pretoria, 10 september 2010 no. 33525 - open gazettes ... 10 september 2010 general notice algemene...

'Vol. 543 Pretoria, 10 September 2010 No. 33525 ~--I

2 No.33525 GOVERNMENT GAZETTE, 10 SEPTEMBER 2010

IMPORTANT NOTICE

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CONTENTS

No.

GENERAL NOTICE

Health, Department of

General Notice 848 Medicines and Related Substances Act

(101/1965): Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7) .......................................................... ..

Page Gazette No. No.

3 33525

INHOUD

No. Bladsy Koerant

ALGEMENE KENNISGEWING

Gesondheld, Departement van

Aigemene Kennisgewing 848 Wet op Beheer van Medisyne en

Verwante Stowwe (101/1965): Medisynebeheerraad: Voorwaardes vir die regisIrasia van 'n medisyne in lerme van die bapalings van artikel 15 (7) ................... ..

No. No.

4 33525

STAATSKOERANT, 10 SEPTEMBER 2010

GENERAL NOTICE

ALGEMENE KENNISGEWING

NOTICE 848 OF 2010

MEDICINES CONTROL COUNCIL

No.33525 3

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. mediclne shall 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. The provisional shetf-life allocated must be confirmed with stability data over the

full shelf·life period on the first two production batches (well-known API) or first three production batches (NCE) in accordance with the Stability Guideline.· Stability testing submitted on any pilot batches must also be completed and reported on. The stability report must be submitted within six months after completion of the stability trial. However, Council has to be informed immediately if any parameter shows a significant change or out-of-specification result during the stability trial.

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

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

11. Marketing of the product may only commence following a satisfactory postregistration inspection report.

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

13. The expiry date allocated shall be modified by adding a statement that the virus strains are currently recommended for South African usage in the specific year.

14. The strains of the master seed viruses must be approved by the Department of Health for each year.

4 No.33525 GOVERNMENT GAZETTE, 10 SEPTEMBER 2010

KENNISGEWING 848 VAN 2010

MED~YNEBEHEERRAAD

VOORWAARDES VIR DIE REG~TRASIE VAN 'N MEDISYNE IN TERME VAN DIE BEPAUNGS VAN ARTIKEL 15(1) VAN DIE WET OP BEHEER VAN MED~VNE EN

VERWANTE STOWWE, 1965 (WET 101 VAN 1965)

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

2. Die vervaardlging van hierdie medisyne is onderhewig aan gereelde ondersoeke en inspeksies deur inspekteurs, aangestel ingevolge Artikel 25 van die Wet, om die nakoming van Goeie Vervaardigingspraktyke te bepaal.

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

4. Die applikant moet voldoen aan aile wetlike vereistes van die Wet op Medisyne en Verwante Stowwe, 1965 (Wet 101 van 1965).

5. Die registrasie van hierdie medisyne is onderhewig aan gereelde hersiening met tussenpose soos deur die Raad bepaal, rakende kwaliteit, veiligheid en effektiwiteit, en die registrasie van hierdie medisyne kan gewysig word onderhewig aan kwessies na goeddunke van die Raad.

6. Die eerste twee produksielotte moet ten volle gevalideer word ooreenkomstig die breedvoerige prosesvalidasie protokol wat ingedien is ten tye van die aansoek om registrasie, en die validB.$ieversiag moet binne die bestek van sen maand na die voltooiing van die validasie ingedien word.

7. Die produk mag slegs aan die beroepe geadverteer word. 8. Die toegekende voorlopige rakleeflyd moet bevestig word met stabiliteitsdata

volgens die Stabiliteitsriglyn op die eerste twee produksielotte (bekende aktiewe bestanddele), of aerste drie produksie/otte (nuwe chemiese entiteite), wat die volle rakleeftydperiode dek. Stabiliteitstoetse wat op proeflotte ingedien is, moet ook voltooi word en die verslae ingedien word. Die stabiliteitsverslag moet binne sea maande na voltooling van die stabiliteitsproef ingedien word. Die Raad moet egter onmiddellik in kennis gestel word indien enige parameter 'n betekenisvolle verandering of buite-spesifikasieresultaat tydens die stabiliteitsproef lewer.

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

10. 'n Na-registrasie-inspeksie moet op die eerate produksielot van die ingevoerde produk uitgevoer word.

11. Bemarking van die prod uk mag slegs 'n aanvang neem nadat 'n bevredigende na-registrasie-inspeksieveralag gedien het.

12. Een monster van elke lot moet tesame met vier kopiei! van die protokolle vir die toets van die massalot en die vullot sowel as ses kopi~ van die vrystellingsertifikaat wat uitgereik is deur die verantwoordelike beheerliggaam in die land waar die produk vervaardig word, ingedien word by die Raad vir lotvrystellingsdoeleindes.

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

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

MRF15 MRF15 MRF 15

Registration number: 36/2.710223 Registration number: A40/16.410358 Registration number: 41120.2.810747

Name of medicine: GRAND-PA PARACETAMOL Name of medicine: STREPSILS STRAWBERRY Name of medicine: PREZISTA TABLETS SUGAR-FREE

Dosage form: TABLET Dosage form: LOZENGES Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH LOZENGE Active Ingredients: EACH TABLET CONTAINS: PARACETAMOL 500,Omg CONTAINS: DARUNAVIR ETHANOLATE SODIUM BICARBONATE AMYLMETACRESOL 0,6 mg EQUIVALENT TO 630,Omg DICHLOROBENZYL· DARUNAVIR 300,0 mg

ALCOHOL 1,2mg

Conditions of registration: 1,2.3,4.5,6 Conditions of registration: 1,2,3,4,5.6,8 Conditions of registration: 1,2,3.4,5.6,7,8

Applicant GROUP LABORATORIES SA Applicant: RECKITT BENCKISER Applicant: PHARMACARE LIMITED Ul (PTY) LTD PHARMACEUTICALS (PTY) ~ LTD

~ Manufacturer: GLAXOSMITHKlINE, Manufacturer: BOOTS MANUFACTURING, Manufacturer: JANSSEN ORTHO LlC, Ul

DUNGARVAN, IRELAND NOTTINGHAM, UK GURA80, PUERTO RICO A 0 GLAXOSMITHKlINE, m

EPPING. CAPE TOWN II

BOOTS MANUFACTURING, »

Packer: GLAXOSMITHKlINE, Packer: Packer: JANSSEN-CILAG SpA. SAN Z DUNGARVAN, IRELAND NOTTINGHAM, UK MICHELE,LATINA, ITALY :-l GLAXOSMITHKUNE, NA TUR PRODUKT PHARMACARE LTD, KORSTEN. .... EPPING, CAPE TOWN PHARMA LTD, OSTROW, PORT ELIZABETH

0 Ul MAZOWIECKA. POLAND m

PHARMACEUTICAL "0 CONTRACTORS, ISANDO. -i KEMPTON PARK m

s:: laboratory: FPRC: GLAXOSMITHKlINE. Laboratory: FPRC: BOOTS MANUFACTURING, Laboratory: FPRC: JANSSEN-CILAG SpA, SAN til

m DUNGARVAN. IRELAND NOTTINGHAM. UK MICHELE, LATINA, ITALY II GLAXOSMITHKlINE, NATUR PRODUKT f\) EPPING, CAPE TOWN PHARMA lTD. OSTROW. 0 ....

