collated list of uk traditional herbal …...enlarged prostate(bhp) 16 thr 13668/0019 06‐aug‐10...

Alliance for Natural Health International UK Main Office: The Atrium, Curtis Road, Dorking, Surrey RH4 1XA, UK

e-mail: [email protected] tel: +44 (0)1306 646 600

www.anhinternational.org

Intl Reg Office: 10 Milton Court, Ravenshead,, Nottingham NG15 9BD, UK. A Not-For-Profit Company, Limited by Guarantee Reg no 4438769.

COLLATEDLISTOFUKTRADITIONALHERBALREGISTRATIONSUNDERDIRECTIVE2004/24/EC(“TRADITIONALHERBALMEDICINALPRODUCTSDIRECTIVE”)BASEDONREGISTRATIONDATAON

MHRAWEBSITEASOF9FEBRUARY2011

2

LicenseNoDate

granted Licensee Brandnames Herbalingredients Excipients Indication

1THR

13668/0010 20‐Feb‐08Bioforce(UK)

LimitedVenaforceHorse

ChestnutGR*tablets

Onegastro‐resistanttabletcontains157.5–225.0mgofextract(asdryextract)fromfreshHorsechestnutseeds(AesculushippocastanumL.,semen)correspondingto50mgtriterpeneglycosides,calculatedasanhydrousβ‐aescin.Extractionsolvent:

ethanol(60%m/m)

Forthetablet:Microcrystallinecellulose,Maizestarch,Colloidal

silica,anhydrous,Soyapolysaccharide.Forthefilm

coating:Methacrylicacid–ethylacrylatecopolymer(1:1)dispersion30percent,

Methacrylicacid–methylmethacrylatecopolymer(1:1),

Talc,Triethylcitrate

Reliefofsymptomsassociatedwith

varicoseveins,suchastiredheavylegs,achingpainfullegs,legcrampsandswollenankles

2THR

23056/0010 01‐Oct‐10SchwabePharma

(UK)Ltd

Thisilyn®MaximumStrengthMilkThistle

Capsules,HigherNatureMilkThistleCapsules

Eachhardcapsulecontains:193mg–261mgofextract(asdryextract)fromMilkThistlefruits(Silybum

marianum(L.)Gaertner)(equivalentto3.725g–10.818gofMilkThistlefruits)correspondingto108mgofsilymarin,calculatedas

silibinin.Extractionsolvent:Acetone

95%v/v.

Extractexcipients:Mannitol.Capsulecontents:Capsulefilling

mass:Mannitol,Cellulosemicrocrystalline,Croscarmellose

sodium,Silicacolloidalanhydrous,MagnesiumStearate.Capsuleshell:Gelatin,Purifiedwater,TitaniumdioxideE171,

Sodiumlaurylsulphate,Iron(III)‐oxideE172(=redironoxide),IronoxidehydrateE172(=

yellowironoxide)

Symptomsassociatedwithoccasionalover

indulgenceinfoodanddrinksuchasindigestionandupsetstomach.

3

3THR

23056/0012 01‐Oct‐10SchwabePharma

(UK)LtdThisilyn®MilkThistle

Capsules

Eachhardcapsulecontains:89mg–121mgofextract(asdryextract)fromMilkThistle

fruits(Silybummarianum(L.)

Gaertner)(equivalentto1.721g–5.000gofMilkThistlefruits)correspondingto50

mgofsilymarin,calculatedassilibinin.

Extractionsolvent:Acetone95%v/v.

Extractexcipients:Mannitol.Capsulecontents:Capsulefilling

mass:Mannitol,Cellulosemicrocrystalline,Croscarmellose

sodium,Silica,colloidalanhydrousMagnesiumStearate.Capsuleshell:Gelatin,Purifiedwater,TitaniumdioxideE171,Sodiumlaurylsulphate,IronoxidehydrateE172(=yellow

ironoxide)

Symptomsassociatedwithoccasionalover

indulgenceinfoodanddrinksuchasindigestionandupsetstomach.

4THR

21710/0001 23‐Feb‐10NBTY

EuropeLimited

Holland&BarrettValerianCapsules,GNC

LiveWellValerianCapsules,LifecycleValerianCapsules,Nature’sGardenValerianCapsules

Eachcapsulecontains337mgofextract(asdryextract)

fromValerianroot(ValerianaofficinalisL)(equivalentto1683mg–2020mgofValerianroot).Extractionsolvent:ethanol

70%v/v.

Magnesiumstearate.Excipientsintheextract:Maltodextrin,Silicacolloidalanhydrous.Capsuleshell:Hypromellose

Temporaryreliefofthesymptomsofmildanxietyandto

aidsleep

5THR

15817/0006 29‐Sep‐10Bio‐HealthLimited HYPERIDRINECapsules

Eachcapsulecontains300mgofStJohn’sWortaerialparts(HypericumperforatumL.) Hypromellose(Capsuleshell)

Reliefofsymptomsofslightlylowmoodandmild

anxiety.

4

6THR

15525/0009 19/11/2010

PharbioMedical

InternationalAB

Echinaboostfilm‐coatedtablets,HerbalClassicsEchinaceaCold

Relieffilm‐coatedtablets

1tabletcontains40mgofextract(asdryextract)(6.5:1)

equivalentto260mgEchinaceapurpurearoot(EchinaceapurpureaL.

Moench.Extractionsolvent:Ethanol45%V/V.

Extractexcipients:Cellulose,Colloidalanhydroussilica

dioxide,Lactosemonohydrate,Glucose(inliquiritaeextract).Tabletcore:Liquiritaeradixextract,Mentholracemic,

Hydrateddextrate,Sorbitol,Talc,Microcrystallinecellulose,Colloidalsilicadioxide,

MagnesiumStearate,EucalyptusOil,AniseOil,FennelOil,Clove

Oil.Tabletcoating:Hypromellose,Macrogol,Water

Reliefofsymptomsofcommoncoldandinfluenzalike

symptoms

5

7THR

15525/0008 19‐Nov‐10

PharbioMedical

InternationalABValerinaNight‐Timefilm‐coatedtablets

1tabletcontains:100mgofextract(asdryextract)(4:1)equivalentto400mgof

Valerianroot(ValerianaofficinalisL.).

Extractionsolvent:Ethanol60%V/V;78mgofextract(as

dryextract)(3.4‐6.4:1)equivalentto382mgofHopsstrobile(HumuluslupulusL.).Extractionsolvent:Ethanol

70%V/V;25mgofextract(asdryextract)(6.5:1)equivalentto162mgofLemonBalmleaf

(MelissaofficinalisL).Extractionsolvent:Ethanol

60%V/V.

Extractexcipients:Cellulose,Colloidalanhydroussilica,

Lactosemonohydrate.Tabletcore:Lactosemonohydrate,PotatoStarch,MagnesiumStearate.Tabletcoating:

Hypromellose,TitaniumDioxide,Macrogol6000

Temporaryreliefofsleepdisturbancesduetosymptomsof

mildanxiety.

8THR

15525/0007 19‐Nov‐10

PharbioMedical

InternationalABValerinaDay‐Timefilm‐

coatedtablets

1film‐coatedtabletcontains:100mgofextract(asdryextract)(4:1)equivalentto400mgofValerianroot(ValerianaofficinalisL.).

Extractionsolvent:Ethanol60%V/V;50mgofextract(asdryextract)(6.5:1)equivalentto325mgofLemonBalmleaf

(MelissaofficinalisL.).Extractionsolvent:Ethanol60%V/V.oxide,Macrogol

6000

Extractexcipients:Cellulose,Colloidalanhydroussilica

dioxide,Lactosemonohydrate.Tabletcore:Lactose

monohydrate,PotatoStarch,CalciumHydrogenPhosphate,

MagnesiumStearate.Tabletcoating:Hypromellose,TitaniumDioxide,Macrogol

6000,Betacarotene

Temporaryreliefofsymptomsofmild

anxiety.

