STAATSKOERANT, 20 FEBRUARIE 2009 No. 31881 3
GENERAL NOTICE ALGEMENE KENNISGEWING
NOTICE 163 OF 2009
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 sholl be subject to review at intervals as determined by Council regarding its quality, 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. A post-registration inspection must be conducted in the first production batch of the locally manufactured product. 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. MRF 15 MRF15
Registration number: 3417.1.3/0334 Registration number: 3417.1.3/0335 Name of medicine: ENVAS2,5 Name of medicine: ENVAS 5 Doscge form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: (JJ ENALAPRIL MALEATE 2,5mg ENALAPRIL MALEATE 5,Omg ~ ~ Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 (JJ A Applicant: THEBE MEDICARE (PTY) LTD Applicant THEBE MEDICARE (PTy) LTD o m CADILA PHARMACEUTICALS, DHOLKA, :0 Man ufacturer: CADILA PHARMACEUTICALS, DHOLKA, Manufacturer: :t> AHMEDABAD, GUJARAT, INDIA AHMEDABAD, GUJARAT, INDIA Z :-I Packer: CADILA PHARMACEUTICALS, DHOLKA, Packer: CADILA PHARMACEUTICALS, DHOLKA, I'V o AHMEDABAD, GUJARAT, INDIA AHMEDABAD, GUJARAT, INDIA "T1m Laboratory FPRC: CADILA PHARMACEUTICALS, DHOLKA, Laboratory: FPRC: CADILA PHARMACEUTICALS, DHOLKA, OJ AHMEDABAD, GUJARAT, INDIA AHMEDABAD, GUJARAT, INDIA :0 C CONSULTING CHEMICAL LABORATORIES, CONSULTING CHEMICAL LABORATORIES, :t> ATLASVILLE, BOKSBURG ATLASVILLE, BOKSBURG :0 m oI'V o to FPRR: THEBE MEDICARE, NORTHRIDING, RANDBURG FPRR: THEBE MEDICARE, NORTHRIDING, RANDBURG Shelf-life 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008
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MRF15 MRF 15 Registration number: 3417.1.3/0336 Registration number: 37/3.110229 Name of medicine: ENVAS10 Name of medicine: CPL ALLIANCE DICLOFENAC 75 INJECTION Dosage form: TABLET Dosage form: INJECTION G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: 0 ENALAPRIL MALEATE 10,0 mg DICLOFENAC SODIUM 25,0 mg
FPRR: HEXAL PHARMA, PINETOWN, KZN FPRR: HEXAL PHARMA, PINETOWN, KZN Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008
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Registration number: A38/2.5/0456 Registration number: A3812.5/0457 Name of medicine: LAMOTEP 100 Name of medicine: LAMOTEP200 Dosage form: TABLET Dosage form: TABLET (j) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: 0 LAMOTRIGINE 100,0 mg LAMOTRIGINE 200,0 mg MRF 15 MRF 15 Registration number: A39/34/0310 Registration number: A39/34/0311 Name of medicine: XOLAIR 75 mg Name of medicine: XOLAIR 150 mg Dosage form: INJECTION Dosage form: INJECTION Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: OMALIZUMAB 75,0 mg OMALIZUMAB 150,0 mg (J) ~ Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 ~ (J) Applicant: NOVARTIS SOUTH AFRICA (PTy) L TO Applicant: NOVARTIS SOUTH AFRICA (PTY) LTO oA Manufacturer: GENENTECH INC, SOUTH SAN FRANCISCO, Manufacturer: GENENTECH INC, SOUTH SAN m CALIFORNIA, USA FRANCISCO, CALIFORNIA, USA z~ Packer: GENENTECH INC, SOUTH SAN FRANCISCO, Packer: GENENTECH INC, SOUTH SAN .--1 CALIFORNIA, USA FRANCISCO, CALIFORNIA, USA I\) NOVARTIS PHARMA STEIN AG, STEIN, NOVARTIS PHARMA STEIN AG, STEIN, o "il SWITZERLAND SWITZERLAND m (II :n Laboratory: FPRC: GENENTECH INC, SOUTH SAN FRANCISCO, Laboratory: FPRC: GENENTECH INC, .SOUTH SAN c CALIFORNIA, USA FRANCISCO, CALIFORNIA, USA » NOVARTIS PHARMA STEIN AG, STEIN, NOVARTIS PHARMA STEIN AG, STEIN, ~ SWITZERLAND SWITZERLAND m I\) M&L LABORATORY SERVICES, ORMONDE, M&L LABORATORY SERVICES, ORMONDE, o o JOHANNESBURG JOHANNESBURG (!) FPRC/FPRR NOVARTIS SA, SPARTAN, KEMPTON PARK FPRC/FPRR: NOVARTIS SA, SPARTAN, KEMPTON PARK Shelf-life: 48 months Shelf-life: 48 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 w OJ OJ... co ~ o z o (.i) ..... CD CD MRF15 MRF 15 Registration number: A39/20.1 .110382 Registration number: A3917.1.410408 Name of medicine: AZITHROMYCIN HEXAL 500 mg TABLET Name of medicine: CARANOR 5,0 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active innr",rli",nt<:.· EACH TABLET CONTAINS: G) AZITHROMYCIN DIHYDRATE EQUIVALENT TO IVABRADINE HYDROCHLORIDE EQUIVALENT o AZITHROMYCIN 500,0 mg TO IVABRADINE 5,0 mg FPRR HEXAL PHARMA, PINETOWN, RSA FPRC/FPRR BIOGARAN SA, RIVONIA, JOHANNESBURG Shelf-life: 24 months (provisional) Shelf-life: 36 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: A39/7.1.4/0409 Registration number: A3917.1.4/041 0 Name of medicine: CARANOR 7,5 mg Name of medicine: CORALAN 5,0 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: IVABRADINE HYDROCHLORIDE EQUIVALENT TO IVABRADINE HYDROCHLORIDE IVABRADINE 7,5 mg EQUIVALENT TO IVABRADINE 5,Omg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 en );! Applicant: BIOGARAN SOUTH AFRICA (PTY) LTO Applicant: SERVIER LABORATORIES SOUTH AFRICA ~ (PTY) LTD en Manufacturer: LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Manufacturer: LES LABORATOIRES SERVIER INDUSTRIE, o FRANCE GIDY, FRANCE "m lJ SERVIER (IRELAND) INDUSTRIES WICKLOW, SERVIER (IRELAND) INDUSTRIES » ARKLOW, IRELAND WICKLOW, ARKLOW, IRELAND Z .-1 I\:) Packer: LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Packer: LES LABORATOIRES SERVIER INDUSTRIE, o FRANCE GIDY, FRANCE SERVIER (IRELAND) INDUSTRIES WICKLOW, SERVIER (IRELAND) INDUSTRIES "m CD ARKLOW, IRELAND WICKLOW, ARKLOW, IRELAND lJ TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, »C FLOR1DA ROBERTVILLE, FLORIDA lJ Laboratory: FPRC: LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Laboratory: FPRC: LES LABORATOIRES SERVIER INDUSTRIE, m I\:) FRANCE GIDY, FRANCE o o SERVIER (IRELAND) INDUSTRIES WICKLOW, SERVIER (IRELAND) INDUSTRIES FPRR: BIOGARAN SA, RIVONIA, JOHANNESBURG FPRR: SERVIER LABORATORIES SA, RIVONIA, JOHANNESBURG Shelf-life: 36 months Shelf-life: 36 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z !' 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MRF 15 MRF 15 Registration number: A39n.1.4/0411 Registration number: A39f8.210444 Name of medicine: CORALAN 7,5 mg Name of medicine: ADCO-ARAVIX Dosage form: TABLET Dosage form: TABLET EACH TABLET CONTAINS: Active ingredients: IVABRADINE HYDROCHLORIDE EQUNALENT TO Active ingredients: EACH TABLET CONTAINS: IVABRADINE 7,5 mg CLOPIDOGREL BISULPHATE EQUNALENTTO CLOPIDOGREL 75,0 mg G> Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 m~ Applicant: SERVIER LABORATORIES SOUTH AFRICA (PTY) LTD Applicant: ADCOCK INGRAM LIMITED ::rJ Z Manufacturer: LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Manufacturer: CADILA HEALTHCARE LTD, SANAND, AHMEDABAD, s::m FRANCE INDIA Z SERVIER (IRELAND) INDUSTRIES WICKLOW, ARKLOW, -I IRELAND G> Packer: LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Packer: CADILA HEALTHCARE LTD, SANAND,AHMEDABAD, ~ FRANCE INDIA ~ SERVIER (IRELAND) INDUSTRIES WlCKLOW, ARKLOW, ADCOCK INGRAM HEALTHCARE, WADEVILLE, -I IRELAND GERMISTON .f11 TECHNIKON LABORATORIES, ROBERTVILLE, FLORIDA I\:) o Laboratory:: FPRC LES LABORATOIRES SERVIER INDUSTRIE, GIDY, Laboratory: FPRC: CADILA HEALTHCARE LTD, SANAND, AHMEDABAD, ." FRANCE INDIA m III SERVIER (IRELAND) INDUSTRIES WICKLOW, ARKLOW, ::rJ IRELAND C M&L LABORATORY SERVICES, ORMONDE, » JOHANNESBURG ::rJ -< I\:) o o FPRR SERVIER LABORATORIES SA, RIVONIA, FPRCfFPRR; ADCOCK INGRAM HEALTHCARE, WADEVILLE, <0 JOHANNESBURG GERMISTON Shelf-life: 36 months FPRR: ADCOCK INGRAM LTD, ERAND GARDENS, MIDRAND Date of registration: 9 DECEMBER 2008 Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 MRF 15 MRF15 Registration number: A39/11 .4.3/0466 Registration number: A39/11.4.3/0467 Name of medicine: ADCO-OMEPRAZOLE 10 Name of medicine: ADCO-OMEPRAZOLE 40 Dosage form: CAPSULE Dosage form: CAPSULE Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: OMEPRAZOLE ...... 10,0 mg OMEPRAZOLE ...... 40,0 mg Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 (JJ ~ Applicant: ADCOCK INGRAM LIMITED Applicant: ADCOCK INGRAM LIMITED ~ (JJ Manufacturer: LlCONSA SA, AZUQUECA DE HENARES, Manufacturer: LlCONSA SA, AZUQUECA DE HENARES, GUADALAJARA, SPAIN GUADALAJARA, SPAIN 0 m'" II Packer: LlCONSA SA, AZUQUECA DE HENARES, Packer: LlCONSA SA, AZUQUECA DE HENARES, » GUADALAJARA, SPAIN GUADALAJARA, SPAIN z ADCOCK INGRAM HEALTHCARE LTD, ADCOCK INGRAM HEALTHCARE LTD, :-I I\l WADEVILLE, GERMISTON WADEVILLE, GERMISTON 0 11 Laboratory: FPRC: LlCONSA SA, AZUQUECA DE HENARES, Laboratory: FPRC: LlCONSA SA, AZUQUECA DE HENARES, m GUADALAJARA, SPAIN GUADALAJARA, SPAIN IIOJ »C II m I\l 0 0 FPRC/FPRR: ADCOCK INGRAM HEALTHCARE LTD, FPRC/FPRR: ADCOCK INGRAM HEALTHCARE LTD, 1(0 WADEVILLE, GERMISTON WADEVILLE, GERMISTON FPRR: ADCOCK INGRAM LTD, ERAND GARDENS, FPRR: ADCOCK INGRAM LTD, ERAND GARDENS, MIDRAND MIDRAND Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 Z a U) OJ OJ ...... 