MAZOWlECKA, POLAND 0 PHARMACEUTICAL CONTRACTORS. ISANDO. KEMPTON PARK PHARMA..Q.INDUSTRIA-WEST. JOHANNESBURG

FPRR: GROUP LABORATORIES. FPRR: RECKITT BENCKISER FPRClFPRR: PHARMACARE LTD. KORSTEN. EPPING, CAPE TOWN PHARMACEUTICALS, PORT ELIZABETH

ELANDSFONTEIN

Shelf-llfe: 24 months Shelf-llfe: 24 months (PrOVisional) FPRR: PHARMACARE LTD. WOODMEAD. SANDTON

I~ Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 Shelf-life: 24 months (Provisional) c..> c.>

Date of registration: 23 JULY 2010 1R3 01

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MRF 15 MRF15 MRF 15

Registration number: 41/2610933 Registration number: 41126/0934 Registration number: 42120.2.810202

Name of medicine: GEMTAZ 1 9 Name of medicine: GEMTAZ 200 mg Name of medicine: NYSlVIR ORAL SOLUTION 2 g

Dosage form: INJECTION Dosage form: INJECTION Dosage form: SOLUTION

Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH VIAL CONTAINS: Active ingredients: EACH 100,0 ml SOLUTION GEMCITABINE GEMCITABINE CONTAINS: HYDROCHLORIDE HYDROCHLORIDE DIDANOSINE 2,Og G)

EQUIVALENT TO EQUIVALENT TO 0 GEMCITABINE 1,0 g GEMCITABINE 200,Omg < m

Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6, 7,8 II Z

Applicant: PHARMAPLAN (PTY) LTD Applicant: PHARMAPLAN (PTY) L TO Applicant: AUR081NDO PHARMA (PTY) s:: m

LTD Z -i

Manufacturer: SUN PHARMACEUTICALS Manufacturer: SUN PHARMACEUTICALS Manufacturer: AUROBINDO PHARMA LTD, G) INDUSTRIES L TO, HALOL, INDUSTRIES L TO, HALOL, UNIT III, QUTHUBULLAPUR » DISTRICT PANCHMAHAL, DISTRICT PANCHMAHAL, MANDAL, RANGA REDDY N

m GUJARAT, INDIA GUJARAT, INDIA DISTRICT, ANDHRA PRADESH, ~ INDIA

Packer: .rn

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GUJARAT, INDIA GUJARAT, INDIA DISTRICT. ANDHRA PRADESH. m "0 INDIA -i

Laboratory: FPRC: SUN PHARMACEUTICALS Laboratory: FPRC: SUN PHARMACEUTICALS Laboratory: FPRC: AUROBINDO PHARMA L TO, m s::

INDUSTRIES LTD, HALOL, INDUSTRIES LTD, HALOL, UNIT III, QUTHUBULLAPUR OJ DISTRICT PANCHMAHAL, DISTRICT PANCHMAHAL, MANDAL, RANGA REDDY m GUJARAT, INDIA GUJARAT, INDIA DISTRICT, ANDHRA PRADESH, II CONSULTING CHEMICAL CONSULTING CHEMICAL INDIA I\:)

0 lABORATORIES. LABORATORIES. -"

A TLASVILLE. BOKSBURG ATLASVlLLE, BOKSBURG 0

FPRR: PHARMAPLAN. MIDRAND. FPRR: PHARMAPLAN, MIDRAND. FPRR: AUROBINDO PHARMA, RSA RSA MEYERSDAL, JOHANNESBURG

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

Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010

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MRF 15 MRF15 I~ RegiStration number: 42121.5.410220 Registration number: 4211.2/0423 Registrallon number: 4211.2/0424

Name of medicine: SEREFLO 25/250 HFA Name of medicine: EFEGENXR75 Name of medicine: EFEGEN XR 150

Dosage fonn: INHALER Dosage fonn: CAPSULE Dosage fonn: CAPSULE

Active ingredients: EACH ACTUATION Active ingredients: EACH CAPSULE Active ingredients: EACH CAPSULE CONTAINS: DEUVERS: CONTAINS: VENLAFAXINE SALMETEROL XINAFOATE VENLAFAXINE HYDROCHLORIDE EQUIVALENT TO HYDROCHLORIDE EQUIVALENT TO G) SALMETEROL 25,0 ~g EQUIVALENT TO VENLAFAXINE 75,0 rng 0 FLUTICASONE VENLAFAXINE 75,0 mg < PROPIONATE 250,0 lAg m

JJ Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2, 3, 4, 5, 6, 7, 8 Z s: Applicant CIPLA MEDPRO(PTY) LTD Applicant: RANBAXY (SA) (PTY) LTD Applicant: RANBAXY (SA) (PlY) LTD m

Z Manufacturer: CIPLA LTD, UNIT II, VERNA, Manufacturer: RANBAXY LABORATORIES Manufacturer: RANBAXY LABORATORIES LTD, -i

SALCETTE, GOA, INDIA LTD, PAONTA SAHIB, PAONTA SAHIB, SIRMOUR, G) » SIRMOUR, HIMACHAL HIMACHAl PRADESH, INDIA N

PRADESH, INDIA m

Packer: CIPLA LTD, UNIT II, VERNA, Packer: RANBAXY LABORATORIES Packer: RANBAXY LABORATDRIES LTD, ::j

SALCETTE, GOA, INDIA LTD, PAONTA SAHIB, PAONTA SAHIB, SIRMOUR, .m SIRMOUR, HIMACHAL HIMACHAL PRADESH, INDIA 0 PRADESH, INDIA (J)

Laboratory: FPRC: CIPLA LTD, UNIT If, VERNA, Laboratory: FPRC: RANBAXY LABORATORIES Laboratory: FPRC RANBAXY LABORATORIES LTD, m 'tJ

SALCETTE, GOA, INDIA LTD, PAONTASAHIB, PAONTA SAHIB, SIRMOUR, -i SIRMOUR, HIMACHAL HIMACHAL PRADESH, INDIA m PRADESH, INDIA KHULUlEKANILABORATORY s:

III KHULULEKANI SERViCES, COVENTRY PARK, m LABORATORY SERVICES, MIDRAND JJ COVENTRY PARK, CONSULTING CHEMICAL f\)

MIDRAND LABORATORIES, ATLASVlllE, 0 ..... CONSULTING CHEMICAL BOKSBURG 0

LABORATORIES, ATLASVILLE, BOKSBURG

FPRR: CIPLA MEDPRO, FPRR RANBAXY (SA), FPRR RANBAXY (SA), CENTURION, ROSENPARK, BELLVILLE CENTURION, RSA RSA .

Shelf·life: 12 months Shelf-life: 24 months (Provisional) Shelf-life: 24 months (ProvisionaQ


MRF15 MRF15 MRF15

Registration number: 4211.210425 Registration number: 4211.210426 Registration number: 4213.1/0467

Name of medicine: RAN VENLAFAXINE XR 75 Name of medicine: RAN VENLAFAXINE XR Name of medicine: AURO MELOXICAM 7,5 mg 150 mg

Dosage form: CAPSULE Dosage form: CAPSULE Dosage form: TABLET

Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH CAPSULE Active ingredients: EACH TABLET CONTAINS: VENlAFAZINE CONTAINS: MELOXICAM 7,5mg HYDROCHLORIDE VENLAFAZINE EQUIVALENT TO HYDROCHLORIDE VENlAFAXINE 75,0 mg EQUIVALENT TO

VENLAFAXINE 150,0 mg

Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 (J)

~ Applicant: RANBAXY (SA) (PTY) LTD Applicant: RANBAXY (SA) (PTY) LTD Applicant: AUROBINDO PHARMA (PTY)

~ LTD (J)

Manufacturer: RANBAXY LABORATORIES Manufacturer: RANBAXY LABORATORIES Manufacturer: AUROBINDO PHARMA LTD, A LTD, PAONTASAHIB, LTD, PAONTA SAHIB, UNIT III, QUTHUBULLAPUR g SIRMOUR, HIMACHAL SIRMOUR, HIMACHAL MANDAL, RANGA REDDY JJ PRADESH, INDIA PRADESH, INDIA DISTRICT, ANDHRA PRADESH, ):-

INDIA Z .:-I

Packer: RANBAXY LABORATORIES Packer: RANBAXY lABORATORIES Packer: AUROBINDO PHARMA LTD, ..... LTD, PAONTASAHIB, LTD, PAONTA SAHIB, UNIT III, QUTHUBULlAPUR 0

SIRMOUR, HIMACHAL SIRMOUR, HIMACHAL MANDAl, RANGA REDDY (f) m

PRADESH, INDIA PRADESH, INDIA DISTRICT. ANDHRA PRADESH. "'0 INDIA -i m

Laboratory: RANBAXY LABORATORIES Laboratory: FPRC: RANBAXY lABORATORIES Laboratory:: AUROBINDO PHARMA LTD, s: FPRC: LTD, PAONTASAHIB. LTD, PAONTA SAHIB, FPRC UNIT III. QUTHUBULlAPUR III

m SIRMOUR, HIMACHAL SIRMOUR, HIMACHAL MANDAL. RANGA REDDY II PRADESH. INDIA PRADESH, INDIA DISTRICT, ANOHRA PRADESH, I\')

KHULULEKANI KHULUlEKANI INDIA 0

lABORATORY SERVICES, LABORATORY SERVICES, ..... 0

COVENTRY PARK. COVENTRY PARK, MIDRAND MIDRAND CONSULTING CHEMICAL CONSULTING CHEMICAL LABORATORIES. LABORATORIES, ATlLASVlLLE. BOKSBURG ATlASVlLLE. BOKSBURG

