Legal Notice No. 33 of 2013.pdf

LEGAL NOTICE NO. 33

REPUBLIC OF TRINIDAD AND TOBAGO

FOOD AND DRUGS ACT, CHAP. 30:01

NOTIFICATION

APPROVAL IN RESPECT OF NEW DRUGS

ISSUED by the Minister on the recommendation of the Drug AdvisoryCommittee in accordance with paragraph 7, Division 3 of the SecondSchedule of the Food and Drugs Regulations.

The Minister signifies his approval in respect of the following newdrugs:

Legal Supplement Part B—Vol. 52, No. 26—21st Febuary, 2013 125

Trade Name and Form Manufacturer Country of Origin Condition of Sale

Glitrol CR 30 Capsules 30 mg

Inventia HealthcarePvt. Ltd.

India Third Schedule

Esomezol 20 Delayed-Release Capsules 20 mg

do. do. do.

Esomezol 40 Delayed-Release Capsules 40 mg

do. do. do.

Loxx 30 Capsules 30 mg do. do. do.

Acteric Prolonged-ReleaseTablets 150 mg

do. do. do.

Radian B Pain Relief Spray Thornton & RossLtd.

United Kingdom Freely

Sunkist Chewable Vitamin CTablets 500 mg-Juicy Orange

Distributed by:WN Pharmaceuti-cals Ltd. Canada(Product of Canada)

Canada do.

Loxx 60 Capsules 60 mg do. do. do.

Acteric Prolonged-ReleaseTablets 75 mg

Manufactured by:Salutas PharmaGmbH for SandozGmbH, Austria

Germany do.

Sunkist Chewable Vitamin CTablets 500 mg-Tropical Breeze

do. do. do.

126 Approval in Respect of New Drugs

Sunkist Chewable Vitamin CTablets 500 mg-Strawberry

Canada Freely


Distributed by:WN Pharmaceuti-cals Ltd. Canada(Product ofCanada

Levitra OrodispersibleTablets 10 mg

Manufactured by:Bayer ScheringPharma AGGermanyPacked inBurgopak by:Brecon Pharma-ceuticalsUnited KingdomSecondary Packaging by:Bayer ScheringPharma AG

Germany Third Schedule

Jalra Tablets 50 mg Manufactured by:Novartis PharmaStein AG Switzerland forMerck, S.A.GuatemalaPackaged by:Farmaquila, S.A.

Guatemala Third Schedule for Specialists and General Practitioners with special interest in Diabetics

Kin Gingival Mouthwash Laboratorios KinS.A.

Spain Freely

Lipitor Tablets 80 mg Manufactured by:Pfizer IrelandPharmaceuticals Ireland Packaged by:PfizerManufacturing,DeutschlandGmbH

Germany do.

Kin Gingival Toothpaste do. do. do.

Perio.KIN ChlorhexidineGel 0.20 %

do. do. do.

Perio.KIN ChlorhexidineSpray 0.20 %

do. do. do.

Elonva Solution for Injection100 micrograms/0.5 ml–Pre-Filled Syringe

Organon (Ireland)Ltd.

Ireland Third Schedule

Elonva Solution for Injection150 micrograms/0.5 ml–Pre-Filled Syringe

do. do. do.

Approval in Respect of New Drugs 127


FerMed Solution forInjection/Concentrate forSolution for Infusion100 mg/5 ml

Germany Third ScheduleMEDICEArzneimittelPütter GmbH &Co. KG

Sandoz Clopidogrel Film-Coated Tablets 75 mg

Manufactured by:Sandoz PrivateLimited forSandoz GmbHAustria


Sandoz Losartan Potassium/Hydrochlorothiazide Film-Coated Tablets 50 mg/12.5 mg

do.Manufactured by:Lek Pharmaceuti-cals d.d. forSandoz GmbHAustria

Slovenia

Sandoz Losartan Potassium/Hydrochlorothiazide Film-Coated Tablets 100 mg/25 mg

do. do. do.

Sandoz MycophenolateMofetil Capsules 250 mg

do. India do.

Sandoz CandesartanCilexetil Tablets 8 mg

do. Slovenia do.


do. do. do.


do. do. do.

CoLosar-Denk 50/12.5 Film-Coated Tablets

DENK PHARMAGmbH & Co. KG

do. do.

Soventol HydroCort Cream0.25%

Manufactured by:NordmarkArzneimittelGmbH & Co. KGfor MEDICEArzneimittelPütter GmbH &Co. KG Germany

do. Freely

Serophene Tablets BP 50 mg

Doppel FarmaceuticiS.R.L.

Italy do.

Gonal-F Solution forInjection in a Pre-FilledPen 900 IU/1.5 ml

Merck Serono S.p.A.

do. do.



Trinclide-60 MR Modified-Release Tablets 60 mg

Manufactured by:AurochemLaboratories (I) Pvt. Ltd. Marketed by:Trinpharm Co. Ltd. Trinidad & Tobago


France Controlled DrugImovane Film-CoatedTablets 7.5 mg (Change of the FilmCoating Composition)

Sanofi WinthropIndustrie

Humulin N InjectableSuspension (Change ofArtwork Design andChange of Packaging)

Eli Lilly andCompany

USA Third Schedule

Humulin R InjectableSolution (Change ofArtwork Design andChange of Packaging)

do. do. do.

Daivobet Gel (Change of Name ofProduct)

LEO Pharmaceuti-cal Products Ltd.A/S

Denmark do.

Sandoz Probitor Gastro-Resistant Capsules 20 mg(Change of Name ofProduct and Change ofPackaging)

Manufactured by:Lek Pharmaceuti-cals d.d. forSandoz GmbHAustria

Slovenia do.

Bondronat Concentrate forSolution for Infusion 6 mg/6 ml (Change of ArtworkDesign)

Germany do.

Fragmin Solution forInjection 2500 IU (Change of Source andChange of Artwork Design)

Manufactured by:Vetter Pharma-Fertigung GmbH& Co. KG forPharmacia NV/SABelgium

do. do.

Fragmin Solution forInjection 5000 IU (Change of Source andChange of ArtworkDesign)

do. do. do.