6

9THR

00904/0003 16‐Nov‐10

KerbinaLimited(tradingasBio‐

Health) Goodnight

Eachcoatedtabletcontains:60mgVerbenaherb(VerbenaofficinalisL.),30mgHopsstrobiles(Humuluslupulus

L.);36mgofextract(asdry

extract)fromValerianroot(ValerianaofficinalisL.)(5:1),

Extractionsolvent:Ethanol60%v/v;30mgofextract(asdry

extract)fromPassionflowerherb(PassifloraincarnataL.)

(3:1),Extractionsolvent:Ethanol60%v/v;18mgofextract(as

dryextract)fromWildLettuceherb(LactucavirosaL.)(5:1),Extractionsolvent:

Water

Excipientsoftheherbalpreparations:Calciumhydrogenphosphate,maltodextrin.Tabletcore:Sucrose,lactose,sodiumstarchglycollate,magnesiumstearate,talc.Tabletcoating:Sucrose,talc,ferricoxide,

titaniumoxideTemporaryreliefofsleepdisturbances

7

10THR

28255/0019 29‐Oct‐10Rutland

BiodynamicsLtd

EnglishHerbalMedicinesHerbal

Quitacoff,HerbsHandsHealingLobeliaandSquillCoughMixture,BrookeGreenLobelia&SquillCoughMixtureandSwissHerbal

RemediesLobeliaandSquillCoughLiquid

Each5mloforalliquidcontains:0.065mlofliquidextractfromdriedLobelia(LobeliainflataL.)herb(1:1,Extractionsolvent:ethanol

50%v/v;1mlofliquidextractfromdriedSquill(UrgineamaritimaL.)bulb(1:10),

Extractionsolvent:aceticacid(5.8%w/v).Each5mloforal

liquidalsocontainsapproximately26mgEthanol(alcohol)equivalentto0.7mlofbeeror0.3mlofwine.

GlycerolConcentratedAppleJuice

Reliefofcoughssuchaschestycoughsanddryticklycoughs.

11THR

33336/0003 20‐Oct‐10NaturesAidLtd UcalmTablets

Eachfilm‐coatedtabletcontains:300mgofextract

(asdryextract)fromStJohn’sWortaerialparts(Hypericum

perforatumL.)(5‐7:1)(equivalentto1500–2100mg

ofStJohn’sWort).ExtractionSolvent:Ethanol

60%v/v.

Herbalextract:Maltodextrin,Silicacolloidalanhydrous.Tablet

core:Calciumhydrogenphosphatedihydrate,Cellulose

microcrystalline,Hydroxypropylmethylcellulose,Croscarmellosesodium,Silicacolloidalhydrated,Magnesium

stearate.Coating:SodiumCarboxymethlycellulose,

Lecithin,Dextrosemonohydrate,Sodiumcitrate,Dextrin


anxiety.

8

12THR

21710/0002 09‐Nov‐10NBTY

EuropeLimited

Holland&BarrettSt.John’sWortCapsules,GNCLiveWellSt.

John’sWortCapsules,LifecycleSt.John’sWortCapsulesandNature’sGardenSt.John’sWortCapsules

Eachcapsulecontains150mgofextract(asdryextract)fromSt.John’sWortaerial

parts(HypericumperforatumL.)(5‐7:1)(Extractionsolvent:

ethanol60%v/v.

Microcrystallinecellulose,Magnesiumstearate,Silica

colloidalhydrated.Excipientsintheextract:Maltodextrin,Silicacolloidalanhydrous.

CapsuleShell:Hypromellose,Titaniumdioxide(E171.)


anxiety.

13THR

21710/0003 09‐Nov‐10NBTY

EuropeLimited

Holland&BarrettMaxStrengthSt.John’sWortCapsules,GNC

LiveWellMaxStrengthSt.John’sWortCapsules,

LifecycleMaxStrengthSt.John’sWort

CapsulesandNature’sGarden

MaxStrengthSt.John’sWortCapsules

Eachcapsulecontains300mgofextract(asdryextract)fromSt.John’sWortaerial

parts(HypericumperforatumL.)(5‐7:1)(Equivalentto1500mg–2100mgofSt.John’sWort),Extractionsolvent:ethanol60%v/v.

Microcrystallinecellulose,Magnesiumstearate,Silica

colloidalhydrated.Excipientsintheextract:Maltodextrin,Silicacolloidalanhydrous.

CapsuleShell:Hypromellose


anxiety.

14THR

00250/0217 14‐Sep‐10PottersLtd

NapiersValerianTincture

Each5mloforalliquidcontains1gofValerianroot(ValerianaofficinalisL.)5ml

oforalliquidcontainsapproximately1.05mlofethanol.(Seesection4.4‘Specialwarningsandprecautionsforuse’.)

RectifiedSpirit(96%ethanol)Water

Toaidsleepandtemporaryreliefofsymptomsopfmild

anxiety

9

15THR

34863/0001 27‐Aug‐10PhytoConGmbH

&CoKGPhytoConSABAL

Capsules

Eachsoftcapsulecontains160mgofextract(assoft

extract)fromSawpalmettofruit(Serenoarepens

(Bartram)Small)(9‐11:1),Extractionsolvent:ethanol

96%(V/V).

Gelatinpolysuccinate,Glycerol85%,Glycerol,Purifiedwater,Titaniumdioxide(E171),Ferric

oxide(E172)

Helprelieveurinarytractdiscomfortinmenwhohave

beentoldtheyhaveenlarged

prostate(BHP)

16THR

13668/0019 06‐Aug‐10 Bioforce(UK)LtdBronchosanPineCough

syrup

5ml[6.95g]oforalliquidcontains1,445mgofextract(assoftextract)fromfreshPiceaabies(L.)Karsten

(spruce)shoots(0.9–1.2:1).Extractionsolvent:Water;

5mlofsyrupcontains5.25gofcarbohydratemainly

presentassucrose,glucoseandfructose.

Purifiedwater,Rawcanesugar,Honey,Concentratedpearjuice,

Pineoil

Reliefofcoughssuchaschestycoughsanddryticklyirritating

coughsandcatarrh

10

17THR

26411/0003 06‐Aug‐10 BIONORICASE Cystipretcoatedtablets

1coatedtabletcontains18mgofCentauryherb

(CentauriumerythraeaRafn.,herba),18mgofLovageroot(LevisticumofficinaleKoch.,radix)and18mgofRosemaryleaf(RosmarinusofficinalisL.,

folium).

Tabletcore:Lactosemonohydrate,Magnesium

stearate,Maizestarch,PovidoneK25,Silica,colloidalanhydrous,.

Tabletcoating:Calciumcarbonate,Castoroilvirgin,

Glucosesyrup(drysubstance),Ironoxide,red(E172),Maizestarch,Maizestarch,modifiedMontanglycolwax,PovidoneK30,Riboflavin(E101),Shellac,Sucrose,Talc,Titanium(IV)oxide

(E171)

Helpflushingoftheurinarytractandto

assistinminorurinarycomplaintsassociatedwithcystitisinwomen

only.