FPRR: RANBAXY (SA), FPRR: RANBAXY (SA), FPRR AUROBINDO PHARMA. CENTURION, RSA CENTURION. RSA MEYERSDA~JOHANNESBURG

Shelf..life: 24 months (Provisional) SheIf..\ife: 24 months (Provisional) Shelf"\ife: 24 months (Provisional)

Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 I Z 9 (.:J (.:J (J1 I\') (J1

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MRF15 MRF15

Registration number: 4213.1/0468 Registration number:

Name of medicine: AURO MELOXICAM 15 mg Name of medicine:

Dosage fonn: TABLET Dosage fonn:

Active ingredients: EACH TABLET CONTAINS: Active ingredients: MELOXICAM 15.0mg

Conditions of registration: 1,2.3,4.5.6.7.8 Conditions of registralion:

Applicant: AUROBINDO PHARMA (PlY) Applicant: LTD

Manufac!urer: AUROBINOO PHARMA LTD, Manufacturer. UNIT III, QUTHUBULLAPUR MANOAL, RANGA REDDY DISTRICT, ANOHRA PRADESH, INDIA

Packer. AUROBINDO PHARMA LTD. Packer: UNIT III, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH. INDIA

Laboratory: FPRC: AUROBINDO PHARMA LTD. Laboratory: F'PRC: UNIT III. QUTHUBULLAPUR MANOAL. RANGA REDDY DISTRICT. ANOHRA PRADESH, INDIA

FPRR: AUROBINDO PHARMA. FPRR: MEYERSOAL,JOHANNESBURG

Shelf..Jifa: 24 months (Provisional) Shelf..Jife:

Date of registration: 23 JULY 2010 Date of registration:

MRF 15

41/3.110469 Registration number.

FLAMARYX 7,5 mg Name of medicine:

TABLET Oosege fonn:

EACH TABLET CONTAINS: Active ingredients: MELOXICAM 7.5mg

1.2,3,4.5,6,7,8 Conditions of registration:

AUROBINDO PHARMA (PlY) Applicant: LTD

AUROBINOO PHARMA LTD. Manufacturer: UNIT III. QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANOHRA PRADESH, INDIA

AUROBINDO PHARMA LTD, Packer. UNIT III, QUTHUBULLAPUR MANDAL. RANGA REDDY DISTRICT. ANDHRA PRADESH, INDIA

AUROBINDO PHARMA LTD, Laboratory: FPRC: UNIT III, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT. ANOHRA PRADESH, INDIA

AUROBINDO PHARMA, FPRR: MEYERSDAL. JOHANNESBURG

24 months (Provisional) Sheff..Jife:

23 JULY 2010 Date of registration:

4113.1/0470

FLAMARYX 15 mg

TABLET

EACH TABLET CONTAINS: MELOXICAM 15,Omg

1. 2. 3, 4. 5, 6, 7. 8

AUROBINOO PHARMA (PTY) LTD

AUROBINDO PHARMA LTD, UNIT III. QU11iUBULLAPUR MANDAL. RANGA REDDY DISTRICT, ANDHRA PRADESH, INDIA

AUROBINDO PHARMA LTD. UNIT III. QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT. ANOHRA PRADESH, INDIA

AUROBINOO PHARMA LTD. UNIT III, QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH. INDIA

AUROSINDO PHARMA. MEYERSOAL,JOHANNESBURG

24 months (Provisional)

23 JULY 2010

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MRF 15 MRF15 MRF15

Registration number: 42120.2.810936 Registration number: 42120.2.8/0973 Registration number: 42120.2.8/0974

Name of medicine: SONKE LAMIVUDINE + Name of medicine: RENZlR50mg Name of medicine: RENZIR 100 mg ZIDOVUDINE 1501300 AND SONKE EFAVIRENZ 600 CO-PACK

DosagefolTl1: TABLETS DosagefolTl1: CAPSULE DosagefolTl1: CAPSULE

Active ingredients: EACH BLISTER CONTAINS: Active ingredients: EACH CAPSULE CONTAINS: Adive ingredients: EACH CAPSULE CONTAINS: 2 x SONKE LAMIVUDINE + EFAVlRENZ 50,0 mg EFAVlRENZ 100.0 mg ZIDOVUDINE TABLETS CONTAINING rn LAMIVUDINE 150,Omg

~ Z1DOVUDINE 300,Omg

1 x SaNKE EFAVlRENZ 600 ~ TABLET CONTAINING C!l

?\ EFAVIRENZ 600,Omg a Conditions of registration: 1, 2, 3.4, S. 6. 7 CondHions of registration: 1.2.3.4.5.6,7.8 Conditions of registration: 1,2.3,4.5,6.7,8 m

JJ Applicant: RANBAXY (SA) (PrY) LTD Applicant: ADCOCK INGRAM LIMITED Apprtcant: ADCOCK INGRAM LIMITED »

Z Manufacturer: RANBAXY LABORATORIES LTD, Manutadurer: ADCOCK INGRAM Manufadurer: ADCOCK INGRAM HEAL THeARE. .-i

PAONTA SAHIB, SIRMOUR. HEAL THCARE, WADEVILLE, WADEVILLE, GERMISTON 0 HIMACHAL PRADESH, INDIA GERMISTON C!l

Packer. RANBAXY LABORATORIES LTD. Packer: ADCOCK INGRAM Packer: ADCOCK INGRAM HEALTHCARE. m PAONTA SAHIB, SIRMOUR, HEALTHCARE. WADEVILLE. WADEVlLlE, GERMISTON 11 HIMACHAL PRADESH. INDIA GERMISTON -i m

Laboratory: FPRC: RANBAXY LABORATORIES LTD. Laboralory: FPRC/FPRR ADCOCK INGRAM laboratory: FPRCIFPRR ADCOCK INGRAM HEAL THeME. s:: PAONTA SAHIB. SIRMOUR, HEAL THeME. WADEVILLE, WADEVILLE, GERMISTON OJ HIMACHAL PRADESH, INDIA GERMISTON ADCOCK INGRAM LTD, AEROTON, m KHULULEKANILABORATORY ADCOCK INGRAM LTD. JOHANNESBURG JJ SERVlCES, COVENTRY PARK. AEROTON. JOHANNESBURG I\)

0 MIDRAND ... CONSULTING CHEMICAL 0 lABORATORIES, ATLASVILLE, BOKSBURG BE·TABS PHARMACEUTICALS. ROODEPOORT. RSA

FPRR: RANBAXY (SA), CENTURION, FPRR: ADCOCK INGRAM LTD. ERAND FPRR: ADCOCK INGRAM LTD, ERAND RSA GARDENS, MIDRAND GARDENS, MIDRAND

Shelf·life: 24mon1hs Shelf-life: 24 months (Provisional) Shelf·rlfe: 24 months (Provisional)


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MRF 15 MRF15

Registration number. 42120.2.810976 Registration number.

Name of mediane: REFAVIN 50 mg Name of medicine:

Dosage form: CAPSULE Dosage form:

Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EFAVIRENZ 50,0 mg

Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration:

Applicant: ADCOCK INGRAM LIMITED Applicant:

Manufacturer: ADCOCK INGRAM Manufacturer. HEALTHCARE. WADEVILLE. GERMISTON

Packer. ADCOCK INGRAM Packer. HEALTHCARE, WADEVILLE, GERMISTON

Laboratory: FPRClFPRR: ADCOCK INGRAM laboratory: FPRClFPRR: HEAL THCARE. WADEVILLE. GERMISTON AOCOCK INGRAM LTD. AEROTON,JOHANNESBURG

FPRR: ADCOCK INGRAM LTD, ERAND FPRR: GARDENS. MIDRAND

Shelf-life: 24 mon1hs (Provisional) Shen:.life:

Date of registration: 23 JULY 2010 Date of registration:

MRF 15

42120.2.810977 Registlation number.

REFAVIN 100 mg Name of medicine:

CAPSULE Dosage form:

EACH CAPSULE CONTAINS: Active ingredients: EFAVIRENZ 100,0 mg

1,2,3,4,5,6,7,8 Conditions of registration:

ADCOCK INGRAM LIMITED Applicant:

ADCOCK INGRAM Manufacturer. HEAL THCARE. WADEVILLE. GERMISTON

ADCOCK INGRAM Packer: HEAL THCARE, WADEVILLE. GERMISTON

ADCOCK INGRAM Laboratory: FPRCIFPRR: HEALTHCARE, WADEVILLE. GERMISTON AOCOCKINGRAM LTD, AEROTON.JOHANNESBURG

ADCOCK INGRAM LTD, ERAMO FPRR: GARDENS, MIDRAND

24 mon1hs (Provisional) Shelf-rife:

