Pretoria, 28 March 2007 Maart - Open Gazettes South … 28 MARCH 2007 INHOUD No. GENERAL NOTICE Page...

Pretoria, 28 March 2007Maart

2 No. 29735

CONTENTS

GOVERNMENT GAZETTE, 28 MARCH 2007

INHOUD

No.

GENERAL NOTICE

Page GazetteNo. No. No. Bladsy Koerant

No. No,

ALGEMENE KENNISGEWING

Health, Department of

General Notice

351 Medicines and Related Substances Act(101/1965): Medicines Control Council:Conditions of registration of a medicinein terms of the provisions of section 15(7) .. ,., . 3 29735

Gesondheld. Departement van

Algemene Kennisgewing

351 Wet op Beheer van Medisyne enVerwante Stowwe (101/1965): Medisynebeheerraad: Voorwaardes vir dieregistrasie van 'n medisyne in terme vandie bepalings van artikel 15 (7) . 4 29735

STAATSKOERANT. 28 MAART 2007

GENERAL NOTICE

ALGEMENE KENNISGEWING

No.29735 3

NOTICE 351 OF 2007

MEDICINES CONTROL COUNCIL

CONDITIONS OF REGISTRATION OF A MEDICINE IN TERMS OF THE PROVISIONS OF SECTION15(7) OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT No. 101 OF 1965)

1. The applicant shall ensure that the medicine is manufactured and controlled in terms of currentGood Manufacturing Practices as determined by Council.

2. The manufacture of this medicine is SUbject to regular investigation and inspections by theinspectors appointed in terms of Section 26 of the Act, to assess compliance with current GoodManufacturing Practices.

3. The information in the package insert shall be updated on a regular basis to conform to thepackage insert recently approved by Council.

4. The applicant must comply with all the legal requirements of the Medicines and RelatedSubstances Act, 1965 (Act No.1 01 of 1965).

5. The registration of this medicine shall be subject to regular review regarding its quality, safetyand efficacy, and the registration of this medicine may be varied subject to issues Council maydeem fit.

6. The first two production batches must be fully validated in terms of the detailed processvalidation protocol submitted at the time of application for registration, and the validation reportmust be submitted within a month after completion of the validation.

7. The registration dossier is SUbject to review at intervals as determined by Council.

8. A post-registration inspection must be conducted in the first production batch of the locallymanufactured product.

9. A post-registration inspection must be conducted on the first production batch manufacturedby each local manufacturer,

10. A post-registration inspection must be conducted on the first production batch of the importedproduct.

11. Marketing of the product may only commence following a satisfactory post-registrationinspection report.

12. One sample of every batch, together with four copies of the protocol for testing of the bulk lotand filling lot, and six copies of the certificate of release issued by a competent authority in thecountry in which the product was manufactured, must be submitted to the Council for lotrelease purposes.

13. The expiry date allocated shall be modified by adding a statement that the virus strains arecurrently 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 eachyear.

4 NO.29735 GOVERNMENT GAZETTE, 28 MARCH 2007

KENNISGEWING 351 VAN 2007

MEDISYNEBEHEERRAAD

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

1. Die applikant sal verseker dat die medisyne vervaardig en beheer word ooreenkomstighuidige Goeie Vervaardigingspraktyke soos bepaal deur die Medisynebeheerraad.

2. Die vervaardiging van hierdie medisyne is onderhewig aan gereelde ondersoeke en inspeksiesdeur inspekteurs, aangestel ingevolge Artikel 26 van die Wet, om die nakoming van GoeieVervaardigingspraktyke te bepaal.

3. Die inligting soos vervat in die voubiljet moet op 'n gereelde grondslag opgedateer word inooreenstemming met 'n voubiljet wat onlangs deur die Raad goedgekeur is.

4. Die applikant moet voldoen aan aile wetlike vereistes van die Wet op Medisyne en VerwanteStowwe, 1965 (Wet No. 101 van 1965).

5. Die registrasie van hierdie medisyne is onderhewig aan gereelde hersiening rakende kwaliteit,veiligheid en effektiwiteit, en die registrasie van hierdie medisyne kan gewysig wordonderhewig aan kwessies soos goedgedink deur die Raad.

6. Die eerste twee produksielotle moet ten volle gevalideer word ooreenkomstig die breedvoerigeprosesvalidasie protokol wat ingedien is ten tye van die aansoek om registrasie, en dievalidasieverslag moet binne die bestek van een maand na die voltooiing van die validasieingedien word.

7. Die registrasie-aansoek is onderhewig aan hersiening met tussenposes soos deur die Raadbepaal.

8. 'n Na-registrasie-inspeksie moet op die eerste produksielot van die plaaslike vervaardigdeproduk uitgevoer word.

9. 'n Na-registrasie-inspeksie moet op die eerste produksielot van elke plaaslike vervaardigeruitgevoer word.

10. 'n Na-registrasie-inspeksie moet op die eerste produksielot van die ingevoerde produkuitgevoer word.

11. Bemarking van die produk mag slegs in aanvang neem nadat 'n bevredigende na-registrasieinspeksieverslag gedien het.

12. Een monster van elke lot moet tesame met vier kopiee van die protokolle vir die toets van diemassalot en die vullot sowel as ses koplee van die vrystellingsertifikaat wat uitgereik is deurdie verantwoordelike beheerliggaam in die land waar die produk vervaardig word, ingedienword by die Raad vir lotvrystellingsdoeleindes.

13. Die vervaldatum toegeken, sal gewysig word deur 'n verklaring by te voeg dat die virusstammetans vir Suid-Afrikaanse gebruik gedurende die gespesifiseerde jaar aanbeveel word.

14. Die stamme van die oorspronklike saadvirusse moet elke jaar deur die Departement vanGesondheid goedgekeur word.

MRF 15 MRF 15

Registration number: 02/3.1/15 Registration number: A05/21.1/02

Name of medicine: NOROCARP INJECTION FOR DOGS Name of medicine: DRAXXIN 100 mg/ml

Dosage form: INJECTION Dosage fomn: INJECTION

Active ingredients: EACH 1,0 mi SOLUTION CONTAINS: Active ingredients: EACH 1,0 ml SOLUTION CONTAINS:CARPROFEN 50 j omg TULATHROMYCIN 100,0 mg Ul

Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1,2,3,4,5,6 i!~

Applicant: NORBROOK LABORATORIES SA (PTY) Applicant: PFIZER LABORATORIES (PTY) LTD UlLTD ;:0;;

0Manufacturer: NORBROOK LABORATORIES LTD, Manufacturer: PFIZER GLOBAL MANUFACTURING, AMBOISE m

JJNEWRY, NORTHERN IRELAND CEDEX,FRANCE l>

ZPacker: NORBROOK LABORATORIES LTD, Packer: PFIZER GLOBAL MANUFACTURING, AMBOISE .-l

NEWRY, NORTHERN IRELAND CEDEX,FRANCE I\lQl

Laboratory: FPRC: NORBROOK LABORATORIES LTO, Laboratory: FPRC: PFIZER GLOBAL MANUFACTURING, AMBOISE s:NEWRY, NORTHERN IRELAND CEDEX, FRANCE ~

FPRR: NORBROOK LABORATORIES,SOUTH AFRICAN BUREAU OF STANDARDS,

~GROENKLOOF, PRETORIACENTURION, RSA I\l

0Shelf-life: 24 months 0

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Date of registration: 2 FEBRUARY 2007 FPRR: PFIZER LABORATORIES, SANDTON, RSA

Shelf-life: 24 months

Date of registration: 1 DECEMBER 2006

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MRF 15

Registration number:

