Women's Health · LP-106
Norethisterone Tablets
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-106Women's Health
- Generic identity
- NorethisteroneTablet
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-106
- Generic ingredient
- Norethisterone
- Dosage form
- Tablet
- Proposed strength
- 5 mg; 350 mcg
- Proposed pack
- 5 mg: blister 10 x 10 tablets; 350 mcg: 28-tablet cycle pack
- Portfolio category
- Women's Health
About Norethisterone
Norethisterone, also called norethindrone, is a progestin used in different hormonal medicines. The source record includes a low-strength contraceptive tablet and a higher-strength tablet used in other gynaecological contexts. These purposes cannot be merged into a single set of instructions. Salt or ester identity also matters when comparing international references, because some references discuss norethindrone acetate rather than the same ingredient presentation.
How to read this profile
Scientific information relates to the ingredient and dosage-form context. It is not approved Luang Pharma labelling, a clinical recommendation, or evidence of equivalence to a referenced product. Multiple strengths or presentations represent separate proposed variants and must not be treated as interchangeable.
02 · Professional background
Scientific & clinical reference
Read the clinical context, selected safety considerations and presentation-specific information below.
Clinical context and therapeutic role
Clinical review establishes whether the intended use is ongoing contraception or management of a particular menstrual or gynaecological condition. Unexplained bleeding requires assessment before a hormonal medicine is selected. The low-strength daily pill is not an emergency contraceptive, and a higher-strength tablet must not be assumed to provide contraception. References below describe separate progestin presentations and do not establish a locally authorized use for the candidate.
Important safety considerations
Irregular bleeding, headache, nausea, breast tenderness and mood changes can occur. Significant liver disease, certain hormone-sensitive cancers, pregnancy and thrombotic history can affect suitability, depending on the presentation. Severe abdominal pain, jaundice, sudden breathlessness or other serious symptoms need assessment. Enzyme-inducing medicines can alter hormonal exposure or contraceptive effectiveness. Product-specific eligibility and interaction review is essential because the strength and indication change the benefit-risk assessment.
These are selected considerations, not a complete list. Use the current instructions or approved label for the exact authorised product and seek appropriate professional advice.
Presentation, handling and storage
The 5 mg and 350 mcg tablets require separate presentation-level descriptions. Confirm whether the ingredient is norethisterone or an ester and whether a cycle pack is intended. Do not transfer a foreign label for a different chemical form.
Keep the medicine in the labelled original pack with its leaflet. Check the expiry date and pack integrity before dispensing. The authorized label must determine storage temperature, protection from moisture or light, and disposal; no shelf life or in-use period can be established from a catalogue entry.
Final composition, instructions, shelf life and storage conditions are not established by this portfolio entry. They must come from the controlled documentation for the specific product.
Points for professional review
Identify exact chemical form, strength and purpose before reviewing pregnancy possibility, bleeding history, liver disease, thrombotic risk and interactions against the current local label.
03 · Product enquiry
Documentation & regulatory status
Evidence status
What is established — and what remains open
This record has received an editorial evidence-layer review. The review separates catalogue facts from unresolved product-specific fields and external context; it is not medical, regulatory or market-authorisation approval.
Layer 01
Controlled catalogue facts
- Generic ingredient
- Norethisterone
- Dosage form / presentation
- Tablet
- Catalogue strength
- 5 mg; 350 mcg
- Catalogue pack
- Blister 10 x 10 tablets or cycle pack
- Portfolio category
- Women's Health
Layer 02
Unresolved product-specific fields
- Source merges 5 mg and 350 mcg. International higher-strength norethindrone acetate references are not exact chemical-form proof for norethisterone.
- P016 — 5 mg and 350 mcg entries share a pack field containing both standard blister and cycle-pack alternatives.
- Exact release/coating/scoring characteristics and formulation-specific administration instructions require controlled product documentation where applicable.
- Approved indication, patient eligibility and dosing are not established by this portfolio record.
- Registration, manufacturing/site status, supply availability, storage conditions and shelf life remain product- and market-specific evidence items.
Layer 03
Attributed external context
- MedlinePlus: norethindrone progestin-only contraceptive tabletsgovernment-hosted medicine monograph
- MedlinePlus: norethindrone / norethisterone acetate — related ingredient referencegovernment-hosted medicine monograph
These references provide scientific or regulatory context only. They are not Luang Pharma product labelling, registration, manufacturing evidence, equivalence evidence or confirmation of supply.
Layer 04
Documents required to close the record
- Exact norethisterone chemical-form confirmation and strength-to-pack mapping for 5 mg and 350 mcg presentations.
- Controlled product master/specification confirming the exact ingredient identity, dosage form, strength variant and pack mapping.
- Destination-market authorisation or other lawful supply-route evidence plus the approved label/leaflet/IFU, where applicable.
- Product-specific composition/excipient, storage, shelf-life and pack-control documentation.
- Manufacturing-site and supply-status evidence before any public claim of installed capability, registration, availability or equivalence.
For LP-106, identify the destination country, intended professional use, proposed presentation and the role of your organisation. The appropriate supply route and available documentation must be confirmed for that case.
- Confirm the legal entity, manufacturing site and authorised scope for the proposed supply chain.
- Confirm product registration or another lawful route, approved labelling and the applicable destination requirements.
- Request relevant product information, specifications and supporting evidence through the company contact.
- Confirm storage, transport, traceability, complaints and safety-reporting responsibilities before any agreement.
The public catalogue extends beyond the initial planned facility modules. A listing does not mean that the dosage form is installed, qualified or licensed at Boten.
04 · External sources
Sources and further reading
- MedlinePlus: norethindrone progestin-only contraceptive tablets
- MedlinePlus: norethindrone / norethisterone acetate — related ingredient reference
External sources are provided for reference. Their authors do not endorse Luang Pharma, and another product’s authorisation does not transfer to this portfolio record. Source availability and wording can change.
Professional enquiries
Request product-specific evidence for LP-106.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.