Balsamum peruvianum - herbal medicinal product

Peru balsam

Overview

As the Committee on Herbal Medicinal Products (HMPC) did not adopt a European Union herbal monograph, no summary for the public will be prepared.

Key facts

• Latin name:
  Balsamum peruvianum
• English common name:
  Peru balsam
• Botanical name:

  Myroxylon balsamum (L.) Harms var. perierae (Royle) Harms

• Status:
  F: Assessment finalised
• Date added to the inventory:
  28/01/2014
• Date added to priority list:
  28/01/2014
• Outcome of European assessment:
  Public statement

Documents

First version

Final assessment report on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

AdoptedReference Number: EMA/HMPC/712648/2014

Final list of references supporting the assessment of Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

AdoptedReference Number: EMA/HMPC/712650/2014

Public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

Reference Number: EMA/HMPC/712649/2014

Consultation

Draft assessment report on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

DraftReference Number: EMA/HMPC/712648/2014Summary:

Peru balsam is obtained from the scorched and wounded trunk of Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms. It contains not less than 45.0-70.0 % m/m of esters, mainly benzyl benzoate and benzyl cinnamate (European Pharmacopeia 01/2008:0754).

Draft list of references supporting the assessment of Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

DraftReference Number: EMA/HMPC/712650/2014Summary:

The European Medicines Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.

Draft public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum

Consultation dates: 11/12/2015 to 15/03/2016Draft: consultation closedReference Number: EMA/HMPC/712649/2014Summary:

The HMPC/MLWP decided to prepare a European Union herbal monograph on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum, as announced in the July 2013 HMPC meeting report. A comprehensive literature search was conducted and available data, including information on products on the market in the European Union, were assessed in relation to the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.