Women's Health · LP-108
Medroxyprogesterone acetate Injection
Generic medicine development record. Review the proposed presentation and the professional reference information below.
Development record
- Portfolio reference
- LP-108Women's Health
- Generic identity
- Medroxyprogesterone acetateInjection
- Registration
- Not establishedProduct-specific evidence required
- Availability
- Not marketedNo offer of supply
01 · Ingredient reference
Record identity and reference background.
- Portfolio reference
- LP-108
- Generic ingredient
- Medroxyprogesterone acetate
- Dosage form
- Injection
- Proposed strength
- 150 mg/mL vial; 104 mg/0.65 mL prefilled device
- Proposed pack
- Vial or prefilled device; storage per approved label
- Portfolio category
- Women's Health
About Medroxyprogesterone acetate
Medroxyprogesterone acetate is a progestin used in long-acting injectable formulations for defined clinical purposes. Depot formulations release medicine over time and have characteristics that differ from oral medroxyprogesterone. This source record combines an intramuscular vial presentation with a subcutaneous device presentation having a different total content and concentration. They require separate labels, administration routes and product specifications and must not be treated as interchangeable because the ingredient is shared.
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 considers eligibility, bleeding changes, the duration of effect and the possibility of delayed return to fertility after stopping. Bone-health considerations can be relevant to ongoing use. Some medroxyprogesterone injection labels also contain other indications, which cannot be transferred between products. A decision should follow the exact locally authorized formulation and a clinical assessment; no administration interval or self-injection programme is established by this catalogue entry.
Important safety considerations
Irregular bleeding, changes in weight, headache and injection-site reactions can occur. Serious concerns include loss of bone mineral density, thrombotic disease in susceptible patients and severe allergic reactions. Unexplained bleeding, breast cancer history and significant liver disease affect eligibility. Meningioma, a tumour affecting the tissue around the brain or spinal cord, is a recognized risk requiring current clinical review. The medicine does not protect against sexually transmitted infections, and pregnancy status requires appropriate 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 vial and prefilled device represent distinct depot formulations and routes. Confirm suspension characteristics, device instructions, exact concentration and route for each presentation. A cold-chain requirement must come from validated product-specific storage data, not from the fact that the product is injectable.
Professional preparation must follow the authorized label and local aseptic procedures. Confirm the correct container, concentration, route and expiry before use. Storage, transport, dilution compatibility and any period after opening or reconstitution require product-specific evidence; this page does not establish them.
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
Review contraceptive or other intended indication, pregnancy possibility, bleeding history, bone health, relevant tumours and vascular or liver disease. Confirm route and presentation before any procurement or clinical decision.
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
- Medroxyprogesterone acetate
- Dosage form / presentation
- Injection
- Catalogue strength
- 150 mg/mL vial; 104 mg/0.65 mL prefilled device
- Catalogue pack
- Vial or prefilled device; cold-chain where required
- Portfolio category
- Women's Health
Layer 02
Unresolved product-specific fields
- P017 — The catalogue combines a 150 mg/mL vial and a 104 mg/0.65 mL prefilled device. Exact presentation, route and formulation must be controlled separately; they are not interchangeable because the ingredient is shared.
- The phrase “cold-chain where required” is not a storage specification. No storage temperature, excursion allowance or transport condition is asserted without variant-specific controlled documentation.
- 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: Medroxyprogesterone Injectiongovernment-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
- Separate controlled masters for the 150 mg/mL vial and 104 mg/0.65 mL prefilled device, including exact formulation, route, device instructions and variant-specific storage/transport conditions.
- 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-108, 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-108.
State the exact presentation, organisation, destination and evidence needed. This public record is not an offer of supply.