Name of medicine:

Dosage form:

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Manufacturer:

Packer:

Laboratory: FPRC/FPRR:

Shelf-life:

Date of registration

38116.4/0021

TEETH AND GUM DEFENCE L1STERINE

SOLUTION

EACH 20,0 ml SOLUTION CONTAINS:SODIUM FLUORIDE 4,420 mgTHYMOL 12,780 mgALCOHOL (95 %) 4,540 ml

1, 2, 3, 4, 5, 6

PFIZER LABORATORIES (PTY) LTD

PFIZER GLOBAL MANUFACTURING, RETREATCAPETOWN



24 months (provisional)

1 DECEMBER 2006

MRF 15


Name of medicine:

Dosage form:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRR

Shelf-life:

Date of registration:

A39/202.8/0343

APEX-ACYCLOVIR 200 mg

TABLET

EACH TABLET CONTAINS:ACYCLOVIR 200,0 mg

1,2,3,4,5,6

CAMOX PHARMACEUTICALS (PTY) LTD

MEDREICH STERILAB LTD, VIRGONARBANGALORE, INDIA


MEDREICH STERILAB LTD, VIRGONARBANGALORE, INDIASOUTH AFRICAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIAINSTITUTE FOR PHARMACEUTICAL SERVICES,SILVERTONDALE, RSAINSPECTORATE M&L, ORMONDE,JOHANNESBURG

CAMOX PHARMACEUTICALS, AMALGAM,JOHANNESBURG,RSA


1 DECEMBER 2006

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Shelf-life:


A391202.810344

APEX-ACYCLOVIR 400 mg

TABLET

EACH TABLET CONTAINS:ACYCLOVIR 400,0 mg

1, 2, 3, 4, 5, 6

CAMOX PHARMACEUTICALS (PTY) LTD


MEDREICH STERILAB LTO, VIRGONARBANGALORE, INDIA

MEDREICH STERILAB LTO, VIRGONARBANGALORE, INDIASOUTH AFRICAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIAINSTITUTE FOR PHARMACEUTICALSERVICES, SILVERTON DALE, RSAINSPECTORATE M&L, ORMONDE,JOHANNESBURG

CAMOX PHARMACEUTICALS, AMALGAM,JOHANNESBURG,RSA


1 DECEMBER 2006

MRF 15


Name of medicine:

Dosage form:

Active ingredients

Conditions of registration·

Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRR:

Shelf-life:


A40/20.2.810261

CIPLA DUOVIR AND NEVIRAPINE COPACK

TABLET

EACH CARTON CONTAINS:DUOVIR TABLETS CONTAINING:LAMIVUDINE 150,0 mgZIDOVUDINE 300,0 mgNEVIRAPINE TABLETS CONTAINING:NEVI RAPINE 200,0 mg

1, 2, 3, 4, 5, 6

CIPLA LIFE SCIENCES (PTY) LTD

CIPLA LTD, VIKHROLl, MUMBAI, INDIA



CIPLA LIFE SCIENCES, ROSENPARK,BELLVILLE, RSA

24 months

2 FEBRUARY 2007

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Dateof registration:

A40/7.1/0284

INDOAMLODIPINE-5

TABLET

EACHTABLETCONTAINS:AMLOOIPINE BESYLATE EQUIVALENT TOAMLOOIPINE 5,0 mg

1, 2, 3, 4, 5, 6

OEZZO TRADING(392) (PTY) LTDUa INDOPHARMA

KOPRAN LTD, KHALAPUR, RAIGAD, INDIA


KOPRAN LTD, KHALAPUR, RAIGAD, INDIACONSULTING CHEMICAL LABORATORIES,STARSTREET, BOKSBURG, RSA

DEZZOTRADING (392) Ua INDO PHARMA,ANCHORVILLE, LENASIA, JOHANNESBURG,RSA

24months (provisional)

2 FEBRUARY 2007

MRF 15


Nameof medicine:

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Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

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Shelf-life:


A40/20.1.210329

INDO AMOXYCILLIN 250

CAPSULE

EACH CAPSULE CONTAINS:AMOXYCILLIN TRIHYDRATEEQUIVALENT TOAMOXYCILLIN 250,0 mg

1,2,3,4,5,6

DEZZO TRADING (392) (pry) LTO tlaINDOPHARMA

KOPRAN LTD, KHALAPUR, RAIGAD,INDIA



DEZZO TRADING (392) tla INDOPHARMA, ANCHORVILLE, LENASIA,JOHANNESBURG, RSA

36 months

2 FEBRUARY 2007

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AMLOBLOC5

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EACH TABLET CONTAINS:AMLODIPINE BESYLATE EQUIVALENT TOAMLODIPINE 5,0 mg

1,2,3,4,5,6

SANDOZ (PTY) LTD

LEK PHARMACEUTICALS dd, VEROVSKOVA,SLOVENIA

LEK PHARMACEUTICALS d.d., VEROVSKOVA,SLOVENIA

NOVARTIS, SPARTAN, KEMPTON PARK

LEK PHARMACEUTICALS d.d., VEROVSKOVA,SLOVENIA


SOUTH AFRICAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIA

ANALYTICON, TERENURE, KEMPTON PARK

SANDOZ, SPARTAN, KEMPTON PARK


FPRR:

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Laboratory:


Applicant:


Name of medicine:

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A40/20.1.2/0330

INDO AMOXYCILLIN 500

CAPSULE

EACH CAPSULE CONTAINS:AMOXYCILLIN TRIHYDRATE EQUIVALENT TOAMOXYCILLIN 500,0 mg

1,2,3,4,5,6

DEllO TRADING (392) (PTY) LTD tia INDOPHARMA



DEllO TRADING (392) tla INDO PHARMA,ANCHORVILLE, LENASIA, JOHANNESBURG, RSA

36 months


FPRR:

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Date of registration: 2 FEBRUARY 2007

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Registration number: MO/7. 1/0436 Registration number: A40/20.2.8/0460

Name of medicine' AMLOBLOC 10 Name of medicine: TRIOMUNE 30

Dosage form: TABLET Dosage form: TABLET

Active ingredients EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:AMLODIPINE BESYLATE EQUIVALENT TO STAVUDINE 30,Omg oAMLODIPINE 10,0 mg LAMIVUDINE 150,0 mg 0

<Conditions of registration: 1, 2, 3, 4, 5, 6

NEVIRAPINE 200,0 mg m:xl

Applicant: SANDOZ (PTY) LTD Conditions of registration: 1,2,3,4,5,6 Zs:

Manufacturer: LEK PHARMACEUTICALS d.d., VEROVSKOVA, Applicant: CIPLA MEDPRO (PTY) mZ

SLOVENIA -iManufacturer: CIPLA LTO, PATALGANGA, MAHARASHTRA, o

INDIA »N

Packer: LEK PHARMACEUTICALS d.d., VEROVSKOVA, Packer: CIPLA LTD, PATALGANGA, MAHARASHTRA, mSLOVENIA INDIA ::jNOVARTIS, SPARTAN, KEMPTON PARK jn

I\)Laboratory: FPRC: LEK PHARMACEUTICALS d.d., VEROVSKOVA, (Xl

SLOVENIA s:NOVARTIS, SPARTAN, KEMPTON PARK Laboratory: FPRC: CIPLA LTD, PATALGANGA, MAHARASHTRA, »

:xlSOUTH AFRICAN BUREAU OF STANDARDS, INDIA ELI LILLY & CO, BASINGSTOKE, oGROENKLOOF, PRETORIA HAMPSHIRE UK IANALYTICON, TERENURE, KEMPTON PARK I\)