23 JULY 2010 Date of registration:

42120.2.810979

ADCO EFAVIRENZ 50 mg

CAPSULE

EACH CAPSULE CONTAINS: EFAVIRENZ 50,0 mg

1,2, 3,4.5,6,7.8

ADCOCK INGRAM LIMITED

ADCOCK INGRAM HEAL THCARE, WADEVILLE. GERMISTON

ADCOCK INGRAM HEALTHCARE. WADEVILLE, GERMISTON

ADCOCK INGRAM HEAL THCARE. WADEVILLE, GERMISTON ADCOCK INGRAM LTD, AEROTON, JOHANNESBURG

AOCOCK INGRAM LTD, ERAND GARDENS. MIDRAND

24 months (Provisional)

23 JULY 2010

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MRF 15 MRF15 MRF 15

Registratlon number: 42120.2.8/0980 Registration number: 42121.211033 Registration number: 42121.211034

Name of medicine: ADCO EFAVIRENZ 100 mg Name of medicine: GLiMY 1 Name of medicine: GLiMY 2

Dosage form: CAPSULE Dosage form: TABLET Dosage form: TABLET

Active ingredients: EACH CAPSULE CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: EFAVIRENZ 100.0 mg GLiMEPIRIDE 1.0 mg GLIMEPIRIDE 2,0 rng

Conditions of registration: 1,2,3.4.5,6,7,8 Conditions of registratlon: 1.2.3,4,5,6,7.8 Conditions of registration: 1. 2, 3, 4. 5. 6. 7, 8

Applicant: ADCOCK INGRAM LIMITED Applicant: DR REDDY'S Applicant: OR REDDY'S LABORATORIES LABORATORIES (PTY) LTD (PlY) LTD en

~ Manufacturer: ADCOCK INGRAM Manufacturer: DR REDDY'S Manufacturer: DR REDDY'S LABORATORIES ~ HEAL THCARE, WADEVILLE, LABORATORIES LTD. LTD. QUTHUBULLAPUR

GERMISTON QUTHUBULLAPUR MANDAL, RANGA REDDY en iI\

MANDAL. RANGA REDDY DISTRICT. ANDHRA PRADESH, 0 DISTRICT, ANDHRA INDIA m PRADESH, INDIA Jl »

Packer: ADCOCK INGRAM Packer. DR REDDY'S Packer: DR REDDY'S LABORATORIES Z HEALTH CARE. WADEVILLE, LABORATORIES LTD. LTD, QUTHUBULLAPUR

.-1 ....

GERMISTON QUTHUBULLAPUR MANDAl. RANGA REDDY 0 MANDAL, RANGA REDDY DISTRICT, ANDHRA PRADESH, en DISTRICT. ANDHRA INDIA m PRADESH, INDlA "'0

-I Laboratory: FPRClFPRR: ADCOCK INGRAM Laboratory: FPRC: DR REDDY'S Laboratory; FPRC: DR REDDY'S LABORATORIES m

1: HEALTHCARE. WADEVILLE, LABORATORIES LTD, LTD, QUTHUBULLAPUR CD GERMISTON QUTHUBULLAPUR MANDAl, RANGA REDDY m ADCOCK INGRAM L TO, MANDAL, RANGA REDDY DISTRICT. ANDHRA PRADESH, Jl AEROTON, DISTRICT, ANDHRA INDIA I\)

0 JOHANNESBURG PRADESH, INDIA RESEARCH INSTITUTE FOR ....

RESEARCH INSTITUTE INDUSTRIAL PHARMACY, 0

FOR INDUSTRIAL NORTH·WEST UNIVERSITY, PHARMACY, NORTH-WEST POTCHEFSTROOM UNIVERSITY, POTCHEFSTROOM

FPRR: ADCOCK INGRAM LTD. FPRR: DRREDDY'S I FPRR: DR REDDY'S LABORATORIES, ERAND GARDENS, LABORATORIES, MURRA YFIELD, PRETORIA MIDRAND MURRAYFIELD, PRETORIA

Shelf-life: 24 months (PrOvisional) Shelf-life: 24 months (Provisional)

I Shelf-life: 24 months (Provisional)

Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 I~ (..) (..) 01 I\) 01

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MRF 15 MRF15 U) (J1 I\)

Registration number: 42121.211035 Registration number. 4311.1.3/0032 Registration number. 4311.1.3/0033 (J1

Name of medicine: GLlMY4 Name of medicine: MIGROBEN 80 TABLET Name of medicine: MIGROBEN 160 TABLET

Dosage form: TABLET Dosage fann: TABLET Dosage form: TABLET

Active ingredienlS: EACH TABLET CONTAINS: Active ingredienlS: EACH TABLET CONTAINS: Adive ingredienlS: EACH TABLET CONTAINS: GLIMEPIRIDE 4,Omg VALSARTAN 80,Omg VALSARTAN lS0,Omg

Com:fHions of registration: 1,2,3,4,5,6,7,8 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 Applicant: NOVARTlS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA (PTY) G) (PTY)LTD (PTY)LTD LTD 0

Manufaclurer: DR REDDY'S LABORATORIES Manufadurer: NOVARTIS PHARMA STEIN Manufaclurer: NOVARTIS PHARMA STEIN AG, < m LTD, QUTHUBUUAPUR AG, STEIN. SWITZERLAND STEIN. SWITZERLAND II MANDAL,RANGAREDDY NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA S.A., Z DISTRICT. ANDHRA PRADESH. SA, BARBERA DEL VALLES, BARBERA DEL VALLES, s: INDIA BARCELONA, SPAIN BARCELONA, SPAIN m

Packer. DR REDDY'S LABORATORIES Packer: NOVARTIS PHARMA STEIN Packer: NOVARTIS PHARMA STEIN AG. Z -l

LTD,OUTHUBUUAPUR AG. STEIN, SWITZERLAND STEIN, SWITZERLAND G) MANDAL,RANGAREDDY NOVARTIS PHARMACEUTICA NOVARTlS PHARMACEUTICA SA., l> DISTRICT, ANDHRA PRADESH, S.A., BARBERA DEL VALLES. BARBERA DEL VALLES. N INDIA BARCaONA. SPAIN BARCELONA, SPAIN m

ALLPACKAG, REINACH. ALLPACK AG. REINACH, ~ SWITZERLAND SWITZERLAND KONAPHARMA AG. KONAPHARMA AG. PRATIELN. !" PRATIElN.SWlTZERLAND SWITZERLAND ..... NOVARTIS PHARMA GmbH. NOVARTlS PHARMA GmbH, 0 WEHRIBADEN.GERMANY WEH~ADEN.GERMANY Cf)

IVERS-LEE AG. BURGDORF. IVERS-LEE AG. BURGDORF, m SWITZERLAND SWITZERLAND 1)

-l NOVARTIS SA, SPARTAN. NOVARTISSA, SPARTAN. m KEMPTON PARK KEMPTON PARK s:

Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: FPRC: NOVARTIS PHARMA STEIN Laboratory: FPRC NOVARTlS PHARMA STEIN AG, O.:! m LTD,OUTHUBUUAPUR AG, STEIN. SWITZERLAND STEIN. SWITZERLAND II MANDAL. RANGA REDDY NOVARTIS PHARMACEUTlCA NOVARTlS PHARMACEUTICA SA., I\) DISTRICT. ANDHRA PRADESH, SA. BARBERA DEL VALLES. BARBERA DEL VALLES. 0 INDIA BARCELONA, SPAIN BARCELONA. SPAIN .... RESEARCH INSTITUTE FOR IVERS-lEEAG. BURGDORF, IVERS-LEE AG. BURGDORF, 0

INDUSTRIAL PHARMACY. SWITZERLAND SWITZERLAND NORTH-WEST UNIVERSITY. M&L LABORATORY SERVICES. M&L LASORA TORY SERVICES, POTCHEFSTROOM ORMONDE, JOHANNESBURG ORMONDE, JOHANNESBURG

FPRR: OR REDDY'S LABORATORIES, FPRCIFPRR: NOVARTlS SA. SPARTAN, FPRClFPRR: NOVARTlS SA, SPARTAN, MURRAYFIELD. PRETORIA KEMPTON PARK KEMPTON PARK

Shelf..fife: 24 months (Provisional) Sheif..life: 36 months Shelf-life: 36 months


MRF 15 MRF15 MRF15

Registration number: 4317 .1.3/0034 Registration number: 4317 .1.3/0035 Registration number: 4317.1.3/0036

