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2019, vol. 69, br. 4, str. 221-269
Biljni i tradicionalni biljni lekovi, monografije EU i lista EU
Univerzitet u Beogradu, Farmaceutski fakultet, Institut za farmakognoziju, Srbija

e-adresasilvana.petrovic@pharmacy.bg.ac.rs
Ključne reči: biljni lekovi; tradicionalni biljni lekovi; Komitet za biljne lekovite proizvode Evropske agencije za lekove (EMA/HMPC); monografije EU; lista EU
Sažetak
Prema zakonskim aktima EU i zakonskim aktima naše zemlje, biljni lekovi (BL) i tradicionalni biljni lekovi (TBL) predstavljaju vrste lekova. Kao aktivne sastojke sadrže biljne droge (supstance biljnog porekla) i/ili preparate biljnih droga (biljne preparate). BL se stavljaju u promet na osnovu potvrđenog kvaliteta, kliničke efikasnosti i bezbednosti. TBL se registruju na osnovu potvrđenog kvaliteta i dovoljno podataka o tradicionalnoj upotrebi kojima se dokazuje da imaju prihvatljiv stepen bezbednosti i očekivanu efikasnost. Komitet za biljne lekovite proizvode (HMPC) Evropske agencije za lekove (EMA) izdaje monografije EU za biljne droge, preparate biljnih droga i njihove kombinacije u kojima se nalaze pretklinički i klinički podaci za BL sa dobro poznatom upotrebom (WEU) i podaci o tradicionalnoj upotrebi (TU) za TBL. HMPC priprema i nacrte unosa u listu EU za TBL, koje usvaja i objavljuje Evropska komisija. Zaključno sa julom 2019. god., HMPC je izdao 160 finalnih monografija, koje su dostupne na web-sajtu EMA (157 monografija za 156 biljnih droga i preparata, dve monografije za dve kombinacije biljnih droga i jednu monografiju za čaj, tj. čajne mešavine); za 13 biljnih droga i preparata objavljeni su unosi u listu EU. U radu je dat prikaz terapijskih oblasti i indikacija koje su odobrene u navedenim finalnim monografijama EU. Takođe, dat je pregled BL i TBL koji imaju dozvole za stavljanje u promet/upisani su u Registar tradicionalnih biljnih lekova u Republici Srbiji.
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European Medicines Agency (2012) Community herbal monograph on Rhodiola rosea L., rhizoma et radix. London, EMA/HMPC/232091/2011, 27 March
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European Medicines Agency (2014) Community herbal monograph on Panax ginseng C.A.Meyer, radix. London, EMA/HMPC/321233/2012 Corr, 25 March
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European Medicines Agency (2010) Community herbal monograph on Ilex paraguariensis St. Hilaire, folium. London, EMA/HMPC/580539/2008, 6 May
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European Medicines Agency (2014) Community herbal monograph on Humulus lupulus L., flos. London, EMA/HMPC/682384/2013, 6 May
European Medicines Agency (2013) Community herbal monograph on Melissa officinalis L., folium. London, EMA/HMPC/196745/2012, 14 May
European Medicines Agency (2014) Community herbal monograph on Passiflora incarnata L., herba. London, EMA/HMPC/669740/2013, 25 March
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European Medicines Agency (2018) European Union herbal monograph on Vitex agnus-castus L., fructus. London, EMA/HMPC/606742/2017, 27 March
European Medicines Agency (2015) European Union herbal monograph on Ginkgo biloba L., folium. London, EMA/HMPC/321097/2012., 28 January
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European Medicines Agency (2017) European Union herbal monograph on Vitis vinifera L., folium. London, EMA/HMPC/464684/2016., 30 May
European Medicines Agency (2018) European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma. London, EMA/HMPC/48745/2017., 27 March
European Medicines Agency (2015) European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus. London, EMA/HMPC/280079/2013, 24 November
European Medicines Agency (2018) European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus. London, EMA/HMPC/294187/2013, 5 June
