What this pack is
NOLVADEX is the brand name in this record; tamoxifen is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
NOLVADEXGeneric nametamoxifen
How this medicine works
The PMDA patient guide classifies this medicine in endocrine-therapy-related treatment and describes action on estrogen receptors to suppress breast-cancer-cell proliferation. This is a regulatory-document mechanism-reading cue, not a decision about anyone's pathology, suitability, tablet count, duration, sequencing with anastrozole/letrozole or another product, co-use or switching.
Read source: Japan ↗Current regulatory record · reviewed 2026-09-08More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- NOLVADEX
- Source-scoped market brand names
- ノルバデックス · JapanCurrent regulator record ↗The current PMDA product page lists NOLVADEX 10 mg/20 mg tablets, tamoxifen citrate and the Japanese marketing authorisation holder. It only supports checking the Japanese trade name, ingredient, strength, form and regulatory-document entry points—not names, packs, supply, purchase eligibility, authenticity or self-directed switching in another market.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- tamoxifen
- Dosage-form class
- Japan PMDA current label: tamoxifen citrate film-coated oral tablets, with tamoxifen 10 mg or 20 mg per tablet.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
JP · Current PMDA public label (revised Mar 2026)
Tamoxifen 10 mg per tablet; product identity listed in the current PMDA label
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- Japan approval No. 21800AMX10347
- Form and route
- NOLVADEX tamoxifen citrate film-coated oral tablet · oral (label product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-26; actual marketing, stock and availability are not established.
- tamoxifen
- 10 mg10 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction
- Labelled appearance
- white · film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions · imprint NOLVADEX 10Score status has not been established from the cited source
JP · Current PMDA public label (revised Mar 2026)
Tamoxifen 20 mg per tablet; product identity listed in the current PMDA label
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- Japan approval No. 21800AMX10348
- Form and route
- NOLVADEX tamoxifen citrate film-coated oral tablet · oral (label product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-26; actual marketing, stock and availability are not established.
- tamoxifen
- 20 mg20 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction
- Labelled appearance
- white · film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions · imprint NOLVADEX 20Score status has not been established from the cited source
LOOK CLOSER · CHECK THE SOURCE
Official product-appearance references
- Check the name and strengthMatch the full medicine name, mg, form and country on your pack to the image title.
- Enlarge to read the markingsFor tablets, read the imprint; for sachets, check the name and strength. Similar colour or shape alone is not enough.
- Compare with the official guideOpen the source below the image. If details differ or are unclear, show the actual pack to a pharmacist.
Scope: dated Japanese PMDA patient-guide images—not an exact outer package, not a China or U.S. pack. Appearance cannot establish authenticity, availability, interchangeability or how much to take.
Japan · PMDA patient guide
NOLVADEX tamoxifen 10 mg tablet: official Japan appearance
Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching.
Open the official PMDA patient guide ↗Japan · PMDA patient guide
NOLVADEX tamoxifen 20 mg tablet: official Japan appearance
Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching.
Open the official PMDA patient guide ↗PACKAGE-VISUAL STATUS
The current PMDA label text was reviewed, but no official package image matching one exact strength and pack was retained, so no package visual is shown
This dossier retains NOLVADEX/ノルバデックス, tamoxifen citrate, 10 mg/20 mg, two approval numbers, the current PMDA label and patient-medicine-guide entry points. This review did not retain an official package image that can safely be matched one-to-one to a single strength and pack; to avoid presenting a version-uncertain image, retail image, another-market image or another-strength image as the exact product, the page withholds package imagery and retains the official electronic leaflet for enlarged reading.
LABEL READING · NOT A PRESCRIPTION
NOLVADEX label reading: check the full name, mg and market together first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module only reads product-identity and safety-reading entries in the current Japanese PMDA NOLVADEX label and patient guide. It provides no individual tablet count, treatment duration, missed-use handling, splitting, co-use, stopping, switching or purchase plan.
- Check the full NOLVADEX/ノルバデックス name, generic tamoxifen, 10 mg or 20 mg per tablet, film-coated oral-tablet form, target market and current prescription together. mg is a labelled amount for an exact tablet, not a web calculation for an individual's tablet count, duration or conversion between strengths.
- ノルバデックス and ノルバスク (NORVASC) differ by only a small amount of text; a partial sound, colour or the fact that both are tablets cannot establish that they are the same medicine. If the name, pack, market or strength is unclear, check the full trade name, generic name, strength, form and accessible source document, and have a pharmacist or prescriber review the actual pack and complete medicine list.
- A patient medicine guide helps patients and families understand a medicine and recognise possible serious adverse reactions early; it does not replace a prescription, treatment team or individual risk assessment. Pregnancy/possible pregnancy, breast-feeding, history, other prescription medicines, OTC products and supplements require item-by-item review by the responsible team before actual use.