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OJ OJ MRF 15 MRF 15 Registration number: A39/20.2.210572 Registration number: A39120.1.110577 Name of medicine: ASPEN FLUCONAZOLE IV Name of medicine: LEVOFLOXACIN-WINTHROP I.V. 250 Dosage form: INFUSION Dosage form: INJECTION Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 50,0 ml VIAL CONTAINS: FLUCONAZOLE 2,0 mg LEVOFLOXACIN HEMIHYDRATE EQUIVALENT TO G) LEVOFLOXACIN 250,0 mg o Date of registration: 9 DECEMBER 2008 MRF 15 MRF15 Registration number: A39/20.1.1/0578 Registration number: A39n.1/0634 Name of medicine: LEVOFLOXACIN-WINTHROP I.V. 500 Name of medicine: ADALAT XL 20 Dosage form: INJECTION Dosage form: TABLET Active ingredients: EACH 100,0 ml VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: LEVOFLOXACIN HEMIHYDRATE EQUIVALENT TO NIFEDIPINE 20,0 mg LEVOFLOXACIN 500,0 mg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 (J) Applicant: AVENTIS PHARMA (PrY) LTD Applicant: BAYER (PrY) LTD ~ Manufacturer: AVENTIS PHARMA DEUTSCHLAND GmbH, Manufacturer: BAYER AG, LEVERKUSEN, GERMANY ~ (J) FRANKFURT,GERMANY A BAYER AG, LEVERKUSEN, GERMANY Packer: Packer: o AVENTIS PHARMA DEUTSCHLAND GmbH, DIVPHARM MANUFACTURING & m FRANKFURT,GERMANY II PACKAGING, LONGDALE, JOHANNESBURG :t> WINTHROP PHARMACEUTICALS, WALTLOO, PHARMACEUTICAL CONTRACTORS, Z _-1 PRETORIA ISANDO, RSA IIJ BAYER ANIMAL HI;:ALTH, WILLOWTON, o -n PIETERMARITZBURG m Laboratory: FPRC: AVENTIS PHARMA DEUTSCHLAND GmbH, Laboratory: FPRC: BAYER AG, LEVERKUSEN, GERMANY IICJ:l FRANKFURT,GERMANY BAYER ANIMAL HEALTH, WILLOWTON, C PIETERMARITZBURG II:t> SOUTH AFRICAN BUREAU OF STANDARDS, fii GROENKLOOF, PRETORIA II.) o RESEARCH INSTITUTE FOR INDUSTRIAL o PHARMACY, NORTH-WEST UNIVERSITY, (0 POTCHEFSTROOM FPRC/FPRR: WINTHROP PHARMACEUTICALS, WALTLOO, FPRR: BAYER, ISANDO, RSA PRETORIA FPRR: AVENTIS PHARMA, MIDRAND, RSA Shelf-life: 36 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o c..> OJ OJ ..... ... 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MRF 15 MRF 15 Registration number: A40/20.2.210070 Registration number: A40/20.2.210071 Name of medicine: ITRACOL Name of medicine: ITRACONAZOLE HEXAL Dosage form: CAPSULE Dosage form: CAPSULE Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: {j) ITRACONAZOLE 100,0 mg ITRACONAZOLE 100,0 mg o ~ Conditions of registration: 1,2,3,4,5,6,8 Conditions of registration: 1,2,3,4,5,6,7 '-i (J) Applicant: ADCOCK INGRAM LIMITED Applicant: GLAXOSMITHKLlNE SOUTH AFRICA (PTY) LTD 6m JJ Manufacturer: ADCOCK INGRAM HEALTHCARE, WADEVILLE, Manufacturer: GLAXOSMITHKLlNE INC, MISSISSAUGA, » GERMISTON ONTARIO, CANADA Z .:-I Packer: ADCOCK INGRAM HEALTHCARE, WADEVILLE, Packer: GLAXOSMITHKLlNE INC, MISSISSAUGA, I'llo GERMISTON ONTARIO, CANADA "Tl GLAXOSMITHKLlNE SA, EPPING, CAPE m c:o TOWN JJ C Laboratory: FPRC/FPRR: ADCOCK INGRAM HEALTHCARE, WADEVILLE, Laboratory: FPRC: GLAXOSMITHKLlNE INC, MISSISSAUGA, » GERMISTON ONTARIO, CANADA mJJ I'll o o (!) FPRR: ADCOCK INGRAM LTD, BRYANSTON, FPRC/FPRR: GLAXOSMITHKLlNE SA, EPPING, CAPE JOHANNESBURG TOWN Shelf-life: 24 months (PrOVisional) Shelf-life: 60 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o w...... ...... Oi) z !' U) -'" (» (» -'" MRF 15 Registration number: A40/34/0211 Registration number: A40/20.1.1/0321 Name of medicine: CONTIFLO SR Name of medicine: SMARTSET GHV GENTAMICIN BONE CEMENT Dosage form: CAPSULE Dosage form: BONE CEMENT GJ Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH 40,0 g CONTAINS: 0 TAMSULOSIN HYDROCHLORIDE 0,4 mg GENTAMICIN SULPHATE EQUIVALENT TO < GENTAMICIN m 1,0 g :II Z Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7 s::m Applicant: RANBAXY (SA) (PTY) LTD Applicant: ORTHOMEDICS PHARMACEUTICALS (PTy) Z LTD -I GJ Manufacturer: RANBAXY LABORATORIES LTD, DEWAS, Manufacturer: DEPUY CMW, BLACKPOOL, LANCASHIRE, » N MADHYA PRADESH, INDIA UK m -I Packer: RANBAXY LABORATORIES LTD, DEWAS, Packer: DEPUY CMW. BLACKPOOL. LANCASHIRE. -I .m MADHYA PRADESH, INDIA UK I\) 0 Laboratory: FPRC: RANBAXY LABORATORIES LTD. DEWAS. Laboratory: FPRC: DEPUY CMW, BLACKPOOL. LANCASHIRE, MADHYA PRADESH, INDIA UK m "III KHULULEKANI LABORATORY SERVICES. :II COVENTRY PARK, MIDRAND »C :II -< I\) 0 FPRR: RANBAXY (SA), CENTURION, RSA FPRR: ORTHOMEDICS PHARMACEUTICALS, 1ij5 SYBRAND PARK, CAPE TOWN Shelf-life: 24 months (Provisional) Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: A40/20.2.2/0614 Registration number: A40/20.2.2/0615 Name of medicine: LAMISPOR 250 Name of medicine: CIPLA-TERBINAFINE 250 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: TERBINAFINE HYDROCHLORIDE EQUIVALENT TERBINAFINE HYDROCHLORIDE (f) TO EQUIVALENT TO );! TERBINAFINE 250,0 mg TERBINAFINE 250,0 mg ~ (f) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 oA Applicant CIPLA MEDPRO (PTY) LTD Applicant: CIPLA LIFE SCIENCES (PTY) LTD m »JJ Manufacturer: CIPLA LTD, PLOT A, PATALGANGA, RAIGAD, Manufacturer: CIPLA LTD, PLOT A, PATALGANGA, Z MAHARASHTRA, INDIA RAIGAD, MAHARASHTRA, INDIA :-1 J\) Packer: CIPLA LTD, PLOT A, PATALGANGA, RAIGAD, Packer: CIPLA LTD, PLOT A, PATALGANGA, o 11 MAHARASHTRA, INDIA RAIGAD, MAHARASHTRA, INDIA m OJ Laboratory: FPRC: CIPLA LTD, PLOT A, PATALGANGA, RAIGAD, Laboratory: FPRC: CIPLA LTD, PLOT A, PATALGANGA, JJ MAHARASHTRA, INDIA RAIGAD, MAHARASHTRA, INDIA »C JJm J\) o o (J) FPRR: CIPLA MEDPRO, ROSENPARK, BELLVILLE FPRR: CIPLA LIFE SCIENCES, ROSENPARK, BELLVILLE Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 U) 0> 0> .... IQ IN o z ? c.u .... ~ .... MRF 15 MRF 15 Registration number: A40/8.210673 Registration number: A4012.6.5/0706 Name of medicine: PLAGROL Name of medicine: PERIZAL 0,5 mg Dosage form: TABLET Dosage form: TABLET G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: o CLOPIDOGREL BISULFATE EQUIVALENT TO RISPERIDONE O,5mg MRF 15 MRF15 Registration number: A4012.6.5/0707 Registration number: A40/2.6.5/070B Name of medicine: PERIZAL 1 mg Name of medicine: PERIZAL 2 mg Dosage form: TABLET Dosage form: TABLET (f) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 1,0 mg RISPERIDONE 2,Omg ~ ~ Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5.6,7 (f) oA Applicant: SPECPHARM (PTY) L TO Applicant: SPECPHARM (PTY) LTD m :0 Manufacturer: PHARMA INTERNATIONAL COMPANY, AMMAN, Manufacturer: PHARMA INTERNATIONAL COMPANY. »z JORDAN AMMAN, JORDAN .-1 Packer: PHARMA INTERNATIONAL COMPANY, AMMAN, Packer: PHARMA INTERNATIONAL COMPANY, ~ JORDAN AMMAN. JORDAN m Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AMMAN, Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY. "OJ :0 JORDAN AMMAN, JORDAN »C :0m I\) o o CD FPRR: SPECPHARM,SANDTON,JOHANNESBURG FPRR: SPECPHARM,SANDTON,JOHANNESBURG Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 oz w ..... ()) ()) ..... I\) .... IN N z ~ (N ..... (Xl (Xl MRF 15 Registration number: A40/2.6.510709 Registration number: A4012.6.5/071 0 Name of medicine: PERIZAL 3 mg Name of medicine: PERIZAL 4 mg Dosage form: TABLET Dosage form: TABLET G) 0 Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: m< RISPERIDONE 3,Omg RISPERIDONE 4,Omg Jl Z Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 m~ Z Applicant SPECPHARM (PTY) LTD Applicant: SPECPHARM (PTY) LTD -l G) Manufacturer: PHARMA INTERNATIONAL COMPANY, AMMAN, Manufacturer: PHARMA INTERNATIONAL COMPANY, » JORDAN AMMAN, JORDAN Nm -l Packer: PHARMA INTERNATIONAL COMPANY, AMMAN, Packer: PHARMA INTERNATIONAL COMPANY, -l JORDAN AMMAN, JORDAN m t\) Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AMMAN, Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, 0 JORDAN AMMAN, JORDAN mi1 llJ Jl C» Jl -< t\) FPRR SPECPHARM,SANDTON,JOHANNESBURG FPRR: SPECPHARM,SANDTON,JOHANNESBURG Ig Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: MO/2.6.5/0727 Registration number: MO/2.6.5/0728 Name of medicine: RISPERLET 0,5 mg Name of medicine: RISPERLET 1 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE O,5mg RISPERIDONE 1,Omg C!l Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 ~ '-I Applicant: JANSSEN PHARMACEUTICA (PTY) LTD Applicant: JANSSEN PHARMACEUTICA (PTY) L TO C!l iii: Manufacturer: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, Manufacturer: JANSSEN-CILAG, BORGO SAN MICHELE, o m ITALY LATINA,ITALY II» Packer: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, Packer: JANSSEN-CILAG, BORGO SAN z ITALY LATINA, ITALY :-I JANSSEN PHARMACEUTICA, WOODMEAD, JANSSEN PHARMACEUTICA, ~ SANDTON SANDTON "m Laboratory: FPRC: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, Laboratory: FPRC: JANSSEN-CILAG, BORGO SAN MICHELE, IIIII ITALY LATINA, ITALY C» II m J\) o o <0 FPRC/FPRR: JANSSEN PHARMACEUTICA, WOODMEAD, FPRR: JANSSEN PHARMACEUTICA, WOODMEAD, SANDTON SANDTON Shelf-life: 24 months in HDPE bottles Shelf-life: 24 months in HDPE boWes 36 months in foil blisters 36 months in foil blisters Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ? w en en 11:1 to) ..II.) z ~ (,) ..... ~ ..... MRF 15 MRF15 Registration number: A40/2.6.5/0729 Registration number: A40/2.210760 Name of medicine: RISPERLET 2 mg Name of medicine; SPEC MIDAZOLAM Dosage form: TABLET Dosage form: INJECTION Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH 3,0 ml AMPOULE CONTAINS: RISPERIDONE 2,Omg MIDAZOLAM HYDROCHLORIDE oGl EQUIVALENT TO < MIDAZOLAM 15,0 mg m JJ Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3.4.5,6,7,8 Z s: Applicant: Applicant: m JANSSEN PHARMACEUTICA (PTY) LTD SPECPHARM (PTY) LTD Z -f Manufacturer: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, Manufacturer: HAMELN PHARMACEUTICALS, HAMELN, Gl ITALY GERMANY ~ Packer: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, Packer: HAMELN PHARMACEUTICALS, HAMELN, m ITALY GERMANY ::t JANSSEN PHARMACEUTICA, WOODMEAD, .m I\) SANDTON o laboratory: FPRC: JANSSEN-CILAG, BORGO SAN MICHELE, LATINA, laboratory: FPRC: HAMELN PHARMACEUTICALS, HAMELN, m ITALY GERMANY "to JJ »C ~ I\) o o Active ingredients: EACH 2,0 ml SOLUTION CONTAINS: Active ingredients: EACH 5,0 ml SOLUTION CONTAINS: en IRINOTECAN HYDROCHLORIDE 40,0 mg IRINOTECAN HYDROCHLORIDE 100,0 ~ mg ~ Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 en oA Applicant: SANDOZ SA (PTY) LTD Applicant: SANDOZ SA (PTY) LTO m JJ Manufacturer: SANDOZ SA, BUENOS AIRES, ARGENTINA Manufacturer: SANDOZ BUENOS AIRES, ARGENTINA SA, »z Packer: SANDOZ SA, BUENOS AIRES, ARGENTINA Packer: SANDOZ SA, BUENOS AIRES, ARGENTINA .