European Medicines Agency (2018) European Union herbal monograph on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria × ananassa (Weston) Duchesne ex Rozier, folium. London, EMA/HMPC/432278/2015, 20 November
European Medicines Agency (2015) European Union herbal monograph on Vaccinium myrtillus L. fructus siccus. London, Doc. Ref. EMA/HMPC/678995/2013. Final: 29 September
European Medicines Agency (2014) Community herbal monograph on Ononis spinosa L., radix. London, EMA/HMPC/138317/2013, 25 March
European Medicines Agency (2010) Community herbal monograph on Orthosiphon stamineus Benth., folium. London, EMA/HMPC/281496/2009, 11 March
European Medicines Agency (2017) European Union herbal monograph on Ribes nigrum L., folium. London, EMA/HMPC/745353/2016, 19 September
European Medicines Agency (2010) Community herbal monograph on Quercus robur L. Quercus petraea. (Matt.) Liebl. Quercus pubescens Willd. cortex. London, Doc. Ref. EMA/HMPC/3203/2009. Final: 25 November
European Medicines Agency (2010) Community herbal monograph on Potentilla erecta (L.) Raeusch., rhizoma. London, EMA/HMPC/5511/2010, 25 November
European Medicines Agency (2010) Community herbal monograph on Arctium lappa L. radix. London, Doc. Ref. EMA/HMPC/246763/2009 Corr. Final: 16 September
European Medicines Agency (2011) Community herbal monograph on Trigonella foenum-graecum L. Semen. London, Doc. Ref. EMA/HMPC/146221/2010; Final: semen. 27 January
European Medicines Agency (2011) Community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma. London, EMA/HMPC/563408/2010,22 November
European Medicines Agency (2014) European Union herbal monograph on Betula pendula Roth and/or Betula pubescens Ehrh. as well as hybrids of both species, folium. London, EMA/HMPC/573241/2014, 24 November
European Medicines Agency (2016) European Union herbal monograph on Equisetum arvense L., herba. London, EMA/HMPC/278091/2015, 2 February
European Medicines Agency (2012) Community herbal monograph on Fraxinus excelsior L. or Fraxinus angustifolia Vahl, folium. London, EMA/HMPC/239271/2011, 27 March
European Medicines Agency (2013) Community herbal monograph on Phaseolus vulgaris L., fructus sine semine. London, EMA/HMPC/317319/2012, 12 November
European Medicines Agency (2015) European Union herbal monograph on Hieracium pilosella L., herba cum radice. London, EMA/HMPC/680374/2013, 5 May
European Medicines Agency (2009) Community herbal monograph on Hypericum perforatum L. herba (well-established medicinal use). London, EMA/HMPC/101304/2008, 12 November
European Medicines Agency (2008) Community herbal monograph on Solidago virgaurea L., herba. London, EMEA/HMPC/285758/2007, 4 September
European Medicines Agency (2009) Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium. London, EMA/HMPC/579636/2008, 12 November
European Medicines Agency (2010) Community herbal monograph on Urtica dioica L.; Urtica urens L., folium. London, EMA/HMPC/508015/2007, 14 January
European Medicines Agency (2013) Community herbal monograph on Solanum dulcamara L., stipites. London, EMA/HMPC/734361/2011, 15 January
European Medicines Agency (2014) Community herbal monograph on Arnica montana L., flos. London, Doc. Ref. EMA/HMPC/198793/2012; Final; 6 May
European Medicines Agency (2009) Community herbal monograph on Juniperus communis L. aetheroleum. Doc. Ref. EMA/HMPC/12402/2010. Final: 25 November
European Medicines Agency (2009) Community herbal monograph on Juniperus communis L. pseudo-fructus. Doc. Ref. EMA/HMPC/441929/2008. Final: 12 November
European Medicines Agency (2011) Community herbal monograph on Achillea millefolium L., flos. London, EMA/HMPC/143949/2010, 12 July
European Medicines Agency (2011) Community herbal monograph on Achillea millefolium L. Herba. Doc. Ref. EMA/HMPC/290284/2009; Final: 12 July
European Medicines Agency (2016) European Union herbal monograph on Origanum majorana L., herba. London, EMA/HMPC/166517/2015, 20 September
European Medicines Agency (2008) Community herbal monograph on Mentha x piperita L. folium. London, Doc. Ref. EMEA/HMPC/193909/2007. Final: 4 September