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FPRR: SANDOZ, SPARTAN, KEMPTON PARK0-.j

Shelf-life: 24 months (provisional) FPRR: CIPLA MEDPRO, ROSENPARK, BELLVILLE

Date of registration: 2 FEBRUARY 2007 Shelf-life: 24 months


MRF15 MRF 15

Shelf-life: 24 months (provisional)

Registration number: A40/21.2/0467

Name of medicine: INDO METFORMIN-850

Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS:METFORMIN HYDROCHLORIDE 850,0 mg

Conditions of registration: 1, 2, 3, 4, 5, 6

Applicant: DEllO TRADING (392) (PTY) LTD Va INDOPHARMA

Manufacturer: RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIA

Packer: RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIA

Laboratory: FPRC RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIACONSULTING CHEMICAL LABORATORIES,ATLASVILLE, BOKSBURG, RSA

FPRR: DEllO TRADING (392) Va INDO PHARMA,ANCHORVILLE, LENASIA, JOHANNESBURG, RSA

Registrationnumber:

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Conditions of registration

Applicant

Manufacturer

Packer:

Laboratory: FPRC

FPRR:

Shelf-life:


A40/21.2/0466

INDO METFORMIN-500

TABLET

EACH TABLET CONTAINS:METFORMIN HYDROCHLORIDE 500,0 mg

1, 2, 3, 4, 5, 6

DEllO TRADING (392) (PTY) LTD Va INDOPHARMA

RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIA

RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIA

RUSAN PHARMA LTD, GANDHIDHAM-KUTCH,INDIACONSULTING CHEMICAL LABORATORIES,ATLASVILLE, BOKSBURG, RSA

DEllO TRADING (392) t/a INDO PHARMA,ANCHORVILLE, LENASIA, JOHANNESBURG, RSA


2 FEBRUARY 2007


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Registration number: A40/7.1.3/0722 Registration number: A40n.1 .3/0723

Name of medicine: AURO-L1SINOPRIL 5 mg Name of medicine: AURO-L1SINOPRIL 10 mg

Dosage form: TABLET Dosageform: TABLET

Active ingredients: EACH TABLETCONTAINS: Active ingredients: EACHTABLETCONTAINS: oL1SINOPRIL DIHYDRATE EQUIVALENT TO L1SINOPRIL DIHYDRATE EQUIVALENT TO 0L1SINOPRIL 5,Omg L1SINOPRIL 10,0mg <m

Conditions or registration: 1, 2, 3, 4, 5, 6 Conditions of registration: 1, 2, 3, 4, 5, 6JlZ

Applicant: AUROBINDO PHARMA (PTY) LTD Applicant: AUROBINDO PHARMA(PTY) LTD1::mz

Manufacturer: AUROBINDO PHARMALTD, QUTHUBULLAPUR Manufacturer: AUROBINDO PHARMALTD, -tMANDAL, ANDHRAPRADESH, INDIA QUTHUBULLAPUR MANDAL, ANDHRA o

PRADESH, INDIA »N

Packer: AUROBINDO PHARMA LTD,QUTHUBULLAPURm

Packer: AUROBINDO PHARMALTD,~MANDAL, ANDHRA PRADESH, INDIA QUTHUBULLAPUR MANDAL, ANDHRA m

PRADESH, INDIA -II:>

Laboratory : FPRC: AUROBINDO PHARMA LTD,QUTHUBULLAPUR Laboratory: FPRC: AUROBINDO PHARMA LTD,ce1::MANDAL, ANDHRA PRADESH, INDIA QUTHUBULLAPUR MANDAL, ANDHRA »

PRADESH, INDIA lJ0

FPRR AUROBINDO PHARMA, ROSEBANK, FPRR: AUROBINDO PHARMA, ROSEBANK, J:JOHANNESBURG JOHANNESBURG II:>

0

Shelf-life: 24 months(provisional) 24 months (provisional)0

Shelf-life: -,J

Dateof registration: 2 FEBRUARY 2007 Date of registration: 2 FEBRUARY 2007

MRF15 MRF 15

Registration number: A39/20.1.1/0303 Registration number: 41/202.8/0235

Nameof medicine: APEX-CEFTRIAXONE 1 g Nameof medicine: ADCO-NEVIRAPINE TABLETS

Dosage form: INJECTION Dosageform: TABLET

Active ingredients: EACH VIAL CONTAINS Active ingredients: EACH TABLETCONTAINS:CEFTRIAXONE SODIUM EQUIVALENT TO NEVIRAPINE 200,OmgCEFTRIAXONE 1,0 g

Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1, 2, 3, 4, 5, 6(f)

Applicant: CAMOXPHARMACEUTICALS (PTY) LTO Applicant: ADCOCKINGRAM LIMITED~Manufacturer: MJ BIOPHARM, RAIGAD, MAHARASHTRA, INDIA Manufacturer: ADCOCK INGRAM HEALTHCARE, WADEVILLE, ;;.;

GERMISTON (f);;0;;

Packer: MJ BIOPHARM, RAIGAD, MAHARASHTRA, INDIA Packer: ADCOCKINGRAMHEALTHCARE, WADEVILLE, 0m

GERMISTON :DADCOCK INGRAMLTO, »BRYANSTON,JOHANNESBURG z

.:-iLaboratory: FPRC: MJ BIOPHARM, RAIGAD, MAHARASHTRA, INDIA Laboratory: FPRC/FPRR ADCOCKINGRAMHEALTHCARE, WADEVILLE, II)

CDIPCA LABORATORIES, ATHAL, DADRA& NAGAR GERMISTON s::HAVELI, INDIA ADCOCKINGRAMLTD, BRYANSTON,

~SOUTH AFRICAN BUREAU OF STANDARDS, JOHANNESBURGIIGROENKLOOF, PRETORIA -i

INSPECTORATE M&L, ORMONDE, II)

JOHANNESBURG 00

INSTITUTE FOR PHARMACEUTICAL SERVICES, "-I

SILVERTONDALE

FPRR: CAMOXPHARMACEUTICALS, AMALGAM, Shelf-life: 24 months (provisional)JOHANNESBURG

Shelf-life: 24 months Dateof registration: 2 FEBRUARY 2007

Dateof registration: 1 DECEMBER 2006

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MRF 15 MRF 15

Registration number: 41/20.28/0236 Registration number: 41/20.2.8/0237

Nameof medicine: ADCO-LAMIVUDINE TABLETS Nameof medicine: ADCO-ZIDOVUDINE TABLETS


Active ingredients: EACH TABLETCONTAINS: Active ingredients: EACHTABLETCONTAINS: CilLAMIVUDINE 150,Omg ZIDOVUDINE 300,0 mg 0

<Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1, 2, 3, 4, 5, 6

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Applicant: ADCOCKINGRAMLIMITED Applicant: ADCOCK INGRAM LIMITED ;:m

Manufacturer: ADCOCKINGRAMHEALTHCARE, Manufacturer' ADCOCK INGRAM HEALTHCARE, Z--l

WADEVILLE, GERMISTON WADEVILLE, GERMISTON oPacker: ADCOCK INGRAM HEALTHCARE, Packer: ADCOCK INGRAMHEALTHCARE, »

NWADEVILLE, GERMISTON WADEVILLE, GERMISTON mADCOCKINGRAMLTD, BRYANSTON, ADCOCKINGRAM LTD, BRYANSTON, :::jJOHANNESBURG JOHANNESBURG m

ADCOCK INGRAMHEALTHCARE,I\)

Laboratory: FPRC/FPRR ADCOCKINGRAM HEALTHCARE, Laboratory: FPRC/FPRR CD

WADEVILLE, GERMISTON WADEVILLE, GERMISTON s:ADCOCKINGRAM LTD, BRYANSTON, ADCOCKINGRAMLTD, BRYANSTON, »