Made for:F. Hoffmann-La Roche Ltd.Switzerland byRoche DiagnosticsGmbH



MICRhoGAM Ultra-Filtered PLUS Injection50 µg Dose (250 IU)-Pre-Filled Syringe-Thimerosal-Free (Change of Formulation)

Ortho ClinicalDiagnostics, Inc. A Johnson andJohnson Company

USA Third Schedule

RhoGAM Ultra-FilteredPLUS Injection 300 µgDose (1500 IU)-Pre-FilledSyringe-Thimerosal-Free (Change of Formulation)

do. do. do.

Covonia MentholatedChesty Cough MixtureExpectorant–Non-Drowsy (Change ofArtwork Design)

Thornton & RossLtd.


Vitalux Plus Time ReleaseMultivitamin/MultimineralCoated Tablets withLutein (Change ofFormulation and Change of Artwork Design)

Manufactured by:NutricorpInternational forNovartis PharmaAG Switzerland

Canada do.

Voltaren SR 75 CoatedTablets 75 mg (Change ofName of Manufacturerand Additional Source)

Manufactured by:Novartis FarmaS.p.A. for NovartisPharma AGSwitzerland

Italy Third Schedule

Co-Diovan 80/12.5 Film-Coated Tablets 80/12.5 mg(Additional Source)

do. do. do.

Co-Diovan 160/12.5 Film-Coated Tablets 160/12.5 mg(Additional Source)

do. do. do.

Co-Diovan 160/25 Film-Coated Tablets 160/25 mg(Additional Source)

do. do. do.

Voltaren 50 mg Enteric-Coated Tablets 50 mg(Additional Source,Change of Name ofProduct and Change ofArtwork Design)

Manufactured by:Novartis ÜrünleriA. S. for NovartisPharma AGSwitzerland

Turkey do.



Trizivir Film-Coated Tablets300 mg/150 mg/300 mg(Change of Name ofManufacturer and Changeof Artwork Design)

Made by: GlaxoOperations UKLimited Trading as:Glaxo WellcomeOperations forViiV HealthcareUK LimitedUnited Kingdom

United Kingdom Third Schedule

Ziagen Film-Coated Tablets300 mg (Additional Sourceand Change of ArtworkDesign)

Made by: GlaxoOperations UKLimited Trading as:Glaxo WellcomeOperationsUnited Kingdom Packed by:GlaxoSmithKlinePharmaceuticalsS.A. for ViiVHealthcare UKLimited, UnitedKingdom

Poland do.

Ziagen Oral Solution 20 mg/mL(Change of ArtworkDesign)

Made by:GlaxoSmithKlineInc for ViiVHealthcare ULCCanada

Canada do.

Procoralan Film-CoatedTablets 5 mg(Extension of Indication)

Manufactured by:Les LaboratoiresServier IndustrieLicence Holder:Les LaboratoiresServier France

France do.

Procoralan Film-CoatedTablets 7.5 mg(Extension of Indication)

do. do. do.

Humulin 70/30 InjectableSuspension 100 units per mL (Change of Packaging)

do. do. do.



DuoTrav Eye Drops Solution40 micrograms/ml + 5 mg/ml-(BAK-Free) (Change of Fromulationand Change of ArtworkDesign)

Alcon-Couvreur Belgium Third Schedule

Zocor Tablets 10 mg(Change of Packaging Site)

Mexcio do.Manufactured by:Merck Sharp &Dohme, LimitedEngland Packaged by:Merck Sharp &Dohme De MéxcioS.A. De C.V.

Zocor Tablets 20 mg (Change of Packaging Site)

do. do. do.


do.

Caltrate 600 + D PlusMinerals Tablets(Additional Source)

Marketed by: Wyeth ConsumerHealthcare, USA(Product of USA)

USA Freely

Xanax Tablets 0.25 mg(Change of Packaging Siteand Change of Packaging)

Marketed by: Sanico N.V.Belgium Packaged by:Pfizer Italia S.r.l.

Italy Controlled Drug


do. do. do.

do. do.


do.do. do.

Humalog U-100 Injection100 units per mL(Change of Packaging)


USA do.

NeoMercazole 5 Tablets 5 mg(Additional Source)

Manufactured by:Cenexi SAS onbehalf ofAmdipharmLimited, Ireland

France do.



Xanax XR Extended-ReleaseTablets 0.5 mg(Change of Packaging Siteand Change of Packaging)

do. do. do.

Adult Robitussin Cough &Chest Congestion DM Non-DrowsySyrup–(Alcohol-Free)(Change of Name ofManufacturer, Change ofName of Product, Changeof Formulation andChange of ArtworkDesign)

Wyeth ConsumerHeaalthcare

USA Freely

do. do.

Children’s Dimetapp Coldand Cough Elixir-GrapeFlavor-(Alcohol-Free)(Change of Name ofManufacturer, Change ofName of Product andChange of ArtworkDesign)

Viagra Tablets 50 mg(Change of ArtworkDesign)

Pfizer S.A. de C.V. Mexico Third Schedule

do.


Marketed by: Sanico N.V.Belgium Packaged by:Pfizer Italia S.r.l.

Italy Controlled Drug

Xanax XR Extended-ReleaseTablets 1 mg(Change of Packaging Siteand Change of Packaging)

do. do. do.

Xanax XR Extended-ReleaseTablets 2 mg(Change of Packaging Siteand Change of Packaging)

do. do. do.

Adult Robitussin Cough &Cold CF Non-DrowsySyrup–(Alcohol-Free)(Change of Name ofManufacturer, Change ofName of Product, Changeof Formulation andChange of ArtworkDesign)

do. do.do.



Geodon Capsules 40 mg(Change of Manufacturerand Packager and Changeof Artwork Design)

Pfizer ManufacturingDeutschland GmbH

Germany


do. do. do.

Fresenius KabiOncology Ltd.

India do.

AlcosulphTM Lotion(Change of Name ofManufacturer)

Chlor-O-Phan Expectorant(Change of Name ofManufacturer)

do. do. do.