Name of medicine: RINTEZEX 80 TABLET Name of mealcine: RINTEZEX 160 TABLET Name of medicine: ZOMEVEK 80 TABLET

Dosage form: TABLET Dosage form: TABLET Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: VALSARTAN 80,0 mg VALSARTAN 160,Omg VALSARTAN 80,Omg

Cond~ions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1,2,3,4,5,6,7

Appficant: NOVARTIS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA (PTY) (PTY) LTD (PTY)LTD LTD

Manufacturer: NOVARTIS PHARMA STEIN AG, Manufacturer: NOVARTIS PHARMA STEIN Manufacturer: NOVARTIS PHARMA STEIN AG, STEIN, SWITZERLAND AG, STEIN, SWITZERLAND STEIN, SWITZERLAND en NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA SA, );! SA, BARERA DEL VALLES, SA, BARERA DEL VALLES, BARERA DEL VALLES, BARCELONA,

~ BARCELONA, SPAIN BARCELONA, SPAIN SPAIN en Packer: NOVARTIS PHARMA STEIN AG, Packer: NOVARTIS PHARMA STEIN Packer: NOVARTIS PHARMA STEIN AG, ;Ii;

STEIN, SWITZERLAND AG, STEIN, SWITZERLAND STEIN, SWITZERLAND 0 NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA SA, m SA, BARERA DEL VALLES, SA, BARERA DEL VALLES, BARERA DEL VALLES, BARCELONA, JJ BARCELONA, SPAIN BARCELONA, SPAIN SPAIN »

Z ALLPACKAG, REINACH, ALLPACKAG, REINACH, ALLPACKAG, REINACH, .-1 SWITZERLAND SWITZERLAND SWITZERLAND KONAPHARMAAG, PRATTELN, KONAPHARMA AG, KONAPHARMA AG, PRA TTELN. ......

0 SWITZERLAND PRATTELN.SWlTZERLAND SWITZERLAND en NOVARTIS PHARMA GmbH. NOVARTIS PHARMA GmbH. NOVARTIS PHARMA GmbH, m WEHRIBADEN.GERMANY WEHR/BADEN. GERMANY WEHR/BADEN. GERMANY 1) IVERS-LEE AG. BURGDORF, IVERS-LEE AG. BURGDORF. IVERS·LEE AG, BURGDORF. -I SWITZERLAND SWITZERLAND SWITZERLAND m NOVARTIS SA. SPARTAN. NOVARTIS SA, SPARTAN. NOVARTIS SA, SPARTAN s:: KEMPTON PARK OJ

m Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, Laboratory: FPRC: NOVARTIS PHARMA STEIN Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, JJ

STEIN, SWITZERLAND AG, STEIN, SWITZERLAND STEIN. SWITZERLAND I\) NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA NOVARTIS PHARMACEUTICA SA, 0 SA, BARERA DEL VALLES, SA, BARERA DEL VALLES, BARERA DEL VALLES, BARCELONA. 0 BARCELONA, SPAIN BARCELONA, SPAIN SPAIN IVERS-LEEAG, BURGDORF, IVERS-LEE AG, BURGDORF, IVERS-LEE AG, BURGDORF, SWITZERLAND SWITZERLAND SWITZERLAND M&L LABORATORY SERVICES, M&L LABORATORY SERVICES, M&L LABORATORY SERVICES, ORMONDE, JOHANNESBURG ORMONDE, JOHANNESBURG ORMONDE, JOHANNESBURG

FPRC/FPRR: NOVARTIS SA, SPARTAN, FPRCIFPRR: NOVARTIS SA, SPARTAN, FPRCIFPRR: NOVARTIS SA, SPARTAN, KEMPTON PARK KEMPTON PARK KEMPTON PARK

Shelf-life: 36 months Shelf-life: 36 months Shelf-life: 36 months

Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 'z

9 C,.) C,.) 01 I\) 01

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MRF15 MRF15 MRF 15 Z 9

Registration number: 4317.1.310037 Registration number: 4317.1.310080 Registration number: 4317.1.3/0081 (J.) (J.)

Name of medicine: ZOMEVEK 160 TABLET Name of medicine: CO-ZOMEVEK 80112,5 TABLET Name of medicine: CO-ZOMEVEK 160112,5 TABLET U1 I\)

Dosage fonn: TABLET DosagefolTl1: TABLET Dosage form: TABLET U1

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: VALSARTAN 160,0 mg VALSARTAN aO,Omg VAlSARTAN l60.0mg

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5mg 12,5mg

CondHions of registration: 1,2,3,4,5,6,7 Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Conditions of registration: 1.2.3,4.5.6,7

Applicant: NOVARTIS SOUTH AFRICA (PrY) Applicant: NOVARTIS SOUTH AFRICA Appficant: NOVARTIS SOUTH AFRICA (PrY) LTD (PTY)LTD LTD G)

Manufacturer: NOVARTIS PHARMA STEIN AG, Manufacturer: NOVARTIS PHARMA STEIN Manufacturer: NOVARTIS PHARMA STEIN AG, 0 STEIN, SWITZERLAND AG, STEIN. SWITZERLAND STEIN, SWITZERLAND < NOVARTIS PHARMACEUTICA NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.p.A., TORRE m

J) SA, BARBERA DEL VALLES, TORRE ANNUNZIATA. ITALY ANNUNZIATA,ITALY Z BARCELONA. SPAIN s::

Packer: NOVARTIS PHARMA STEIN AG, Packer: NOVARTIS PHARMA STEIN Packer: NOVARTIS PHARMA STEIN AG. m Z STEIN, SWITZERLAND AG, STEIN, SWITZERLAND STEIN, SWITZERLAND -I

NOVARTIS PHARMACEUTICA NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.p.A., TORRE G) SA. BARBERA DEL VALLES, TORRE ANNUNZIATA, ITALY ANNUNZIATA, ITALY » BARCELONA, SPAIN AlLPACKAG, REINACH, ALLPACKAG, REINACH, N ALLPACK AG, REINACH, SWITZERLAND SWITZERLAND m SWITZERLAND KONAPHARMA AG, KONAPHARMA AG, PRATTELN, -I KONAPHARMA AG, PRA TTELN. PRATTELN,SVflTZERLAND SWITZERLAND -I SWITZERLAND NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH, m NOVARTIS PHARMA GmbH, WEHR/BADEN. GERMANY WEHR/BADEN, GERMANY WEHRIBADEN, GERMANY IVERS-LEE AG. BURGDORF, IVERS-LEE AG, BURGDORF, 0 IVERS-LEE AG, BURGDORF, SWITZERLAND SWITZERLAND CJl SWITZERLAND LAMP S. PROSPERO SpA. SAN LAMP S. PROSPERO SpA. SAN m NOVARTIS SA. SPARTAN, PROSPERO, MODENA,ITALY PROSPERO, MODENA, ITALY 1J KEMPTON PARK MIPHARM SpA, MILAN,ITALY MIPHARM SpA, MILAN,ITALY -I m NOVARTIS SA, SPARTAN, NOVARTIS SA, SPARTAN. s:: KEMPTON PARK KEMPTON PARK !D

Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, Laboratory: FPRC: NOVARTIS PHARMA STEIN Laboratory: FPRC: NOVARTIS PHARMA STEIN AG, m J)

STEIN, SWITZERLAND AG, STEIN. SWITZERLAND STEIN, SWITZERLAND I\) NOVARTIS PHARMACEUTICA NOVARTIS FARMA S.pA., NOVARTIS FARMA S.p.A., TORRE a

SA., BARBERA DEL VALLES, TORRE ANNUNZIATA, ITALY ANNUNZIATA,ITALY .... BARCELONA, SPAIN NOVARTIS PHARMA GmbH, NOVARnS PHARMA GmbH, 0 IVERS-LEE AG, BURGDORF, WEHR/BADEN. GERMANY WEHRIBADEN.GERMANY SWITZERLAND M&l LABORATORY SERVICES, M&L LABORATORY SERVICES, M&L LABORATORY SERVICES, ORMONDE. JOHANNESBURG ORMONDE, JOHANNESBURG ORMONDE, JOHANNESBURG

FPRClFPRR: NOVARTIS SA, SPARTAN, FPRC/FPRR NOVARTIS SA, SPARTAN, FPRCIFPRR: NOVARTIS SA, SPARTAN. KEMPTON PARK KEMPTON PARK KEMPTON PARK

Shelf-llfe: 36 months Shelf-life: 24 months Shelf-life: 24 months


MRF 15 MRF15 MRF 15 Registration number. 4317.1.3/0082 Registration number: 4317 .1.3/00B3 Registration number: 4317 .1.3/0084

