Phynova Joint and Muscle Relief Tablets THR ….docx
- 文档编号:174160
- 上传时间:2022-10-05
- 格式:DOCX
- 页数:19
- 大小:247.55KB
Phynova Joint and Muscle Relief Tablets THR ….docx
《Phynova Joint and Muscle Relief Tablets THR ….docx》由会员分享,可在线阅读,更多相关《Phynova Joint and Muscle Relief Tablets THR ….docx(19页珍藏版)》请在冰豆网上搜索。
&MHRA
•ee•RegulatingMedicinesandMedicalDevices
PhynovaJointandMuscleReliefTablets
THR41783/0001
UKPAR
TABLEOFCONTENTS
Laysummary
Page2
Scientificdiscussion
Page3
Stepstakenforassessment
Page12
SummaryofProductCharacteristics
Page13
ProductInformationLeaflet
Page14
Labelling
Page15
MedicinesandHealthcareProductsRegulatoryAgency*—
PHYNOVAJOINTANDMUSCLERELIEFTABLETS
THR41783/0001
LAYSUMMARY
TheMedicinesandHealthcareproductsRegulatoryAgency(MHRA)grantedPhynovaGroupLtdaTraditionalHerbalRegistrationCertificateforthetraditionalherbalmedicinalproductPhynovaJointandMuscleReliefTablets(TraditionalHerbalRegistrationnumber:
THR41783/0001)on18thFebruary2015.PhynovaJointandMuscleReliefTabletsareavailablewithoutprescriptionandcanbeboughtfrompharmaciesandotheroutlets.
TheactiveingredientinPhynovaJointandMuscleReliefTabletscomesfromtheaerialpartsoftheSigesbeckiaorientalisL.subsp.pubescens(Makino)H.Koyamaplant*.PhynovaJointandMuscleReliefTabletsisatraditionalherbalmedicinalproductusedforthereliefofbackache,minorsportsinjuries,rheumaticormuscularpainsandgeneralachesandpainsinthemuscleandjoints,basedontraditionaluseonly.
ThisregistrationisbasedexclusivelyuponthelongstandinguseofSigesbeckiaorientalisL.subsp.pubescensaerialpartsasatraditionalherbalmedicineandnotupondatageneratedfromclinicaltrials.ThereisnorequirementundertheTraditionalHerbalRegistrationSchemetoprovescientificallythataproductworks.
Noneworunexpectedsafetyconcernsarosefromthisapplicationanditwas,therefore,decidedthataTraditionalHerbalRegistrationCertificatecouldbegranted.
*Siegesbeckiapubescensisusedinthescientificliterature.Howeverthecorrectbotanicalnameisasabove.
PHYNOVAJOINTANDMUSCLERELIEFTABLETS
THR41783/0001
SCIENTIFICDISCUSSION
TABLEOFCONTENTS
Introduction
Pharmaceuticalassessment
Non-clinicalassessment
Clinicalassessment
Page4
Page5
Page8
Page9
Page11
Overallconclusionsandriskassessment
INTRODUCTION
TheMHRAgrantedaTraditionalHerbalRegistrationCertificateforthetraditionalherbalmedicinalproductPhynovaJointandMuscleReliefTablets(THR41783/0001)toPhynovaGroupLtdon18thFebruary2015.Thisproductisonthegeneralsaleslist(GSL).
ThisapplicationwassubmittedaccordingtoArticle16.cofDirective2001/83EC,asamended,aspartoftheTraditionalHerbalMedicinesRegistrationScheme.PhynovaJointandMuscleReliefTabletsisatraditionalherbalmedicinalproductusedforthereliefofbackache,minorsportsinjuries,rheumaticormuscularpainsandgeneralachesandpainsinthemuscleandjoints,basedontraditionaluseonly.
ThereissufficientevidencetodemonstrateuseofSigesbeckiaorientalisL.subsp.pubescensaerialpartsforatleast30years,ofwhichatleast15yearshavebeeninanEUMemberState.AsatisfactoryreviewoftheavailablesafetydataonSigesbeckiaorientalisL.subsp.pubescensaerialpartshasalsobeenprovided,togetherwithanExpertSafetyReportsupportingtheproposedproduct.
PHARMACEUTICALASSESSMENT
HERBALSUBSTANCE:
SIGESBECKIAORIENTALISL.SUBSP.
PUBESCENSAERIALPARTS
Scientificnameoftheplant:
SigesbeckiaorientalisL.subsp.pubescens
(Makino)H.Koyama
Commonnames:
StPaul’swort(English)
XiXiaoCao(Chinese)
Plantfamily:
Compositae
ManufactureofHerbalSubstance
TheplantsarecollectedfromthewildinChina.Thewholeaerialpartsarecollectedbeforefloweringorduringthefloweringseasoninthesummerorearlyautumn.Followingcollection,theplantsarewashed,softenedslightly,cutintosectionsanddried.
TheplantsarecollectedinaccordancewiththeprinciplesofGoodAgriculturalandCollectionPractice(GACP)guidelines.Itisalsostatedthattheplantsarenottreatedwithpesticides,herbicides,fungicidesorethyleneoxide.
ControlofHerbalSubstance
Anappropriatespecificationisappliedtakingaccountofcurrentguidelinesandpharmacopoeialrequirementsandisacceptable.Thespecificationissupportedbythebatchdataprovided.
ContainerClosureSystem
Satisfactorydetailsofthecontainerclosuresystemareprovidedandconfirmationhasbeengiventhatallcomponentsofthecontainerclosuresystemcomplywithcurrentlegislationrelatingtoplasticmaterialsandarticlesintendedtocomeintocontactwithfoodstuffs.
StabilityofHerbalSubstance
Confirmationisgiventhattheherbalsubstancewillbetestedimmediatelypriortobeingusedtomaketheherbalpreparation.Ashelf-lifefortheherbalsubstanceisnotnecessarybecauseitisonlyaprecursoroftheactivesubstance,theherbalpreparation.Theactualguidelinerequires
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- Phynova Joint and Muscle Relief Tablets THR
![提示](https://static.bdocx.com/images/bang_tan.gif)