11

18THR

20894/0070 06‐Aug‐10

BrunelHealthcare

ManufacturingLimited

Sainsbury’sEchinaceaSkinCareTablets,

TescoEchinaceaSkinCareTablets,SuperdrugEchinaceaSkinCareTablets,Gerard

HouseEchinaceaSkinCareTabletsand

HerbalstoreEchinaceaSkinTablets

Eachfilmcoatedtabletcontains:71.5mgofextract(dryextract)fromEchinacea

purpurearoot(6‐7:1)(equivalentto429mg‐

500mgofEchinaceapurpurea(L.)Moench,root),Extractionsolvent:Ethanol30%v/v.

Excipientsoftheherbalpreparation;Maltodextrin,

ColloidalAnhydrousSilica.TabletCore:

CalciumHydrogenPhosphateDihydrate,MicrocrystallineCellulose,Croscarmellose

SodiumColloidalAnhydrousSilica,MagnesiumStearate.Film

coating:Hypromellose,PurifiedTalc,MastercoteGreen

FA0511G,(VegetableCarbonBlack(E153),Copper,

Chlorophylin(E141),TitaniumDioxide(E171))

Symptomaticreliefofminorskin

conditionssuchasspot,pimplesand

blemishes.

12

19THR

20894/0062 17‐Mar‐10

BrunelHealthcare


Sainsbury’sEchinaceaColdandFluRelief,TescoEchinaceaCold

andFluRelief,MorrisonsEchinaceaColdandFluRelief,SuperdrugEchinaceaColdandFluRelief,WilkoEchinaceaColdandFluRelief,Co‐

opEchinaceaColdandFluRelief,Gerard

HouseEchinaceaColdandFluRelief,HERBALSTORE

EchinaceaColdandFluReliefandWaitroseEchinaceaColdand

FluRelief


purpurearoot(6‐7:1)(equivalentto429mg‐

500mgofEchinaceapurpurea(L.)Moench,root).Extractionsolvent:Ethanol30%v/v.




Sodium,ColloidalAnhydrousSilica,MagnesiumStearate.Film

coating:Hypromellose,PurifiedTalc,

MastercoteGreenFA0511G,(VegetableCarbonBlack(E153),

CopperChlorophylin(E141),Titanium

Dioxide(E171))

Reliefofthesymptomsof

commoncoldandinfluenzatypeinfections

13

20THR

20894/0063 17‐Mar‐10

BrunelHealthcare


Sainsbury’sMaxStrengthEchinaceaColdandFluRelief,TescoMaxStrength

EchinaceaColdandFluRelief,MorrisonsMaxStrengthEchinaceaColdandFluRelief,SuperdrugMax

StrengthEchinaceaColdandFluRelief,WilkoMaxStrength

EchinaceaColdandFluRelief,Co‐opMaxStrengthEchinaceaColdandFluRelief,GerardHouseMaxStrengthEchinacea

ColdandFluReliefandWaitroseMaxStrength

EchinaceaColdandFluRelief


purpurearoot(6‐7:1)(equivalentto858mg–1000mgofEchinaceapurpurea(L.)Moench,root).Extractionsolvent:Ethanol30%v/v




Sodium,ColloidalAnhydrousSilica,MagnesiumStearate.Film

coating:Hypromellose,PurifiedTalc,

MastercoteYellowFA0117(TitaniumDioxide(E171),Yellow

IronOxide(E172))



14

21THR

18397/0005 09‐Jun‐10Swiss

CapsGmbHHarpagoCaps,soft

capsules

Onesoftcapsulecontains225mgofextract(asdryextract)

fromHarpagophytumprocumbens

D.C.and/orH.zeyheriL.Decne,radix(Devil'sclawroot)(3‐5:1).

Extractionsolvent:Ethanol60%V/V

Capsulefilling:Lactosemonohydrate,Silicondioxide,precipitated,Soya‐beanoil,refined,Coconutoil,refined,Palmkerneloil,fractionated,

Beeswax,yellow,Phospholipidsfromsoya‐beans(Lecithin),

Butterfat,Capsuleshell,Gelatin,Glycerol,Sorbitol,liquid,partiallydehydratedFerric(III)‐hydroxide‐

oxide(E172)(Ferricoxideyellow)Water,purified

Thereliefofbackache,

rheumaticormuscularpain,andgeneralachesandpainsinthemusclesandjoints.Digestivedisorderssuchasbloatingand

flatulencewherethereislossof

appetite.

22THR

23056/0002 16‐Oct‐07MHPharma(UK)

LtdPremHerbFilm‐coated

Tablets

Eachfilm‐coatedtabletcontains:4.0mgofextract(asdryextract)fromAgnuscastusfruit(Vitexagnus

castusL.)(7‐13:1)(equivalentto28‐52mgofAgnuscastus).Extractionsolvent:Ethanol

60%m/m.

Tabletcore:Liquidglucose(drysubstance),Silica,colloidal

anhydrous,Lactosemonohydrate,Magnesium

stearate,Maizestarch,Cellulose,microcrystalline,Sodiumstarchglycolate(TypeA).Filmcoating:

Lactosemonohydrate,HypromelloseMacrogol4000,TitaniumdioxideE171,Iron(III)‐oxideE172(==redironoxide)

Reliefofpremenstralsymptoms.

15

23THR

23056/0007 20‐Feb‐08MHPharma(UK)

Ltd HyperiCalm®Tablets

Eachcoatedtabletcontains:425mgofextract(asdry

extract)fromStJohn’swortaerialparts(HypericumperforatumL.)(3.5‐

6:1)(equivalentto1490–2550mgofStJohn’swort).Extractionsolvent:Ethanol

60%v/v.

Tabletcore:Maltodextrin,Silica,colloidalanhydrous,Cellulose,microcrystalline,Croscarmellosesodium,Sodiumstarchglycolate(TypeA),Magnesiumstearate.Coating:Hypromellose,Sucrose,Talc,CalciumcarbonateE170,Tragacanth,Acacia,Liquidglucose(drysubstance),

TitaniumdioxideE171,IronoxidehydrateE172(=yellowironoxide),Vanillin,Beeswaxwhite,

Carnaubawax,Shellac

Relieffromthesymptomsof

slightlylowmoodandmildanxiety.

16

24THR

18397/0003 16‐Jun‐08 SwissCapsGmbHECHINAFLUsoft

capsules

Onesoftcapsulecontains176mgofdriedpressedjuicefromfreshflowering

Echinaceapurpurea(L.)Moenchherb(20‐28:1).

Excipientsoftheherbalpreparation:Maltodextrin,

Precipitatedsilicondioxide,Citricacidmonohydrate.Excipientsofthesoftcapsule:Refinedsoya‐beanoil,Refinedcoconutoil,Whitebeeswax,Ricestarch,Fractionatedpalmkerneloil,

Phospholipidsfromsoya‐beans,Succinylatedgelatine,Glycerol,

Non‐crystallisingsorbitolsolution70%,TitaniumdioxideE171,Ferric(II,III)oxideE172,QuinolineyellowE104,PatentblueVE131,Purifiedwater

Relievethesymptomsofthecommoncoldandinfluenzatypeinfections

25THR

13668/0009 30‐Oct‐06Bioforce(UK)

Limited AtrogelArnicaGel

1ggelcontains:500mgextract(asliquidextract)offreshArnicaFlowers(ArnicamontanaL.)(equivalentto120‐200mgfreshArnica

Flowers)Extractant:ethanol58%v/v

Ethanol(96%),Purifiedwater,Glycerol(85%),Hypromellose

Symptomaticreliefofmuscularaches,painsandstiffnessandsprains,bruises

andswelling.

17

26THR

13668/0011 10‐Sep‐07Bioforce(UK)

LimitedProstasanSaw

PalmettoCapsules

1capsulecontains320mgofextract(assoftextract)fromSawpalmettofruit(Serenoa

repens(Bartram)Smallfructus(Sabalserrulata

(Michaux)Nicholsfructus))(9‐12:1).Extractionsolvent:

Ethanol96%V/V.