Ferrovite LiquidMultivitamin and IronSupplement (Change ofName of Manufacturer)

Crestor Tablets 5 mg(Change of ArtworkDesign)

Manufactured by:IPR Pharmaceuti-cals Inc. forAstraZeneca UKLimited United Kingdom

Puerto Rico Third Schedule

Viagra Tablets 100 mg(Change of ArtworkDesign)

Pfizer S.A. de C.V. Mexico Third Schedule

do.

Gonal-F 75 IU LyophilizedPowder & Solvent forSolution for Injection(Change of Name ofManufacturer)

Merck Serono S.A. Switzerland do.

Fytosid Injection USP 100 mg/5 ml–Single DoseVial (Change of Name ofManufacturer)

New GPC Inc. Guyana Freely

do. do.do.

Phanadyl Paediatric Elixir(Change of Name ofManufacturer)

do. do. do.

Rector’s Remedy Ointment(Change of Name ofManufacturer)

do. do. do.


do. do. do.



Seroquel XR Extended-Release Tablets 50 mg(Additional Indication)

AstraZeneca UKLimited

United Kingdom


do.do. do.

do.Seroquel XR Extended-Release Tablets 300 mg(Additional Indication)


do.

Diprivan (2%) Emulsion forInfusion 20 mg/mL(Change of Name ofManufacturer and Changeof Packaging Site)

Ciproxina XR Modified-Release Coated Tablets500 mg (Change of Nameof Manufacturer andChange of Name ofProduct)

Made by:Bayer ScheringPharma AGGermanyPackaged by:Bayer, S.A.

El Salvador Third Schedule

Ciproxina XR Modified-Release Coated Tablets1000 mg (Change of Nameof Manufacturer andChange of Name ofProduct)

do. do.

Manufacture by:Corden PharmaSpA Italy Packed by:AstraZeneca UK Ltd forAstraZeneca UKLtd United Kingdom


Manufactured by:IPR Pharmaceuti-cals Inc. forAstraZeneca UKLimited United Kingdom

Puerto Rico Third Schedule


do. do. do.


do. do. do.

do.

do. do.

do. do. do.do.

do.do.

do.



Ciproxina Infusion Solution0.2 g (Change of Name ofManufacturer)

do. do.

Angeliq Film-CoatedTablets (Change ofArtwork Design)

Manufactured by:Schering GmbH &Co. ProduktionsKG, GermanyPacked by:Schering doBrasil, Química eFarmacêuticaLtda.

Brazil do.

Betaferon Powder andSolvent for Solution forInjection 250 microgram/mL (Change of Name ofManufacturer, Change ofPackaging and Change ofArtwork Design)

Bayer ScheringPharma AG

Germany do.

Primoteston DepotInjectable Solution 250 mg(Additional Source)

do. do. do.

Androcur Tablets 50 mg(Change of Name ofManufacturer, Change ofPackaging Site andChange of ArtworkDesign)

Manufactured by:Delpharm LilleS.A.S. FrancePacked by:Schering doBrasil, Química eFarmacêuticaLtda.

Brazil

Androcur Tablets 100 mg(Change of Name ofManufacturer, Change ofPackaging Site andChange of ArtworkDesign)

do. do. do.

Magnevist Solution forInjection 14.07 g-Vial(Change of Name ofManufacturer and Changeof Artwork Design


Germany do.

Made by:Bayer ScheringPharma AGGermanyPackaged by:Bayer, S.A.


Ciproxina Infusion Solution0.4 g (Change of Name ofManufacturer)

do.

do.



Climene Tablets (Change of ArtworkDesign)

Schering do Brasil,Química eFarmacêuticaLtda.

Brazil Third Schedule

Yasmin Film-CoatedTablets (Change ofArtwork Design)

do. do.

Gyno-Travogen Ovule 600 mg (Change of Source, Changeof Artwork Design andChange of Packaging)

Bayer de Mexico,S.A. de C.V.

Mexico

Ultravist-300 AqueousSolution(Change of Name ofManufacturer and Changeof Artwork Design)


Germany do.

do. do. do.Ultravist-370 AqueousSolution(Change of Name ofManufacturer and Changeof Artwork Design)

Manufactured by:NovartisFarmacéutica S.A. for NovartisPharma AGSwitzerland

Spain do.Exforge Film-CoatedTablets 10 mg/160 mg(Change of Source)

pms-Isoniazid Tablets USP100 mg(Change of Distributor)

Pharmascience Inc. Canada

Presartan-50 Film-CoatedTablets 50 mg (Change of Distributor)

Ipca LaboratoriesLimited

India

Solvin Plus Tablets (Change of Distributor)

do. do. do.

do.

Gynera Tablets (Change of Source, Changeof Artwork Design andChange of Packaging)

do. do. do.

do.

do.

do.

SedoSolvin Syrup(Change of Distributor)

do. do. Freely

Solvin Tablets (Change of Distributor)

do. do. Third Schedule

Solvin Elixir (Change of Distributor)

do. do. Freely



Manufactured by:Genzyme IrelandLtd. for GenzymeEurope B.V. The Netherlands

Ireland do.

Telzir Film-Coated Tablets700 mg (Change of Nameof Manufacturer, Changeof Artwork Design andChange of Source)

Made by: Glaxo Operations UK Limited Trading as:Glaxo Wellcome Operations United Kingdom Packed by: Glaxo Wellcome S.A. for ViiV Healthcare UK Limited United Kingdom

Spain do.

Zentel Suspension (Change of Artwork Design)

GlaxoSmithKlineMexico S.A. deC.V.

Mexico Freely

Lomez BP Capsules 20 mg Meyer HealthcarePvt. Ltd.


VP Inhaler Manufactured inPRC under licensefor GenethicsPharmaceuticalsLimited Trinidad andTobago

People’sRepublic ofChina

Freely

BronchoSolvin Syrup(Change of Distributor)

Ipca Laboratories Limited


do.Normax USP Tablets(Change of Distributor)

do. do.

do.Lisoril-10 USP Tablets(Change of Distributor)

do. do.

do.Simlo-20 USP Film-CoatedTablets 20 mg(Change of Distributor)

do. do.

do.Lomoflox Film-CoatedTablets(Change of Distributor)

do. do.