JlJOHANNESBURG JOHANNESBURG oJ:

Shelf-life: 24 months (provisional) Shelf-life: 24 months (provisional) III00

Dateof registration: 2 FEBRUARY 2007 Dateof registration: 2 FEBRUARY 2007 '-J

MRF 15 MRF 15

Registration number: A40n.1.3I0724 Registration number: 41/7.310092

Nameof medicine: AURO-L1SINOPRIL 20 mg Name of medicine: CIPLA-SUMATRIPTAN 100


Active ingredients: EACH TABLETCONTAINS: Active ingredients: EACHTABLETCONTAINS:L1SINOPRIL DIHYDRATE EQUIVALENT SUMATRIPTAN SUCCINATE EQUIVALENT TOTO SUMATRiPTAN 100,0mg (fl

L1SINOPRIL 20,0 mg ~Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1, 2, 3, 4, 5, 6 '-l

(fl

Applicant: AUROBINDO PHARMA(PTY) LTO Applicant: CIPLALIFE SCIENCES (PTY) LTD '"0Manufacturer:

mAUROBINDO PHARMALTD, Manufacturer: CIPLA LTO, UNITIII, VERNA, GOA, INDIA IIQUTHUBULLAPUR MANDAL, ANDHRA »

ZPRADESH, INDIA .-1

Packer: AUROBINDO PHARMALTO, Packer: CIPLA LTD, UNITIII, VERNA, GOA, INDIA II)lX>

QUTHUBULLAPUR MANDAL, ANDHRA s:PRADESH, INDIA

~Laboratory: FPRC AUROBINDO PHARMALTD, Laboratory: FPRC CIPLA LTD, UNITIII, VERNA, GOA,INDIA II

-lQUTHUBULLAPUR MANDAL, ANDHRA II)

PRADESH, INDIA 00"'-J

FPRR AUROBINDO PHARMA, ROSEBANK, FPRR: CIPLA LIFESCIENCES, ROSENPARK, BELLVILLEJOHANNESBURG

Shelf-life 24 months (provisional) Shelf-life: 24 months

Dateof registration: 2 FEBRUARY 2007 Dateof registration: 2 MARCH 2007

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MEDICINEDEVELOPERS INTERNATIONAL ce

IMPILO DRUGS (1966), ISITHEBE, KZN, RSA

IMPILO DRUGS (1966), ISITHEBE, KZN, RSA

IMPILO DRUGS (1966), ISITHEBE, KZN, RSACONSULTINGCHEMICALLABORATORIES,ATLASVILLE, BOKSBURGCONSULTINGMICROBIOLOGICALLABORATORIES, MOREHILL, BENONISOUTH AFRICAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIAINSTITUTEFOR PHARMACEUTICAL SERVICES,SILVERTONDALE, RSA

MDI ce, MENLO PARK, PRETORIA

24 months (previsional)

2 MARCH 2007

38/13,1/0195

MDI POVIDONE GEL

GEL

EACH 1,0 g GEL CONTAINS:POVIDONEIODINE

FPRR:

FPRC:

Packer:

Laboratory:

37/34/0528

NORBROOKWATER FOR INJECTION

INJECTION

EACH VIAL CONTAINS:WATER FOR INJECTIONS 1,0 ml

1, 2, 3, 4, 5, 6

NORBROOKLABORATORIES SA (PTY) LTD

NORBROOKLABORATORIES LTD, NEWRY,NORTHERN IRELAND



NORBROOKLABORATORIES, CENTURION, RSA

36 months

2 MARCH2007


Nameof medicine:

Dosageform:

Active ingredients:

Conditionsof registration:

Applicant:

Manufacturer:

Packer:

Laboratory FPRC

FPRR

Shelf-life:


MRF 15 MRF 15

10,0 ug

30,0 iu40,01u25,0 ug

Dosage form:

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Name of medicine:

Ul

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25,0 ug40,0 D units8,0 D units

32,0 D units

EACH 0,5 ml DOSE CONTAINS:PURIFIED DIPHTHERIA TOXOIDPURIFEID TETANUS TOXOIDPURIFIED PERTUSSIS TOXOIDPURIFIED PERTUSSIS FILAMENTOUSHAEMAGGLUTININPOLIOVIRUS D ANTIGEN TYPE 1POLIOVIRUS D ANTIGEN TYPE 2POLIOVIRUS D ANTIGEN TYPE 3

A38130.110526

TETRAXIM

INJECTION

1,2, 3, 4,5,6

AVENTIS PHARMA (PTY) LTD

AVENTIS PASTEUR, L'ETOILE, FRANCE


AVENTIS PASTEUR, L'ETOILE, FRANCEFPRC:


Applicant

Manufacturer:

Packer:

Laboratory:



A38/30.1/0525

PENTAXIM

INJECTION

EACH 0,5 ml DOSE CONTAINSPURIFIED DIPHTHERIA TOXOIDPURIFEID TETANUS TOXOIDPURIFIED PERTUSSIS TOXOIDPURIFIED PERTUSSIS FILAMENTOUSHAEMAGGLUTININ 25,0 ugPOLIOVIRUS D ANTIGEN TYPE 1 40,0 D unitsPOLIOVIRUS D ANTIGEN TYPE 2 8,0 D unitsPOLIOVIRUS D ANTIGEN TYPE 3 32,0 D unitsHAEMOPHILUS INFLUENZA TYPE bPOLYSACCHARIDE

1, 2, 3, 4, 5, 6

AVENTIS PHARMA (PTY) LTD



Name of medicine:

Dosage form:

Active ingredients:

Laboratory: FPRC:


Applicant

Manufacturer'

Packer:

FPRR:

Shelf-life:


AVENTIS PHARMA, WALTLOO, PRETORIA

36 months

2 MARCH 2007

FPRR: AVENTIS PHARMA, WALTLOO, PRETORIA

Shelf-life: 36 months

Date of registration: 2 MARCH 2007

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Laboratory: FPRC:

FPRR:

Shelf-iife:


A39/20.1.7/0383

MERCK-ITRACONAZOLE 100 mg

CAPSULE

EACH CAPSULE CONTAINS:ITRACONAZOLE 100,0 mg

1, 2, 3, 4, 5, 6

MERCK GENERICS RSA (PTY) LTO

MARTEC PHARMACEUTICAL INC, TOPPING, KANSASCITY. USA

MARTEC PHARMACEUTICAL INC, TOPPING, KANSASCITY, USAGENERICS (UK) LTO, POTTERS BAR,HERTFORDSHIRE, UKGERARD LABORATORIES, DUBLIN, iRELANDMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTON

MARTEC PHARMACEUTICAL INC, TOPPING,KANSAS CITY, USAGENERiCS (UK) LTO, POTTERS BAR,HERTFORDSHIRE, UKGERARD LABORATORIES, DUBLIN, IRELANDMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTONRESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY. POTCHEFSTROOMSOUTH AFRiCAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIA

MERCK GENERICS RSA, MODDERFONTEIN, RSA

24 months

2 MARCH 2007

Packer:

Laboratory:

Shelf-life:


FPRC:

FPRR:

A39/10.2.1I0482

ASTHAVENT RESPULES

SOLUTION

EACH 2,5 ml SOLUTION CONTAINS:SALBUTAMOL SULPHATE EQUIVALENT TOSALBUTAMOL 2,5 m9

1,2, 3.4,5, 6

CIPLA-MEDPRO (PTY) LTO

CIPLA LTD, UNIT I, VERNA, GOA, INDIA



CIPLA MEDPRO, ROSENPARK, BELLVILLE

24 months

2 MARCH 2007

G>o<mIIZs::mz-lo~

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Registration number: A39/10.2.1I0483 Registration number: A39/8.4/0518