Gelatin,Glycerol,Sorbitol,Ferricoxidered,Ferricoxideblack,Ferricoxideyellow,Purified

water

Relieveofsymptomsofanenlargedprostateinmen,suchastheneedtourinate

frequently(especiallyatnight),weakorinterruptedurinaryflow,orthefeelingofnotbeingabletoemptythebladdercompletely

27THR

23056/0006 19‐Dec‐07MHPharma(UK)

Ltd NiteHerbTablets

150mgofextract(asdryextract)fromValerianroot

(ValerianaofficinalisL.)(equivalentto450‐900mgofValerianroot).Extractionsolvent:Ethanol70%v/v.Onecoatedtabletcontains35mgofglucoseand136mg

ofsucrose.

Liquidglucosespraydried,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellosesodium,Stearicacid,Talc,Sucrose,CalciumcarbonateE170,Acacia,Tragacanth,

TitaniumdioxideE171,Capol600T.S.containing:Beeswaxwhite,Carnaubawax,Shellac


mildanxiety.

18

28THR

23056/0001 26‐Jan‐07MHPharma(UK)

LtdFlexiherbFilm‐coated

Tablets

1film‐coatedtabletcontains600mgofextract(asdry

extractaqueous)fromDevil’sClawroot(Harpagophytumprocumbens)(equivalentto900‐1500mgofDevil’sClaw

root).

Cellulosepowdered,Lactosemonohydrate,SodiumStarchGlycolate(TypeA),Silica

colloidalanhydrous,Magnesiumstearate,Sucrose,TitaniumdioxideE171,Hypromellose,Cellulosemicrocrystalline,

Stearicacid.

Reliefofbackache,rheumaticor

muscularpain,andgeneralachesandpainsinthemuscles

andjoints

29THR

05332/0003 26‐Mar‐08

Dr.WillmarSchwabeGmbH&Co.KGLtd

KalobaOralDrops,solution

10g(=9.75ml)oforalsolutioncontains8.0gextractfromtherootsof

PelargoniumsidoidesDC(1:8‐10)(EPs®7630).Extractionsolvent:11%ethanol(w/w).1ml(approximately20drops)ofKalobaOralDrops,solution

contains120mgethanol(alcohol)equivalentto2.4ml

beeror1.0mlofwine. Glycerol85%,Ethanol

Reliefofthesymptomsofupperrespiratorytract

infections,includingcommoncold,suchassorethroat,

coughandblockedorrunnynose

19

30THR

14369/0007 30‐Apr‐08

PASCOEpharmazeutischePraparateGmbH

BOTANOVA,Film‐coatedtablets

60mgofextract(asdryextract)fromStJohn'sWortHerb(HypericumperforatumL.)(4.6‐6.5:1),Extraction

solvents:Ethanol38%(m/m);28mgofextract(asdry

extract)fromValerianRoot(ValerianaofficinalisL.)(3.8‐5.6:1),Ethanol40%(m/m);32mgofextract(asdry

extract)fromPassionFlowerHerb(PassifloraincarnataL.)(6.25‐7.1:1),Ethanol60%(m/m)Eachfilm‐coated

tabletalsocontains:Lactosemonohydrate(90.5mg)and

glucose(10.4mg)

Excipientsoftheherbalpreparation:Lactose

monohydrate,glucoseliquidspray‐dried,maltodextrin,silicacolloidalanhydrous.Excipients

ofthetablet:Lactosemonohydrate,silicacolloidalanhydrous,talc,magnesium

stearate,povidoneK30,glycerol(85percent),croscarmellosesodium.Excipientsofthefilm

coating:Basicbutylatedmethacrylatecopolymer,talc,titaniumdioxide(E171),indigocarminelaquer(E132),macrogol

6000,magnesiumstearate.

Relieveslightlylowmoodandmildanxietyandsleepdisturbancesduetosymptomofmild

anxiety

20

31THR

23056/0003 25‐Jun‐07MHPharma(UK)

LtdMenoherb®Film‐coatedTablets

6.5mgofextract(asdryextract)fromBlackCohoshrhizomeandroot(Cimicifugaracemosa(L.)Nutt.)(4.5‐8.5:1)(equivalentto29.25‐55.25mgofBlackCohosh).Extractionsolvent:Ethanol60%v/v.Onefilm‐coated

tabletcontains142mglactosemonohydrate.


monohydrate,Cellulosepowdered,Silicacolloidal

anhydrous.Excipientsofthetablet:Silicacolloidalanhydrous,

Magnesiumstearate,Maizestarch,Cellulose

microcrystalline,Sodiumstarchglycolate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide

E171

Reliefofsymptomsofthemenopause,suchashotflushes,nightsweatsor

temporarychangesofmood

21

32THR

23056/0009 03‐Mar‐08MHPharma(UK)

Ltd NiteHerbPlus®tablets

125mgofextract(asdryextract)fromValerianroot(ValerianaofficinalisL.)(3‐6:1)(equivalentto375–750

mgofValerianroot).Extractionsolvents:Ethanol70%v/v,and250mgof

extract(asdryextract)fromPassionflowerherb

(PassifloraincarnataL.)(5‐7:1)(equivalentto1250–1750mgofPassionflowerherb),Ethanol50%v/v

Tabletcore:Maltodextrin,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellose

sodium,Magnesiumstearate,Stearicacid,Talc,Liquidglucosespraydried.Coating:Sucrose,Talc,CalciumcarbonateE170,Acacia,Tragacanth,TitaniumdioxideE171,Liquidglucose

spraydried,IronoxidehydrateE172(=yellowironoxide),

Hypromellose,Capol600T.S.containing:whiteBeeswax,

Carnaubawax,Shellac


mildanxiety

33THR

18397/0004 16‐Jun‐08 SwissCapsGmbHECHINAFLU

effervescenttablets

Oneeffervescenttabletcontains176mgofdriedpressedjuicefromfresh

floweringEchinaceapurpurea(L.)Moenchherb(20‐28:1).Thisproductcontains17.05mmol(or392mg)sodiumper

tablet.

Excipientsoftheherbalpreparation:Maltodextrin,

Precipitatedsilicondioxide,Citricacidmonohydrate.Excipientsofthetablet:Ascorbicacid,Sodiumhydrogencarbonate,Saccharinsodium,Sodiumcyclamate,Citricacidanhydrous,Citricflavour,

Permaseal84260‐51.


22

34THR

16409/0002 31‐Jul‐08NaturesAid

HealthProducts EchinEezeTablets

Onetabletcontains70mgofextract(asdryextract)fromEchinaceapurpurearoot

(equivalentto460–530mgofEchinaceapurpurea(L.)Moenchroot.)Extractionsolvent:Ethanol30%v/v.

Herbalextract:Maltodextrin,Silicacolloidalhydrated.Tablet

core:Calciumhydrogenphosphatedihydrate,Cellulosemicrocrystalline,Silicacolloidalhydrated,Crosscarmellose

sodium,Magnesiumstearate


35THR

05332/0004 24‐Jul‐08

Dr.WillmarSchwabeGmbH

&Co.KGVitanoFilm‐coated

Tablets

200mgofextract(asdryextract)fromRhodiolaroseaL.rootsandrhizomes(1.5–5:1)(WS®1375)(equivalentto300–1000mgofRhodiolarosearootsandrhizomes)Extractionagent:ethanol60

%(m/m)

Microcrystallinecellulose,croscarmellosesodium,

precipitatedsilicondioxide,magnesiumstearate,

hypromellose,stearicacid,ironoxidered(iron(III)oxide),titaniumdioxide,antifoam

emulsion.