Renvela Film-CoatedTablets 800 mg(Additional Indication andChange of ArtworkDesign)

VP Rub VaporizingOintment-PlasticContainer

do. do. do.



Sunkist Chewable Vitamin CTablets 500 mg-Cherry

Distributed by: WN Pharmaceuti-cals Ltd. Canada (Product of Canada)

Canada do.

Natrol Mood Positive 5-HTPTablets 50 mg

Natrol, Inc. USA

Psyllium PlantagoPlantafiber Light OralPowder-Orange FlavorSugar Free

Laboratorios Stein,S.A.

Costa Rica Freely (Pharmacist only)

Psyllium PlantagoPlantafiber Oral Powder -Natural Flavor

do. do. do.

Jamieson Flax Seed OilCapsules 1000 mg

JamiesonLaboratories

Canada Freely

Jamieson Lycopene Caplets do. do. do.

Mentat Syrup(Change of Formulationand Change of ArtworkDesign)

India do.

Mentat Tablets(Change of Formulationand Change of ArtworkDesign)

do. do.

Septilin Syrup(Change of Formulationand Change of ArtworkDesign)

Rumalaya Cream(Change of Formulationand Change of ArtworkDesign)

The Himalaya DrugCompany

do.

Manufactured inPRC under licensefor GenethicsPharmaceuticalsLimited Trinidad andTobago

People’sRepublic ofChina

FreelyVP Rub VaporizingOintment-Metal Container

do.

do. do.do.

do. do.do.



Sunkist Vitamin C Tablets500 mg -Orange Scent

Distributed by: WNPharmaceuticalsLtd. Canada(Product ofCanada)

Canada

Sunkist Chewable Vitamin CTablets 500 mg -Citrus Squeeze

do. do. do.

Natrol Fish Oil + VitaminD3 Softgels

Natrol, Inc. USA

Flashclot Manufactured by:ShenzhenHonghuaPharmaceuticalCo. Ltd. for BiolotusBiotechnology,LDA. Portugal

People’s Republicof China

Tasigna Capsules 150 mg Manufactured by:Novartis PharmaStein AG forNovartisPharma AGSwitzerland

Switzerland Third Schedule

Exforge HCT Film-CoatedTablets 10 mg/160 mg/25 mg

do.

Natrol Melatonin 3 mgTablets

do. do. do.

Natrol Melatonin 5 mgTablets

do. do. do.

Freely(Pharmacistonly)

do. do. do.

Exforge HCT Film-CoatedTablets 10 mg/320 mg/25 mg

do. do. do.

do.

Jevtana Concentrate andSolvent for Solution forInfusion 60 mg/1.5 ml

Aventis Pharma United Kingdom Third Schedule

Radian B Ibuprofen Gel Thornton & Ross Ltd. do. Freely



Vimovo Modified-ReleaseTablets 500 mg/20 mg

Manufactured by:PatheonPharmaceuticalsInc. USA Packed by:AstraZeneca AB

Sweden

Visanne Tablets 2 mg Schering GmbH &Co. ProduktionsKG

Germany

Ventavis Nebuliser Solution10 mcg/ml

Spain

Palixid Film-Coated Tablets10 mg

Manufactured by:BerliMed S.A. forBayer ScheringPharma AGGermany

Hungary

Iiliadin Nasal DecongestantSolution Pediatric Drops0.01%

Manufactured by:Merck, S.A. deC.V. Mexico Packaged by:Farmaquila, S.A.

Guatemala Freely

Iiliadin Nasal DecongestantSolution Children Drops0.025%

do. do. do.

Intelence Tablets 100 mg Italy

Coveram Tablets 5 mg/5 mg Ireland do.

Janssen-Cilag S.p.A.

Manufactured by:Les LaboratoriesServier (Ireland)Industries Ltd.Licence Holder:Les LaboratoriesServier France

do.

do.

Gedeon Richter Plc. do.

Iiliadin Nasal DecongestantSolution Adult Drops0.05%

do. do.do.

Third Schedule

Ilaris 150 mg Powder forSolution for Injection150 mg/mL

Manufactured by:Novartis PharmaStein AG forNovartisPharma AG,Switzerland


do.



Little Colds Multi-SymptomCold Formula -Natural Berry Flavor

Distributed by:Medtech ProductsInc. A Prestige BrandsCompany USA(Product of USA)

USA Freely

Little Tummys Gas ReliefDrops-Natural Berry Flavor

Little Fevers Children’sFever/Pain Reliever Syrup-NaturalCherry Flavor -No Alcohol

Little Fevers Fever/Pain Reliever -Natural Flavor

do. do.

do. do. do.

do. do. do.

Little Noses Sterile Saline Nasal Mist-No Alcohol

do. do.

C-Cyclocel 50 Film-CoatedTablets USP 50 mg

Celon Laboratories Ltd.

Third Schedule

C-Celofem 2.5 Film-CoatedTablets USP 2.5 mg

do. do. do.

Travatan Eye DropsSolution 40 micrograms/ml(BAK-Free)

Alcon-Couvreur Belgium do.

do.

do.

Dopasol Injection USP 200 mg/5 ml

SG Pharma Pvt. Ltd. India

do.do.



Cari Med AntisepticMouthwash -Fresh Mint

Distributed by:CaribaInternationalCorp. USA(Product of USA)

USA Freely

C-Armilon Film-CoatedTablets 1 mg

Celon LaboratoriesLtd.


Sandoz TramadolHydrochloride Solution for Injection 100 mg/2 ml

JENAHEXAL Pharma GmbH

Germany do.

Sandoz Bisoprolol/Hydro-chlorothiazide Film-Coated Tablets5 mg/12.5 mg

do. do.Manufactured by:Salutas PharmaGmbH forSandos GmbHAustria

Delmed Dextrose I.V.Solution 50% - Sterile,Nonpyrogenic

Champix Film-Coatedtablets 0.5 mg and 1 mg

PfizerManufacturingDeutschlandGmbH

Germany do.

do. do. do.

