Anti-Infectives · LP-026
Artemether + lumefantrine Tablet/dispersible tablet
Medicine dossier. Catalogue identity is separated from unresolved product-specific fields and from external scientific references.
Development record
This dossier integrates an archived editorial source review dated 2026-09-11. Website reconciliation does not constitute a new medical or regulatory review. Controlled product approval, use instructions and supply status remain unestablished.
- Portfolio reference
- LP-026Anti-Infectives
- Generic identity
- Artemether + lumefantrineTablet/dispersible tablet
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Layers 01–02 · Evidence boundary
What this public record establishes — and what remains held.
- Portfolio reference
- LP-026
- Generic identity
- Artemether + lumefantrine
- Presentation
- Tablet/dispersible tablet
- Catalogue strength
- 20 mg + 120 mg tablet; 20 mg + 120 mg dispersible tablet
- Catalogue pack
- Blister pack; adult 6-dose pack and paediatric dispersible pack per national malaria protocol
- Public status
- Development presentation
Layer 01 · Controlled catalogue facts
- Generic combination identity: artemether + lumefantrine.
- Catalogue component pair: 20 mg artemether + 120 mg lumefantrine.
- Catalogue dosage-form field: tablet/dispersible tablet.
- General catalogue pack field: blister pack.
Layer 02 · Unresolved product-specific fields
- Whether the intended portfolio includes a conventional tablet, a dispersible tablet, or both as separately controlled products.
- Exact blister count/configuration for each dosage form; the inherited “adult 6-dose/pediatric packs” sentence is not a controlled SKU map.
- Approved indication, weight/age eligibility, regimen and national-program alignment for any exact product.
- Exact excipients, storage, shelf life, registration, manufacturing route and supply status.
Identity note
B01 issue P006 remains open. WHO records show that 20 mg/120 mg conventional and dispersible products can exist as distinct finished products with their own pack configurations; they do not identify LP-026 or establish Luang Pharma prequalification.
02 · Variants
Preserve each catalogue row without inferring missing SKU relationships.
| Variant | Proposed strength / concentration | Dosage form | Presentation detail | Pack relationship | Evidence status |
|---|---|---|---|---|---|
| A | 20 mg artemether + 120 mg lumefantrine | Tablet | — | Blister pack; exact count/configuration not supplied | Do not convert regimen/protocol language into a pack SKU. |
| B | 20 mg artemether + 120 mg lumefantrine | Dispersible tablet | — | Blister pack; exact count/configuration not supplied | Dispersible status is kept separate; no paediatric authorisation or pack size is inferred. |
The table reproduces or structures catalogue-level fields. It does not create an approved SKU, instruction or specification where the source record does not provide one.
03 · External reference context
Ingredient and dosage-form background
Artemether with lumefantrine is an artemisinin-based antimalarial combination used in appropriate cases of uncomplicated malaria. It is not a preventive travel medicine and does not replace the management required for severe malaria. Parasite species, geography and national resistance guidance matter. This educational profile describes the ingredient combination and does not certify a Luang Pharma formulation, establish a WHO prequalification claim or provide a treatment regimen.
Clinical context and therapeutic role
Suspected malaria needs timely diagnostic testing and assessment of severity. A professional determines whether an oral combination is appropriate and whether vomiting, inability to eat or other factors could compromise treatment. Severe disease, altered consciousness, marked weakness, jaundice or breathing difficulty requires urgent care. National malaria policy and current resistance information should guide selection; a tablet or dispersible format cannot establish the correct clinical role on its own.
Selected safety context
The combination can affect heart rhythm, particularly with a prolonged QT interval, electrolyte abnormalities or interacting medicines. Dizziness, headache, nausea and poor appetite may occur. Important interactions can reduce effectiveness or increase toxicity, so antiretrovirals, other antimalarials and herbal products need review. Fainting, palpitations or severe allergy require urgent assessment. Pregnancy and pediatric eligibility follow current local guidance. Persistent or recurrent fever after treatment must be reassessed for treatment failure or another illness.
Selected external context only. It is not a complete risk profile or Luang Pharma approved labelling. The exact authorised IFU/label and applicable professional guidance control product use.
Formulation, presentation and handling evidence
The catalogue combines conventional and dispersible tablet presentations. These should be identified separately in authorized product information and procurement specifications. A dispersible format has its own preparation instructions, and a conventional tablet should not automatically inherit them. The combination strength does not establish device or administration equivalence.
Preserve the labeled pack and verify which formulation is supplied before administration. Follow its exact preparation and handling instructions. No reconstitution technique, food instruction, storage temperature or shelf life should be borrowed from another product solely because the active ingredients are the same.
Final instructions, storage conditions, shelf life and any after-opening/in-use limits require the exact controlled product documentation; none is created from a comparator reference.
Points for professional review
A qualified prescriber should establish the infection and need for treatment, consult current local guidance and resistance information where relevant, and select a suitable route. Generic reference literature is not a substitute for the authorized local product information.
04 · Layer 04 · Documentation gate
Controlled product documents must close the held fields.
Before this medicine record can support product-specific clinical, technical or supply claims, the exact finished-product documentation must resolve the held fields.
Controlled product list identifying which dosage form(s) are actually intended.
Finished-product formula/specification for each exact dosage form.
Approved label/leaflet plus exact blister configuration/SKU matrix.
Registration/prequalification/market-status evidence for the exact Luang Pharma presentation, if applicable.
Editorial source check: archived record dated 2026-09-11.
Qualified product/medical review: Not recorded at B07b checkpoint
Approved Luang Pharma label: Not provided or established
Registration / availability / supply: not established by this public record.
05 · Layer 03 · Sources & review
External references are attributed, not adopted as Luang Pharma labelling.
| Source | Recorded revision / check | How it is used |
|---|---|---|
| WHO Prequalification: Artemether/lumefantrine tablet 20 mg/120 mg — MA211Archived source classification: WHO prequalified-product reference | Source revision recorded: Prequalified 27 August 2026; Archived access check: 2026-09-11 | External WHO comparator record showing that exact dosage form, pack configuration and product identity matter; not evidence that LP-026 is this product or is prequalified. |
| WHO prequalified medicines list: artemether/lumefantrine tablet and dispersible-tablet presentationsArchived source classification: WHO prequalified-medicines register | Source revision recorded: Access checked 11 September 2026; Archived access check: 2026-09-11 | External WHO register context showing separate tablet and dispersible-tablet products; not Luang Pharma approval, equivalence or SKU evidence. |
External sources may describe authorised products, public-health guidance or device classes. They do not establish equivalence, approval, model performance, manufacturing status or supply eligibility for LP-026.
Professional enquiries
Request product-specific evidence for LP-026.
State the exact presentation or configuration, organisation, destination and evidence you need. The public portfolio record is not an offer of supply.