Women's Health · LP-101

Ethinylestradiol + levonorgestrel Tablet cycle pack

Generic medicine development record. Review the proposed presentation and the professional reference information below.

Development record

Illustrative packaging concept for Ethinylestradiol + levonorgestrel Tablet cycle pack
Illustrative packaging concept · visual reference only · final registered artwork and brand presentation to be confirmed.
Portfolio reference
LP-101Women's Health
Generic identity
Ethinylestradiol + levonorgestrelTablet cycle pack
Registration
Not establishedProduct-specific evidence required
Availability
Not marketedNo offer of supply

01 · Ingredient reference

Record identity and reference background.

Portfolio reference
LP-101
Generic ingredient
Ethinylestradiol + levonorgestrel
Dosage form
Tablet cycle pack
Proposed strength
30 mcg + 150 mcg; 30 mcg + 250 mcg
Proposed pack
21/28-tablet cycle pack
Portfolio category
Women's Health

About Ethinylestradiol + levonorgestrel

Ethinylestradiol and levonorgestrel combine an estrogen and a progestin in oral contraceptive products. The combination acts principally by suppressing ovulation, with other effects contributing to contraception. Suitability depends on medical history and cardiovascular and thrombotic risk, not merely the strength or cycle-pack size. This catalogue description is education about a hormonal combination and should not be read as a recommendation to start it.

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

Contraceptive counselling includes method choice, ability to follow the specific pack, interactions and circumstances that can reduce effectiveness. Combined oral contraception does not protect against sexually transmitted infections. The sequence and number of active and inactive tablets vary by product. The source catalogue lists two component-strength combinations, so a verified individual presentation and current local product information are essential before any clinical use or procurement specification is finalized.

Important safety considerations

Blood clots, stroke and myocardial infarction are important serious risks. Smoking, increasing age, previous thrombosis, certain migraine patterns, uncontrolled hypertension and relevant heart or liver disease require careful eligibility assessment. Sudden chest pain, shortness of breath, unilateral leg swelling or neurological symptoms require emergency assessment. Review interacting medicines, including enzyme-inducing therapies, and unexplained vaginal bleeding. This is not a complete contraindication list.

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

Each cycle pack must identify the hormone content and sequence of every tablet. The catalogue does not establish whether a 28-tablet pack includes placebo or other non-hormonal tablets. The listed component strengths must remain separate specifications until verified.

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

Assess contraceptive eligibility, blood pressure, smoking, migraine and thrombotic history, pregnancy possibility and interacting medicines. Verify the precise cycle pack and locally approved patient information.

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
Ethinylestradiol + levonorgestrel
Dosage form / presentation
Tablet cycle pack
Catalogue strength
30 mcg + 150 mcg; 30 mcg + 250 mcg
Catalogue pack
21/28-tablet cycle pack
Portfolio category
Women's Health

Layer 02

Unresolved product-specific fields

  • The 30 mcg + 250 mcg entry requires exact formulation and registration verification; do not normalize to a more familiar combination.
  • P013 — One cycle-pack record lists 30 mcg + 150 mcg and 30 mcg + 250 mcg, without supporting product-specific composition evidence.
  • 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

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

  • Product-specific composition evidence for each ethinylestradiol/levonorgestrel strength and exact 21/28-day cycle-pack configuration.
  • 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-101, 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

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-101.

State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.

Contact Luang Pharma