Temporaryreliefofsymptoms

associatedwithstress,suchas

fatigue,exhaustionandmildanxiety

36THR

15817/0004 11‐Jul‐08Bio‐HealthLimited VALDRIANCapsules

Eachcapsulecontains400mgofValerianroot.(Valeriana

officinalisL.) Hypromellose(capsuleshell)

Temporaryreliefofmildanxietyandto

aidsleep

37THR

13668/0014 21‐May‐08 Bioforce(UK)HyperiforceSt.John’s

worttablets

Onetabletcontains40‐73mgofextract(asdryextract)fromfreshStJohn’swort(HypericumperforatumL.)floweringherb(3.1‐4.0:1).Extractionsolvent:Ethanol

68%V/V.Onetabletcontains5.5mgsoyapolysaccharide.

Microcrystallinecellulose,Maizestarch,Soyapolysaccharide,Hydrogenatedcottonseedoil

Relieffromthesymptomsof

slightlylowmoodandmildanxiety

23

38THR

01175/0004 10‐Oct‐08A.Nelson&Co.

LimitedDuchyHerbalsEchina‐

ReliefTincture

Each1mloforalliquidcontains1mloftincturefromdriedEchinaceapurpurea(L.)

Moenchroot(1:3)(equivalentto33mgdriedroot).Extractionsolvent:Ethanol45%v/v.1mlof

tincturecontainsapproximately360mg

ethanol(alcohol)equivalentto9mlbeeror4mlwine. Ethanol(fromtincture)


39THR

01175/0123 10‐Oct‐08A.Nelson&Co.

LimitedDuchyHerbalsHyperi‐

liftTincture

Each1mloforalliquidcontains1mloftincturefrom

driedStJohn’sWort(HypericumperforatumL.)

floweringtops(1:4).Extractionsolvent:Ethanol45%v/v.1mloftincturecontainsapproximately360mgethanol(alcohol),

equivalentto9mlofbeeror4mlofwine. Ethanol(fromtincture)

Relievethesymptomsof

slightlylowmoodandmildanxiety

24

40

THR33518/0011‐

12 16‐Dec‐08

DiapharmRegulatory

ServicesGmbH DiaSleepandDiaNight

150mgofextract(asdryextract)fromValerianroot(ValerianaofficinalisL.)

(equivalentto450‐900mgofValerianroot).Extractionsolvent:Ethanol70%v/v.Onecoatedtabletcontains35mgofglucoseand136mg

ofsucrose.

Liquidglucosespraydried,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellosesodium,Stearicacid,Talc,Sucrose,CalciumcarbonateE170,Acacia,Tragacanth,

TitaniumdioxideE171,Capol600T.S.containing:Beeswaxwhite,Carnaubawax,Shellac

Temporaryreliefofsymptomsofmildanxietyandasan

aidtosleep.Temporaryreliefofsleepdisturbancesduesymptomsofmildanxiety.

41

THR33518/0001‐

2 22‐Dec‐08

DiapharmRegulatory

ServicesGmbH

DiaSleepPlustabletsandDiaNightPlus

tablets

125mgofextract(asdryextract)fromValerianroot(ValerianaofficinalisL.)(3‐6:1)(equivalentto375–750

mgofValerianroot).Extractionsolvent:Ethanol70%v/v,and250mgof

extract(asdryextract)fromPassionflowerherb

(PassifloraincarnataL.)(5‐7:1)(equivalentto1250–1750mgofPassionflowerherb),Ethanol50%v/v

Tabletcore:Maltodextrin,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellose

sodium,Magnesiumstearate,Stearicacid,Talc,Liquidglucosespraydried.CoatingSucrose:Talc,CalciumcarbonateE170,Acacia,Tragacanth,TitaniumdioxideE171,Liquidglucose

spraydried,IronoxidehydrateE172(=yellowironoxide),

Hypromellose,Capol600T.S.containing:Beeswaxwhite,

Carnaubawax,Shellac

Temporaryreliefofsleepdisturbancesduesymptomsofmildanxiety.

25

42THR

13668/0017 19‐Feb‐09 Bioforce(UK)LtdDormeasanValerian‐

Hopsoraldrops

0.5mloftincturefromValerianroot(ValerianaofficinalisL.)(1:10‐11).

Extractionsolvent:Ethanol58%V/V.and0.5mlof

tincturefromHopstrobile(HumuluslupulusL.)(1:12‐13).Extractionsolvent:Ethanol65%V/V.1mlisequivalentto35drops. Fromtincture:Ethanol,Water

Temporaryreliefofsleepdisturbances

causedbysymptomsofmild

anxiety.

43THR

23056/0005

19February2009

SchwabePharma(UK)Ltd

Digestherbhardcapsules

400mgofextract(asdryextract)fromArtichokeleaf

(CynarascolymusL.)(equivalentto1600‐2400mg

ofdryherb).Extractionsolvent:Water.Eachcapsule

contains85mglactose.

Extractexcipients:Lactosemonohydrate,Silicacolloidalanhydrous.Otherexcipients:

Talc,Magnesiumstearate,Silicacolloidalanhydrous,Maize

starch,Lactosemonohydrate,Gelatin,TitaniumdioxideE171,Sodiumlaurylsulfate,Iron(III)‐oxideE172(=redironoxide)IronoxidehydrateE172(=yellowironoxide),Chlorophyllincopper

complexE141

Reliefofdigestivecomplaintssuchasindigestion,upsetstomach,nausea,feelingsoffullnessandflatulence

(wind)particularlywhencausedbyoverindulgencein

food&drink

26

44THR

23056/0008

27February2009

SchwabePharma(UK)Ltd

RelaxHerbcoatedTablets

1coatedtabletcontains425mgofextract(asdryextractaqueousethanolic

50%v/v)fromPassionflower(Passifloraincarnata

L.)(equivalentto2125–2975mgofPassionflower).Eachcoatedtabletcontains187mgofsucroseand5mgof

glucose.

Extractexcipients:Maltodextrin,Silicacolloidalanhydrous.Tablet

core:Maltodextrin,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellose

sodium,Magnesiumstearate,Stearicacid,Talc.Coating:

Sucrose,Talc,CalciumcarbonateE170,Acacia,Tragacanth,

TitaniumdioxideE171,Liquidglucosespraydried,IronoxidehydrateE172(=yellowiron

oxide),HypromelloseCapol600T.S.containing:Beeswaxwhite,

Carnaubawax,Shellac

Temporaryreliefofthesymptomsassociatedwith

stress,suchasmildanxiety.

45THR

13668/0016 15‐May‐09 Bioforce(UK)LtdGinkgoforceGinkgo

bilobatablets

1tabletcontains90mgofextract(asdryextract)fromGinkgobilobaL.freshleaf(3‐

5:1).Extractionsolvent:Ethanol60%m/m.

Microcrystallinecellulose,Magnesiumstearate,Soya

polysaccharide

ReliefofthesymptomsofRaynaud’s

syndromeandtinnitus.

27

46THR

12297/0013 15‐Apr‐09LABORATOIRESARKOPHARMA HARPADOL

Eachcapsulecontains435mgDevil’sClawroot(Harpagophytum

procumbensD.C.and/orH.zeyheriL.Decne).

Magnesiumstearate,Silicacolloidalhydrated,Hypromellose

(capsuleshell)


rheumaticormuscularpain,andgeneralachesandpainsinthemuscles

andjoints.

47THR

05332/0005 31‐Mar‐09


&Co.KGKalobafilm‐coated

tablets

1film‐coatedtabletcontains20mgofextract(asdryextract)fromtherootsof

PelargoniumsidoidesDC(1:8‐10)(EPs®7630)Extractionsolvent11%ethanol(w/w).