Name of medicine: CIPLA-SALBUTAMOL RESPULES Name of medicine: VENOFUNDIN

Dosage form: SOLUTION Dosage form: SOLUTION

Active ingredients: EACH 2,5 ml SOLUTION CONTAINS Active ingredients: EACH 1000,0 ml SOLUTION CONTAINS:SALBUTAMOL SULPHATE EQUIVALENT TO HETASTARCH 60,OgSALBUTAMOL 2,5mg SODIUM CHLORIDE 9,0 g C/l

Conditions of registration" 1,2,3,4,5,6 Conditions of registration: 1,2,3,4,5,6 ~~

Applicant: CIPLA LIFE SCiENCES (PTY) LTO Applicant: B BRAUN MEDICAL (PTY) LTD C/lxManufacturer: CIPLA LTO, UNIT I, VERNA, GOA, INDIA Manufacturer: B BRAUN MEDICAL AG, CRISSIER, 0

SWITZERLAND mJJ

Packer: CIPLA LTD, UNIT I, VERNA, GOA, INDIA Packer: B BRAUN MEDICAL AG, CRISSIER, ~Z

SWITZERLAND .-1

B BRAUN MEDICAL AG, CRISSiER,I\)

Laboratory: FPRC: 00Laboratory: FPRC: CIPLA LTD, UNIT I, VERNA, GOA, INDIA SWITZERLAND s:

CONSULTING CHEMICAL LABORATORIES, ~~

ATLASVILLE, BOKSBURG JJ-I

FPRR CIPLA LIFE SCIENCES, ROSENPARK, FPRR: B BRAUN MEDICAL, HONEYDEW, GAUTENG I\)

BELLVILLE PHARMA DYNAMICS, 0

Shelf-life: 24 months 0SILVERWOOD, WESTLAKE, RSA -..j

Date of registration: 2 MARCH 2007

Shelf-life:


24 months

2 MARCH 2007

zoI\)(0

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IPCA LABORATORIES LIMITED, SILVASSA,DADRA& NAGAR HAVELI, INDIASOUTHAFRICAN BUREAU OF STANDARDS,GROENKLOOF, PRETORIAINSPECTORATE M&L, ORMONDE,JOHANNESBURGINSTITUTEFOR PHARMACEUTICALSERVICES, SILVERTONDALE, RSA

AUSTELLLABORATORIES, SPRINGFIELD,JOHANNESBURG


2 MARCH2007

A39/7.1/0546

AUSTELL-AMLODIPINE 10 mg

TABLET

EACHTABLETCONTAINS:AMLODIPINE BESYLATE EQUIVALENT TOAMLODIPINE 10,0mg

1, 2, 3, 4, 5, 6

AUSTELL LABORATORIES (pTY) LTD

IPCA LABORATORIES LIMITED, SILVASSA,DADRA& NAGAR HAVELI, INDIA

IPCA LABORATORIES LIMITED, SILVASSA,DADRA& NAGARHAVEL!, INDIA

FPRC:

FPRR:

Packer:

Laboratory:

A39/7.1/0545

AUSTELL-AMLODIPINE 5 mg

TABLET

EACHTABLETCONTAINS:AMLODIPINE BESYLATE EQUIVALENT TOAMLODIPINE 5,0 mg

1, 2, 3, 4, 5, 6

AUSTELL LABORATORIES (PTY) LTD

IPCA LABORATORIES LIMITED, SILVASSA, DADRA& NAGARHAVELI, INDIA

IPCA LABORATORIES LIMITED, SILVASSA, DADRA& NAGARHAVELI, INDIA

IPCA LABORATORIES LIMITED, SILVASSA, DADRA& NAGAR HAVELI, INDIASOUTH AFRICAN BUREAUOF STANDARDS,GROENKLOOF, PRETORIAINSPECTORATE M&L, ORMONDE,JOHANNESBURGINSTITUTE FOR PHARMACEUTICAL SERVICES,SILVERTONDALE, RSA

AUSTELL LABORATORIES, SPRINGFIELD,JOHANNESBURG


2 MARCH 2007


Nameof medicine:

Dosageform:

Active ingredients:

FPRR:


Applicant:

Manufacturer:

Laboratory: FPRC:

Packer:


Shelf-life:

MRF 15 MRF 15


Name of medicine:

Shelf-life:


Dosage form:

Active ingredients:


Applicant:

Manufacturer:

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2 MARCH 2007

A40/21.210152

ACTAZON30

TABLET

EACH TABLET CONTAINS:PIOGLITAZONE HYDROCHLORIDE EQUIVALENTTOPIOGLITAZONE 30,0 mg

1,2,3,4,5,6

CIPLA MEDPRO (PTY) LTD

CIPLA LTD, SALCETTE, GOA, INDIA


CIPLA LTD, SALCETTE, GOA, INDIAFPRC:

FPRR

Laboratory:


24 months

2 MARCH 2007

A40/21.2/0151

ACTAZON 15

TABLET

EACH TABLET CONTAINS:PIOGLITAZONE HYDROCHLORIDE EQUIVALENTTOPIOGLITAZONE 15,0 mg

1,2,3,4,5,6

CIPLA MEDPRO (PTY) LTD




FPRR

Laboratory: FPRC:

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Name of medicine:


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MO/2.5/0168

PHARMA DYNAMICS LAMOTRIGINE 200 mg

TABLET

EACH TABLETCONTAINS:LAMOTRIGINE 200,0 mg

1, 2, 3, 4. 5, 6

PHARMA DYNAMICS (PTY) LTD

MEDOCHEMIE LTD, L1MASSOL, CYPRUS

MEDOCHEMIE LTD, L1MASSOL, CYPRUSDIVPHARM MANUFACTURING & PACKAGING,LONGDALE, JOHANNESBURGTECHNIKON LABORATORIES, FLORIDA. RSAPHARMACEUTICAL ENTERPRISES, N'DABENI,KZNIMPILO DRUGS, ISITHEBE, KZN

MEDOCHEMIE LTD, L1MASSOL, CYPRUSCONSULTING CHEMICALLABORATORIES,ATLASVILLE, BOKSBURG, RSATECHNIKON LABORATORIES, FLORIDA, RSAIMPILO DRUGS, ISITHEBE, KZN

PHARMA DYNAMICS, SILVERWOOD,WESTLAKE, RSA

24 months

2 MARCH 2007

MRF 15


Nameof medicine:

Dosageform:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC:

FPRR:

Shelf-life:


MO/2.5/0170

PHARMADYNAMICS LAMOTRIGINE 100 mg

TABLET

EACHTABLETCONTAINS:LAMOTRIGINE 100,0 mg

1,2,3,4,5,6

PHARMADYNAMICS (PTY) LTD

MEDOCHEMIE LTD, L1MASSOL, CYPRUS

MEDOCHEMIE LTD, LIMASSOL,CYPRUSOlVPHARM MANUFACTURING & PACKAGING,LONGDALE, JOHANNESBURGTECHNIKON LABORATORIES, FLORIDA, RSAPHARMACEUTICAL ENTERPRISES, N'DABENI,KZNIMPILODRUGS, ISITHEBE, KZN

MEDOCHEMIE LTD, L1MASSOL, CYPRUSCONSULTING CHEMICAL LABORATORIES,ATLASVILLE, BOKSBURG, RSATECHNIKON LABORATORIES, FLORIDA, RSAIMPILO DRUGS, IS/THEBE, KZN