European Medicines Agency (2016) European Union herbal monograph on Peumus boldus Molina, folium. Doc. Ref. EMA/HMPC/453725/2016; Final: 22 November
European Medicines Agency (2011) Community herbal monograph on Chamaemelum nobile (L.) All. flos. Doc. Ref. EMA/HMPC/560734/2010. Final: 22 November
European Medicines Agency (2011) Community herbal monograph on Cinnamomum verum J.S. Presl, corticis aetheroleum. Doc. Ref. EMA/HMPC/706229/2009. Final: 10 May
European Medicines Agency (2011) Community herbal monograph on Cinnamomum verum J.S. Presl, cortex. Doc. Ref. EMA/HMPC/246774/2009. Final: 10 May
European Medicines Agency (2013) Community herbal monograph on Cichorium intybus L., radix. Doc. Ref. EMA/HMPC/121816/2010. Final: radix. 15 January
European Medicines Agency (2014) Community herbal monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma. London, EMA/HMPC/604600/2012, 28 January
European Medicines Agency (2018) European Union herbal monograph on Cynara cardunculus L. (syn. Cynara scolymus L.), folium. London, EMA/HMPC/194014/2017, 27 March
European Medicines Agency (2011) Community herbal monograph on Fumaria officinalis L. herba. London, Doc. Ref. EMA/HMPC/574766/2010. Final: 13 September
European Medicines Agency (2016) European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos. London, EMA/HMPC/41108/2015, 5 April
European Medicines Agency (2009) Community herbal monograph on Taraxacum officinale Weber ex Wigg. radix cum herba. London, Doc. Ref. EMA/HMPC/212895/2008; Final: 12 November
European Medicines Agency (2016) European Union herbal monograph on Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or Primula elatior (L.) Hill, radix. London, EMA/HMPC/84990/2015 Corr, 5 April
European Medicines Agency (2015) European Union herbal monograph on Echinacea purpurea (L.) Moench, herba recens. London, EMA/HMPC/48704/2014 Corr., 24 November
European Medicines Agency (2010) Community herbal monograph on Rosmarinus officinalis L., aetheroleum. London, EMA/HMPC/235453/2009, 15 July
European Medicines Agency (2010) Community herbal monograph on Rosmarinus officinalis L., folium. London, EMA/HMPC/13633/2009, 15 July
European Medicines Agency (2016) European Union herbal monograph on Salvia officinalis L., folium. London, EMA/HMPC/277152/2015, 20 September
European Medicines Agency (2014) Assessment report on Ginkgo biloba L., folium. London, EMA/HMPC/321095/2012, 28 January
European Medicines Agency (2017) European Union herbal monograph on Hedera helix L., folium. London, EMA/HMPC/325716/2017 November
European Medicines Agency (2007) Community herbal monograph on Mentha x piperita L. aetheroleum. London, Doc. Ref. EMEA/HMPC/349466/2006. Final: 31 October
European Medicines Agency (2012) Community herbal monograph on Zingiber officinale Roscoe, rhizoma. London, EMA/HMPC/749154/2010, 27 March
European Medicines Agency (2016) European Union herbal monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus. London, Doc. Ref. EMA/HMPC/625788/2015 Corr. Final: 22 November
European Medicines Agency (2006) Community herbal monograph on Rhamnus frangula L. cortex. London, Doc. Ref. EMEA/HMPC/76307/2006 Corrigendum. Final: 26 October
European Medicines Agency (2007) Community herbal monograph on Rhamnus purshianus D.C. cortex. London, Doc. Ref. EMEA/HMPC/513579/2006Corr. Final: 7 September
European Medicines Agency (2007) Community herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix. London, Doc. Ref. EMEA/HMPC/189624/2007Corr. Final: 31 October
European Medicines Agency (2006) Community herbal monograph on Cassia senna L. and Cassia angustifolia Vahl, folium. London, Doc. Ref. EMEA/HMPC/51869/2006 Corrigendum. Final 26 October
European Medicines Agency (2006) Community herbal monograph on Cassia senna L. fructus and Cassia angustifolia Vahl. fructus. London, Doc. Ref. EMEA/HMPC/51871/2006 Corr. Final:26 October