Name of medicine: CO-ZOMEVEK 160125 TABLET Name of medicine: CO-MIGROBEN 80/12.5 Name of medicine: CO-MIGROBEN 160/12.5 TABLET TABLET


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABlET CONTAINS: Active ingredients: EACH TABLET CONTAINS: VALSARTAN 1eo.omg VALSARTAN 80.0mg VALSARTAN lS0.0mg HYDROCHLOROTH~DE HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25,Omg 12.5mg 12,5mg

Conditions of registration: 1, 2, 3, 4, 5, 6, 7 Condliions of registration: 1.2,3,4.5,6,7 Conditions of registration: 1, 2, 3, 4. 5. 6. 1

Applicant: NOVARTIS SOUTH AFRICA Applicant NOVARTIS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA (PTY) (J) (PTY)LTD (PTY)LTD LTD ~ Manufacturer. NOVARTIS PHARMA STEIN AG, Manufacturer. NOV ARTIS PHARMA STEIN Manufacturer. NOVARTIS PHARMA STEIN AG. ~ STEIN. SWITZERLAND AG, STEIN. SWITZERLAND STEIN, SWITZERlAND (J) NOVARTIS FARMA S.pA. NOVARTIS FARMA S.p.A .• NOVARTIS FARMA S.pA. TORRE A TORRE ANNUNZIATA, ITALY TORRE ANNUNZIATA. ITALY ANNUNZIATA.ITAL Y 0

Packer. NOVARTIS PHARMA STEIN AG, Packer. NOVARTIS PHARMA STEIN Packer. NOVARTIS PHARMA STEIN AG. m II STEIN. SWITZERlAND AG. STEIN. SWITZERLAND STEIN. SWITZERlAND » NOVARTIS FARMA S.pA. NOVARTIS FARMA S.p.A .• NOVARTIS FARMA S.p,A .• TORRE Z TORRE ANNUNZIATA. ITALY TORREANNUNZIATA,ITALY ANNUNZIATA,ITALY .:-i ALUPACK AG, REINACH. ALlPACKAG, REINACH, ALlPACK AG, REINACH,

SWITZERLAND SWITZERLAND SWITZERLAND 0 KONAPHARMAAG. PRATTELN, KONAPHARMAAG, KONAPHARMA AG, PRA TTELN, (J) SWITZERlAND PRATTELN,SWlTZERLAND SWITZERLAND m NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH. NOVARTIS PHARMA GmbH, "U WEHRIBADEN,GERMANY WEH~DEN,GERMANY WEH~EN,GERMANY --I IVERs-LEE AG, BURGDORF, IVERS-LEE AG. BURGDORF, IVERS-LEE AG. BURGDORF. m SWITZERLAND SWITZERlAND SWITZERLAND s: LAMP S. PROSPERO SpA. SAN LAMP S, PROSPERO SpA, SAN LAMP S. PROSPERO SpA. SAN OJ

m PROSPERO, MODENA,ITALY PROSPERO, MODENA, ITALY PROSPERO. MODENA, ITALY II MIPHARM SpA, MILAN, ITALY MIPHARM SpA, MILAN, ITALY MIPHARM SpA, MILAN, ITALY I\) NOVARTlS SA, SPARTAN, NOVARTIS SA, SPARTAN. NOVARTlS SA, SPARTAN, 0 KEMPTON PARK KEMPTON PARK KEMPTON PARK ..... 0

laboratory: FPRC: NOVARTIS PHARMA STEIN AG, Laboratory: FPRC: NOVARTIS PHARMA STEIN Laboratory: FPRC: NOVARTIS PHARMA STEIN AG. STEIN, SWITZERLAND AG, STEIN, SWITZERLAND STEIN. SWITZERLAND NOVART1S FARMA S,pA, NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.pA, TORRE TORREANNUNZIATA,ITALY TORREANNUNZlATA,ITALY ANNUNZIATA, ITALY

/' NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH, /'

'" WEH~ADEN,GERMANY WEH~DEN.GERMANY WEHRlBADEN, GERMANY M&L LABORATORY SERVICES, M&L lABORATORY SERVICES, M&L LABORATORY SERVICES, ORMONDE. JOHANNESBURG ORMONDE, JOHANNESBURG ORMONDE, JOHANNESBURG

FPRClFPRR: NOVARTIS SA, SPARTAN, FPRCIFPRR: NOVARTIS SA: SPARTAN, FPRClFPRR: NOVARTIS SA, SPARTAN, KEMPTON PARK KEMPTON PARK KEMPTON PARK \

SheJl.life: \ 24monihs Shelf-Ufe: 24 months Shelf-life: 24 months Z \ 9 Date of regist.r8\iOn: 23 JULY 2010 Date of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 (,.) (,.) 01 I\) 01

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MRF15 MRF15 c.:> MRF 15 C1l I\)

Registration number. 4317.1.310085 Registration number: 4317.1.310087 Registration number: 43n.1.3/0088 C1l

Name of medicine: CO-MIGROBEN 160'25 TABLET Name of medicine: RINTEZeX CO 80/12,5 TABlET Name of medicine: RINTEZEX CO 160112,5 TABLET


Active ingrea,ants: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: VALSARTAN 160.0mg VALSARTAN BO.Omg VALSARTAN lBO,Omg HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25.0mg 12,5mg 12.5mg

Conditions of registration: 1.2,3,4.5, B. 7 Conditions of registration: 1, 2. 3, 4, 5, 6, 7 Conditions of registration: 1,2.3.4.5.6,7 G) 0

Applicant: NOVARTIS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA Applicant: NOVARTIS SOUTH AFRICA (PrY) < (PTY)LTD (PTY)LTD LTD m

JJ Manufacturer. NOVARTIS PHARMA STEIN AG, Manufacturer: NOVARTIS PHARMA STEIN Manufacturer: NOVARTIS PHARMA STEIN AG, Z

STEIN. SWITZERLAND AG, STEIN. SWflZERLANO STEIN, SWflZERLAND s: NOVARTIS FARMA S.p.A .• NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.pA.. TORRE m TORRE ANNUNZIATA. ITALY TORRE ANNUNZIATA, ITALY ANNUNZIATA, ITALY Z

-i Packer: NOVARTIS PHARMA STEIN AG, Packer: NOVARTIS PHARMA STEIN Packer: NOVARTIS PHARMA STEIN AG. G)

STEIN. SWITZERLAND AG. STEIN. SWITZERLAND STEIN. SWITZERLAND ~ NOVARTIS FARMA S.p.A.. NOVARTIS FARMA S.pA.. NOVARTIS FARMA S.p.A .• TORRE TORRE ANNUNZIATA, ITALY TORREANNUNZIATA,ITALY ANNUNZIATA, ITALY m

-i ALLPACK AG. REINACH, ALLPACKAG. REINACH, ALLPACKAG, REINACH, -i SWITZERLAND SWITZERLAND SWITZERLAND m KONAPHARMAAG, PRATTELN, KONAPHARMA AG, KONAPHARMA AG, PRA TTELN. SWITZERLAND PRATTELN,SWlTZERLAND SWITZERLAND 0 NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH, NOVARTIS PHARMA GmbH. CJ) WEHR~EN,GERMANY WEHR~EN,GERMANY WEHR/BADEN, GERMANY m IVERS-LEE AG, BURGDORF. IVERS-LEE AG, BURGDORF, IVERS-LEE AG. BURGDORF. 1l SWITZERLAND SWITZERLAND SWflZERLAND -i LAMP S. PROSPERO SpA, SAN . LAMP S. PROSPERO SpA, SAN LAMP S. PROSPERO SpA. SAN m PROSPERO, MODENA, ITALY PROSPERO, MODENA. ITALY PROSPERO. MODENA. ITALY s: MIPHARM SpA. MILAN. ITALY MIPHARM SpA, MILAN. ITALY MIPHARM SpA, MILAN, ITALY OJ NOVARTIS SA. SPARTAN. NOVARTIS SA. SPARTAN, NDVARTIS SA, SPARTAN. m KEMPTON PARK KEMPTON PARK KEMPTON PARK JJ

I\) Laboratory: FPRC: NOVARTIS PHARMA STEIN AG. Laboratory: FPRC: NOVARTIS PHARMA STEIN Laboratory: FPRC: NOV ARTIS PHARMA STEIN AG. 0 ... STEIN. SWITZERLAND AG, STEIN, SWITZERLAND STEIN. SWITZERLAND 0 NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.p.A., NOVARTIS FARMA S.p.A., TORRE