PHARMADYNAMICS, SILVERWOOD, WESTLAKE,RSA

24 months

2 MARCH2007

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Registration number: A40/2.5/0171 Registration number: A40/2.510172

Name of medicine: PHARMA DYNAMICS LAMOTRIGINE 25 mg Name of medicine: PHARMA DYNAMICS LAMOTRIGINE 50 mg


Active ingredients EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:LAMOTRIGINE 25,0 mg LAMOTRIGINE 50,0 mg

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Conditions of registration: 1,2,3,4,5,6 Conditions of registration' 1,2,3,4,5,6 ~Applicant: PHARMA DYNAMICS (PTY) LTO Applicant: PHARMA DYNAMICS (PTY) LTO ~

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Manufacturer: MEDOCHEMIE LTO, L1MASSOL, CYPRUS Manufacturer' MEDOCHEMIE LTO, L1MASSOL, CYPRUS;>;arn

Packer: MEDOCHEMIE LTO, L1MASSOL, CYPRUS Packer: MEDOCHEMIE LTD, L1MASSOL, CYPRUS IIDIVPHARM MANUFACTURING & PACKAGING, DIVPHARM MANUFACTURING & PACKAGING, »zLONGDALE, JOHANNESBURG LONGDALE, JOHANNESBURG ."'"TECHNIKON LABORATORIES, FLORIDA, RSA TECHNIKON LABORATORIES, FLORIDA, RSA I\)

PHARMACEUTICAL ENTERPRISES, N'DABENI, KZN PHARMACEUTICAL ENTERPRISES, N'DABENI, 0:>

IMPILO DRUGS, ISITHEBE, KZN KZN s:IMPILO DRUGS, ISITHEBE, KZN ~

Laboratory: FPRC: MEDOCHEMIE LTD, L1MASSOL, CYPRUS FPRC: MEDOCHEMIE LTD, L1MASSOL, CYPRUSII

Laboratory: -tCONSULTING CHEMICAL LABORATORIES, CONSULTING CHEMICAL LABORATORIES, I\)

0ATLASVILLE, BOKSBURG, RSA ATLASVILLE, BOKSBURG, RSA 0

TECHNIKON LABORATORIES, FLORIDA, RSA TECHNIKON LABORATORIES, FLORIDA, RSA '-l

IMPILO DRUGS, ISITHEBE, KZN IMPILO DRUGS, ISITHEBE, KZN

FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE, FPRR: PHARMA DYNAMICS, SILVERWOOD, WESTLAKE,RSA RSA

Shelf-life: 24 months Shelf-life: 24 months

Date of registration: 2 MARCH 2007 Date of registration: 2 MARCH 2007

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Registration number: A40/2.510183 Registration number: A40/2.5/0185

Nameof medicine: ADCO-MICTRIN 200 Name of medicine: ADCO-MICTRIN 50oDosageform: TABLET Dosage form: TABLET 0<Active ingredients: EACH TABLETCONTAINS: Active ingredients: EACH TABLETCONTAINS: mIILAMOTRIGINE 200,0 mg LAMOTRIGINE 50,0 mg Zs::Conditions of registration: 1,2,3,4,5,6 Conditions of registration: 1, 2, 3, 4, 5, 6 mZ

Applicant: ADCOCK INGRAMLIMITED Applicant: ADCOCKINGRAMLIMITED ""oManufacturer: DELTA LIMITED, HAFNARFJORDUR, ICELAND Manufacturer: DELTA LIMITED, HAFNARFJORDUR, ICELAND »

NmPacker: DELTA LIMITED, HAFNARFJORDUR, ICELAND Packer: DELTALIMITED, HAFNARFJORDUR, ICELAND ~ADCOCK INGRAMHEALTHCARE, WADEVILLE, ADCOCKINGRAMHEALTHCARE, WADEVILLE, .mGERMISTON GERMISTONI\lcoLaboratory: FPRC: DELTA LIMITED, HAFNARFJORDUR, ICELAND Laboratory: FPRC: DELTALIMITED, HAFNARFJORDUR, ICELAND s::

FPRC/FPRR: ADCOCK INGRAMHEALTHCARE, WADEVILLE, FPRC/FPRR: ADCOCKINGRAMHEALTHCARE, WADEVILLE, »II

GERMISTON GERMISTON 0:r

Shelf-life: 24 months Shelf-life: 24 months I\l0

Dateof registration: 2 MARCH 2007 Dateof registration: 2 MARCH 2007 0

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MRF 15 MRF 15


Dosageform:

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Name of medicine:

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PHARMADYNAMICS, SILVERWOOD,WESTLAKE, RSA

24 months

2 MARCH2007

A401114310247

LANCAP 15 mg

CAPSULE

EACHCAPSULE CONTAINS:LANSOPRAZOLE 15,0 mg

1,2,3,4,5,6

PHARMADYNAMICS (PTY) LTO

KRKA DD, NOVOMESTO, SLOVENIA

KRKA DD, NOVOMESTO, SLOVENIADIVPHARM MANUFACTURING & PACKAGING,LONGDALE, JOHANNESBURGTECHNIKON LABORATORIES, FLORIDA, RSAPHARMACEUTICAL ENTERPRISES, N'DABENI,KZNIMPILO DRUGS, ISITHEBE, KZN

KRKA DD, NOVOMESTO, SLOVENIACONSULTING CHEMICAL LABORATORIES,ATLASVILLE, BOKSBURG, RSATECHNIKON LABORATORIES, FLORIDA, RSAIMPILO DRUGS, ISITHEBE, KZN

FPRR:

FPRC:Laboratory:

Applicant:

Manufacturer:

Packer:

2 MARCH2007

DELTALIMITED, HAFNARFJORDUR, ICELAND

A40/2.510186

ADCO-MICTRIN 100

TABLET

EACHTABLETCONTAINS:LAMOTRIGINE 100,0 mg

ADCOCKINGRAMHEALTHCARE, WADEVILLE,GERMISTON

24 months

1,2,3,4,5,6

ADCOCKINGRAMLIMITED

DELTALIMITED, HAFNARFJORDUR, ICELAND

DELTALIMITED, HAFNARFJORDUR, ICELANDADCOCKINGRAMHEALTHCARE, WADEVILLE,GERMISTON

FPRC/FPRR:


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Registration number: A40111.4. 3/0248 Registration number: A40127/0266

Name of medicine: LANCAP 30mg Name of medicine: EXJADE 125 mg

Dosage form: CAPSULE Dosage form: TABLET

Active ingredients: EACHCAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: oaLANSOPRAZOLE 30,0 mg DEFERASIROX 125,0mg <mConditionsof registration: 1, 2, 3, 4, 5, 6 Conditions of registration: 1,2, 3, 4, 5, 6 ::0

ZApplicant: PHARMADYNAMICS (PTY) LTO Applicant NOVARTIS SOUTH AFRICA (PTY) LTD s::

mManufacturer: KRKA DD, NOVO MESTO, SLOVENIA Manufacturer: NOVARTISPHARMA STEIN AG, STEIN,

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SWITZERLAND o»Packer KRKADO, NOVO MESTO, SLOVENIA Packer' NOVARTIS PHARMA STEIN AG, STEIN, N

DIVPHARM MANUFACTURING & PACKAGING, SWITZERLAND 9LONGDALE, JOHANNESBURGTECHNIKON LABORATORIES, FLORIDA, RSA [Tl

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CONSULTING CHEMICAL LABORATORIES, SWITZERLAND J:ATLASVILLE, BOKSBURG, RSA INSPECTORATEM&L, ORMONDE, I\l

