Draft Public Statement On Syzygium Aromaticum (L.) Merill Et L.M. Perry, Flos
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
31 March 2011
EMA/HMPC/112102/2011
Committee on Herbal Medicinal Products (HMPC)
Public statement on Syzygium aromaticum (L.) Merill et L.M. Perry, flos
Herbal medicinal products; HMPC; Community herbal monographs; Community list entries; Public statements; Syzygium aromaticum (L.) Merill et L.M. Perry, flos; Caryophylli flos; clove
Draft
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Discussion in Working Party on Community Monographs and Community List (MLWP) |
September 2010 November 2010 March 2011 |
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Adoption by HMPC for release for consultation |
31 March 2011 |
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End of consultation (deadline for comments). Comments should be provided using this template. The completed comments form should be sent to hmpc.secretariat@ema.europa.eu |
15 August 2011 |
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Agreed by HMPC Working Party on Community Monographs and Community List (MLWP) | |
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Adoption by HMPC |
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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
Public statement on Syzygium aromaticum (L.) Merill et L.M Perry, flos
PROBLEM STATEMENT
The HMPC/MLWP decided to prepare a Community herbal monograph on Syzygium aromaticum (L.) Merill et L.M. Perry, flos as announced in the 2011 MLWP work programme.
After reviewing information on the products containing Syzygium aromaticum (L.) Merill et L.M. Perry, flos and preparations thereof marketed in the European Union, it appears that no single-ingredient products are available. Furthermore, after consultation with interested parties on priority levels for anticipated assessment works in 2010, a low level of priority was identified for the establishment of a monograph on Caryophylli flos.
The Rapporteur has integrated relevant published data in the joint assessment report on Caryophylli aetheroleum and Caryophylli flos.
CONCLUSIONS
Based on the above-mentioned information, the HMPC decided that no Community herbal monograph on Syzygium aromaticum (L.) Merill et L.M. Perry, flos will be established, unless new data are provided.
To read more about the assessment carried out, a link is provided to the page where to access the draft assessment report on Caryophylli aetheroleum and Caryophylli flos and its list of references.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/herbal/medicines/herbal med 0001 66.isp&murl = menus/medicines/medicines.isp&mid=WC0b01ac058001fa1d
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Public statement on Syzygium aromaticum (L.) Merill et L.M. Perry, flos EMA/HMPC/112102/2011