Delmed Dextrose I.V.Solution 10% -Sterile, Nonpyrogenic

Little Noses Saline Spray/Drops-No Alcohol

USA Freely

Delmed Ringer LactateInjectable I.V. Solution-Sterile, Nonpyrogenic

LaboratoriosBiogalenic S.A. de C.V.


Distributed by:Medtech ProductsInc. A Prestige BrandsCompany USA(Product of USA)

do. do. do.


Sandoz VenlafaxineProlonged ReleaseCapsules 75 mg

India Third ScheduleManufactured by:Sandoz PrivateLimited forSandoz GmbHAustria

do.do.Sandoz VenlafaxineProlonged ReleaseCapsules 150 mg

Sandoz Anastrozole Film-Coated Tablets 1 mg

Manufactured by:Salutas PharmaGmbH for SandozGmbH Austria

Germany do.

Sandoz Letrozole Film-Coated Tablets 2.5 mg

Manufactured by:Novartis PharmaStein AG forSandoz GmbHAustria

Switzerland do.

Sandoz LisdeneTablets 5 mg

Manufactured by:Sandoz do BrasilIndustriaFarmaceuticaLtda for SandozGmbH Austria

Brazil do.


do. do. do.


do. do.do.

do.

Sandoz GabapentinCapsules 300 mg

IndiaManufactured by:Sandoz PrivateLimited forSandoz GmbHAustria

do.Sandoz GabapentinCapsules 400 mg

do. do.

Cellerate Rx Gel Distributed by:Wound CareInnovations, LLCUSA(Product of USA)

USA Freely

Trivedon MR Film-CoatedTablets 35 mg

Cipla Ltd. India Third Schedule

Gavindol Film-CoatedTablets

Merck S.A. de C.V. Mexico do.

do.




Cebión Vitamin C ChewableTablets 500 mg-Tropical Flavour

Merck S.A. Colombia Freely

Cebión Zinc Vitamin C 1 g +Zinc 10 mg EffervescentTablets-Orange Flavour

Manufactured by:Merck S.A. forMerck S.A.Guatemala

do. do.

Uvex 500 Film-CoatedTablets 500 mg

Manufactured by:Meyer HealthcarePvt. Ltd. forMeyer OrganicsPvt. Ltd., India


Pregnon Film-CoatedTablets BP 0.75 mg

Famy Care Ltd. do. do.

Brilinta Film-CoatedTablets 90 mg

Manufactured by:AstraZeneca AB,SwedenPacked by:AstraZeneca doBrasil Ltda., forAstraZeneca AB,Sweden

Brazil do.

Auroflam-P Film-CoatedTablets

Manufactured by:AurochemLaboratories (I)Pvt. Ltd.Marketed by:Trinpharm Co.Ltd., Trinidad andTobago

India do.

Auroflam-MX Film-CoatedTablets

Jamieson’s Omega-3Complete Capsules

JamiesonLaboratories

Canada Freely

Jamieson’s Kids D ChewableTablets 400 IU/10 mcg-Strawberry

do. do.do.

Oplat Injection USP 150 mg Manufactured by:Laboratories IMAS.A.I.C. ArgentinaPackaged by:GlenmarkGenerics S.A.

Argentina Third Schedule

do. do.do.

Oplat Injection USP 450 mg do. do. do.

Dubirox Injection USP10 mg

do. do. do.



Erohist B Syrup Manufactured by:U SquareLifescience Pvt. Ltd.Manufactured for:Trinpharm Co. Ltd.Trinidad andTobago

India Freely

Dexam Injection BP 4 mg/mL do. do. Third Schedule

Trinclide-30 MR Modified-Release Tablets 30 mg

Manufactured by:AurochemLaboratories (I)Pvt. Ltd.Marketed by:Trinpharm Co.Limited, Trinidadand Tobago

do. do.

Pio-G 15 Tablets 15 mg do. do. do.

Pio-G 30 Tablets 30 mg do. do. do.

Olex-5 Film-Coated Tablets do. do.

Manufactured by:Laboratories IMAS.A.I.C., ArgentinaPackaged by:GlenmarkGenerics S.A.

Argentina Third ScheduleDubirox Injection USP50 mg

Schiff Probiotic AcidophilusTablets

Schiff NutritionGroup, Inc.

USA

do.

Freely

do.Schiff CoQ-10 Softgels100 mg

do.

Sandoz Rosuvastatin Film-Coated Tablets 10 mg

Manufactured by:LekPharmaceuticalsfor Sandoz GmbHAustria

Slovenia Third Schedule


do. do. do.


do. do.

Micardis Plus Tablets80 mg/25 mg

BoehringerIngelheim PharmaGmbH & Co. KG

Germany do.

do.

Ipca LaboratoriesLtd.



Clinoleic 20% Emulsion forIntravenous Infusion-Sterile, Nonpyrogenic

Manufactured by:Baxter S.A.Distributed by:Baxter HealthcarePty. Ltd.United Kingdom

Belgium

Resolor Film-CoatedTablets 1 mg

Janssen-Cilag S.p.A.Via C. Janssen

Italy do.

do.Resolor Film-CoatedTablets 2 mg

do. do.

Prograf XL Extended-Release Capsules 1 mg

Astellas Ireland Co.,Ltd.

Ireland do.

Prograf XL Extended-Release Capsules 5 mg

do. do. do.

Panadol Joints ProlongedRelease Tablets 665 mg

Manufactured by:GlaxoSmithKlineDungarvan Ltd.IrelandPacked by:GlaxoSmithKlinePanamá S.A

Panama Freely

Plavix Film-CoatedTablets 75 mg(Additional Indication)

Sanofi WinthropIndustrie

France Third Schedule

Plavix Film-CoatedTablets 300 mg(Additional Indication)

do. do. do.

Third Schedule

Clopidogrel Winthrop Film-Coated Tablets 75 mg(Additional Indication)

Herceptin Injection 440 mg(Additional Indication)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byGenentech Inc.

USA do.