-i I\) NOVARTIS SA, SPARTAN, KEMPTON PARK NOVARTIS SA, SPARTAN, KEMPTON o PARK "'Tl m Laboratory: FPRC: SANDOZ SA, BUENOS AIRES, ARGENTINA Laboratory: FPRC: SANDOZ SA, BUENOS AIRES, ARGENTINA OJ JJ NOVARTIS SA, SPARTAN, KEMPTON PARK NOVARTIS SA, SPARTAN, KEMPTON C LEK dd, VEROVSKOVA, LJUBLJANA, SLOVENIA PARK » JJ SOUTH AFRICAN BUREAU OF STANDARDS, LEK dd, VEROVSKOVA, LJUBLJANA, m GROENKLOOF, PRETORIA SLOVENIA I\) o SOUTH AFRICAN BUREAU OF STANDARDS, o GROENKLOOF, PRETORIA (!) FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o w -" ()) ()) -" N U1 I\) 0') z !l c.u ...... g: ...... MRF15 Registration number: 41126/0030 Registration number: 41126/0031 Name of medicine: TECORIN40 Name of medicine: TECORIN 100 Dosage form: INFUSION Dosage form: INFUSION Active ingredients: EACH 2,0 ml SOLUTION CONTAINS: Active ingredients: EACH 5,0 ml SOLUTION CONTAINS: IRINOTECAN HYDROCHLORIDE 40,0 IRINOTECAN HYDROCHLORIDE 100,0 mg G> mg o Packer: SANDOZ SA, BUENOS AIRES, Packer: SANDOZ SA, BUENOS AIRES, ARGENTINA ~ ARGENTINA NOVARTIS SA, SPARTAN, KEMPTON PARK NOVARTIS SA, SPARTAN, KEMPTON 9 PARK !" f\) Laboratory: FPRC: SANDOZ SA, BUENOS AIRES, Laboratory: FPRC: SANDOZ SA, BUENOS AIRES, ARGENTINA o ." ARGENTINA NOVARTIS SA, SPARTAN, KEMPTON PARK m ttl NOVARTIS S.A., SPARTAN, KEMPTON LEK dd, VEROVSKOVA, LJUBLJANA, SLOVENIA II PARK SOUTH AFRICAN BUREAU OF STANDARDS, C LEK dd, VEROVSKOVA, LJUBLJANA, GROENKLOOF, PRETORIA » SLOVENIA ~ SOUTH AFRICAN BUREAU OF f\) o STANDARDS, GROENKLOOF, PRETORIA o <0 FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF15 Registration number: 41/8.2/0051 Registration number: 41/8.210052 Name of medicine: CLOPIDOGREL·WINTHROP Name of medicine: CLOPIDOGREL-SANOFI-AVENTIS Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: CLOPIDOGREL HYDROGEN SULPHATE CLOPIDOGREL HYDROGEN SULPHATE EQUIVALENT TO CLOPIDOGREL 75,0 mg EQUIVALENT TO CLOPIDPGREL 75,Omg (f) Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 ii Applicant: SANOFI·SYNTHELABO (PTY) L TO Applicant: SANOFI·SYNTHELABO (PTY) LTD ~ (f) Manufacturer: SANOFI WINTHROP INDUSTRIE, CARBON BLANC, Manufacturer: SANOFI WINTHROP INDUSTRIE, CARBON BLANC, CEDEX, CEDEX,FRANCE FRANCE 6 SANOFI·SYNTHELABO LTD, FAWDON, NEWCASTLE SANOFI-SYNTHELABO LTD, FAWDON, NEWCASTLE UPON m UPON TYNE, UK TYNE, UK »JJ Packer: Z SANOFI WINTHROP INDUSTRIE, CARBON BLANC, Packer: SANOFI WINTHROP INDUSTRIE, CARBON BLANC, CEDEX, .:-i CEDEX,FRANCE FRANCE I\) SANOFI-SYNTHELABO LTD, FAWDON, NEWCASTLE SANOFI-SYNTHELABO LTD, FAWDON, NEWCASTLE UPON o UPON TYNE, UK TYNE, UK 11 WINTHROP PHARMACEUTICALS, WALTLOO, WINTHROP PHARMACEUTICALS, WALTLOO, PRETORIA m aJ PRETORIA JJ C Laboratory: FPRC: SANOFI WINTHROP INDUSTRIE, CARBON BLANC, Laboratory: FPRC: SANOFI WINTHROP INDUSTRIE, CARBON BLANC, CEDEX, » CEDEX,FRANCE FRANCE JJ SANOFI-SYNTHELABO LTO, FAWDON, NEWCASTLE SANOFI-SYNTHELABO LTD, FAWDON, NEWCASTLE UPON iii I\) UPON TYNE, UK TYNE,UK o WINTHROP PHARMACEUTICALS, WALTLOO, WINTHROP PHARMACEUTICALS, WALTLOO, PRETORIA o PRETORIA M&L LABORATORY SERVICES, ORMONDE, CD M&L LABORATORY SERVICES, ORMONDE, JOHANNESBURG JOHANNESBURG PHARMACEUTICAL CONTRACTORS, ISANDO PHARMACEUTICAL CONTRACTORS, ISANDO FPRR: SANOFI·SYNTHELABO, MIDRAND FPRR: SANOFI-SYNTHELABO, MIDRAND Shelf·life: 36 months Shelf-life: 36 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ~ w.... (Xl (Xl .... II:! .... II) CD z !=l w ..... I~ Registration number: 41/34/0068 Registration number: 41/34/0069 Name of medicine: BYETIA5ug Name of medicine: BYETIA 10 ug Dosage form: INJECTION Dosage form: INJECTION Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: EXENATIDE 250,0 ug EXENATIDE 250,0 ug Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 G) 0 < Applicant: ELI LILLY (S.A.) (PTY) LTD Applicant: ELI LILLY (SA) (PTy) LTD m :0 Manufacturer: WOCKHARDT UK LTD, WREXHAM, UK Manufacturer: WOCKHARDT UK LTD, WREXHAM, UK Z BAXTER PHARMACEUTICAL SOLUTIONS, BAXTER PHARMACEUTICAL SOLUTIONS, s:: BLOOMINGTON, INDIANA, USA BLOOMINGTON,INDIANA, USA zm -i Packer: LILLY PHARMA FERTIGUNG & Packer: LILLY PHARMA FERTIGUNG & DISTRIBUTION G) DISTRIBUTION GmbH & Co, GIESSEN, GmbH & Co, GIESSEN, GERMANY » N GERMANY m Laboratory: FPRC: CHARLES RIVER LABORATORIES Laboratory: FPRC: CHARLES RIVER LABORATORIES PRECLINICAL ~ PRECLINICAL SERVICES, TRANENT, SERVICES, TRANENT, EDINBURGH, SCOTLAND, JT1 I\) EDINBURGH, SCOTLAND, UK UK 0 SGS INSTITUT FRESENIUS BERLIN GmbH & SGS INSTITUT FRESENIUS BERLIN GmbH & Co, Co, BERLIN, GERMANY BERLlN,GERMANY "m CD SGS INSTITUT FRESENIUS GmbH, SGS INSTITUT FRESENIUS GmbH, TAUNUS- :0 TAUNUS-STEIN, GERMANY STEIN, GERMANY »C LILLY PHARMA FERTIGUNG & LILLY PHARMA FERTIGUNG & DISTRIBUTION :0 DISTRIBUTION GmbH & Co, GIESSEN, GmbH & Co, GIESSEN, GERMANY -< I\) GERMANY SOUTH AFRICAN BUREAU OF STANDARDS, 0 GROENKLOOF, PRETORIA 0 SOUTH AFRICAN BUREAU OF c.o STANDARDS, GROENKLOOF, PRETORIA FPRR: ELI LILLY, BRYANSTON, RSA FPRR: ELI LILLY, BRYANSTON, RSA Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 Registration number: 41/8.210146 Registration number: 4112.1/0191 Name of medicine: MISTRO Name of medicine: TERRELL Dosage form: TABLET Dosage form: LIQUID Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH GLASS BOTILE CONTAINS: CLOPIDOGREL BISULFATE EQUIVALENT TO ISOFLURANE 100,0 ml CLOPIDOGREL 75,0 mg (J) Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 ~ ~ Applicant: DR REDDY'S LABORATORIES (PTY) LTD Applicant: SAFELINE PHARMACEUTICALS (PTY) (J) :i\ LTD o m Manufacturer: DR REDDY'S LABORATORIES LTD, RANGA Manufacturer: MINRAD INC, BETHLEHEM, REDDY DISTRICT, ANDHRA PRADESH, INDIA PENNSYLVANIA, USA z~ .-1 Packer: DR REDDY'S LABORATORIES LTD, RANGA Packer: MINRAD INC, BETHLEHEM, I\) REDDY DISTRICT, ANDHRA PRADESH, INDIA PENNSYLVANIA, USA o II DRA PHARMACEUTICALS, IRENE, CENTURION m Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, RANGA Laboratory: FPRC: MINRAD INC, BETHLEHEM, IIOJ REDDY DISTRICT, ANDHRA PRADESH, INDIA PENNSYLVANIA, USA C INSTITUTE FOR PHARMACEUTICAL INSTITUTE FOR PHARMACEUTICAL :t> ;!1 SERVICES, SIL VERTONDALE, PRETORIA SERVICES, SILVERTONDALE, PRETORIA m RESEARCH INSTITUTE FOR INDUSTRIAL I\) o PHARMACY, NORTH-WEST UNIVERSITY, o POTCHEFSTROOM (() FPRR: DR REDDY'S LABORATORIES, MURRAYFIELD, FPRR: SAFELINE PHARMACEUTICALS, PRETORIA FLORIDA, JOHANNESBURG Shelf-life: 24 months Shelf-life: 60 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z p W -4 0> 0> .... I\) co !g z !' w .... g: ..... MRF15 MRF 15 Registration number: 41/1.210209 Registration number: 41/1.210210 Name of medicine: SERMAX50 Name of medicine: SERMAX 100 Dosage form: TABLET Dosage form: TABLET G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: o SERTRALINE HYDROCHLORIDE EQUIVALENT SERTRALINE HYDROCHLORIDE Manufacturer: TORRENT PHARMACEUTICALS LTO, Manufacturer: TORRENT PHARMACEUTICALS LTO, ~ MEHSANA, GUJARAT, INDIA MEHSANA, GUJARAT, INDIA m ~ Packer: TORRENT PHARMACEUTICALS LTD, Packer: TORRENT PHARMACEUTICALS L TO, m MEHSANA, GUJARAT, INDIA MEHSANA, GUJARAT, INDIA I\) o Laboratory: FPRC: TORRENT PHARMACEUTICALS LTD, Laboratory: FPRC: TORRENT PHARMACEUTICALS LTO, ." m MEHSANA, GUJARAT, INDIA MEHSANA, GUJARAT, INDIA III JJ »C JJ -< I\) o o FPRC/FPRR: BE-TABS PHARMACEUTICALS, ROODEPOORT, FPRC/FPRR: BE-TABS PHARMACEUTICALS, (!) RSA ROODEPOORT, RSA Shelf-life: 36 months Shelf-life: 36 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: 41/20.2.8/0218 Registration number: 41121.5.1/0238 Name of medicine: CIPLA DUOVIR AND EFAVIRENZ CO-PACK Name of medicine: INFLANAZE 100 Dosage form: TABLET Dosage form: NASAL SPRAY Active ingredients: EACH PACK CONTAINS: Active ingredients: EACH METERED DOSE CONTAINS: DUOVIR TABLETS CONTAINING: BUDESONIDE 100,0 ug LAMIVUDINE 150,0 mg en ZIDOVUDlNE 300,0 mg ~ EFAVIR 600 TABLETS CONTAINING: ~ EFAVIRENZ 600,0 mg en Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1.2.3,4,5,6,7.8 o "m II Applicant: CIPLA MEDPRO (PTY) LTD Applicant: INGELHEIM PHARMACEUTICALS (PTY) » LTD z ;-i Manufacturer: CIPLA LTD, VIKHROLl, MUMBAI, INDIA Manufacturer: MIPHARM S.pA, MILAN, ITALY CIPLA LTD, UNIT IV, SALCETTE, GOA, INDIA ~ m Packer: CIPLA LTD, UNIT IV, SALCETTE, GOA, INDIA Packer: MIPHARM S.pA, MILAN, ITALY " IIOJ Laboratory: FPRC: FPRC: CIPLA LTD. VIKHROLl, MUMBAI, INDIA Laboratory: MIPHARM S.p.A., MILAN, ITALY »C CIPLA LTD, UNIT IV, SALCETTE, GOA, INDIA WINTHROP PHARMACEUTICALS, II WALTLOO, PRETORIA m I\) o o (0 FPRR: CIPLA MEDPRO. ROSEN PARK, BELLVILLE FPRR: INGELHEIM PHARMACEUTICALS, RANDBURG,RSA Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o w.... g; .... ...c.l W Ilo'l z !J w Cl) Cl) ..... Registration number: 41/2.6.5/0264 Registration number: 4112.6.510265 Name of medicine: AUROPIDONE 1 mg Name of medicine: AUROPIDONE 2 mg Dosage form: TABLET Dosage form: TABLET G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: 0 RISPERIDONE 1.0mg RISPERIDONE 2.0mg m< :D Conditions of registration: 1.2.3.4.5.6.7 Conditions of registration: 1.2,3,4,5,6.7 Z s: Applicant: AUROBINDO PHARMA (PTY) LTO Applicant: AUROBINDO PHARMA (PTY) LTO m Z Manufacturer: AUROBINDO PHARMA LTD, UNIT III. RANGA Manufacturer: AUROBINDO PHARMA LTD. UNIT I", -I REDDY DISTRICT. ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA G) PRADESH. INDIA m~ AUROBINDO PHARMA LTD, UNIT III, -I Packer: AUROBINDO PHARMA LTD, UNIT III, RANGA Packer: -I REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA m PRADESH, INDIA I\) 0 Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III. RANGA Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III. II m REDDY DISTRICT, ANDHRA PRADESH. INDIA RANGA REDDY DISTRICT, ANDHRA [l) PRADESH, INDIA :D C» :D -< I\) 0 FPRR: AUROBINDO PHARMA, MEYERSDAL. FPRR: AUROBINDO PHARMA, MEYERSDAL, 1:5 JOHANNESBURG JOHANNESBURG Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 Registration number: 41/2.6.5/0266 Registration number: 41/2.6.5/0267 Name of medicine: AUROPIDONE 3 mg Name of medicine: AUROPIDONE 4 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 3,Omg RISPERIDONE 4,Omg (J) Conditions registration: Conditions of registration: of 1,2,3,4,5,6,7 1,2,3,4,5,6,7 ~ Applicant: Applicant: AUROBINDO PHARMA (PTY) LTD ~ AUROBINDO PHARMA (PTY) LTD (J) ;iii; Manufacturer: AUROBINDO PHARMA LTD, UNIT III, RANGA Manufacturer: AUROBINDO PHARMA LTD, UNIT III, RANGA 0 REDDY DISTRICT, ANDHRA PRADESH, REDDY DISTRICT, ANDHRA PRADESH, INDIA m INDIA »:D z Packer: AUROBINDO PHARMA LTD. UNIT III, RANGA Packer: AUROBINDO PHARMA LTD, UNIT III, RANGA .-1 REDDY DISTRICT. ANDHRA PRADESH. REDDY DISTRICT, ANDHRA PRADESH, INDIA I\) INDIA 0 m Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III, RANGA Laboratory: FPRC: AUROBINDO PHARMA LTD. UNIT III. RANGA "III REDDY DISTRICT, ANDHRA PRADESH, REDDY DISTRICT, ANDHRA PRADESH, INDIA :D C INDIA » :D m I\) 0 0 (.0 FPRR: AUROBINDO PHARMA, MEYERSDAL, FPRR: AUROBINDO PHARMA. MEYERSDAL. JOHANNESBURG JOHANNESBURG Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ? (.) .... co co .... (0) (0) w ~ z 9 U) ..... (Xl (Xl MRF 15 MRF 15 ..... Registration number: 41/2.6.5/0339 Registration number: 4112.6.5/0340 Name of medicine: ASPEN RISPERIDONE 0,5 mg Name of medicine: ASPEN RISPERIDONE 1 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 0,5 mg RISPER1DONE 1,0 mg Gl Conditions of registration: 1.2.3.4,5,6,7.8 Conditions of registration: 1,2,3,4,5,6.7,8 o m< Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED JJ Z s: Manufacturer: PHARMA INTERNATIONAL COMPANY, AL Manufacturer: PHARMA INTERNATIONAL COMPANY, AL m JUBEIHA. AMMAN, JORDAN JUBEIHA, AMMAN, JORDAN -;Z Packer: PHARMA INTERNATIONAL COMPANY, AL Packer: PHARMA INTERNATIONAL COMPANY, AL Gl JUBEIHA, AMMAN, JORDAN JUBEIHA, AMMAN, JORDAN ~ CHANELLE MEDICAL, LOUGH REA. COUNTY CHANELLE MEDICAL, LOUGHREA, COUNTY m GALWAY. IRELAND GALWAY, IRELAND m~ Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AL Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AL I\) JUBEIHA. AMMAN, JORDAN JUBEIHA, AMMAN, JORDAN o CHANELLE MEDICAL, LOUGHREA. COUNTY CHANELLE MEDICAL, lOUGHREA, COUNTY ." m GALWAY, IRELAND GALWAY, IRELAND III SOUTH AFRICAN BUREAU OF STANDARDS, SOUTH AFRICAN BUREAU OF STANDARDS, JJ GROENKLOOF, PRETORIA GROENKLOOF, PRETORIA C» RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, SILVERTONDALE. PRETORIA PHARMACY, SILVERTONDALE, PRETORIA ~ I\) M&L LABORATORY SERVICES, ORMONDE, M&l LABORATORY SERVICES, ORMONDE, o o JOHANNESBURG JOHANNESBURG ~ FPRR: PHARMACARE LTD, WOODMEAD, SANDTON FPRR: PHARMACARE LTD, WOODMEAD, SANDTON Shelf-life: 24 months (Provisionai) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF15 MRF 15 Registration number: 41/2.6.5/0341 Registration number: 41/2.6.5/0346 Name of medicine: ASPEN RISPERIDONE 2 mg Name of medicine: ASPEN RISPERIDONE 3 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 2,0 mg RISPERIDONE 3,0 mg Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 (J) Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED ~ ~ Manufacturer: PHARMA INTERNATIONAL COMPANY, AL Manufacturer: PHARMA INTERNATIONAL COMPANY, (J) JUBEIHA, AMMAN, JORDAN AL-JUBEIHA, AMMAN, JORDAN A o Packer: PHARMA INTERNATIONAL COMPANY, AL Packer: PHARMA INTERNATIONAL COMPANY, m JJ JUBEIHA, AMMAN, JORDAN AL-JUBEIHA, AMMAN, JORDAN » CHANELLE MEDICAL, LOUGH REA, COUNTY CHANELLE MEDICAL, LOUGH REA, Z .-1 GALWAY, IRELAND COUNTY GALWAY, IRELAND of\J Laboratory: PHARMA INTERNATIONAL COMPANY, Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AL FPRC: 'TJ JUBEIHA, AMMAN, JORDAN AL-JUBEIHA, AMMAN, JORDAN m Cll CHANELLE MEDICAL, LOUGH REA, COUNTY CHANELLE MEDICAL, LOUGHREA, JJ GALWAY,IRELAND COUNTY GALWAY, IRELAND »C SOUTH AFRICAN BUREAU OF STANDARDS, SOUTH AFRICAN BUREAU OF JJ GROENKLOOF, PRETORIA STANDARDS, GROENKLOOF, PRETORIA m RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL f\J o PHARMACY, SILVERTONDALE, PRETORIA PHARMACY, SILVERTONDALE, o M&L LABORATORY SERVICES, ORMONDE, PRETORIA c.o JOHANNESBURG M&L LABORATORY SERVICES, ORMONDE, JOHANNESBURG FPRR: PHARMACARELTD,WOODMEAD,SANDTON FPRR: PHARMACARE LTD, WOODMEAD, SANDTON Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 w ~ co co Co) CI1 CAl CD z !=l w .... I~ Registration number: 4112.6.5/0347 Registration number: 41121.1210351 Name of medicine: ASPEN RISPERIDONE 4 mg Name of medicine: FINAP 5mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 4,Omg FINASTERIDE 5,0 mg G) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7 0 < Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED m JJz Manufacturer: PHARMA INTERNATIONAL COMPANY, AL- Man ufacturer: FAMAR SA, ANTHOUSSA, ATTIKIS, s: JUBEIHA, AMMAN, JORDAN GREECE mz Packer: PHARMA INTERNATIONAL COMPANY, AL Packer: FAMAR SA, ANTHOUSSA, ATTIKIS, -! JUBEIHA, AMMAN, JORDAN GREECE G)» CHANELLE MEDICAL, LOUGHREA, COUNTY N GALWAY, IRELAND m ~ Laboratory: FPRC: PHARMA INTERNATIONAL COMPANY, AL- Laboratory: FPRC: FAMAR SA, ANTHOUSSA, ATTIKIS, !l1 JUBEIHA, AMMAN, JORDAN GREECE I\) CHANELLE MEDICAL, LOUGHREA, COUNTY PHARMATHEN SA, PALLINI ATTIKIS, 0 GALWAY,IRELAND GREECE m" SOUTH AFRICAN BUREAU OF STANDARDS, SOUTH AFRICAN BUREAU OF III JJ GROENKLOOF, PRETORIA STANDARDS, GROENKLOOF, PRETORIA c RESEARCH INSTITUTE FOR INDUSTRIAL M&L LABORATORY SERVICES, » JJ PHARMACY, SILVERTONDALE, PRETORIA ORMONDE, JOHANNESBURG -< M&L LABORATORY SERVICES, ORMONDE, RESEARCH INSTITUTE FOR INDUSTRIAL I\) 0 JOHANNESBURG PHARMACY, NORTH WEST UNIVERSITY, 0 POTCHEFSTROOM ~ Col Q) z p v:>.... ()) ()) .... MRF15 MRF 15 Registration number: 41/2.5/0375 Registration number: 41/3.2/0431 Name of medicine: LAMITOR-200 Name of medicine: BONIRAN 10 Dosage fonn: TABLET Dosage fonn: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS; LAMOTRIGINE 200,0 mg SODIUM ALENDRONATE EQUIVALENT TO GJ ALENDRONIC ACID 10,0 mg o m< Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7,8 II Z Applicant: DR REDDY'S LABORATORIES (PTY) LTD Applicant: RANBAXY (SA) (PTy) LTD s: m Manufacturer: Manufacturer: z TORRENT PHARMACEUTICALS LTD, RANBAXY LABORATORIES LTD, PAONTA -l MEHSANA, INDIA SAHIB, HIMACHAL PRADESH, INDIA GJ» Packer: TORRENT PHARMACEUTICALS LTD, Packer: RANBAXY LABORATORIES LTD, PAONTA N MEHSANA, INDIA SAHIB, HIMACHAL PRADESH, INDIA m DRA PHARMACEUTICALS, IRENE, ~ CENTURION m I\) Laboratory: FPRC: TORRENT PHARMACEUTICALS LTD, Laboratory: FPRC RANBAXY LABORATORIES LTD, PAONTA o ." MEHSANA, INDIA SAHIB, HIMACHAL PRADESH, INDIA m INSTITUTE FOR PHARMACEUTICAL CONSULTING CHEMICAL LABORATORIES, IIlD SERVICES, SILVERTONDALE, PRETORIA ATLASVILLE, BOKSBURG C RESEARCH INSTITUTE FOR INDUSTRIAL KHULULEKANI LABORATORY SERVICES, » PHARMACY, NORTH-WEST UNIVERSITY, COVENTRY PARK, MIDRAND II -< POTCHEFSTROOM,RSA I\) o o FPRR: DR REDDY'S LABORATORIES, FPRR: RANBAXY (SA), CENTURION, RSA <0 MURRAYFIELD, PRETORIA Shelf-life: 24 months Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 Registration number: 41/2.6.5/0445 Registration number: 41/2.6.5/0446 Name of medicine: ZOXADON 1 mg Name of medicine: ZOXADON 2mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 1,0 mg RISPERIDONE 2,0 mg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7 Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD UJ Manufacturer: ACTAVIS hf, KOPAVOGUR, ICELAND Manufacturer: ACTAVIS hf, KOPAVOGUR, ICELAND ~ ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND ~ ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA UJ o=" Packer: ACTAVIS hf, KOPAVOGUR, ICELAND Packer: ACTAVIS hf, KOPAVOGUR, ICELAND m ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND ~ ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA Z TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, --I I\) FLORIDA ROBERTVILLE;, FLORIDA o DIVPHARM MANUFACTURING & PACKAGING, DIVPHARM MANUFACTURING & LONGDALE, JOHANNESBURG PACKAGING, LONGDALE, JOHANNESBURG "m OJ PHARMACEUTICAL ENTERPRISES, N'DABENI, PHARMACEUTICAL ENTERPRISES, JJ KZN N'DABENI, KZN »C JJ Laboratory: FPRC: ACTAVIS hf, KOPAVOGUR, ICELAND Laboratory: FPRC ACTAVIS hf, KOPAVOGUR, ICELAND m ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND I\) o ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA o TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, <.0 FLORIDA ROBERTVILLE, FLORIDA CONSULTING CHEMICAL LABORATORIES, CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG ATLASVILLE, BOKSBURG FPRR: PHARMA DYNAMICS, SILVERWOOD, FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE WESTLAKE Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ~ w ..... Q) Q) c,,) <0 s z 9 (,;) ..... CD CD MRF15 MRF15 ..... Registration number: 4112.6.510447 Registration number: 4112.6.510468 Name of medicine: ZOXADON6mg Name of medicine: ZOXADON 0,5 mg Dosage fonn: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIOONE 6,0 mg RISPERIDONE 0,5 mg G> Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,2,3,4,5,6,7 o < Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD m :0 Manufacturer: ACTAVIS hf, KOPAVOGUR, ICELAND Manufacturer: ACTAVIS hf, KOPAVOGUR, ICELAND Z s:: ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND m ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA Z -! Packer: ACTAVIS hf, KOPAVOGUR, ICELAND Packer: ACTAVIS hf, KOPAVOGUR, ICELAND ACTAVIS ht, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA m~ TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, ROBERTVILLE, ~ FLORIDA