEVILLE,RESEARCHADCOCK INGRAM INGRAMGERMISTON, & DEVELOPMENT, LIMITED HEALTHCARE, RSA Shelf -life: 24 months Shelf-life: 24 months Shelf-life: 24ADCOCKAEROTON, monthsGARDENS, INGRAM JOHANNESBURG, MIDRAND, LIMITED, RSA ERAND RSA Date of registration: 20 APRIL 2012 Date of registration: 20 APRIL 2012 Date of registration: 20 APRIL 2012 75 76 o 50 GOVERNMENT GAZETTE,8JUNE2012 No. 35409 RegistrationMRF 15 number: 45/20.2.8/0111 RegistrationMRF15 number: 45/20.2.8/0169 MRF 15 Registration number: 45/20.2.8/0336 ActiveDosageName ingredients: of form: medicine: TABLETEACHRILOVIA TABLET 200/50 CONTAINS: ActiveDosageName ingredients: of form: medicine: TABLETEFRIN DosageName of form: medicine: TABLETRILOVIA 100/25 Conditions of registration: 1,RITONAVIRLOPINAVIR 2, 3, 4, 5, 6,200,050,0 7 mg mg Conditions of registration: EFAVIRENZEACH1, 2, TABLET 3, 4, 5, 6,CONTAINS: 7 600,0 mg ConditionsActive ingredients: of registration: 1,RITONAVIRLOPINAVIREACH 2, 3, TABLET4, 5, 6,100,025,0 7, CONTAINS: 8mg mg Applicant:Manufacturer: MYLANSINNAR,MATRIX (PTY) LABORATORIESNASHIK, LTD MAHARASHTRA, LIMITED, Applicant:Manufacturer: LIMITED,MATRIXMYLAN (PTY) LABORATORIES SINNAR, LTD NASHIK, Manufacturer:Applicant: LIMITED,MATRIXMYLAN (PTY) LABORATORIES SINNAR, LTD NASHIK, Packer: MATRIXINDIASINNAR, LABORATORIES NASHIK, MAHARASHTRA, LIMITED, Packer: MAHARASHTRA,LIMITED,MATRIX LABORATORIES SINNAR, INDIA NASHIK, Packer: MAHARASHTRA,LIMITED,MATRIX LABORATORIES SINNAR, INDIA NASHIK, Laboratory: FPRC: LABORATORIES,CONSULTINGMAHARASHTRA,SINNAR,MATRIX LABORATORIES CHEMICAL INDIAATLASVILLE, LIMITED, NASHIK, Laboratory: FPRC: CONSULTINGMAHARASHTRA,LIMITED,MATRIX LABORATORIES SINNAR, CHEMICAL INDIA NASHIK, Laboratory: FPRC CONSULTINGMAHARASHTRA,LIMITED,MATRIX LABORATORIES SINNAR, CHEMICAL INDIA NASHIK, JOHANNESBURG,ACORNBOKSBURG,LTD, NORTHPHARMACEUTICALS RSA RIDING, RSA (PTY) JOHANNESBURG,(PTY)ACORNBOKSBURG,LABORATORIES, LTD, PHARMACEUTICALS NORTH RSA ATLASVILLE, RSARIDING, ACORNATLASVILLE,PHARMACEUTICALSRSALABORATORIES, BOKSBURG, (PTY) FPRR: MODDERFONTEIN,MYLAN (PTY) LTD, GAUTENG, RSA FPRR: MODDERFONTEIN,MYLAN (PTY) LTD, FPRR: JOHANNESBURG,MODDERFONTEIN,MYLANLTD, NORTH (PTY) RIDING, LTD, RSA DateShelf-life: of registration: 2024 monthsAPRIL 2012 DateShelf-life: of registration: 2024JOHANNESBURG, APRILmonths 2012 RSA Shelf-life:Date of registration: 24GAUTENG, 20months APRIL (Provisional) RSA2012 NameRegistrationMRF 15 of medicine: number: MACLEODS45/20.2.8/0538 LAMIVUDINE 150 ActiveDosage ingredients: form: LAMIVUDINEEACHTABLET TABLET CONTAINS: Applicant:Conditions of registration: PHARMACEUTICALSMACLEODS1, 2, 3, 4, 5, 6, 7 SA (PTY) 150,0 mg Manufacturer: PHARMACEUTICALSMACLEODSLTD LTD, No.35409 STAATSKOERANT, 8JUNIE2012 Packer: KACHIGAM,PHARMACEUTICALSMACLEODS DAMAN, LTD,INDIA Laboratory: FPRC: CONSULTINGLABORATORIESKACHIGAM,PHARMACEUTICALSMACLEODS CHEMICAL DAMAN, (PTY) LTD,INDIA LTD, GROENKLOOF,CHEMISTRYATLASVILLE,PHARMACEUTICALSABS COMMERCIAL DEPARTMENT, BOKSBURG, PRETORIA, (PTY) RSA LTD FPRR: LTD,MACLEODSPHARMACEUTICALSRSA WOODMEAD, SANDTON, SA (PTY) DateShelf-life: of registration: 2024RSA APRILmonths 2012 77 78 No. 35409 GOVERNMENT GAZETTE, 8 JUNE 2012

*ADDITIONAL CONDITIONS OF REGISTRATION

Due to the non discriminating nature of the dissolution method (2 % SLS in water, at 100 fpm) used for release and stability testing of Efavirenz containing products, the following must be complied with:

Develop an appropriate (discriminating) dissolution method for release and stability testing and submit for evaluation.

As an interim measure, continue to use the current dissolution medium (2 % SLS in water, at 100 rpm) for a maximum period of twelve months from the date of registration or until implementation of the new method, whichever is sooner.

Provide periodic progress reports on the method development and data.

**ADDITIONAL CONDITIONS OF REGISTRATION

Develop an appropriate (discriminating) dissolution method for release and stability testing and submit for evaluation.

As an interim measure, continue to use the current dissolution medium (2 % SLS in water, at 100 rpm) for a maximum period of twelve months from the date of registration or until implementation of the new method, whichever is sooner.

Provide periodic progress reports on the method development and data.

A new bioequivalence study in support of the safety and efficacy of this product must be submitted within 12 months (by 03 February 2013). STAATSKOERANT, 8 JUNIE 2012 No. 35409 79 80 No. 35409 GOVERNMENT GAZETTE, 8 JUNE 2012

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