TORRE ANNUNZIATA, ITALY TORRE ANNUNZIATA, ITALY ANNUNZIATA,ITALY NOVARTIS PHARMA GmbH. NOVARTIS PHARMA GmbH. NOV ARTIS PHARMA GmbH. ~HRlBADEN.GERMANY WEHRIBADEN,GERMANY ~DEN,GERMANY M&L LABORATORY SERVICES, M&L LASORA TORY SERVICES, M&l LABORATORY SERVICES. ORMONDE, JOHANNESBURG ORMONDE. JOHANNESBURG ORMONDE. JOHANNESBURG

FPRClFPRR: NOVARTIS SA. SPARTAN. FPRClFPRR: NOVARTIS SA, SPARTAN, FPRCIFPRR: NOVARTIS SA, SPARTAN. KEMPTON PARK KEMPTON PARK KEMPTON PARK

Shelf-life: 24 months Shelf-life: 24rnon1hs Shelf..fife: 24 months

Dale of registration: 23 JULY 2010 Oate of registration: 23 JULY 2010 Oate of registration: 23 JULY 2010

MRF15 MRF15 MRF 15

Registration number: 4317.1.310089 Registration number: 43121.210605 Registration number: 43121.210606

Name of medicine: RINTEZEX CO 160125 TABLET Name of medicine: DRL GLIMEPIRIDE 1 Name of medicine: DRL GLIMEPIRIDE 2

Dosage form: TABLET OosIIge form: TABLET Dosage form: TABLET

Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: VALSARTAN 160,omg GLiMEPIRIDE 1,Omg GLiMEPIRIDE 2,Omg HYDROCHLOROTH~DE 25,Omg

Conditions of registration: 1,2, 3, 4, 5, 6, 7 Cond~ions of registration: 1, 2, 3, 4, 5, 6, 7. 8 Conditions of registration: 1,2.3.4,5,6,7, 8

Applicant; NOVARTIS SOUTH AFRICA Applicant: DR REDDY'S LABORATORIES Applicant: DR REDDY'S LABORATORIES (PlY) (PrY) LTD (PlY) LTD LTD

MlII1ufaeturer: NOVARTIS PHARMA STEIN AG, Manufacturer: DR REDDY'S LABORATORIES Manufacturer: DR REDDY'S LABORATORIES LTD, CJ) STEIN, SWITZERLAND lTD, QUTHUBULLAPUR QUTHUBULLAPUR MANDAL, RANGA

~ NOVARTIS FARMA S.p.A., MANDAL, RANGA REDDY REDDY DISTRICT, ANDHRA TORRE ANNUNZIATA. ITALY DISTRICT, ANDHRA PRADESH, PRADESH, INDIA

INDIA '-i CJ)

Packer: NOVARTIS PHARMA STEIN AG, Packer: DR REDDY'S LABORATORIES Packer: OR REDDY'S LABORATORIES LTD. A 0 STEIN, SWITZERLAND LTD,QUTHUBULLAPUR QUTHUBULLAPUR MANDAL, RANGA m

NOVARTIS FARMA S.p.A., MANDAL, RANGA REDDY REDDY DISTRICT, ANDHRA JJ TORREANNUNZlATA,lTAlY DISTRICT. ANDHRA PRADESH, PRADESH, INDIA » ALLPACKAG, REINACH, INDIA ORA PHARMACEUTICALS, IRENE. Z SWITZERLAND DRA PHARMACEUTICALS. CENTURION .-i KONAPHARMAAG, PRAITELN, IRENE, CENTURION TECHNIKON LABORATORIES, ..... SWITZERLAND TECHNIKON LABORATORIES, ROBERTVlllE, FLORIDA 0 NOVARTIS PHARMA GmbH. ROBERTVILLE. FLORIDA DIVPHARM MANUFACTURING & CJ) WEH~EN,GERMANY DIVPHARM MANUFACTURING PACKAGING, LONGDALE, m IVERS-LEE AG, BURGDORF, & PACKAGING, LONGDAlE, JOHANNESBURG "U SWITZERLAND JOHANNESBURG -l LAMP S. PROSPERO SpA, SAN m PROSPERO, MODENA, ITALY s: MIPHARM SpA, MILAN, ITALY III

m NOVARTISSA, SPARTAN, JJ KEMPTON PARK I\:)

laboratory: FPRC: NOVARTIS PHARMA STEIN AG. Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: FPRC:: DR REDDY'S LABORATORIES LTD. 0 .....

STEIN, SWITZERLAND LTD. QUTHUBULLAPUR QUTHUBULLAPUR MANDAL, RANGA 0 NOVARTIS FARMA S.p.A.. MANDAL, RANGA REDDY REDDY DISTRICT, ANDHRA TORREANNUNZlATA,ITALY DISTRICT, ANDHRA PRADESH, PRADESH, INDIA NOVARTIS PHARMA GmbH, INDIA RESEARCH INSTITUTE FOR WEH~EN.GERMANY RESEARCH INSTITUTE FOR INDUSTRIAL PHARMACY, NORTH· M&l LABORATORY SERVICES. INDUSTRIAL PHARMACY, WEST UNIVERSITY, ORMONDE. JOHANNESBURG NORTH-WEST UNIVERSITY. POTCHEFSTROOM

POTCHEFSTROOM

FPRCIFPRR: NOVARTIS SA. SPARTAN, FPRR: DR REDDY'S LABORATORIES. FPRR: DR REDDY'S LABORATORIES, KEMPTON PARK MURRAYFIELD, PRETORIA MURRAYFIELD, PRETORIA

Shelf·life: 24 months Shelf..Jife: 24 months (Provisional) Shelf·flfe: 24 months (Provisional) Z

Date of registration: 23 JULY 2010 Dale of registration: 23 JULY 2010 Date of registration: 23 JULY 2010 9 U) U) 01 I\:) 01

... ID

I\) 0

MRF 15 MRF15 MRF15 Z 9

Registration number: 43/21.210607 Registration number: 43120.2.810832 Registration number: 44120.2.8/0294 VJ VJ

Name of medicine: DRL GLIMEPIRIDE 4 Name of medicine: ASPEN LAMIVUDINE 300 mg Name of medicine: ADCO LAMIVUDINE 300 mg (]I I\)

TABLETS (]I


Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: Active ingredients: EACH TABLET CONTAINS: GLIMEPIRIDE 4,Omg LAMIVUDINE 300,Omg LAMIVUDINE 300,Omg

Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1,2,3,4,5,6,7,8 Conditions of registration: 1, 2, 3, 4, 5, 6, 7

Applicant: DR REDDY'S LABORATORIES Applicant: PHARMACARE LIMITED Applicant: ADCOCK INGRAM LIMITED (pTY}Lm

Manufacturer. DR REDDY'S LABORATORIES Manufacturer: STRIDES ARCOLAB L m, Manufacturer: HETERO DRUGS, JEEDIMETLA, G> 0 LTD,QUTHUBULLAPUR ANEKAL TALUK, BANGALORE, HYDERABAD, INDIA < MANDAL, RANGA REDDY INDIA ADCOCK INGRAM HEAL THCARE, m

DISTRICT, ANDHRA PRADESH, ASPED OSO, GIBAUD ROAD, WADEVILLE, GERMISTON ::D INDIA PORT ELIZABETH Z

Packer: DR REDDY'S LABORATORIES Packer: STRIDES AReOLAS L m, Packer: HETERO DRUGS, JEEDIMETLA, s:: m

Lm, QUTHUBULLAPUR ANEKAL TALUK, BANGALORE, HYDERABAD, INDIA Z MANDAL, RANGAREDDY INDIA ADCOCK INGRAM HEAL THCARE, -I DISTRICT, ANDHRA PRADESH, ASPED OSD, GIBAUD ROAD, WADEVILLE, GERMISTON G> INOlA PORT ELIZABETH » ORA PHARMACEUTICALS, N IRENE, CENTURION m TECHNIKON LABORATORIES, ::j ROBERTVILLE, FLORIDA .m DIVPHARM MANUFACTURING & PACKAGING, LONGDALE, .... JOHANNESBURG 0

(f) Laboratory: FPRC: DR REDDY'S LABORATORIES Laboratory: FPRC: STRIDES ARCOLAS L m, Laboratory: FPRC: HETERO DRUGS, JEEOIMETLA, m