FLORIDA m DIVPHARM MANUFACTURING & PACKAGING, DIVPHARM MANUFACTURING & PACKAGING, LONGDALE, JOHANNESBURG LONGDALE, JOHANNESBURG I\lo PHARMACEUTICAL ENTERPRISES, N'DABENI, KZN PHARMACEUTICAL ENTERPRISES, N'DABENI, KZN m "III Laboratory: FPRC: ACTAVIS hf, KOPAVOGUR, ICELAND Laboratory: FPRC: ACTAVIS hf, KOPAVOGUR, ICELAND :0 ACTAVIS ht, HAFNARFJORDUR,ICELAND ACTAVIS hf, HAFNARFJORDUR,ICELAND C ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA » TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, ROBERTVILLE, ~ FLORIDA FLORIDA I\lo CONSULTING CHEMICAL LABORATORIES, CONSULTING CHEMICAL LABORATORIES, o ATLASVILLE, BOKSBURG ATLASVlLLE, BOKSBURG <0 FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF15 MRF 15 Registration number: 41/2.6.5/0469 Registration number: 41/2.6.510470 Name of medicine: ZOXADON3mg Name of medicine: ZOXADON4 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 3,0 mg RISPERIDONE 4,0 mg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1, 2, 3,4, 5, 6, 7 (J) Applicant: PHARMA DYNAMICS (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD );! ~ Manufacturer: ACTAVIS hf, KOPAVOGUR, ICELAND Manufacturer: ACTAVIS hf, KOPAVOGUR,ICELAND (J) ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA a '"m Packer: ACTAVIS hf, KOPAVOGUR, ICELAND Packer: ACTAVIS hf, KOPAVOGUR, ICELAND lJ ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND ~ ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS L TO, ZEJTUN, MALTA :-I TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, ROBERTVILLE, I\) FLORIDA FLORIDA o DIVPHARM MANUFACTURING & PACKAGING, DIVPHARM MANUFACTURING & PACKAGING, ." m LONGDALE, JOHANNESBURG LONGDALE, JOHANNESBURG OJ PHARMACEUTICAL ENTERPRISES, N'DABENI, KZN PHARMACEUTICAL ENTERPRISES, N'DABENI, lJ KZN »C Laboratory: FPRC: ACTAVIS hf, KOPAVOGUR, ICELAND Laboratory: FPRC: ACTAVIS hf, KOPAVOGUR, ICELAND lJ ACTAVIS hf, HAFNARFJORDUR, ICELAND ACTAVIS hf, HAFNARFJORDUR, ICELAND m I\) ACTAVIS LTD, ZEJTUN, MALTA ACTAVIS LTD, ZEJTUN, MALTA o TECHNIKON LABORATORIES, ROBERTVILLE, TECHNIKON LABORATORIES, ROBERTVILLE, o FLORIDA FLORIDA co CONSULTING CHEMICAL LABORATORIES, CONSULTING CHEMICAL LABORATORIES, ATLASVILLE, BOKSBURG ATLASVlLLE, BOKSBURG FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ? 00 .... 00 00 ,jIo .... .j:o N Z !' Registration number: 41124/0553 Registration number: 4117.1/0562 Ii Name of medicine: 0,9 % SODIUM CHLORIDE AND 5 % GLUCOSE Name of medicine: DYNAAMLODIPINE BESYLATE 5 mg BBRAUN Dosage form: INFUSION Dosage form: TABLET Active ingredients: EACH 1000,0 ml SOLUTION CONTAINS: Active ingredients: EACH TABLET CONTAINS: GLUCOSE MONOHYDRATE EaUIVALENT TO AMLODIPINE BESYLATE EaUIVALENTTO GLUCOSE 50,Og AMLODIPINE 5,Omg SODIUM CHLORIDE 9,Og (j) Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1,2,3,4,5,6,7,8 0 m< Applicant: B BRAUN MEDICAL (PTY) LTD Applicant: PHARMA DYNAMICS (PTY) LTD :D Z Manufacturer: KRKA, NOVO MESTO, SLOVENIA B BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY Manufacturer: s::: PRODUCTION PHARMA PFIEFFEWIESEN, m MELSUNGEN,GERMANY Z B BRAUN MEDICAL SA, BARCELONA, SPAIN -I (j) Packer: B BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY Packer: KRKA , NOVO MESTO, SLOVENIA » N PRODUCTION PHARMA PFIEFFEWIESEN, TECHNIKON LABORATORIES, ROBERTVILLE, m MELSUNGEN,GERMANY FLORIDA ::j B BRAUN MEDICAL SA, BARCELONA, SPAIN DIVPHARM MANUFACTURING & PACKAGING, LONGDALE, JOHANNESBURG JT1 I\) PHARMACEUTICAL ENTERPRISES, N'DABENI, 0 PINELANDS i1m Laboratory: FPRC: B BRAUN MELSUNGEN AG, MELSUNGEN, Laboratory: FPRC: KRKA, NOVO MESTO, SLOVENIA OJ GERMANY TECHNIKON LABORATORIES, ROBERTVILLE, :D C M&L LABORATORY SERVICES, ORMONDE, FLORIDA » JOHANNESBURG CONSULTING CHEMICAL LABORATORIES, :D COSI PHARMACEUTICALS, INDUSTRIA WEST, ATLASVILLE, BOKSBURG -< I\) JOHANNESBURG 0 CONSULTING CHEMICAL LABORATORIES, 0 (l) ATLASVILLE, BOKSBURG FPRR: B BRAUN MEDICAL, HONEYDEW, GAUTENG FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE Shelf-life: 36 months Shelf-life: 24 months (PrOVisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF15 MRF 15 Registration number: 41/7.1/0563 Registration number: 41/20.2.8/0692 Name of medicine: DYNA AMLODIPINE BESYLATE 10 mg Name of medicine: CIPLA-ABACAVIR 300 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: AMLODIPINE BESYLATE EQUIVALENT TO ABACAVIR SULPHATE EQUIVALENT TO AMLODIPINE 10,0 mg ABACAVIR 300,0 mg (J) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 i! Applicant: PHARMA DYNAMICS (PTY) LTD Applicant CIPLA MEDPRO (PTY) LTD ::; (J) Manufacturer: KRKA , NOVO MESTO, SLOVENIA Manufacturer: CIPLA LTD, PATALGANGA, RAIGAD, oA MAHARASHTRA, INDIA m II Packer: KRKA , NOVO MESTO, SLOVENIA PaCker: CIPLA LTD, PATALGANGA, RAIGAD. » TECHNIKON LABORATORIES, ROBERTVILLE, MAHARASHTRA, INDIA Z .-i FLORIDA I\) DIVPHARM MANUFACTURING & PACKAGING, o ." LONGDALE, JOHANNESBURG m PHARMACEUTICAL ENTERPRISES, N'DABENI, OJ PINELANDS II C Laboratory: FPRC: KRKA , NOVO MESTO, SLOVENIA Laboratory: FPRC: CIPLA LTD, PATALGANGA, RAIGAD, » TECHNIKON LABORATORIES, ROBERTVILLE, MAHARASHTRA, INDIA m~ FLORIDA I\) o CONSULTING CHEMICAL LABORATORIES, o ATLASVILLE, BOKSBURG <0 FPRR: PHARMA DYNAMICS, SILVERWOOD, FPRR: CIPLA MEDPRO, ROSENPARK, WESTLAKE BELLVILLE Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 (.U ... (XI (XI... .j:I. Col t z ? cu CXI CXI... Registration number: 41/20.2.810693 Registration number: 41120.2.810733 Name of medicine: ABAMUNE300 Name of medicine: ZETRODIN 100 mg Dosage form: TABLET Dosage form: CAPSULE Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: G) 0 ABACAVIR SULPHATE EQUIVALENT TO ZIDOVUDINE 100,0 mg < ABACAVIR 300,0 mg m lJ Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Z s:: m Applicant: CIPLA LIFE SCIENCES (PTY) L TO Applicant: ADCOCK INGRAM LIMITED Z -f Manufacturer: CIPLA L TO, PATALGANGA, RAIGAD, Manufacturer: ADCOCK INGRAM HEALTHCARE, G) MAHARASHTRA, INDIA WADEVILLE, GERMISTON » N m Packer: CIPLA LTO, PATALGANGA, RAIGAD, Packer: ADCOCK INGRAM HEALTHCARE, -f MAHARASHTRA, INDIA WADEVILLE, GERMISTON -f ADCOCK INGRAM LTO. AEROTON, m I\) JOHANNESBURG 0 Laboratory: FPRC: CIPLA LTD, PATALGANGA, RAIGAD, Laboratory: FPRC/FPRR: ADCOCK INGRAM HEALTHCARE, m"T1 MAHARASHTRA, INDIA WADEVILLE. GERMISTON ro lJ ADCOCK INGRAM LTO, AEROTON, C JOHANNESBURG » lJ -< I\) 0 .<00 FPRR: CIPLA LIFE SCIENCES, ROSENPARK, FPRR: ADCOCK INGRAM LTO, ERAND BELLVILLE GARDENS, MIDRAND Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 Registration number: 41/20.2.8/0734 Registration number: 41/8.210766 Name of medicine: ZETRODIN 250 mg Name of medicine: CLOPIVAS Dosage form: CAPSULE Dosage form: TABLET Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: ZIDOVUDINE 250,Omg CLOPIDOGREL BISULPHATE EQUIVALENT TO CLOPIDOGREL 75,Omg en Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 ~ ~ Applicant: ADCOCK INGRAM LIMITED Applicant: CIPLA MEDPRO (PTy) LTD en A Manufacturer: ADCOCK INGRAM HEALTHCARE, Manufacturer: CIPLA LTD, UNIT VII, VERNA, GOA, INDIA 0 WADEVILLE, GERMISTON m »Jl Packer: ADCOCK INGRAM HEALTHCARE, Packer: CIPLA LTD, UNIT VII, VERNA, GOA, INDIA Z WADEVILLE, GERMISTON .:-I N ADCOCK INGRAM LTD, AEROTON, 0 JOHANNESBURG m Laboratory: FPRC/FPRR: ADCOCK INGRAM HEALTHCARE, Laboratory: FPRC: CIPLA LTD, UNIT VII, VERNA, GOA, INDIA "III Jl WADEVILLE, GERMISTON c ADCOCK INGRAM LTD, AEROTON, » JOHANNESBURG ~ m N 0 0 (0 FPRR ADCOCK INGRAM LTD, ERAND GARDENS, FPRR: CIPLA MEDPRO, ROSENPARK, BELLVILLE MIDRAND Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o (,J .... ~ .... ~ ~ z o w ...... ~ ..... Registration number: 41/8.2/0767 Registration number: 41/8.2/0768 Name of medicine: CIPLA-CLOPIDOGREL Name of medicine: MEDPRO-CLOPIDOGREL Dosage form: TABLET Dosage form: TABLET G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: 0 CLOPIDOGREL BISULPHATE EQUIVALENT TO CLOPIDOGREL BISULPHATE Date of registration: 9 DECEMBER 2008 z ? w CD CD ..... .j:> -..j lit z ? CJJ ..... (l) (l) ..... MRF 15 MRF 15 Registration number: 41120.2.8/0799 Registration number: 41/20.2.8/0856 CIPLA-OSELTAMIVIR Name of medicine: Name of medicine: ABAMUNE ORAL SOLUTION CAPSULE Dosage form: Dosage form: SOLUTION oG> m< II Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH 1.0 ml SOLUTION CONTAINS: z OSELTAMIVIR PHOSPHATE EQUIVALENT TO ABACAVIR SULPHATE EQUIVALENT TO s:: OSELTAMIVIR 75.0 mg ABACAVIR 20.0 mg mz Conditions of registration: 1.2.3.4.5.6.7.8 Conditions of registration: 1.2.3.4.5.6.7,8 -I G> Applicant: CIPLA LIFE SCIENCES (PrY) LTD Applicant: CIPLA LIFE SCIENCES (PrY) LTO ~ m Manufacturer: CIPLA LTD. VERNA. GOA, INDIA Manufacturer: CIPLA LTO, UNIT I. VERNA, SALCETTE, GOA. INDIA m~ I\) Packer: CIPLA LTD. VERNA. GOA, INDIA Packer: CIPLA LTD. UNIT I, VERNA. SALCETTE. o GOA. INDIA ." m Laboratory: FPRC: CIPLA LTD. VERNA. GOA, INDIA Laboratory: FPRC: CIPLA LTD, UNIT I. VERNA, SALCETTE, OJ GOA, INDIA II C II» -< I\) o o (0 FPRR: CIPLA LIFE SCIENCES. ROSENPARK, FPRR: CIPLA LIFE SCIENCES. ROSENPARK. BELLVILLE BELLVILLE Shelf-life: 24 months (Provisional) Shelf-life: 24 months (ProviSional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: 41/20.2.8/0857 Registration number: 41115.4/0860 Name of medicine: CIPLA-ABACAVIR ORAL SOLUTION Name of medicine: LUCENTIS Dosage form: SOLUTION Dosage form: SOLUTION Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: ABACAVIR SULPHATE EQUIVALENT TO RANIBIZUMAB 10,0 mg ABACAVIR 20,0 mg (J) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 ~ Applicant: CIPLA MEDPRO (PTY) LTD Applicant: NOVARTIS SOUTH AFRICA (PTY) LTD ~ o Manufactu rer: CIPLA LTD, UNIT I, VERNA, SALCETTE, GOA, Manufacturer: NOVARTIS PHARMA STEIN AG, STEIN, "m INDIA SWITZERLAND »JJ Z Packer: CIPLA LTD, UNIT I, VERNA, SALCETTE, GOA, Packer: NOVARTIS PHARMA STEIN AG, STEIN, .