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FPRR: PHARMADYNAMICS, SILVERWOOD, WESTLAKE, FPRCIFPRR: NOVARTIS, SPARTAN, KEMPTON PARKRSA

Shelf-life: 24 months Shelf·life: 24 months (provisional)

Date of registration: 2 MARCH 2007 Date of registration: 2 MARCH2007

MRF 15 MRF 15

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A40/27/0268

EXJADE 500 mg

TABLET

EACH TABLET CONTAINS:DEFERASIROX 500,0 mg

1,2,3,4,5,6

NOVARTIS SOUTH AFRICA (PTY) LTD

NOVARTIS PHARMA STEIN AG, STEIN,SWITZERLAND


NOVARTIS PHARMA STEIN AG, STEIN,SWITZERLANDINSPECTORATE M&L, ORMONDE,JOHANNESBURG


FPRC:Laboratory:

Packer

A40/27/0267

EXJADE 250 mg

TABLET

EACH TABLET CONTAINS:DEFERASIROX 250,0 mg

1, 2, 3, 4, 5, 6

NOVARTIS SOUTH AFRICA (PTY) LTD



NOVARTIS PHARMA STEIN AG, STEIN,SWITZERLANDINSPECTORATE M&L, ORMONDE,JOHANNESBURG

NOVARTIS, SPARTAN, KEMPTON PARKFPRC/FPRR:

Laboratory: FPRC


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Active ingredients:


Name of medicine:

Shelf-life:



2 MARCH 2007

Shelf-life:



2 MARCH 2007

zoI\)<0(jen

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Shelf-life:


A40/2 5/0348

TOPLEP 25

TABLET

EACHTABLETCONTAINS:TOPIRAMATE 25,0 mg

1, 2, 3, 4, 5, 6

RANBAXY (SA) (PTY) LTD

RANBAXY LABORATDRIES LTD, DEWAS, INDIA

RANBAXY LABORATORIES LTD, DEWAS, INDIA

RANBAXY LABORATORIES LTD, DEWAS, INDIAKHULULEKANI LABORATORY SERVICES,MIDRAND, RSA

RANBAXY, CENTURION, RSA

24 months

2 MARCH 2007

MRF 15


Name of medicine:

Dosageform:

Active ingredients:


Applicant:

Manufacturer:

Packer:

Laboratory: FPRC

FPRR:

Shelf-life:


A40/2.5/0349

TOPLEP 50

TABLET

EACHTABLET CONTAINS:TOPIRAMATE 50,0 mg

1,2,3,4,5,6

RANBAXY(SA) (PTY) LTD

RANBAXYLABORATORIES LTD, DEWAS, INDIA

RANBAXYLABORATORIES LTD, DEWAS, INDIA

RANBAXY LABORATORIES LTD, DEWAS, INDIAKHULULEKANI LABORATORY SERVICES,MIDRAND,RSA


24 months

2 MARCH 2007

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Name of medicine:

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Manufacturer:

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Laboratory: FPRC:

FPRR:

Shelf-life:


A40/2.5/0350

TOPLEP 100

TABLET

EACH TABLET CONTAINS:TOPIRAMATE 100,0 mg

1,2,3,4,5,6




RANBAXY LABORATORIES LTD, DEWAS, INDIAKHULULEKANI LABORATORY SERVICES,MIDRAND, RSA


24 months

2 MARCH 2007

Packer:

Laboratory: FPRC:

FPRR:

A40/2.5/0351

TOPLEP 200

TABLET

EACH TABLET CONTAINS:TOPIRAMATE 200,0 mg

1,2,3,4,5,6


RANBAXY LABORATORIES LTD, DEWAS,INDIA

RANBAXY LABORATORIES LTD, DEWAS,INDIA

RANBAXY LABORATORIES LTD, DEWAS,INDIAKHULULEKANI LABORATORY SERVICES,MIDRAND, RSA


24 months

2 MARCH 2007

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A40/5.10/0484

ZYDUS-ONDANSETRON 4 mg INJECTION

INJECTION

EACH1,0ml SOLUTION CONTAINS:ONDANSETRON HYDROCHLORIDE EQUIVALENTTOONDANSETRON 2,0 mg

1,2,3,4,5,6

ZYDUS HEALTHCARE SA (PTY) LTO

ZYDUSCADILAHEALTHCARE LIMITED, SANAND,AHMEDABAD, INDIA

ZYDUSCADILAHEALTHCARE LIMITED, SANAND,AHMEDABAD, INDIA

ZYDUS CADILAHEALTHCARE LIMITED, SANAND,AHMEDABAD, INDIAINSTITUTE FOR PHARMACEUTICAL ANDCHEMICAL SERVICES, SILVERTONDALE, RSAINSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY, POTCHEFSTROOM

ZYDUSHEALTHCARE, VAN DER HOFF PARK,POTCHEFSTROOM


Nameof medicine:

Dosage form:

Active ingredients:


Applicant

Manufacturer:

Packer:

Laboratory: FPRC:

FPRR:

Shelf-life:

A40/5.10/0485

ZYDUS-ONDANSETRON 8 mg INJECTION

INJECTION

EACH 1,0 ml SOLUTION CONTAINS:ONDANSETRON HYDROCHLORIDE EQUIVALENTTOONDANSETRON 2,0 mg

1, 2, 3, 4, 5, 6

ZYDUSHEALTHCARE SA (PTY) LTD

ZYDUSCADILA HEALTHCARE LIMITED, SANAND.AHMEDABAD, INDIA

ZYDUSCADILA HEALTHCARE LIMITED, SANAND,AHMEDABAD, INDIA

ZYDUSCADILAHEALTHCARE LIMITED, SANAND,AHMEDABAD, INDIAINSTITUTE FOR PHARMACEUTICAL ANDCHEMICAL SERVICES, SILVERTONDALE, RSAINSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY, POTCHEFSTROOM

ZYDUSHEALTHCARE, VAN DER HOFF PARK,POTCHEFSTROOM


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Shelf-life:


24 months(provisionel)

2 MARCH 2007

Dateof registration: 2 MARCH 2007

Registration number: A40/20.1.2I0500 Registration number: A4017.1.3/0601

Name of medicine: BIQ-AMOKSIKLAV 1 000 Name of medicine: QUINAGEN 5 mg


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:AMOXYCILLIN TRIHYDRATE EQUIVALENT TO QUINAPRIL HYDROCHLORIDE EQUIVALENT TOAMOXYCILLIN 875,0 mg QUINAPRIL 5,OmgPOTASSIUM CLAVULANATE EQUIVALENT TOCLAVULANIC ACID 125,0 mg

Conditions of registration:en

1,2,3,4,5,8 Conditions of registration: 1,2,3,4, 5, 6

~Applicant: BIOTECH LABORATORIES (PTY) LTD Applicant: MERCK GENERICS RSA (PTY) LTD '-lManufacturer LEK PHARMACEUTICAL & CHEMICAL CO d.d., Manufacturer: MERCK FARMA Y QUIMICA SA, BARCELONA, SPAIN en

"PREVALJE, SLOVENIA MERCK PHARMACEUTICAL MANUFACTURING, 0WADEVILLE, GERMISTON m

JlPacker LEK PHARMACEUTICAL & CHEMICAL CO d.d. Packer" MERCK FARMA Y QUIMICA SA, BARCELONA, SPAIN }>

PREVALJE, SLOVENIA MERCK PHARMACEUTICAL MANUFACTURING, ZDIVPHARM MANUFACTURING & PACKAGING, WADEVILLE, GERMISTON

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LONGDALE, INDUSTRIA GERARD LABORATORIES, DUBLIN, IRELAND I\l00

GENERICS (UK) LTD, POTTERS BAR, s:HERTFORDSHIRE, UK }>

Laboratory: FPRC: LEK PHARMACEUTICAL & CHEMICAL CO d.d., Laboratory' FPRC MERCK FARMA Y QUIMICA SA, BARCELONA, SPAIN}>Jl