Extract:Maltodextrin.Tabletcore:Maltodextrin,

Microcrystallinecellulose,Lactosemonohydrate,Croscarmellosesodium,

Precipitatedsilica,Magnesiumstearate.Film‐coating:

Hypromellose5mPas,Macrogol1500,IronoxideyellowE172,IronoxideredE172,TitaniumdioxideE171,Talc,Simeticone,Methylcellulose,Sorbicacid.

Reliefofsymptomsofupperrespiratory

tractinfectionincludingcommoncold,sorethroat,cough,blocked&

runnynose

48THR

20346/0003 23‐Jun‐09ViridianPharma

LtdPeppermintWaterBP

1973

Each5mloforalsolutioncontains2.5microlitresofPeppermintoil(Menthax

piperitaL.)

Glycerol,NipaseptSodium,(sodiummethyl,ethylandpropyl

parahydroxybenzoates[E219,E215andE217])

Carbomer,CitricAcidanhydrous,PurifiedWater

Symptomaticrelieveofminor

digestivecomplaintssuchas

indigestion,flatulenceand

stomachcramps.

28

49THR

13668/0013 11‐Jun‐09 Bioforce(UK)LtdEchinaforceForteCold

&FluTablets

Onetabletcontains1,140mgofextract(asdryextract)fromfreshEchinacea

purpurea(L.)Moenchherb(1:12)and60mgofextract(asdryextract)fromfreshEchinaceapurpurea(L.)Moenchroot(1:11).

Extractionsolvent:Ethanol65%v/v

Lactosemonohydrate,Pregelatinisedstarch,Soyapolysaccharide,Magnesium

stearate


commoncold&influenzatypeinfections

50THR

15817/0005 03‐Sep‐09Bio‐HealthLimited SALVIANCapsules

Eachcapsulecontains300mgofSageLeaf.(Salviaofficinalis

L.) Hypromellose(capsuleshell)

Reliefofexcessivesweatingassociated

withthemenopause

51THR

34768/0002 08‐Jul‐09Bioplanta(UK)

LtdMenoCool®Film‐coated

Tablets

6.5mgofextract(asdryextract)fromBlackCohoshrhizomeandroot(Cimicifugaracemosa(L.)Nutt.)(4.5‐8.5:1)(equivalentto29.25‐55.25mgofBlackCohosh).Extractionsolvent:Ethanol60%v/v.Onefilm‐coatedtabletcontains142mglactosemonohydrate.






E171


menopausesuchhotflushes,night

sweatsandtemporarychanges

inmood.

29

52

THR33518/0009‐

10 09‐Jul‐09

DiapharmRegulatory

ServicesGmbHDiaHarpTabletsandDiaBackpainTablets

600mgofextract(asdryextractaqueous)fromDevil’sClawroot(Harpagophytumprocumbens)(equivalentto900‐1500mgofDevil’sClaw

root).

Cellulosepowdered,Lactosemonohydrate,SodiumStarchGlycolate(TypeA),Silica

colloidalanhydrous,Magnesiumstearate,Sucrose,TitaniumdioxideE171,HypromelloseCellulosemicrocrystalline,

Stearicacid


rheumaticormuscularpain,andgeneralachesandpainsinthemuscles

andjoints.

53THR

33518/0005 03‐Jul‐09

DiapharmRegulatory

ServicesGmbH DiaCimiTablets

6.5mgofextract(asdryextract)fromBlackCohoshrhizomeandroot(Cimicifugaracemosa(L.)Nutt.)(4.5‐8.5:1)(equivalentto29.25‐55.25mgofBlackCohosh).Extractionsolvent:Ethanol

60%v/v.






E171

Reliefofthesymptomsofthe

menopause,suchashotflushes,nightsweats,nervousirritabilityandrestlessness

30

54THR

33518/0006 04‐Jul‐09

DiapharmRegulatory

ServicesGmbHDiaBlackCohosh

Tablets

6.5mgofextract(asdryextract)fromBlackCohoshrhizomeandroot(Cimicifugaracemosa(L.)Nutt.)(4.5‐8.5:1)(equivalentto29.25‐55.25mgofBlackCohosh).Extractionsolvent:Ethanol

60%v/v.






E171


menopause,suchashotflushes,nightsweats,nervousirritabilityandrestlessness

31

55THR

33518/0008 07‐Jul‐09

DiapharmRegulatory

ServicesGmbH DiaPassionTablets

425mgofextract(asdryextract)fromPassionflowerherb(PassifloraincarnataL.)(5‐7:1)(equivalentto2125‐2975mgofPassionflowerherb).Extractionsolvent:

Ethanol50%v/v

Extractexcipients:Maltodextrin,Silicacolloidalanhydrous.Tabletcore:Silicacolloidalanhydrous,

Cellulosepowdered,Croscarmellosesodium,

Magnesiumstearate,Stearicacid,Talc,Coating:Sucrose,Talc,CalciumcarbonateE170,Acacia,Tragacanth,TitaniumdioxideE171,Liquidglucosespraydried,IronoxidehydrateE172(=

yellowironoxide),HypromelloseCapol600T.Scontaining:

Beeswaxwhite,Carnaubawax,Shellac

Temporaryreliefofthesymptomsassociatedwith

stress,suchasmildanxiety

32

56THR

29860/0002 04‐Aug‐09Cassella‐MedGmbH&Co.KG

Kira®menofilm‐coatedtablets

6.5mgofextract(asdryextract)fromBlackCohoshrhizomeandroot(Cimicifugaracemosa(L.)Nutt.)(4.5–8.5:1)(equivalentto29.25‐55.25mgofBlackCohosh).ExtractionSolvent:Ethanol60%(v/v).Onefilm‐coatedtabletcontains142mglactosemonohydrate.





microcrystalline,Sodiumstarchglycollate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide

E171


menopause,suchashotflushes,night

sweatsandtemporarychanges

inmood(forinstanceirritabilityandrestlessness).

57THR

33518/0013 29‐Jul‐09

DiapharmRegulatory

ServicesGmbHDiaMigraineHard

capsules

1hardcapsulecontains:100mgFeverfewherb

(Tanacetumparthenium).

Dextrinwhite,Silicacolloidalanhydrous,Talc,Magnesium

stearate,TitaniumdioxideE171,Hypromellose

Preventionofmigraineheadaches

58THR

33518/0014 29‐Jul‐09

DiapharmRegulatory

ServicesGmbHDiaFeverfewHard

capsules

1hardcapsulecontains:100mgFeverfewherb

(Tanacetumparthenium).




33

59THR

34768/0001 27‐Jul‐09 BioplantaUKLtdMoodBoostfilm‐coatedtablets

250mgofextract(asdryextract)fromStJohn’swortaerialparts(HypericumperforatumL.)(3.5‐

6:1)(equivalentto875–1500mgofStJohn’swort).

Extractionsolvent:Ethanol60%v/v.Eachfilm‐coatedtabletcontains:Lactosemonohydrate(11mg).

Extract:Lactosemonohydrate,Calciumhydrogenphosphatedihydrate,Cellulosepowdered,Silicacolloidalanhydrous.Tablet

core:Cellulosepowdered,MagnesiumStearate,Silicacolloidalanhydrous,Sodium

starchglycolate(typeA),Stearicacid.Film‐coating:EudragitE100,Hypromellose,Macrogol6000,Talc,TitaniumdioxideE171,IronoxidehydrateE172(=

yellowironoxide)



34

60THR

23056/0011 27‐Jul‐09SchwabePharma

(UK)Ltd

Karmamoodfilm‐coatedtabletsandLloydspharmacySt

John’swortfilm‐coatedtablets

250mgofextract(asdryextract)fromStJohn’swortaerialparts(HypericumperforatumL.)(3.5‐

6:1)(equivalentto875–1500mgofStJohn’swort).