Lm,OUTHUBULLAPUR ANEKAL TALUK, BANGALORE, HYDERASAO, INDIA 1J MANDAL, RANGA REDDY INDIA -I m DISTRICT, ANDHRA PRADESH, M&L LABORATORY SERVICES. s:: INDIA ORMONDE, JOHANNESBURG OJ RESEARCH INSTITUTE FOR RESEARCH INSTITUTE FOR m INDUSTRIAL PHARMACY, INDUSTRIAL PHARMACY, ::D NORTH-WEST UNIVERSITY, NORTH-WEST UNIVERSITY, I\) POTCHEFSTROOM POTCHEFSTROOM 0

SABS PHARMACEUTICAL .... CHEMISTRY LABORATORY,

0

GROENKLOOF, PRETORIA

FF'RR: DR REDDY'S LABORATORIES, FPRClFPRR: ASPEN OSO, GIBAUD ROAD, FPRC/FPRR: ADCOCK INGRAM HEAL THCARE. MURRAYFIELD. PRETORIA PORT ELIZABETH WAOEVlLLE, GERMISTON

ADCOCK INGRAM LTD, AEROTON, JOHANNESBURG

Shelf-life: 24 months (Provisiona~ FPRR: F'HARMACARE LTD, FPRR: ADCOCK INGRAM LTD, ERANO WOOOMEAD,SANDTON GARDENS, MIDRAND

Date of registration: 23 JULY 2010 StleIf-ilfe: 24 months (ProvlslonaQ Shelf-life: 24monlhs

Date of negistration: 23 JULY 2010 Date of registration: 23 JULY 2010

MRF 15 MRF15 MRF 15 Registration number. 44120.2.810295 RegI$1ratlon number. 44120.2.8/0296 Registration number. 44/30.1/0897

Name of mediei!le: RETlAM 300 mg TABLETS Name of me<lldne: LAVOS 300 mg TABLETS Name of medicine: AREPANORIX H1N1

Dosage form: TABLET Dosage loon: TABlET Dosage form: INJECnON

Active Ingredlen1s: EACH TABLET CONTAINS: Active ingnIdien1e: EACH TABLET CONTAINS: Active ingredients: EACH 0,5 ml DOSE CONTAINS: lAMlVUDINE 3oo,Omg lAMlVUDINE 3OO,Omg SPLIT INFLUENZA VIRUS

AlCAUFORNIAl71200Q(Hl N1) V-lIKE VIRUS 3,751'9

Conditions of registralion: 1,2,3,4,5.8,7 Conditions of re;lslratioo: 1,2.3.4. S. e, 7 Conditions of registJa!ion: 1,2.3.4,5,8,7

Applicant: ADCOCK INGRAM LIMITED Applicant ADCOCK INGRAM LIMITED AppHcant. GlAXOSMITHKlINE SA (PTY) LTD

Manufacturer. HETERO DRUGS. JEEDIMETLA. Manufacturer. HETERO DRUGS, JEEDIMETlA, Manufacturer, GlAXOSMITHKlINE BIOLOGICALS NORTH HYDERABAD, INDIA HYDERABAD. INDIA AMERICA, SAlNTE·FOY. QUEBEC. ADCOCK INGRAM HEALTHCARE, ADCOCK INGRAM HEALTHCARE, CANADA WADEVILLE. GERMISTON WADEVILLE. GERM1STON GLAXOSMITHKlINE BIOLOGICALS

MANUFACTURING SA. RIXENSART, BELGIUM GLAXOSMITHKlINE BIOLOGICALS (Jl MANUFACTURING SA. WAVRE. BELGIUM

~ GlAXOSMITHKlINE BIOLOGICALS, SAINT AMAND LES EAUX, FRANCE ~ GlAXOSMITHKlINE BIOLOGICALS NORTH AMERICA. MARIETTA. PA. USA (Jl GlAXO WELCOME OPERATIONS UK, ;;Ii; BARNARD CASTLE, OUR HAM, UK 0 VETTER ?KARMA INTERNATIONAL GmbH. m MooSWlESEN. RAVENSBURG. GERMANY Jl OSM. GREENVILLE, NC, USA » BAXTER PHARMACEUTICAL SOLUTIONS. Z BLOOMINGTON, INDIANA, USA :-I HOSPIRA INC, MCPHERSON. KANSAS, USA ....

0 Packer. HETERO DRUGS. JEEDIMETlA, Packer. HETERO ORUGS. JEEOIMETLA. Packer. GlAXOSMITHKlINE BIOlOGICALS NORTH (Jl

HYDERABAD. INDIA HYDERABAD, INDIA AMERICA. SAiNTE-FOY. QUEBEC, m ADCOCK INGRAM HEAL THCARE. ADCOCK INGRAM HEALTHCARE. CANADA "'0 WADEVILLE. GERMISTON WAOEVILLE. GERMISTON GlAXOSMITHKlINE BIOLOGICALS -I MANUFACTURING SA, RIXENSART. m BELGIUM s: GLAXOSMITHKLINE BIOLOGICALS III MANUFACTURING SA. WAVRE. BELGIUM m GLAXOSMITHKLlNE BIOLOGICALS NORTH Jl AMERICA. MARIETTA. PA, USA GLAXO WELCOME OPERATIONS UK, I\)

0 BARNARD CASTLE. DURHAM. UK .... VETTER PHAMRA INTERNATIONAl GmbH, 0 MooSWlESEN.RAVENSBURG,GERMANY HOWSTER-STIER LABORATORIES, SPOKANE, WA. USA OSM. GREENVILLE. NC. USA PIERRE FABRE MEDICAMENT PRODUCTION. CHATEAU RENARD, FRANCE PIERRE FABRE MEDICAMENT PRODUCTION. CHEMIN DE MAZEROLLES, IDRON. FRANCE PIERRE FABRE MEDICAMENT PROoucnON. IORON FRANCE BAXTER PHARMACEUTICAL SOLUTIONS. BLOOMINGTON, INDIANA, USA

Z HOSPlRA INC, MCPHERSON, KANSAS, USA 9 GLAXOSMITHKLINE SA. EPPING, CAPE CN TOWN CN

t..abora!llty: FPRC: HETERO DRUGS. JEEDIMETLA, Laborntory: FPRC: HETERO DRUGS. JEEDIMETlA, Leboratory: FPRC: GLAXOSMITHKLINE BIOlOGICALS NORTH OJ I\) OJ

I\) ....

Ff'RClFPRR:

Ff'RR:

Shelf-life:

Date of registration:

HYDERABAD. INDIA

ADCOCK INGRAM HEAlTHCARE. WADEVllle. GERMISTON ADCOCK INGRAM LTD. AEROTON. JOHANNESBURG

ADCOCK INGRAM LTD. ERAND GARDENS. MIDRAND

24monlhs

23 JULY 2010

FPRClFPRR:

FPRR:

SheIf-life:


HYDERABAO. INOlA

ADCOCK INGRAM HEALTHCARE. WADEVIlLE. GERMISTON ADCOCK INGRAM LTD. AEROTON. JOHANNESBURG

ADCOCK INGRAM LTD. ERAND GARDENS. MlORAND

24mon1hs

23 JULY 2010

FPRCIFPRR:

Shelf·life:


AMERICA. SAINTE-FOY. QUEBEC. CANADA GLAXOSMITHKUNE BIOLOGICAlS MANUFACTURING SA. RIXENSART. BELGIUM GLAXOSMITHKlINE BIOLOGICAlS MANUFACTURING SA. WAVRE. BELGIUM GLAXOSMITHKlINE BIOLOGiCAlS. SAINT AMAND LES EAUX. FRANCE GLAXOSMITHKLINE BIOLOGiCAlS NORTH AMERICA.IIIARIETTA. PA. USA GLAXO WELCOME OPERATIONS UK, BARNARD CASTLE. DURHAM. UK VETTER PHARMA INTERNATIONAL GmbH. ~ESEN.RAVENSBURG.GERMANY HOWSTER-STIER LABORATORIES. SPOKANE. WA. USA OSI\!. GREENVILLE. NC. USA PIERRE FABRE MEDICAMENT PRODUCTION. CHATEAURENARD. FRANCE PIERRE FABRE MEDICAMENT PRODUCTION. CHEMIN DE MAZEROLLES. IORON, FRANCE PIERRE FABRE MEDICAMENT PRODUCTION. IORON FRANCE BAXTER PHARMACEUTiCAl SOLUTIONS, BLOOMINGTON. INOVINA. USA HOSPIRA INC. MCPHERSON. KANSAS. USA

GLAXOSMITHKLINE SA, EPPING, CAPE TOWN

24mon1hs

23 JULY 2010

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pretoria, 10 september 2010 no. 33525 - open gazettes ... 10 september 2010 general notice algemene...

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