European Medicines Agency (2016) European Union herbal monograph on Ricinus communis L. oleum. London, Doc. Ref. EMA/HMPC/572974/2014 Corr. Final: 2 February
European Medicines Agency (2008) Community herbal monograph on Urtica dioica L. and Urtica urens L., herba. London, EMEA/HMPC/170261/2006, 4 September
European Medicines Agency (2018) European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium. London, EMA/HMPC/750269/2016, 30 January
European Medicines Agency (2011) Community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba. London, EMA/HMPC/262766/2010, 12 July
European Medicines Agency (2012) Community herbal monograph on Cucurbita pepo L., semen. London, EMA/HMPC/136024/2010, 20 November
European Medicines Agency (2015) European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba. London, EMA/HMPC/712511/2014, 24 November
European Medicines Agency (2009) Community herbal monograph on Hypericum perforatum L. herba (traditional use). London, EMEA/HMPC/745582/2009, 12 November
European Medicines Agency (2016) European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex. London, EMA/HMPC/680626/2013, 12 July
European Medicines Agency (2012) Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix. London, EMA/HMPC/461160/2008, 24 September
European Medicines Agency (2012) Community herbal monograph on Aesculus hippocastanum L., cortex. London, EMA/HMPC/354156/2011, 22 May
European Medicines Agency (2017) European Union herbal monograph on Melilotus officinalis (L.) Lam., herba. London, EMA/HMPC/44166/2016, 21 November
European Medicines Agency (2015) European Union herbal monograph on Vaccinium myrtillus L., fructus recens. London, EMA/HMPC/375808/2014,29 September
European Medicines Agency (2018) European Union herbal monograph on Ruscus aculeatus L., rhizoma. London, EMA/HMPC/188804/2017, 20 November
European Medicines Agency (2011) Community herbal monograph on Hamamelis virginiana L., cortex. London, EMA/HMPC/114583/2008 Corr, 6 June
European Medicines Agency (2009) Community herbal monograph on Hamamelis virginiana L., folium. London, EMA/HMPC/114586/2008, 12 November
European Medicines Agency (2015) European Union herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum. London, EMA/HMPC/320930/2012, 24 November
European Medicines Agency (2018) European Union herbal monograph on Calendula officinalis L., flos. London, EMA/HMPC/437450/2017, 27 March
European Medicines Agency (2011) Community herbal monograph on Commiphora molmol Engler, gummi-resina. London, EMA/HMPC/96911/2010, 12 July
European Medicines Agency (2013) Community herbal monograph on Juglans regia L., folium. London, EMA/HMPC/346737/2011, 9 July
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European Medicines Agency (2011) Community herbal monograph on Syzygium aromaticum (L.) Merill et L. M. Perry, floris aetheroleum. London, EMA/HMPC/534924/2010,13 September
European Medicines Agency (2014) Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos. London, EMA/HMPC/137299/2013, 1 July
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European Medicines Agency (2017) European Union herbal monograph on Glycine max (L.) Merr., oleum raffinatum. London, EMA/HMPC/338914/2016, 31 January
European Medicines Agency (2018) European Union herbal monograph on Oenothera biennis L. or Oenothera lamarckiana L., oleum. London, EMA/HMPC/753041/2017, 5 June
European Medicines Agency (2011) Community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos. London, EMA/HMPC/585558/2007 Corr, 6 June
European Medicines Agency (2015) European Union herbal monograph on Symphytum officinale L., radix. London, Doc. Ref. EMA/HMPC/572846/2009; Final; 5 May
European Medicines Agency (2010) Community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba. London, EMA/HMPC/587578/2009, 25 November
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O članku

jezik rada: srpski
vrsta rada: pregledni članak
DOI: 10.5937/arhfarm1904221P
objavljen u SCIndeksu: 09.11.2019.
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