collated list of uk traditional herbal...
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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
Reliefofsymptomsofslightlylowmoodandmild
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.)
Reliefofsymptomsofslightlylowmoodandmild
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
Reliefofsymptomsofslightlylowmoodandmild
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
ManufacturingLimited
Sainsbury’sEchinaceaColdandFluRelief,TescoEchinaceaCold
andFluRelief,MorrisonsEchinaceaColdandFluRelief,SuperdrugEchinaceaColdandFluRelief,WilkoEchinaceaColdandFluRelief,Co‐
opEchinaceaColdandFluRelief,Gerard
HouseEchinaceaColdandFluRelief,HERBALSTORE
EchinaceaColdandFluReliefandWaitroseEchinaceaColdand
FluRelief
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
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
ManufacturingLimited
Sainsbury’sMaxStrengthEchinaceaColdandFluRelief,TescoMaxStrength
EchinaceaColdandFluRelief,MorrisonsMaxStrengthEchinaceaColdandFluRelief,SuperdrugMax
StrengthEchinaceaColdandFluRelief,WilkoMaxStrength
EchinaceaColdandFluRelief,Co‐opMaxStrengthEchinaceaColdandFluRelief,GerardHouseMaxStrengthEchinacea
ColdandFluReliefandWaitroseMaxStrength
EchinaceaColdandFluRelief
Eachfilmcoatedtabletcontains:143.0mgofextract(dryextract)fromEchinacea
purpurearoot(6‐7:1)(equivalentto858mg–1000mgofEchinaceapurpurea(L.)Moench,root).Extractionsolvent:Ethanol30%v/v
Excipientsoftheherbalpreparation;Maltodextrin,
ColloidalAnhydrousSilica.TabletCore:
CalciumHydrogenPhosphateDihydrate,MicrocrystallineCellulose,Croscarmellose
Sodium,ColloidalAnhydrousSilica,MagnesiumStearate.Film
coating:Hypromellose,PurifiedTalc,
MastercoteYellowFA0117(TitaniumDioxide(E171),Yellow
IronOxide(E172))
Reliefofthesymptomsof
commoncoldandinfluenzatypeinfections
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
Temporaryreliefofsleepdisturbancesduetosymptomsof
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.
Excipientsoftheherbalpreparation:Lactose
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
Temporaryreliefofsleepdisturbancesduetosymptomsof
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.
Relievethesymptomsofthecommoncoldandinfluenzatypeinfections
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
Relievethesymptomsofthecommoncoldandinfluenzatypeinfections
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)
Relievethesymptomsofthecommoncoldandinfluenzatypeinfections
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)
Thereliefofbackache,
rheumaticormuscularpain,andgeneralachesandpainsinthemuscles
andjoints.
47THR
05332/0005 31‐Mar‐09
Dr.WillmarSchwabeGmbH
&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
Reliefofthesymptomsof
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.
Excipientsoftheherbalpreparation:Lactose
monohydrate,Cellulosepowdered,Silicacolloidal
anhydrous.Excipientsofthetablet:Silicacolloidalanhydrous,
Magnesiumstearate,Maizestarch,Cellulose
microcrystalline,Sodiumstarchglycolate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide
E171
Reliefofthesymptomsof
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
Thereliefofbackache,
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.
Excipientsoftheherbalpreparation:Lactose
monohydrate,Cellulosepowdered,Silicacolloidal
anhydrous.Excipientsofthetablet:Silicacolloidalanhydrous,
Magnesiumstearate,Maizestarch,Cellulose
microcrystalline,Sodiumstarchglycolate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide
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.
Excipientsoftheherbalpreparation:Lactose
monohydrate,Cellulosepowdered,Silicacolloidal
anhydrous.Excipientsofthetablet:Silicacolloidalanhydrous,
Magnesiumstearate,Maizestarch,Cellulose
microcrystalline,Sodiumstarchglycolate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide
E171
Reliefofthesymptomsofthe
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.
Excipientsoftheherbalpreparation:Lactose
monohydrate,Cellulosepowdered,Silicacolloidal
anhydrous.Excipientsofthetablet:Silicacolloidalanhydrous,
Magnesiumstearate,Maizestarch,Cellulose
microcrystalline,Sodiumstarchglycollate(typeA).Excipientsofthefilm‐coating:Hypromellose,Macrogol4000,Titaniumdioxide
E171
Reliefofthesymptomsofthe
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).
Dextrinwhite,Silicacolloidalanhydrous,Talc,Magnesium
stearate,TitaniumdioxideE171,Hypromellose
Preventionofmigraineheadaches
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)
Reliefofthesymptomsof
slightlylowmoodandmildanxiety.
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)
Reliefofthesymptomsof
slightlylowmoodandmildanxiety.
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
purpurea(L.)Moenchherb(1:12)and20mgofextract(asdryextract)fromfreshEchinaceapurpurea(L.)Moenchroot(1:11).
Extractionsolvent:Ethanol65%v/v
Sorbitol,Betadex,Silicacolloidalanhydrous,Magnesiumstearate,
Orangeflavour
Reliefofthesymptomsof
commoncoldandinfluenzatypeinfections
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).
Extractionsolvent:Ethanol50%v/v
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
Reliefofthesymptomsof
commoncoldandinfluenzatypeinfections
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
Reliefofsymptomsofslightlylowmoodandmild
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
Dr.WillmarSchwabeGmbH
&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
purpurea(L.)Moenchherb(1:12)and20mgofextract(asdryextract)fromfreshEchinaceapurpurea(L.)Moenchroot(1:11).
Extractionsolvent:Ethanol65%v/v
Sorbitol,Betadex,Silicacolloidalanhydrous,Magnesiumstearate,
Orangeflavour
Reliefofthesymptomsof
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)
Dextrinwhite,Silicacolloidalanhydrous,Talc,Magnesium
stearate,TitaniumdioxideE171,Hypromellose
Preventionofmigraineheadaches