Tykerb Film-CoatedTablets 250 mg(Additional Indication)

Made by:Glaxo OperationsUK Ltd.Trading as:Glaxo WellcomeOperations

United Kingdom do.

Kandicide Ear Drops Manufactured by:AurochemLaboratories (I)Pvt. Ltd.Marketed for:Trinpharm Co.Ltd., Trinidad andTobago

India Freely

do. do. do.



Glucophage 750 XRExtended-ReleaseTablets 750 mg

Manufactured by:Merck KGaAGermany forMerck, S.A.,GuatemalaPackaged by:Farmaquila, S.A.

Guatemala Third Schedule

Pergoveris Powder andSolvent for Solution forInjection 150 IU/75 IU

Manufactured by:Merck Serono S.A.SwitzerlandPacked by:Merck SeronoS.p.A.

Italy do.

Actemra Concentrate forSolution for Infusion20 mg/ml (80 mg/4 ml)(New Indication)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byChugai PharmaManufacturingCo., Ltd.

Japan do.


do. do. do.


Tamiflu Capsules 30 mg(Additional Source andChange of Artwork Design)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byRoche S.p.A.Licenser:Gilead SciencesUSA

Italy do.


do. do. do.


do. do. do.

Copegus Film-CoatedTablets 200 mg(New Indication andChange of Artwork Design)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byPatheon Inc.

Canada do.

do.do.do.

Glucophage 1000 XRExtended-ReleaseTablets 1000 mg

do. do. do.



Invirase Film-CoatedTablets 500 mg(Change of ArtworkDesign)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byRoche Farma S.A.

Spain

Kytril InjectableSolution i.v. 3 mg/3 ml(Change of ArtworkDesign)

Made for:F. Hoffmann-La Roche Ltd.Switzerland byCENEXI SAS

France do.

Mircera Solution forInjection50 micrograms/0.3 ml-Pre-Filled Syringe(Change of ArtworkDesign)

Made for:F. Hoffmann-La Roche Ltd.Switzerland byRoche DiagnosticsGmbH

Germany do.


do.do.do.

Third Schedule



do.do.do.

Tavanic Film-CoatedTablets 500 mg(Change of Name ofManufacturer and Changeof Packaging)

Manufactured by:Sanofi WinthropIndustrie, FrancePacked by:Lancasco, S.A. forsanofi-aventis deGuatemala, S.A.,Guatemala

Guatemala do.

Alimta Powder forConcentrate for Solutionfor Infusion 500 mg(Change of ArtworkDesign and Change ofPrimary Packaging)

Lilly France S.A.S. France do.

Xarelto Film-CoatedTablets 10 mg(Change of Name ofManufacturer)


Germany do.

do.do.do.



Nimotop Solution forInfusion(Change of Name ofManufacturer)

Manufactured by:Bayer ScheringPharma AGGermanyPackaged by:Bayer, S.A.

El Salvador

Levitra Film-CoatedTablets 10 mg(Change of Name ofManufacturer and Changeof Artwork Design)


Germany do.

Levitra Film-CoatedTablets 20 mg(Change of Name ofManufacturer and Changeof Artwork Design)

do. do. do.

Third Schedule

Avelox Film-CoatedTablets 400 mg(Change of Name ofManufacturer)

Manufactured by:Bayer ScheringPharma AGGermanyPackaged by:Bayer, S.A.

El Salvador

Avelox I.V. Solution forIntravenous Infusion(Change of Name ofManufacturer)

do. do. do.

Adalat OROS Extended-Release Tablets 60 mg(Change of Name ofManufacturer)

do. do. do.

Humatrope Injection 5 mg(Change of Packaging)


USA do.

Eurax Lotion 10%(Change of ArtworkDesign)

Novartis ConsumerHealth S.A.

Switzerland do.

Recormon MultidoseLyophilized Powder andSolvent for Solution forInjection 50000 IU(Change of ArtworkDesign)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byRoche DiagnosticsGmbH

Germany do.

Lofral-5 Tablets(Change of Name ofProduct and Change ofName of Manufacturer)

Manufactured by:Atlantic Pharmafor Mepha Lda.,PortugalUnderSupervision of:Mepha Ltd.,Switzerland

Portugal do.

do.



Lofral-10 Tablets(Change of Name ofProduct and Change ofName of Manufacturer)

Portugal

Listerine Total Care PlusWhitening AnticavityMouthwash-Fresh Mint

Distributed by:Johnson &JohnsonHealthcareProductsDivision ofMcNeil-PPC, Inc.USA (Product ofUSA)

USA Freely

Third Schedule

Invega Sustenna ProlongedRelease Suspension forIntramuscularInjection 50 mg

JanssenPharmaceuticaN.V.

Belgium Third Schedule


do. do. do.


do. do. do.


do. do. do.

Cinno Vex LyophilizedPowder and Solvent forSolution forIntramuscularInjection 30 µg (6 MIU)-Vial

CinnaGen Co. Iran do.

Nexavar Film-CoatedTablets 200 mg(Change of Name ofManufacturer)


Germany do.

Cymbalta Hard Gastro-Resistant Capsules 30 mg(Change of Packaging)

Lilly S.A Spain do.

Cymbalta Hard Gastro-Resistant Capsules 60 mg(Change of Packaging)

do. do. do.

Manufactured by:Atlantic Pharmafor Mepha Lda.,PortugalUnderSupervision of:Mepha Ltd.,Switzerland



Microgynon 30 CoatedTablets(Change of Name ofManufacturer)

Manufactured by:Schering GmbH &Co., ProduktionsKG, GermanyPackaged by:Bayer ScheringPharma AGUnder Licence of:Bayer ScheringPharma AGGermany


Diane-35 Coated Tablets(Change of Name ofManufacturer)

Logynon Coated Tablets(Change of Name ofManufacturer)

do. do. do.

Metronidazole MKTablets 500 mg(Change of Packaging)

LaboratorioCorporaciónBonima,S.A. DE C.V.

El Salvador do.