-1 INDIA SWITZERLAND I\) NOVARTIS SA, SPARTAN, KEMPTON o PARK m"T1 OJ Laboratory: FPRC: CIPLA LTD, UNIT I, VERNA, SALCETTE, GOA, Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, STEIN, JJ INDIA SWITZERLAND »C NOVARTIS PHARMA AG, BASLE, JJ SWITZERLAND m I\) M&L LABORATORY SERVICES, o o ORMONDE, JOHANNESBURG (!) FPRR: CIPLA MEDPRO, ROSEN PARK, BELLVILLE FPRC/FPRR: NOVARTIS SA, SPARTAN, KEMPTON PARK Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z !=l (.oJ .... CIl CIl .... ~ IQ! o z !l (,l MRF 15 ..... 0> 0> Registration number: 4112.6.5/0874 Registration number: 41/2.6.5/0875 Name of medicine: MERCK-RISPERIOONE 0,25 Name of medicine: MERCK-RISPERIDONE 0.5 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 0,25 mg RISPERIDONE 0,5mg Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1.2,3.4,5,6.7 G> Applicant: MERCK GENERICS RSA (PTY) LTD Applicant: MERCK GENERICS RSA (PTY) LTD o < Manufacturer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Manufacturer: PHARMA INTERNATIONAL CO, AL-JUBEIHA. m :D JORDAN AMMAN, JORDAN Z !l: Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Packer: PHARMA INTERNATIONAL CO. AL-JUBEIHA, m JORDAN AMMAN, JORDAN Z CHANELLE MEDICAL. LOUGH REA, Co GALWAY, CHANELLE MEDICAL, LOUGHREA. Co -f IRELAND GALWAY,IRELAND G> GENERICS (UK) LTD, STATION CLOSE, GENERICS (UK) LTD, STATION CLOSE, » N HERTFORDSHIRE, UK HERTFORDSHIRE, UK m GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN, IRELAND MERCK PHARMACEUTICAL MANUFACTURERS, MERCK PHARMACEUTICAL ~m WADEVILLE, GERMISTON MANUFACTURERS, WADEVILLE, GERMISTON I\) Laboratory: FPRC: PHARMA INTERNATIONAL CO, AL-JUBEIHA. o Laboratory: FPRC: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, ." JORDAN AMMAN, JORDAN m CHANELLE MEDICAL, LOUGH REA, Co GALWAY, CHANELLE MEDICAL, LOUGH REA, Co OJ IRELAND GALWAY, IRELAND :D C GENERICS (UK) LTD, STATION CLOSE, GENERICS (UK) LTD, STATION CLOSE, » HERTFORDSHIRE, UK HERTFORDSHIRE, UK GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN. IRELAND ~ I\) MERCK PHARMACEUTICAL MANUFACTURERS, MERCK PHARMACEUTICAL o WADEVILLE, GERMISTON MANUFACTURERS, WADEVILLE. GERMISTON o RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL <:0 PHARMACY, NORTH-WEST UNIVERSITY, PHARMACY, NORTH-WEST UNIVERSITY. POTCHEFSTROOM POTCHEFSTROOM FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA FPRR: MERCK GENERICS RSA, MODDERFONTE!N, RSA Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF Registration number: 41/2.6.5/0876 Registration number: 41/2,6.5/0877 Name of medicine: MERCK-RISPERIDONE 1 Name of medicine: MERCK-RISPERIDONE 2 Dosage fonn: TABLET Dosage fonn: TABLET Active ingredients: EACH TABLET CONTAINS Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 1,0 mg RISPERIDONE 2,Omg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Applicant: MERCK GENERICS RSA (PTY) LTD Applicant: MERCK GENERICS RSA (PTY) LTO (fJ Manufacturer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Manufactu rer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, ~ JORDAN AMMAN, JORDAN ~ (fJ Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, A JORDAN AMMAN, JORDAN o CHANELLE MEDICAL, LOUGHREA, CD GALWAY, CHANELLE MEDICAL, LOUGH REA, Co m IRELAND GALWAY, IRELAND Jl );> GENERICS (UK) LTO, STATION CLOSE, GENERICS (UK) LTD, STATION CLOSE, Z HERTFORDSHIRE, UK HERTFORDSHIRE, UK ;-I GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN, IRELAND I\l MERCK PHARMACEUTICAL MANUFACTURERS, MERCK PHARMACEUTICAL o "Tl WADEVILLE, GERMISTON MANUFACTURERS, WADEVILLE, GERMISTON m IJJ Laboratory: FPRC' PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Laboratory: FPRC: PHARMA INTERNATIONAL CO, AL-JUBEIHA, Jl JORDAN AMMAN, JORDAN C CHANELLE MEDICAL, LOUGHREA, CD GALWAY, CHANELLE MEDICAL, LOUGHREA, CD );> IRELAND GALWAY, IRELAND Jl GENERICS (UK) LTD, STATION CLOSE, GENERICS (UK) LTD, STATION CLOSE, m I\l HERTFORDSHIRE, UK HERTFORDSHIRE, UK o o GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN, IRELAND (,0 MERCK PHARMACEUTICAL MANUFACTURERS, MERCK PHARMACEUTICAL WADEVILLE, GERMISTON MANUFACTURERS, WADEVILLE, GERMISTON RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTHWEST UNIVERSITY, PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM POTCHEFSTROOM FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA Shelf·life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o w -" Cll Cll -" ...(J1 (11 I\) z o w ..... (Xl (Xl MRF 15 MRF15 Registration number: 41/2.6.510878 Registration number: 41/2.6.5/0879 Name of medicine: MERCK-RISPERIDONE 3 Name of medicine: MERCK-RISPERIDONE 4 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 3,Omg RISPERIDONE 4,Omg oG) Conditions of 1,2,3,4,5,6,7 Conditions of 1, 2, 3, 4, 5, 6, 7 < registration: registration: m II Applicant: MERCK GENERICS RSA (PTY) LTD Applicant: MERCK GENERICS RSA (PTY) LTD Z s:: Manufacturer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN Manufacturer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN mz Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN -i CHANELLE MEDICAL, LOUGHREA, Co GALWAY, IRELAND CHANELLE MEDICAL, LOUGHREA, Co GALWAY,IRELAND G) GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, UK GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, UK ~ GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN, IRELAND m MERCK PHARMACEUTICAL MANUFACTURERS, WADEVILLE, MERCK PHARMACEUTICAL MANUFACTURERS, WADEVILlE, -i GERMISTON GERMISTON m-i I\) Laboratory: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN Laboratory: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, JORDAN o FPRC: CHANELLE MEDICAL, LOUGHREA, Co GALWAY, IRELAND FPRC: CHANELLE MEDICAL, LOUGH REA, Co GALWAY, IRELAND ." GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, UK GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, UK m GERARD LABORATORIES, DUBLIN, IRELAND GERARD LABORATORIES, DUBLIN, IRELAND II) MERCK PHARMACEUTICAL MANUFACTURERS, WADEVILLE, II MERCK PHARMACEUTICAL MANUFACTURERS, WADEVILLE, C GERMISTON GERMISTON » RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH II WEST UNIVERSITY, POTCHEFSTROOM WEST UNIVERSITY, POTCHEFSTROOM -< I\) o o (0 FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF15 MRF15 Registration number: 41/2.6.5/0880 Registration number: 41/1.2/0896 Name of medicine: MERCK-RISPERIDONE 6 Name of medicine: ASPEN ESCITALOPRAM 5 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 6,Omg ESCITALOPRAM OXALATE EQUIVALENT TO ESCITALOPRAM 5,0 mg Conditions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1,2,3,4,5,6,7,8 Applicant: MERCK GENERICS RSA (PTY) LTD Applicant: PHARMACARE LIMITED (f) Man ufactu rer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Manufacturer; ALPHAPHARM, CAROLE PARK, QUEENSLAND, );! JORDAN AUSTRALIA ~ MERCK PHARMA YQUI MICA, MOLLET DEL (f) VALLES, BARCELONA, SPAIN oA ALPHAPHARM, CAROLE PARK, QUEENSLAND, m Packer: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Packer: II JORDAN AUSTRALIA » CHANELLE MEDICAL, LOUGH REA, Co GALWAY, IRELAND MERCK PHARMA YQUIMICA, MOLLET DEL Z GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, VALLES, BARCELONA, SPAIN :-i UK GERARD LABORATORIES, DUBLIN, IRELAND I\:l GERARD LABORATORIES, DUBLIN, IRELAND GENERICS (UK) LTD, STATION CLOSE, o MERCK PHARMACEUTICAL MANUFACTURERS, HERTFORDSHIRE, UK m WADEVILLE, GERMISTON "(Jl II Laboratory: FPRC: PHARMA INTERNATIONAL CO, AL-JUBEIHA, AMMAN, Laboratory: FPRC ALPHAPHARM, CAROLE PARK, QUEENSLAND, C JORDAN AUSTRALIA » CHANELLE MEDICAL, LOUGH REA, Co GALWAY, IRELAND MERCK PHARMA YQUIMICA, MOLLET DEL II GENERICS (UK) LTD, STATION CLOSE, HERTFORDSHIRE, VALLES, BARCELONA, SPAIN m I\:l UK GERARD LABORATORIES, DUBLIN, IRELAND o SOUTH AFRICAN BUREAU OF STANDARDS, o GERARD LABORATORIES, DUBLIN, IRELAND co MERCK PHARMACEUTICAL MANUFACTURERS, GROENKLOOF, PRETORIA WADEVILLE, GERMISTON M&L LABORATORY SERVICES, ORMONDE, RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, JOHANNESBURG NORTH-WEST UNIVERSITY, POTCHEFSTROOM RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH WEST UNIVERSITY, POTCHEFSTROOM FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA FPRR: PHARMACARE LTD, WOODMEAD, SANDTON Shelf-life: 24 months Shelf-life: 24 months (Provisional) z Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 p w -" OJ OJ -" UI (,oJ ~ z !' Ul I~ Registration number: 41/1.210897 Registration number: 4111 .2/0898 Name of medicine: ASPEN ESCITALOPRAM 10 mg Name of medicine: ASPEN ESCITALOPRAM 15 mg Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: ESCITALOPRAM OXALATE EQUIVALENT TO ESCITALOPRAM OXALATE EQUIVALENT TO ESCITALOPRAM 10,Omg ESCITALOPRAM 15,0 mg Conditions of registration: 1, 2, 3, 4, 5,6, 7, 8 Conditions of registration: 1,2,3,4,5,6,7,8 G> 0 Applicant: PHARMACARE LIMITED Applicant: PHARMACARE LIMITED FPRR: PHARMACARE LTD, WOODMEAD, SANDTON FPRR: PHARMACARE LTD, WOODMEAD, SANDTON Shelf·life: 24 months (Provisional) Shelf·life: 24 months (ProviSional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: 41/1.210899 Registration number: 4112.6.5/0937 Name of medicine: ASPEN ESCITALOPRAM 20 mg Name of medicine: RISPONZ 1 TABLETS Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: ESCITALOPRAM OXALATE EQUIVALENT TO RISPERIDONE 1,0 mg ESCITALOPRAM 20,0 mg Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Applicant: PHARMACARE LIMITED Applicant: ZYDUS HEALTHCARE SA (PTY) LTO (J) Manufacturer: ALPHAPHARM, CAROLE PARK, QUEENSLAND, Manufacturer: ZYDUS CADILA HEALTHCARE LTD, SANAND, ~ AUSTRALIA AHMEDABAD, INDIA ~ MERCK PHARMA YQUIMICA, MOLLET DEL VALLES, (J) BARCELONA, SPAIN Packer: ALPHAPHARM, CAROLE PARK, QUEENSLAND, Packer: ZYDUS CADILA HEAL THCARE LTO, SANAND, 6m AUSTRALIA AHMEDABAD, INDIA »lJ MERCK PHARMA YQUIMICA, MOLLET DEL VALLES, Z BARCELONA, SPAIN .