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ATC codes: N02BE01
EMLc
Indication
Pain ICD11 code: ML0Z
INN
Paracetamol
Medicine type
Chemical agent
List type
Core Not recommended for anti-inflammatory use due to lack of proven benefit to that effect.
Formulations
Oral > Liquid: 125 mg per 5 mL ; 120 mg per 5 mL
Oral > Solid: 100 to 500 mg
Local > Rectal > Suppository: 100 mg
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 1987 (TRS 770)
Changed in 2007 (TRS 950)
Changed in 2017 (TRS 1006)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Expert Committee recommendation
The Expert Committee recommended the addition of the new strength of paracetamol oral liquid, 120 mg/5 mL to the EML and EMLc, noting its wider global market availability than the currently listed 125 mg/5 mL strength. The Committee considered that inclusion of the new strength would assist countries and procurement agencies in their efforts to make appropriate paediatric dose forms of paracetamol available through their national schemes and programmes.
Background
The application requested the addition of a new strength formulation of paracetamol oral liquid (120 mg/5 mL) to the EML and EMLc based on its availability in the market. Paracetamol oral liquid 125 mg/5 mL has been included on the EML since 1977 and the EMLc since 2007. Other dose forms of paracetamol listed include suppositories and tablets.
Cost / cost effectiveness
The 2014 International Drug Price Indicator Guide reports a median supplier price for paracetamol oral liquid 120 mg/5 mL of US$ 0.0054/mL and a median buyer price of US$ 0.0042/mL. It does not report prices for the 125 mg/5 mL formulation (1).
Availability
UNICEF advised that it procures paracetamol oral liquid as listed on the EML and EMLc (oral liquid 125 mg/5 mL). It stated that most suppliers from it procures paracetamol oral liquid offer the alternative strength of 120 mg/5 mL and proposed the addition of this alternative strength on the basis of market availability. Paracetamol oral liquid 120 mg/5 mL is widely available globally.
1. International Drug Price Indicator Guide. Medford, MA: Management Sciences for Health; 2014 (http://mshpriceguide.org/wp-content/uploads/2016/06/MSH-International-Drug-Price-Indicator- Guide-2014.pdf, accessed 19 January 2017).