Cool Mint ListerineAntiseptic Mouthwash(Change of Importer/LocalAgent and Change ofDistributor)

Distributed by:Johnson &JohnsonHealthcareProducts, Divisionof McNeil-PPC,Inc. USA(Product of USA)

USA Freely

FreshBurst ListerineAntiseptic Mouthwash(Change of Importer/LocalAgent and Change ofDistributor)

do. do. do.

Advanced Listerine withTartar ProtectionAntiseptic Mouthwash-Artic Mint(Change of Importer/LocalAgent and Change ofDistributor)

do. do. do.

O

do.do.

R

do.



Advanced Listerine withTartar ProtectionAntiseptic Mouthwash-Citrus(Change of Importer/LocalAgent and Change ofDistributor)

Distributed by:Johnson andJohnsonHealthcareProducts, Divisionof McNeil-PPC,Inc. USA(Product of USA)

USA Freely

Listerine Total CareAnticavity Mouthwash-Fresh Mint(Change of Importer/LocalAgent and Change ofDistributor)

Becloforte PressurisedSolution for Inhalation250 mcg/dose (CFC Free)(Change of Name ofManufacturer, Change ofName of Product andChange of ArtworkDesign)

Manufactured by:Glaxo WellcomeProduction forLaboratoireGlaxoSmithKlineFrance

France Third Schedule

Betnovate Scalp Lotion 0.1%(Change of Name ofManufacturer, Change ofName of Product andChange of ArtworkDesign)

Aspen Bad OldesloeGmbH

Germany do.

Kivexa Film-Coated Tablets600 mg/300 mg-BlisterPack(Change of Source andChange of ArtworkDesign)

Made by:Glaxo OperationsUK LimitedTrading as:Glaxo WellcomeOperationsUnited KingdomPacked by:Glaxo WellcomeS.A.

Spain do.

do.do.

Seretide EvohalerSuspension for Inhalation25/50 mcg/dose (CFC Free)(Additional Source andChange of ArtworkDesign)

Made by:Glaxo WellcomeS.A. forGlaxoSmithKlineAG Switzerland

do. do.

do.



Seretide EvohalerSuspension for Inhalation25/125 mcg/dose (CFCFree) (Additional Sourceand Change of ArtworkDesign)

Seretide EvohalerSuspension for Inhalation25/250 mcg/dose (CFCFree) (Additional Sourceand Change of ArtworkDesign)

do. do. do.

Made by:Glaxo WellcomeS.A. forGlaxoSmithKlineAG Switzerland

Spain Third Schedule

Made by:S.C. EuropharmS.A. for ViiVHealthcare UKLimitedUnited Kingdom

RomaniaRetrovir Capsules 100 mg(Additional Source andChange of ArtworkDesign)

OR

Panadol Ultra Caplets(Change of ArtworkDesign)

GlaxoSmithKlinePanamá, S.A.

Panama Freely

Enerexin Forte DrinkablePlastic Ampoules(Change of Name ofProduct, Change ofPackaging and Change ofArtwork Design)

Dreampak, L.L.C. USA do.

Valium Tablets 5 mg(Change of ArtworkDesign)

Made for:F. Hoffmann-La Roche Ltd.,Switzerland byRoche Farma SA

Spain Controlled Drug

Neulastim Solution forInjection 6 mg/0.6 ml-Pre-Filled Syringe(Change of ArtworkDesign)

F. Hoffmann-La Roche Ltd


Neupogen Solution forInjection 30 MU-Pre-FilledSyringe(Change of ArtworkDesign)

do. do. do.

Mab Thera Concentrate forSolution for Infusion100 mg/10 ml(New Indication andChange of ArtworkDesign)

do. do. do.

do.



Mab Thera Concentrate forSolution for Infusion500 mg/50 ml(New Indication andChange of ArtworkDesign)

Galvus Tablets 50 mg Manufactured by:Novartis PharmaStein AG forNovartis PharmaAG Switzerland

do. Third Schedule(For use bySpecialistPhysiciansincludingGeneralPractitionerswith DiabetesSpeciality)

F. Hoffmann-La Roche Ltd


Galvus Met Film-CoatedTablets 50 mg/500 mg


do. do. do.


do. do. do.

Glychek 80 Tablets BP Indoco RemediesLtd.


Dolo-Neurobión Injection-Dual-Chamber PrefilledSyringe

Manufactured by:Merck, S.A. deC.V., Mexico forMerck, S.A.GuatemalaPackaged by:Farmaquila, S.A.

Guatemala do.

Alzole-400 ChewableTablets USP 400 mg

Vance & HealthPharmaceuticalsPvt. Ltd.

India Freely

Alzole Suspension do. do. do.

Ketomed Cream USP 2% do. do. Third Schedule

GNC Glucosamine/Chondroitin Tablets

Distributed by:General NutritionCorporation USA(Product of USA)

USA Freely

do. do. do.



GNC Pro Performance L-Arginine L-OrnithineTablets 1500 mg/1000 mg

Odizole Suspension200 mg/5 ml

Manufactured by:AurochemLaboratories (I)Pvt. Ltd.Marketed by:Trinpharm Co.Ltd., Trinidad andTobago

India do.

Distributed by:General NutritionCorporation USA(Product of USA)

USA Freely

Odizole Chewable Tablets400 mg

do. do. do.

Kandicide Cream USP1 % w/w

Third Schedule

Lergi Film-Coated Tablets10 mg

do. do. do.

Delmed Mixed SolutionChloride 0.225 % I.V. BGInjectable Solution-Sterile,Nonpyrogenic

LaboratoriosBiogalenicS.A. de C.V.

El Salvador do.

Covonia Dry & Tickly CoughLinctus Oral Solution-Non Drowsy

Thornton & RossLtd.


Covonia Cold & FluFormula Oral Solution

do. do. do.

Hedrin 4% Lotion do. do. do.

Clonotril 2 Tablets Remedica Ltd. Cyprus Controlled Drug

Kandicide-B Cream Manufactured by:AurochemLaboratories (I)Pvt. Ltd.Marketed by:Trinpharm Co.Ltd., Trinidad andTobago


Bupivacan Injection BP0.5 %

Claris LifesciencesLimited

do. do.

do.do.