-1 GERARD LABORATORIES, DUBLIN, IRELAND I\) GENERICS (UK) LTD, STATION CLOSE, o "Tl HERTFORDSHIRE, UK m FPRC: ZYDUS CADILA HEALTHCARE LTD, SANAND, III Laboratory: FPRC: ALPHAPHARM, CAROLE PARK, QUEENSLAND, Laboratory: lJ AUSTRALIA AHMEDABAD, INDIA C MERCK PHARMA YQUIMICA, MOLLET DEL VALLES, INSTITUTE FOR PHARMACEUTICAL » BARCELONA, SPAIN SERVICES, SILVERTON DALE, PRETORIA lJ GERARD LABORATORIES, DUBLIN, IRELAND RESEARCH INSTITUTE FOR INDUSTRIAL m I\) SOUTH AFRICAN BUREAU OF STANDARDS, PHARMACY, NORTH-WEST UNIVERSITY, o GROENKLOOF, PRETORIA POTCHEFSTROOM o M&L LABORATORY SERVICES, ORMONDE, Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z !::l VJ ..... ~ ..... (II (II UI 01 z o w ..... OJ OJ MRF 15 MRF 15 Registration number: 41/2.6.5/0938 Registration number: 4112.6.5/0939 Name of medicine: RISPONZ 2 TABLETS Name of medicine: RISPONZ 3 TABLETS Dosage form: TABLET Dosage form: TABLET G> 0 Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: < RISPERIDONE 2,0 mg RISPERIDONE 3,Omg m :n Z Conditions of registration: 1, 2, 3, 4, 5, 6, 7, 8 Conditions of registration: 1,2.3.4,5,6,7,8 ~ m Applicant: ZYDUS HEALTHCARE SA (PTY) LTD Applicant: ZYDUS HEALTHCARE SA (PTY) LTD Z -I Manufacturer: ZYDUS CADILA HEAL THCARE LTD, SANAND, Manufacturer: ZYDUS CADI LA HEALTHCARE LTO. »G> AHMEDABAD, INDIA SANAND, AHMEDABAD, INDIA N m Packer: ZYDUS CADILA HEAL THCARE LTO, SANAND. Packer: ZYDUS CADI LA HEALTHCARE LTO, -I AHMEDABAD, INDIA SANAND, AHMEDABAD, INDIA -I J11 !\) Laboratory: FPRC: ZYDUS CADILA HEALTHCARE LTD, SANAND. Laboratory: FPRC: ZYDUS CADILA HEALTHCARE LTO, 0 AHMEDABAD, INDIA SANAND, AHMEDABAD, INDIA i1 INSTITUTE FOR PHARMACEUTICAL SERVICES. INSTITUTE FOR PHARMACEUTICAL m iD SIL VERTONDALE, PRETORIA SERVICES, SILVERTONDALE, PRETORIA c:n RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL » PHARMACY, NORTH-WEST UNIVERSITY. PHARMACY, NORTH-WEST UNIVERSITY, :n POTCHEFSTROOM POTCHEFSTROOM -< !\) 0 FPRR: ZYDUS HEAL THCARE, VAN DER HOFF PARK, FPRR: ZYDUS HEAL THCARE, VAN DER HOFF 0 POTCHEFSTROOM PARK, POTCHEFSTROOM CD Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: 4112.6.5/0940 Registration number: 41126/1039 Name of medicine: RISPONZ 4 TABLETS Name of medicine: SPRYCEL 20 mg TABLETS Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 4,Omg DASATINIB 20,0 mg (j) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 ~ Applicant: ZYDUS HEALTHCARE SA (PTY) LTO Applicant: BRISTOL-MYERS SQUIBB (PTY) LTD ~ (j) A Manufacturer: ZVDUS CADILA HEALTHCARE LTO, SANAND, Manufacturer: BRISTOL-MYERS SQUIBB CO, VERNON, 0 AHMEDABAD, INDIA INDIANA, USA m :0 Packer: ZYDUS CADILA HEALTHCARE L TO, SANAND, Packer: BRISTOL-MYERS SQUIBB CO, VERNON, » Z AHMEDABAD, INDIA INDIANA, USA .-1 BRISTOL-MYERS SQUIBB, EPERNON, f\) FRANCE 0 -n m Laboratory: FPRC: ZYDUS CADILA HEALTHCARE LTD, SANAND, Laboratory: FPRC: BRISTOL-MYERS SQUIBB, EPERNON, (D AHMEDABAD, INDIA FRANCE :0 INSTITUTE FOR PHARMACEUTICAL MERCK PHARMACEUTICAL »C SERVICES, SILVERTONDALE, PRETORIA MANUFACTURING, WADEVILLE, :0 RESEARCH INSTITUTE FOR INDUSTRIAL GERMISTON m PHARMACY, NORTH-WEST UNIVERSITY, CONSULTING CHEMICAL f\) 0 POTCHEFSTROOM LABORATORIES, ATLASVILE, BOKSBURG 0 <.0 FPRR: ZYDUS HEALTHCARE, VAN DER HOFF PARK, FPRR: BRISTOL-MYERS SQUIBB, POTCHEFSTROOM BEDFORDVIEW, RSA Shelf-life: 24 months (PrOVisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z ~ (J,) .... 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Registration number: 41/26/1040 Registration number: 4112611041 Name of medicine: SPRYCEL 50 mg TABLETS Name of medicine: SPRYCEL 70 mg TABLETS Dosage form: TABLET Dosage form: TABLET G) Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: 0 DASATINIB 70,0 mg < DASATINIB 50,Omg m ::D Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Z ~ Applicant: BRISTOL-MYERS SQUIBB (PTY) LTD Applicant BRISTOL-MYERS SQUIBB (PTY) LTD m Z Manufacturer: BRISTOL-MYERS SQUIBB CO, VERNON, Manufacturer: BRISTOL-MYERS SQUIBB CO, VERNON, -I G) INDIANA, USA INDIANA, USA » N Packer: BRISTOL-MYERS SQUIBB CO, VERNON, Packer: BRISTOL-MYERS SQUIBB CO, VERNON, m INDIANA, USA INDIANA, USA =I BRISTOL-MYERS SQUIBB, EPERNON, FRANCE BRISTOL-MYERS SQUIBB, EPERNON, m FRANCE I\) 0 Laboratory: FPRC: BRISTOL-MYERS SQUIBB, EPERNON, FRANCE Laboratory: FPRC BRISTOL-MYERS SQUIBB, EPERNON, m"Tl MERCK PHARMACEUTICAL MANUFACTURING, FRANCE Il'J WADEVILLE, GERMISTON MERCK PHARMACEUTICAL c::D CONSULTING CHEMICAL LABORATORIES, MANUFACTURING, WADEVILLE, » ATLASVILE, BOKSBURG GERMISTON ::D -< CONSULTING CHEMICAL I\) LABORATORIES, ATLASVILE, BOKSBURG 0 0 (J:) FPRR: BRISTOL-MYERS SQUIBB, BEDFORDVIEW, FPRR: BRISTOL-MYERS SQUIBB, RSA BEDFORDVIEW, RSA Shelf-life: 24 months (Provisiona!) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 Registration number: 41/2.6.5/1056 Registration number: 41/2.6.5/1057 Name of medicine: AUROPIDONE SOLUTION 1 mg/ml Name of medicine: AURO-RISPERIDONE SOLUTION 1 mg/ml Dosage form: SOLUTION Dosage form: SOLUTION Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: Active ingredients: EACH 1,0 ml SOLUTION CONTAINS: RISPERIDONE 1,Omg RISPERIDONE 1,0 mg en Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 ~ ~ Applicant: AUROBINDO PHARMA (PTy) LTD Applicant: AUROBINDO PHARMA (PTY) LTD en aA Manufacturer: AUROBINDO PHARMA LTD, UNIT III, RANGA Manufacturer: AUROBINDO PHARMA LTD, UNIT III, m REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA :JJ PRADESH, INDIA » Z Packer: AUROBINDO PHARMA LTD, UNIT III, RANGA Packer: AUROBINDO PHARMA LTD, UNIT III, .:-I I\) REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA 0 PRADESH, INDIA TIm Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III, RANGA Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III, cc :JJ REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA C PRADESH, INDIA » lJ iii I\) 0 0 <0 FPRR: AUROBINDO PHARMA, MEYERSDAL, FPRR: AUROBINDO PHARMA, MEYERSDAL, JOHANNESBURG JOHANNESBURG Shelf-life: 24 months (Provisional) Shelf-life: 24 months (ProviSional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z !' w CD CD .... en 1.0 g z p Co) &3 ..... MRF 15 MRF 15 Registration number: 41/26/1092 Registration number: 41/26/1093 Name of medicine: SANDOZ PACLITAXEL 30 Name of medicine: SANDOZ PACLITAXEL 100 Dosage form: INFUSION Dosage form: INFUSION G> Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: o PACLITAX EL 30,Omg PACLITAXEL 100,0 m< mg II Z Conditions of registration: 1, 2, 3,4, 5,6, 7, 8 Conditions of registration: 1,2,3,4,5,6,7,8 s: m Z Applicant: SANDOZ S.A.(PTY) LTO Applicant: SANDOZ S.A.(PTY) LTO -I Manufacturer: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Manufacturer: HAUPT PHARMA WOLFRATSHAUSEN G> WOLFRATSHAUSEN, GERMANY GmbH, WOLFRATSHAUSEN, GERMANY ~ Packer: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Packer: HAUPT PHARMA WOLFRATSHAUSEN ~ WOLFRATSHAUSEN,GERMANY GmbH, WOLFRATSHAUSEN, GERMANY .m I\l Laboratory: FPRC: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Laboratory: FPRC: HAUPT PHARMA WOLFRATSHAUSEN o WOLFRATSHAUSEN,GERMANY GmbH, WOLFRATSHAUSEN, GERMANY 'Tl SOUTH AFRICAN BUREAU OF STANDARDS, SOUTH AFRICAN BUREAU OF m CD GROENKLOOF, PRETORIA STANDARDS, GROENKLOOF, PRETORIA II C» ~ I\lo FPRC/FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK FPRC/FPRR: SANDOZ SA, SPARTAN, KEMPTON o PARK (Cl Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF15 MRF 15 Registration number: 41/26/1094 Registration number: 41/34/1125 Name of medicine: SANDOZ PACLITAXEL 300 Name of medicine: BICAVERA 1,5 % GLUCOSE (SOLUTION FOR PERITONEAL DIALYSIS) Dosage form: INFUSION Dosage form: SOLUTION Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH 1000,0 ml SOLUTION CONTAINS: PACLITAXEL 300,0 mg SODIUM CHLORIDE 11,57 9 CALCIUM CHLORIDE DIHYDRATE 0,5145 g MAGNESIUM CHLORIDE HEXA-HYDRATE (f) 0,2033 9 );! GLUCOSE MONOHYDRATE EQUIVALENT TO ~ GLUCOSE 30,0 9 (f) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6 (3 m Applicant: SANDOZ SA(PTY) LTD Applicant: FRESENIUS KABI SOUTH AFRICA (PTY) LTD JJ» Manufacturer: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Manufacturer: FRESENIUS MEDICAL CARE DEUTSCHLAND Z WOLFRATSHAUSEN,GERMANY GmbH, WENDEL, GERMANY --I I\) o Packer: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Packer: FRESENIUS MEDICAL CARE DEUTSCHLAND WOLFRATSHAUSEN, GERMANY GmbH, WENDEL, GERMANY m"T1 OJ Laboratory: FPRC: HAUPT PHARMA WOLFRATSHAUSEN GmbH, Laboratory: FPRC: FRESENIUS MEDICAL CARE DEUTSCHLAND JJ WOLFRATSHAUSEN,GERMANY GmbH, WENDEL, GERMANY C SOUTH AFRICAN BUREAU OF STANDARDS, BODENE, tfa INTRAMED, KORSTEN, PORT » JJ GROENKLOOF, PRETORIA ELIZABETH m I\) o o (!J FPRC/FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK FPRR: FRESENIUS KABI SA, HALFWAY HOUSE, RSA Shelf-life: 24 months (Provisonal) Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z o w-' co co .... ...Ql 01 I\) z !:l w CD CD ..... MRF 15 MRF 15 Registration number: 41/34/1126 Registration number: 41/34/1127 Name of medicine: BICAVERA 2,3 % GLUCOSE (SOLUTION FOR Name of medicine: BICAVERA 4,25 % GLUCOSE (SOLUTION FOR PERITONEAL DIALYSIS) PERITONEAL DIALYSIS) Dosage form: SOLUTION Dosage form: SOLUTION G) o Active ingredients: EACH 1000,0 ml SOLUTION CONTAINS: Active ingredients: EACH 1000,0 ml SOLUTION CONTAINS: < SODIUM CHLORIDE 