PREVALJE, SLOVENIA MERCK PHARMACEUTICAL MANUFACTURING, -iLEK PHARMACEUTICAL & CHEMICAL CO d.d., WADEVILLE, GERMISTON I\lLJUBLJANA, SLOVENIA GERARD LABORATORIES, DUBLIN, IRELAND 0

0INSTITUTE FOR PHARMACEUTICAL SERVICES, GENERICS (UK) LTD, POTTERS BAR, -..ISILVERTONDALE, RSA HERTFORDSHIRE, UK

RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY, POTCHEFSTROOM

FPRR: BIOTECH LABORATORIES, MIDRAND, RSA FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSA

Shelf-life: 24 months Shelf-I~e: 24 months

Date of registration: 2 MARCH 2007 Dale of registration: 2 MARCH 2007

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MRF 15


Name of medicine

Dosage lonn:

Active ingredients:

Conditions ofregistration:

Applicant:

Manufaclurer:

Packer:

Laboralory: FPRC:

FPRR:

Shell-lile:

Date 01registration:

A40/7.1.3/0602

QUINAGEN 10 mg

TABLET

EACH TABLET CONTAINS:QUINAPRIL HYDROCHLORIDE EQUIVALENT TOQUINAPRIL 10,0 mg

1,2,3,4,5,6

MERCK GENERICS RSA (PTY) LTD

MERCK FARMA Y QUIMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTON

MERCK FARMA Y QUlMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTONGERARD LABORATORIES, DUBLIN, IRELANDGENERICS (UK) LTD, POTIERS BAR,HERTFORDSHIRE, UK

MERCK FARMA Y QUIMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVtLLE, GERMISTONGERARD LABORATORIES, DUBLIN, IRELANDGENERICS (UK) LTO, POTIERS BAR,HERTFORDSHIRE, UKRESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY, POTCHEFSTROOM


24 months

2 MARCH 2007

MRF 15


Name 01medicine:

Dosage lonn:

Active ingredients:


Applicant:

Manulacturer:

Packer:

Laboralory: FPRC:

FPRR:

Shell-lile:

Date ofregistration:

M0/7.1.3/0603

QUINAGEN 20 mg

TABLET

EACH TABLET CONTAINS:QUINAPRIL HYDROCHLORIDE EQUIVALENT TOQUINAPRIL 20,0 mg

1,2,3,4,5,6

MERCK GENERICS RSA (PTY) LTD

MERCK FARMA Y QUIMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTON

MERCK FARMA Y QUIMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVILLE, GERMISTONGERARD LABORATORIES, DUBLIN, IRELANDGENERICS (UK) LTD, POTIERS BAR,HERTFORDSHIRE, UK

MERCK FARMA Y QUIMICA SA, BARCELONA, SPAINMERCK PHARMACEUTICAL MANUFACTURING,WADEVILlE, GERMISTONGERARD LABORATORIES, DUBLIN, IRELANDGENERICS (UK) LTD, POTIERS BAR,HERTFORDSHIRE, UKRESEARCH INSTITUTE FOR INDUSTRIALPHARMACY, NORTH-WEST UNIVERSITY,POTCHEFSTROOM


24monlhs

2 MARCH 2007

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MRF 15 MRF 15

Registration number. A4017.1.3f0604 Registration number: 41n.3f0089

Nameof medicine> QUINAGEN 40 mg Name of medicine: SUMIG 50


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS:QUINAPRIL HYDROCHLORIDE EQUiVALENT TO SUMATRIPTAN SUCCINATE EQUIVALENT TOQUINAPRIL 40,Omg SUMATRIPTAN 50,0 mg

Conditions of registration: 1,2, 3,4, 5, 6 Conditions of registration: 1,2,3,4,5, 6 en

Applicant: MERCK GENERICS RSA (PTY) LTD Applicant: CIPLA MEDPRO (PTY) LTD ~;:;

Manufacturer: MERCK FARMA Y QUIMiCA SA, BARCELONA, SPAIN Manufacturer: CIPLA LTO, UNIT III, VERNA, GOA, INDIA enMERCK PHARMACEUTICAL MANUFACTURING,

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WADEVILLE, GERMISTON mPacker: MERCK FARMA Y QUIMICA SA, BARCELONA, SPAIN Packer: CIPLA LTD, UNIT III, VERNA, GOA, INDIA

:0»MERCK PHARMACEUTICAL MANUFACTURING, ZWADEVILLE, GERMISTON ;-l

GERARD LABORATORIES, DUBLIN, IRELAND I\l

GENERICS (UK) LTO, POTIERS BAR,a>

HERTFORDSHIRE, UK s:Laboratory: FPRC: MERCK FARMA Y QUIMICA SA, BARCELONA, SPAtN Laboratory: FPRC: CIPLA LTD, UNIT III, VERNA, GOA, INDIA ~

MERCK PHARMACEUTICAL MANUFACTURING,:0-l

WADEVILLE, GERMISTON I\lGERARD LABORATORIES, DUBLIN, IRELAND oGENERICS (UK) LTO, POTIERS BAR,

e...HERTFORDSHIRE, UKRESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY,NORTH-WEST UNIVERSITY, POTCHEFSTROOM

FPRR: MERCK GENERICS RSA, MODDERFONTEIN, RSAFPRR CIPLA MEDPRO, ROSENPARK, BELLVILLE

Shelf-life: 24 months Sheil-life: 24 months

Date of registration: 2 MARCH 2007 Date of registration: 2 MARCH 2007

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MRF 15 MRF 15

Registration number: 41/7.3/0090 Registration number: 4117.3/0091 GlNameof medicine: SUMIG 100 Name of medicine: CIPLA-SUMATRIPTAN 50 0

<Dosage form: TABLET Dosageform: TABLET

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Active ingredients: EACH TABLETCONTAINS: Active ingredients: EACHTABLET CONTAINS:Zs:

SUMATRIPTAN SUCCINATE EQUIVALENT TO SUMATRIPTAN SUCCINATE EQUIVALENT TO mSUMATRIPTAN 100,0mg SUMATRIPTAN 50,0mg Z

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Conditions of registration: 1, 2, 3,4, 5, 6 Conditions of registration: 1,2,3,4,5,6 o»Applicant CIPLAMEOPRO (PTY)LTD Applicant CIPLA LIFE SCIENCES (PTY) LTD

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9Manufacturer: CIPLA LTO, UNITIII, VERNA, GOA, INDIA Manufacturer: CIPLA LTO, UNITIII, VERNA, GOA, INDIA.m

Packer: CIPLALTO, UNIT III, VERNA, GOA, INDIA Packer: CIPLA LTD, UNITIII, VERNA, GOA, INDIA I\l(Xl

Laboratory: FPRC' CIPLALTD, UNIT III, VERNA, GOA, INDIA Laboratory: FPRC: CIPLA LTD, UNITIII, VERNA, GOA, INDIA s:FPRR: CIPLA LIFESCIENCES, ROSENPARK, BELLVILLE FPRR: CIPLA LIFE SCIENCES, ROSENPARK, BELLVILLE

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Shelf-life: I24 months Shelf-life: 24 months I\l

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Dateof registration: 2 MARCH 2007 Date of registration: 2 MARCH2007 ,'l

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