Extractionsolvent:Ethanol60%v/v.Eachfilm‐coatedtabletcontains:Lactosemonohydrate(11mg).

Extract:Lactosemonohydrate,Calciumhydrogenphosphatedihydrate,Cellulosepowdered,Silicacolloidalanhydrous.Tablet

core:Cellulosepowdered,MagnesiumStearate,Silicacolloidalanhydrous,Sodium

starchglycolate(typeA),Stearicacid.Film‐coating:EudragitE100,Hypromellose,Macrogol6000,Talc,TitaniumdioxideE171,IronoxidehydrateE172(=

yellowironoxide)



61THR

29860/0003 07‐Oct‐09Cassella‐med

GmbH&Co.KGKiraPremFilm‐coated

Tablets

4mgofextract(asdryextract)fromAgnusCastus

fruit(VitexagnuscastusL.)(7–13:1)(equivalentto28‐52

mgofAgnusCastus).ExtractionSolvent:Ethanol

60%(m/m).

Tabletcore:Liquidglucose(drysubstance),Silicacolloidal

anhydrous,Lactosemonohydrate,Magnesium

stearate,Maizestarch,Cellulosemicrocrystalline,Sodiumstarchglycollate(typeA).Film‐coating:

Hypromellose,Lactosemonohydrate,Macrogol4000,TitaniumdioxideE171Iron(III)‐oxideE172(redironoxide)

Reliefofpremenstrualsymptoms

35

62THR

14369/0008 21‐Dec‐09

PASCOEpharmazeutischePraparateGmbH PASCOECalmtablets

425mgofextract(asdryextract)fromPassionFlowerHerb(PassifloraincarnataL.)(5‐7:1).Extractionsolvent:ethanol50%v/vEachcoatedtabletcontains5mgglucose

and187mgsucrose.

Extractexcipients:Maltodextrin,Silicacolloidalanhydrous.Tablet

core:Maltodextrin,Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellose

sodium,Magnesiumstearate,Stearicacid,Talc.Coating:

Sucrose,Talc,CalciumcarbonateE170,Acacia,Tragacanth,

TitaniumdioxideE171,Liquidglucosespraydried,IronoxidehydrateE172(=yellowiron

oxide),Hypromellose,Capol600T.S.containing:Beeswaxwhite,

Carnaubawax,Shellac

Temporaryreliefofmildanxietyandto

aidsleep.

36

63THR

01074/0002 05‐Mar‐10G.R.LaneHealthProductsLimited KalmsNight

DryextractfromValerianroot(ValerianaofficinalisL.,)(equivalentto1.5‐2.5gofValerianroot)Extractionsolvent:Ethanol60%V/V

Extractexcipients:Maltodextrin,Colloidalanhydroussilica.TabletCore:CroscarmelloseSodium,MagnesiumStearate,Prosolv

SMCC50(SilicifiedMicrocrystallineCellulose),Talc,SiliconDioxide.TabletCoating:OpadryWhite(PolyvinylAlcohol(PVA)parthydrolysed,TitaniumDioxide,PolyethyleneGlycol

(PEG)3350,Talc)Temporaryreliefofsleepdisturbances

64THR

13668/0015 14‐Jan‐10 Bioforce(UK)LtdEchinaforceJuniorCold

&FluTablets

Onetabletcontains380mgofextract(asdryextract)fromfreshEchinacea



Sorbitol,Betadex,Silicacolloidalanhydrous,Magnesiumstearate,

Orangeflavour



37

65THR

26411/0001 24‐Mar‐10 BIONORICASECyclopretFilm‐Coated

Tablets

1film‐coatedtabletcontains4.0mgofextract(asdry

extract)fromAgnuscastusfruit(VitexagnuscastusL.,

fructus)(7‐11:1).Extractionsolvent:Ethanol70%V/V.

Alsocontainslactosemonohydrate(25mgper

tablet).

HerbalPreparation:Povidone.Tabletcore:Silicacolloidalanhydrous,Potatostarch,

Lactosemonohydrate,Cellulosemicrocrystalline,Magnesiumstearate.Filmcoating:Talc,Titaniumdioxide(E171),Ironoxideyellow(E172),Indigo

carmine(E132),Macrogol6000,Ammoniummethacrylate‐

copolymer(typeA)

Tohelprelivepremenstrual

symptomssuchasirritability,moodswings,breasttenderness,bloatingand

menstrualcramps.

66THR

13668/0020 12‐Mar‐10 Bioforce(UK)Ltd MenoforceSagetablets

1tabletcontains51mgofdriedtincturefromfreshSage(SalviaofficinalisL.)

leaves(1:17‐18).Extractionsolvent:Ethanol68%V/V.

Microcrystallinecellulose,Sucroselaurate,Hydrogenated

cottonseedoil

Reliefofexcessivesweatingassociatedwithmenopausal

hotflushes,includingnight

sweats.

38

67THR

33518/0003 08‐Mar‐10

DiapharmRegulatory

ServicesGmbH DiaRelaxTablets

112.5mgofextract(asdryextract)fromMelissaleaf

(MelissaofficinalisL.)(4‐6:1)(equivalentto450‐675mgof

Melissaleaf).Extractionsolvent:Methanol30%v/vand125mgofextract(asdryextract)fromValerianroot(ValerianaofficinalisL.)(3‐6:1)(equivalentto375–750

mgofValerianroot).Extractionsolvent:Ethanol

70%v/v,and80mgofextract(asdryextract)fromPassion

flowerherb(PassifloraincarnataL.)(5‐7:1)

(equivalentto400‐560mgofPassionflowerherb).


Excipientsoftheherbalpreparations:Maltodextrin,

Silicacolloidalanhydrous,Liquidglucosespraydried.Excipientsof

thetablet:Silicacolloidalanhydrous,Cellulosepowdered,Croscarmellosesodium,Stearicacid,Talc.Excipientsofthe

coating:Sucrose,Talc,CalciumcarbonateE170,Acacia,

Tragacanth,TitaniumdioxideE171,Liquidglucosespraydried,QuinolineyellowE104,Indigotin

85E132,Beeswaxwhite,Carnaubawax,Shellac

Temporaryreliefofthesymptomsofmildanxiety,toaidsleepandformild

digestivecomplaints,suchas

bloatingandflatulence.

39

68THR

12063/0010 23‐Mar‐10

WraftonLaboratories

Limited

GalpharmHerbalColdandFluSachets,AsdaHerbalColdandFluSachets,TescoHerbalColdandFluSachets,MorrisonsHerbalCold

andFluSachets,SuperdrugHerbalColdandFluSachets,WilkoHerbalColdandFluSachets,BootsHerbalFluReliefSachets,

HerbalstoreHerbalColdandFluSachetsand

Sainsbury'sHerbalColdandFluSachets

71.5mgextract(dryextract)fromEchinaceapurpurearoot(6‐7:1)(equivalentto429–500mgofEchinaceapurpurea(L.)Moench,root)Extractionsolvent:Ethanol30%v/vAncilliaryvitamins/mineralsZinc5mg(as13.73mgsulphatemonohydrate)

AscorbicAcid60mg.