11,57 g SODIUM CHLORIDE 11,57 9 m CALCIUM CHLORIDE DIHYDRATE 0,5145 9 CALCIUM CHLORIDE DIHYDRATE 0,5145 9 :0 Z MAGNESIUM CHLORIDE HEXA-HYDRATE 0,2033 9 MAGNESIUM CHLORIDE HEXA-HYDRATE 0,2033 9 s: GLUCOSE MONOHYDRATE EQUIVALENT TO GLUCOSE MONOHYDRATE EQUIVALENT TO m GLUCOSE 45,46 g GLUCOSE 85,0 g Z --1 Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1, 2, 3, 4, 5, 6 G> Applicant: FRESENIUS KABI SOUTH AFRICA (PTY) LTO Applicant: FRESENIUS KABI SOUTH AFRICA (PTY) LTO ~ m Manufacturer: FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, Manufacturer: FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, ::j WENDEL, GERMANY WENDEL, GERMANY JT1 II) Packer: FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, Packer: FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, o WENDEL, GERMANY WENDEL, GERMANY m Laboratory: FPRC; FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, Laboratory: FPRC: FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH, " OJ WENDEL, GERMANY WENDEL, GERMANY :0 BODENE, tla INTRAMED, KORSTEN, PORT BODENE, tla INTRAMED, KORSTEN, PORT ELIZABETH »C ELIZABETH :0 -< II) o o (j) FPRR: FRESENIUS KABI SA, HALFWAY HOUSE, RSA FPRR: FRESENIUS KABI SA, HALFWAY HOUSE, RSA Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF 15 Registration number: 42/20.1.1/0004 Registration number: 42126/0018 Name of medicine: CURITAZ4,5 Name of medicine: ASPEN EPIRUBICIN 10 mg Dosage form: INJECTION Dosage form: INJECTION Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: PIPERACILLIN SODIUM EQUIVALENT TO EPIRUBICIN HYDROCHLORIDE 10,0 mg PIPERACILLIN 4,0 g TAZOBACTAM SODIUM EQUIVALENT TO TAZOBACTAM 500,0 mg C!l Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 ~ Applicant SANDOZ SA (PTY) LTD Applicant: PHARMACARE LIMITED ~ C!l Manufacturer: SANDOZ GmbH, KUNDL, AUSTRIA Manufacturer: THYMOORGAN GmbH PHARMAZIE & CO, A VIENENBURG, GERMANY o m S.C. SINDAN-PHARMA SRL, BUCHAREST, JJ ROMANIA > Z Packer: SANDOZ GmbH, KUNDL, AUSTRIA Packer: THYMOORGAN GmbH PHARMAZIE & CO, .-1 VIENENBURG, GERMANY N S.C. SINDAN-PHARMA SRL, BUCHAREST, o ROMANIA m"T1 III Laboratory: FPRC: SANDOZ GmbH, KUNDL, AUSTRIA Laboratory: FPRC: THYMOORGAN GmbH PHARMAZIE & CO, JJ NOVARTIS SA, SPARTAN, KEMPTON PARK VIENENBURG, GERMANY C SOUTH AFRICAN BUREAU OF STANDARDS, S.C. SINDAN-PHARMA SRL, BUCHAREST, > GROENKLOOF, PRETORIA ROMANIA ~ SOUTH AFRICAN BUREAU OF STANDARDS, m GROENKLOOF, PRETORIA No RESEARCH INSTITUTE FOR INDUSTRIAL o <0 PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM M&L LABORATORY SERVICES, ORMONDE, JOHANNESBURG FPRR: SANDOZ SA, SPARTAN, KEMPTON PARK FPRR: PHARMACARE LTO, WOODMEAD, SANDTON Shelf-life: 24 months Shelf-life: 24 months Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 VJ ..... CD CD ..... ~ ~ z 9 c.u co co ..... MRF 15 MRF 15 Registration number: 4212610019 Registration number: 42/2.6.5/0101 Name of medicine: ASPEN EPIRUBICIN 50 mg Name of medicine: SANDOZ RISPERIDONE 0,5 Dosage form: INJECTION Dosage form: TABLET Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH TABLET CONTAINS: EPIRUBICIN HYDROCHLORIDE 50,0 mg RISPERIDONE 0,5 mg oG) < Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 m JJ Applicant: PHARMACARE LIMITED Applicant: SANDOZ SA (PTY) LTD Z ~ Manufacturer: THYMOORGAN GmbH PHARMAZIE & CO, Manufacturer: SALUTAS PHARMA GmbH, BARLEBEN, m VIENENBURG, GERMANY GERMANY z S.C. SINDAN-PHARMA SRL, BUCHAREST, ROMANIA -I G) Packer: THYMOORGAN GmbH PHARMAZIE & CO, Packer: SALUTAS PHARMA GmbH, BARLEBEN, ~ VIENENBURG, GERMANY GERMANY m S.C. SINDAN-PHARMA SRL, BUCHAREST, ROMANIA SANDOZ SA, SPARTAN,KEMPTON PARK ::j Laboratory: FPRC: THYMOORGAN GmbH PHARMAZIE & CO, Laboratory: FPRC: SALUTAS PHARMA GmbH, BARLEBEN, m I\) VIENENBURG, GERMANY GERMANY o S.C. SINDAN-PHARMA SRL, BUCHAREST, ROMANIA ANALYTICON, TERENURE, KEMPTON PARK SOUTH AFRICAN BUREAU OF STANDARDS, SOUTH AFRICAN BUREAU OF STANDARDS, "m GROENKLOOF, PRETORIA GROENKLOOF, PRETORIA CO RESEARCH INSTITUTE FOR INDUSTRIAL JJ C PHARMACY, NORTH-WEST UNIVERSITY, l> POTCHEFSTROOM JJ M&L LABORATORY SERVICES, ORMONDE, -< I\) JOHANNESBURG o o FPRR: PHARMACARELTD,WOODMEAD,SANDTON FPRCIFPRR: SANDOZ SA, SPARTAN, KEMPTON PARK (0 Shelf-life: 24 months Shelf-fife: 24 months Date of iegistration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF15 Registration number: 4217.3/0269 Registration number: 4217.3/0270 AURO-SUMATRIPTAN TABLETS 100 mg Name of medicine: AURO-SUMATRIPTAN TABLETS 50 mg Name of medicine: Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: SUMATRIPTAN SUCCINATE EQUIVALENT TO SUMATRIPTAN SUCCINATE EQUIVALENT SUMATRIPTAN 50,0 mg TO (J) SUMATRIPTAN 100,0 ~ mg ~ (J) Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 oA Applicant: AUROBINDO PHARMA (PTY) LTO Applicant AUROBINDO PHARMA (PTy) LTO m J) Manufacturer: AUROBINDO PHARMA LTD, UNIT III, RANGA Manufacturer: AUROBINDO PHARMA LTD, UNIT III, :l> Z REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA ,-I PRADESH, INDIA I\) o Packer: AUROBINDO PHARMA LTD, UNIT III, RANGA Packer: AUROBINDO PHARMA LTD, UN.IT III, ." m REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT. ANDHRA (lJ PRADESH, INDIA J) C :l> Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III, RANGA Laboratory: FPRC: AUROBINDO PHARMA LTD, UNIT III, J) REDDY DISTRICT, ANDHRA PRADESH, INDIA RANGA REDDY DISTRICT, ANDHRA m PRADESH. INDIA I\) o o <.0 FPRR: AUROBINDO PHARMA, MEYERSDAL, FPRR: AUROBINDO PHARMA, MEYERSDAL, JOHANNESBURG JOHANNESBURG Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 tv OJ OJ 01 en Q) Q) z ? U) .... MRF 15 MRF 15 (Xl (Xl Registration number: A40/2.6.5/0688 Registration number: A40/2.6.5/0689 Name of medicine: DRL RISPERIDONE 0,5 Name of medicine: DRL RISPERIDONE 1 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 0,5 mg RISPERIDONE 1.0 mg Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3.4,5,6,7,8 Ci) Applicant: DR REDDY'S LABORATORIES (PTY) LTD ~ DR REDDY'S LABORATORIES (PTY) LTD Applicant: m :Il Manufacturer: DR REDDY'S LABORATORIES LTD, Manufacturer: DR REDDY'S LABORATORIES LTD, Z BACHUPALLY VILLAGE, QUTUBULLAPUR BACHUPALL Y VILLAGE, QUTUBULLAPUR s: m MANDAL, RANGA REDDY DISTRICT, ANDHRA MANDAL, RANGA REDDY DISTRICT, z PRADESH, INDIA ANDHRA PRADESH, INDIA -i Ci) Packer: DR REDDY'S LABORATORIES LTD, Packer: DR REDDY'S LABORATORIES LTD, BACHUPALL Y VILLAGE. QUTUBULLAPUR BACHUPALLY VILLAGE, QUTUBULLAPUR m~ MANDAL, RANGA REDDY DISTRICT, ANDHRA MANDAL, RANGA REDDY DISTRICT, PRADESH, INDIA ANDHRA PRADESH, INDIA ~m DRA PHARMACEUTICALS, IRENE. CENTURION DRA PHARMACEUTICALS, IRENE, N CENTURION o 'TI Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, m III BACHUPALLY VILLAGE. QUTUBULLAPUR BACHUPALLY VILLAGE, QUTUBULLAPUR :Il MANDAL. RANGA REDDY DISTRICT, ANDHRA MANDAL, RANGA REDDY DISTRICT, »C PRADESH, INDIA ANDHRA PRADESH, INDIA :Il RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL -< PHARMACY, NORTH-WEST UNIVERSITY, PHARMACY, NORTH-WEST UNIVERSITY, o~ POTCHEFSTROOM POTCHEFSTROOM (0 FPRR: DR REDDY'S LABORATORIES. MURRAYFIELD. FPRR: DR REDDY'S LABORATORIES, PRETORIA MURRAYFIELD, PRETORIA Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 MRF 15 MRF15 Registration number: A40/2.6.5/0690 Registration number: A40/2.6.5/0691 Name of medicine: DRL RISPERIDONE 2 Name of medicine: DRL RISPERIDONE 3 Dosage form: TABLET Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 2,0 mg RISPERIDONE 3,0 mg Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 (f) Applicant: DR REDDY'S LABORATORIES (PTy) LTD Applicant: DR REDDY'S LABORATORIES (PTY) LTD ~ Manufacturer: DR REDDY'S LABORATORIES LTD, Manufacturer: DR REDDY'S LABORATORIES LTD, ~ BACHUPALLY VILLAGE, QUTUBULLAPUR BACHUPALLY VILLAGE, QUTUBULLApUR (f) A MANDAL, RANGA REDDY DISTRICT, ANDHRA MANDAL. RANGA REDDY DISTRICT, o PRADESH, INDIA ANDHRA PRADESH, INDIA m lJ Packer: DR REDDY'S LABORATORIES LTD, Packer: DR REDDY'S LABORATORIES LTD, » Z BACHUPALL Y VILLAGE, QUTUBULLAPUR BACHUPALL Y VILLAGE, QUTUBULLAPUR -.., MANDAL, RANGA REDDY DISTRICT, ANDHRA MANDAL, RANGA REDDY DISTRICT, I\) PRADESH, INDIA ANDHRA PRADESH, INDIA o 'Tl ORA PHARMACEUTICALS, IRENE, CENTURION ORA PHARMACEUTICALS, IRENE, m CENTURION ro lJ Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, »C BACHUPALLY VILLAGE, QUTUBULLAPUR BACHUPALL Y VILLAGE, QUTUBULLApUR lJ MANDAL, RANGA REDDY DISTRICT, ANDHRA MANDAL, RANGA REDDY DISTRICT, m I\) PRADESH, INDIA ANDHRA PRADESH, INDIA o RESEARCH INSTITUTE FOR INDUSTRIAL RESEARCH INSTITUTE FOR INDUSTRIAL o <0 PHARMACY, NORTH-WEST UNIVERSITY, PHARMACY, NORTH-WEST UNIVERSITY, POTCHEFSTROOM POTCHEFSTROOM FPRR: DR REDDY'S LABORATORIES, MURRAYFIELD, FPRR: DR REDDY'S LABORATORIES, PRETORIA MURRAYFIELD, PRETORIA Shelf-life: 24 months (Provisional) Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008 Date of registration: 9 DECEMBER 2008 z 9 c.v co co-' ~ m z ~ w .... MRF15 ....~ Registration number: MO/2.6.5/0692 Name of medicine: DRL RISPERIDONE 4 Dosage form: TABLET Active ingredients: EACH TABLET CONTAINS: RISPERIDONE 4,0 mg (j) Conditions of registration: 1,2,3,4,5,6,7,8 o Packer: DR REDDY'S LABORATORIES LTD, m~ BACHUPALLY VILLAGE, QUTUBULLAPUR :j MANDAL, RANGA REDDY DISTRICT, ANDHRA m PRADESH, INDIA I\) ORA PHARMACEUTICALS, IRENE, CENTURION o i1 Laboratory: FPRC: DR REDDY'S LABORATORIES LTD, m CD BACHUPALLY VILLAGE, QUTUBULLAPUR JJ MANDAL, RANGA REDDY DISTRICT, ANDHRA C» PRADESH, INDIA JJ RESEARCH INSTITUTE FOR INDUSTRIAL -< I\) PHARMACY, NORTH-WEST UNIVERSITY, o POTCHEFSTROOM o c.o FPRR: DR REDDY'S LABORATORIES, MURRAYFIELD, PRETORIA Shelf-life: 24 months (Provisional) Date of registration: 9 DECEMBER 2008