Simvatab Film-CoatedTablets USP 40 mg

The MadrasPharmaceuticals

Amiodarone HydrochlorideInjection 50 mg/mL-Pre-Filled Syringe

Gland PharmaLimited

do. do.

Lamictal XR ExtendedRelease Tablets 25 mg

GlaxoSmithKlineLLC,

USA do.


do. do. do.


do. do. do.




do. do. do.

Flomax CR Controlled-Release Tablets 0.4 mg(Change of Source andChange of Release Time)

Manufactured by:Astellas PharmaEurope B.V.Distributed by:BoehringerIngelheim(Canada) Ltd.Canada

The Netherlands do.

Solvin Plus Liquid(Change of Importer/LocalAgent)

Ipca LaboratoriesLtd.

India Freely

Glycinorm-80 Tablets BP(Change of Importer/LocalAgent)


Nimulid Tablets (Change ofImporter/Local Agent)

do. do.Panacea Biotec Ltd.

Nimulid-MD FlavouredDispersible Tablets(Change of Importer/LocalAgent)

do. do. do.

Nimulid Nugel Gel(Change of Importer/LocalAgent)

do. do. Freely

Nimulid Transgel Gel 1.0 % w/w(Change of Importer/LocalAgent)

do. do. do.

do.do. do.



Glizid-80 Tablets IP(Change of Importer/LocalAgent)

Third Schedule

Glizid-M Tablets(Change of Importer/LocalAgent)

do. do. do.

Lexapro Film-CoatedTablets 10 mg(Change of Name ofMarketing AuthroizationHolder)

Manufactured by:H. Lundbeck A/Sfor LundbeckMexico,S.A. de C.V.Mexico

Denmark do.

Panacea Biotec Ltd. India

Vaxigrip, Suspension forInjection in PrefilledSyringe, InactivatedInfluenza Vaccine (SplitVirion) (Change of Nameof Manufacturer, Changeof Formulation, Change ofPackaging and Change ofManufacturing Process)

Sanofi Pasteur SA France

Vaxigrip Pediatric Use,Suspension for Injection inPrefilled Syringe,Inactivated InfluenzaVaccine (Split Virion)(Change of Name ofManufacturer, Change ofFormulation, Change ofPackaging and Change ofManufacturing Process)

do. do. do.

TRIMOVAX MÉRIEUXPowder and Solvent forSolution for Injection-Attenuated Live VirusVaccine against Measles,Mumps and Rubella(Change of Name ofManufacturer)

do. do. do.

AVAXIM 160 U,Suspension for Injection ina Prefilled Syringe-Inactivated AdsorbedHepatitis A Vaccine(Change of Name ofProduct and Change ofName of Manufacturer)

do. do. do.

do.



MeningococcalPolysaccharide A+CVaccine-Powder andSolvent for Suspension forInjection in PrefilledSyringe (Change of Nameof Manufacturer)

Simva-Denk 40 Film-CoatedTablets 40 mg(Change of ArtworkDesign)


Germany do.

Vit-B-Denk Film-CoatedTablets(Change of ArtworkDesign)

do. do. Freely

Sanofi Pasteur SA France Third Schedule

Third ScheduleMetformin Denk 500 Film-Coated Tablets(Change of ArtworkDesign and Change ofIndication)

Metformin Denk 850 Film-Coated Tablets(Change of ArtworkDesign and Change ofIndication)

do. do. do.

do. do. FreelyPara-Denk 125 SupposSuppositories(Change of ArtworkDesign and Change ofDosing Regimen)

Para-Denk 250 SupposSuppositories(Change of ArtworkDesign and Change ofDosing Regimen)

do. do. do.

Clotri-Denk 1 % Cream(Change of ArtworkDesign)


Diclo-Denk 50 EntericCoated Tablets 50 mg(Change of ArtworkDesign)

do. do. do.

Diclo-Denk 100 RetardDelayed-ReleaseTablets 100 mg(Change of ArtworkDesign)

do. do. do.

do. do.



Captopril Denk 25 Tablets(Change of Name ofManufacturer and Changeof Artwork Design)

do. do. do.Nifedi-Denk 10 RetardExtended-ReleaseTablets 10 mg(Change of ArtworkDesign)

Captopril + HCT Denk50/25 Tablets(Change of Artwork)

do. do. do.

Zentel Tablets 200 mg(Change of ArtworkDesign)

GlaxoSmithKlineMexico S.A. deC.V.

Mexico Freely



Trizivir Film-Coated Tablets300 mg/150 mg/300 mg(Additional Source)

Manufactured by:Glaxo OperationsUK LimitedTrading as:Glaxo WellcomeOperationsUnited KingdomPacked by:GlaxoSmithKlinePharmaceuticalsSA

Poland Third Schedule

Combivir Film-CoatedTablets 150 MG-300 MG(Additional Source)

do. do. do.

Extra Strength PanadolTablets 500 mg(Change of ArtworkDesign and Change ofLogo on Tablets)

GlaxoSmithKlinePanamá, S.A.

Panama Freely

Baby Panadol SolutionDrops (2 months to2 years)-Rasberry Flavour(Change of ArtworkDesign, Change of DosingRegimen and Change ofName of Product)

GlaxoSmithKlineCosta Rica S.A.

Costa Rica do.

Children Panadol Syrup(2 to 12 years)-Rasberry Flavour(Change of ArtworkDesign, Change of DosingRegimen and Change ofName of Product)

do. do. do.



Eprex 40000 InjectionSolution 40000 IU/1.0 ml-Prefilled Syringe(Change of Source)

Switzerland Third ScheduleCilag AG

Zideuno-30 ModifiedRelease Tablets 30 mg

Wockhardt Limited India do.

Dated this 11th day of January, 2013.

F. KHANMinister of Health

PRINTED BY THE GOVERNMENT PRINTER, PORT-OF-SPAINREPUBLIC OF TRINIDAD AND TOBAGO—2013

Legal Notice No. 33 of 2013.pdf

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Transcript of Legal Notice No. 33 of 2013.pdf