Excipientsoftheherbalpreparation;Maltodextrin,Silica

colloidalanhydrous.Otherexcipients;Maltodextrin,SodiumCitrate,CitricAcid,AcesulflameK,Aspartame(E951),QuinolineYellow(E104),LemonFlavour

F/29088,LemonFlavourF/29089,LemonFlavourF/28151,LemonFlavour

501.476/AP05.04



69THR

18397/0008 23‐Mar‐10 SwissCapsGmbHProstamensoft

capsules

Onesoftcapsulecontains160mgofextract(assoftextract)

fromSawpalmettofruit(Serenoarepens(Bartram)

Smallfructus(Sabalserrulata(Michaux)Nicholsfructus))(10‐14:1).Extractionsolvent:

Ethanol90%(m/m)Succinylatedgelatine,glycerol,

purifiedwater

Reliefoflowerurinarytract

symptomsinmenwhohavea

confirmeddiagnosisofbenignprostatic

hypertrophy.

40

70THR

26411/0004 26‐May‐10 BIONORICASENeuropretCoated

Tablets

Eachcoatedtabletcontains425mgofextract(asdry

extract)fromSt.John'swortaerialparts(HypericumperforatumL.)(3.5‐6:1)

(equivalentto1490‐2550mgofSt.John’swort).Extractionsolvent:Ethanol60%m/m.

Extractexcipients:Maltodextrin,Silicacolloidalanhydrous.Tabletcore:Silicacolloidalanhydrous,

Cellulosemicrocrystalline,Croscarmellosesodium,Sodium

starchglycolate(typeA),Magnesiumstearate.Coating:Hypromellose,Sucrose,Talc,CalciumcarbonateE170,Tragacanth,Acacia,Liquidglucose(drysubstance),

TitaniumdioxideE171,IronoxidehydrateE172(=yellowironoxide),Vanillin,Beeswaxwhite,Carnaubawax,Shellac


anxiety.

41

71THR

26411/0002 09‐Jun‐10 BIONORICASEMenopretFilm‐coated

Tablets

Onefilm‐coatedtabletcontains6.5mgofextract(as

dryextract)fromblackcohoshrhizomeandroot(Cimicifugaracemosa(L.)

Nutt.)(4.5–8.5:1)(equivalentto29.25‐55.25

mgofblackcohosh).Extractionsolvent:Ethanol60%V/V.Onefilm‐coatedtablet

contains23mglactosemonohydrate.

Herbalpreparation:Lactosemonohydrate,Cellulosepowdered,Silicacolloidal

anhydrous.Tabletcore:Cellulosepowder,Silicacolloidalanhydrous,Lactose

monohydrate,Magnesiumstearate,Maizestarch,Calciumhydrogenphosphate,Sodiumstarchglycolate(typeA).Tabletcoating:Lactosemonohydrate,Hypromellose,Macrogol4000,Titaniumdioxide(E171),Ironoxidered(E172),Ironoxide

yellow(E172)

Reliefofsymptomsassociatedwiththemenopause,suchashotflushes,nightsweats,poorsleep,moodchanges,and

irritability

72THR

28255/0017 29‐Jun‐10Rutland

BiodynamicsLtd

EnglishHerbalMedicinesValerianRelaxisleep,Herbs

HandsHealingValRelax,BrookeGreenValerianElixirandSwissHerbalRemediesValerianElixir

Each5mloforalliquidcontains1.5mloftincture

fromdriedValerian(ValerianaofficinalisL.)root(1:8).Extractionsolvent:

Ethanol57%v/v.5mloforalliquidcontainsapproximately

1.25gEthanol(alcohol),equivalentto32mlofbeeror13mlofwineand734mg

sucrose.

LiquoriceLiquidExtract,OrangeOil,LemonOil,CorianderOil,AniseOil,Ethanol(90%,)

Sucrose,Water

Temporaryreliefofsymptomsofmildanxietyandasan

aidtosleep.

42

73THR

05332/0006 11‐Jun‐10


&Co.KG KalobaSyrup

100g(=93.985ml)syrupcontain0.2506gdriedliquidextractfromtherootsof

PelargoniumsidoidesDC(1:8‐10)(EPs®7630).Theextractionagentis11%

ethanol(w/w).

Extract:Maltodextrin.Syrup:Xylitol,Glycerol85%,Citricacidanhydrous,Potassiumsorbate,Xanthangum,Purifiedwater

Reliefofsymptomsofupperrespiratory

tractinfectionincludingcommoncold,sorethroat,cough,blocked&

runnynose

74THR

13668/0025 06‐Jul‐10 Bioforce(UK)LtdEchinaforceChewableCold&FluTablets

Onetabletcontains380mgofextract(asdryextract)fromfreshEchinacea



Sorbitol,Betadex,Silicacolloidalanhydrous,Magnesiumstearate,

Orangeflavour


commoncold&influenzatypeinfections

75THR

32294/0001 26‐Jul‐10 PlantaPhileLtdSinueezeCoated

Tablets

12mgGentianroot(GentianaluteaL.),36mgVerbenaherb(VerbenaofficinalisL.),36mgSorrelherb(Rumexacetosa

L.),36mgElderflower(SambucusnigraL.),36mgPrimulaflowerwithcalyx

(PrimulaverisL.).

Tabletcore:Colloidalanhydroussilica,Cellulosepowder,

Maltodextrin,Croscarmellosesodium,Magnesiumstearate(vegetable).Tabletcoating:Hypromellose,Sucrose,Talc,

Calciumcarbonate,Tragacanth,Acacia,TitaniumdioxideE171,Anhydrousglucose,Shellac,

Whitebeeswax,Carnaubawax

Relievenasalcongestion&

sinusitis

43

76THR

32294/0002 26‐Jul‐10 PlantaPhileLtdSinuherbCoated

Tablets

12mgGentianroot(GentianaluteaL.),36mgVerbenaherb(VerbenaofficinalisL.),36mgSorrelherb(Rumexacetosa

L.),36mgElderflower(SambucusnigraL.),36mgPrimulaflowerwithcalyx

(PrimulaverisL.).

Tabletcore:Colloidalanhydroussilica,Cellulosepowder,

Maltodextrin,Croscarmellosesodium,Magnesiumstearate(vegetable).Tabletcoating:Hypromellose,Sucrose,Talc,

Calciumcarbonate,Tragacanth,Acacia,TitaniumdioxideE171,Anhydrousglucose,Shellac,

Whitebeeswax,Carnaubawax

Relievenasalcongestion&

sinusitis

77THR

12297/0014 20‐Jul‐10LABORATOIRESARKOPHARMA PHYTOCALM

1capsulecontains300mgPassionFlowerherb

(PassifloraincarnataL.,herba). Hypromellose(capsuleshell)

Temporaryreliefofsymptoms

associatedwithstresssuchasmildanxietyandtoaid

sleep.

78THR

13668/0012 11‐Jan‐08AtrosanDevil’sClawtablets Bioforce(UK)Limited

Onefilm‐coatedtabletcontains480mgofextract(asdryextract)fromDevil'sclaw

(HarpagophytumprocumbensD.C.and/orH.zeyheriL.Decne.)root(1.5‐3.0:1).Extractionsolvent:

Ethanol60%V/V.

Forthetablet:Lactosemonohydrate,Maizestarch,

Cellulosemicrocrystalline,Silicacolloidalanhydrous,Magnesiumstearate(vegetablesource),

Silicaprecipitated.Forthefilmcoating:Talc,Titaniumdioxide,

Macrogol,Hypromellose

Reliefofbackache,rheumaticor

muscularpain,andgeneralachesandpainsinthemuscles

andjoints

79THR

23056/0004 03‐Apr‐07MigraHerbHard

capsules MHPharma(UK)Ltd100mgFeverfewherb

(Tanacetumparthenium)




collated list of uk traditional herbal …...enlarged prostate(bhp) 16 thr 13668/0019 06‐aug‐10...

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