- With breathing difficulty, swelling of the face or throat, chest pain, sudden one-sided limb swelling/pain, sudden neurologic change or another acute serious concern, prioritise local emergency medical support; do not test the cause by stopping or changing several medicines yourself.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkPMDA · Japan · Regulatory product record · 2026-08-26
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- Japan · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routePMDA: current NOLVADEX 10 mg/20 mg product page ↗Current regulatory record · reviewed 2026-08-26
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- PMDA · Japan · Regulatory product record · 2026-08-26PMDA: current NOLVADEX 10 mg/20 mg label (Mar 2026 revision) ↗Current regulatory record · reviewed 2026-08-26
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about NOLVADEX (tamoxifen). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
NOLVADEX is the brand in this record and tamoxifen is the active-ingredient name. Check both with the dosage form (Japan PMDA current label: tamoxifen citrate film-coated oral tablets, with tamoxifen 10 mg or 20 mg per tablet.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- PMDA: current NOLVADEX 10 mg/20 mg product page ↗Current regulatory record · reviewed 2026-08-26
- PMDA: current NOLVADEX 10 mg/20 mg label (Mar 2026 revision) ↗Current regulatory record · reviewed 2026-08-26
HOW IT WORKS · NOT A TREATMENT PLAN
How tamoxifen works: a receptor-related explanation cannot replace an individual treatment decision
- “Estrogen receptor”, “endocrine therapy” or a shared disease name does not make NOLVADEX, ARIMIDEX, FEMARA or another treatment self-switchable, combinable, alternatable or convertible by mg. Exact products, market, test materials and the complete medicine list require oncology-team review together.
- A mechanism explanation is not a tool for interpreting an individual's breast imaging, pathology, hormone receptors, genetic report or recurrence risk, and cannot replace assessment of prior treatment, pregnancy possibility, coexisting conditions, organ function and all co-medications.
- Do not use mechanism or label numbers to handle an acute symptom, missed use, stopping, make-up use, co-use or switching. Real questions must return to the current target-market label for the exact product and the responsible treatment team or pharmacist.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- PMDA: current NOLVADEX 10 mg/20 mg product page ↗Current regulatory record · reviewed 2026-08-26
- PMDA: current NOLVADEX 10 mg/20 mg label (Mar 2026 revision) ↗Current regulatory record · reviewed 2026-08-26
- PMDA: NOLVADEX 10 mg/20 mg patient medicine guide (May 2023 update) ↗Current regulatory record · reviewed 2026-09-08
SOURCE-TRACEABLE ARCHIVE
NOLVADEXtamoxifen
This page links to public primary-source material for NOLVADEX. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
10 mg marketing start listed in the current Japanese PMDA label
The current PMDA label lists Sep 1981 as the marketing start for NOLVADEX 10 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability.
PMDA: current NOLVADEX 10 mg/20 mg label (Mar 2026 revision) ↗20 mg marketing start listed in the current Japanese PMDA label
The current PMDA label lists Jun 1990 as the marketing start for NOLVADEX 20 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability.
PMDA: current NOLVADEX 10 mg/20 mg label (Mar 2026 revision) ↗Current PMDA label revision record
The current PMDA product page links the 17 Mar 2026 label and patient-medicine-guide entry point. This date locates a reviewable document version; it is not a conclusion about individual use, package supply, purchase or another-market status.
PMDA: current NOLVADEX 10 mg/20 mg product page ↗
MARKET SCOPE
Market-record boundary
Japan
Current PMDA product page, label, patient guide and two tablet identities linkedThis page separately records only NOLVADEX 10 mg (approval No. 21800AMX10347) and 20 mg (21800AMX10348), labelled amount per tablet and official-document entry points in current Japanese PMDA materials; it does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, duration, co-use, stopping, switching or interchangeability.
Mainland China, the United States, the EU and other markets
Current market record not establishedNo local trade name, approval, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from Japanese PMDA brand, approval numbers, historical marketing-start dates, label, patient guide or marketing-authorisation holder; each market requires separate checking against current local regulatory material.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Can 10 mg, 20 mg and Japanese approval numbers tell me how many to take or whether I can change to another endocrine treatment?
No. These fields only identify the exact Japanese tablets in current PMDA materials. A shared treatment area, nearby mg number, similar name, label or package appearance does not establish self-initiation, increase, make-up use, stopping, co-use, alternation, conversion or substitution; have the oncology team or pharmacist review the actual pack, current prescription and complete medicine list.
Why does the page flag similar NOLVADEX/NORVASC names without telling me whether to stop or change medicine?
A similar-name reminder helps prevent an uncertain pack from being misread as another medicine; it is not a treatment decision. Do not self-stop, change, combine or increase any medicine from a partial sound, colour, online photo or webpage; with a suspected mix-up, acute serious concern or need to check an actual prescription, prioritise local medical support or the responsible team.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.