Regulatory record

Regulatory recordSupporting passage inspected

No current UK-licensed Summary of Product Characteristics for Proviron or mesterolone could be located on the UK electronic medicines compendium (emc) as of this access date, and a UK consumer medicines-information reference states Pro-Viron tablets were discontinued in the UK in September 2018. Proviron/mesterolone is not absent from the market everywhere: a current Bayer Proviron SmPC (authorisation last renewed May 2023) remains in active use in at least the United Arab Emirates, Oman and Kuwait, and an EMA list of nationally authorised mesterolone products dated October 2025 shows Proviron products still authorised in Spain, Greece and Portugal. Presenting Proviron/mesterolone as a currently UK-licensed medicine, or describing its 2008 UK label as a current authoritative label, would be inaccurate.[6][7][3][8]

Jurisdiction
European Union (Spain, Greece, Portugal per EMA's October 2025 list)
Product
Proviron (mesterolone) 25 mg tablets
Indication
Currently nationally authorised in the listed EU member states, and separately marketed under a currently renewed Bayer label in the United Arab Emirates, Oman and Kuwait; no current UK-licensed SmPC was found on the UK emc as of this access date, and the commonly cited September 2018 UK discontinuation rests on a secondary consumer reference, not a primary MHRA determination
Record date
2026-09-08
  • No official MHRA discontinuation record was located or inspected; the September 2018 date rests on a secondary consumer-health reference, not a primary regulator record, and remains an externally unresolved point for a future worker with MHRA-specific access.
  • An empty emc search result is a strong but not absolute indicator; emc is a near-comprehensive registry of UK-licensed medicines, not a legally exhaustive one.
  • This claim describes market/authorisation status only; it makes no statement about the safety, efficacy or endocrine effects of mesterolone.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· New claim added after finding no current UK SmPC for Proviron/mesterolone and confirming active authorisations elsewhere; separates current regulatory status from the existing pharmacokinetics claim, which continues to rest on the historical 2008 UK label plus a corroborating current non-UK label. Independent editorial review pending; no qualified clinical review.

Safety findings

Human observational studySupporting passage inspected

A study of male weightlifters associated long-term mixed AAS exposure with lower left-ventricular function and greater coronary plaque volume than in non-users. The observational design cannot isolate an individual steroid or prove a precise risk of heart attack.[4]

  • Class-context evidence from selected male weightlifters; residual confounding and uncertain historical exposures remain.
  • This finding and the interaction file's "safety-aas-cardiovascular" note rest on the same single study, held under two source records. Seeing both is not two studies agreeing.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.

· Fresh source inspection and atomic assertion review; formulation, endpoints and limits reconciled in endocrine dossier. Prior history preserved; independent editorial review remains pending.

· Added a note that this finding and the interaction file's cardiovascular safety note come from the same single study, after an independent reviewer identified the duplicate source record. No scientific content changed.

Human observational studySupporting passage inspected

The HAARLEM echocardiography cohort found increased left-ventricular mass and reduced function during mixed AAS use. Left-ventricular mass and the E/A ratio returned to baseline at follow-up, when only 25 of 31 participants had recovery imaging. These group findings cannot promise that every person or repeated exposure recovers.[5]

  • Small cohort, coexposures and missing follow-up; no clinical-event or molecule-specific risk estimate.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.

· Fresh source inspection and atomic assertion review; formulation, endpoints and limits reconciled in endocrine dossier. Prior history preserved; independent editorial review remains pending.

Human observational studySupporting passage inspected

A cross-sectional study of male weightlifters associated long-term illicit AAS use with impaired cardiac function and more coronary plaque. The study cannot establish the risk from one particular compound, dose or combination.[4]

  • This note and the compound records' "general-anadrol-safety-86" finding rest on the same single study, held under two source records. Seeing both is not two studies agreeing.
  • Observational evidence, self-reported mixed exposures and potential confounding; not a comparison of medically indicated testosterone treatment.
  • This is the same underlying study cited at full-text scope elsewhere in the site (content/evidence/general.ts "general-aas-cardiovascular-full"); it is one single source, not independent corroboration.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently upgraded this source from abstract to full text on 2026-09-09 via the PMC full text; identified that content/evidence/general.ts already cites the identical paper (same PMID/DOI) at full-text scope and flagged this as a duplicate record, not independent corroboration.

Regulatory recordSupporting passage inspected

FDA reports serious liver injury and other serious reactions involving steroid or steroid-like bodybuilding products. It advises immediately consulting a healthcare professional, including before abrupt cessation, because of dangerous withdrawal problems that can arise from quickly stopping such products.[9]

  • General product safety communication, not an incidence estimate for every listed steroid.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently re-read the live FDA page via the connected browser on 2026-09-09 (the automated tool was blocked) and located its "Content current as of: 09/20/2024" date, correcting the source's prior "undated" status.

Endocrine & recovery

Human observational studySupporting passage inspected

In the HAARLEM cohort of men using mixed anabolic-androgenic steroids, testosterone and sperm recovery differed. The final visit was one year after cycle start, not one year after cessation, and some abnormal final results were already present at baseline. The study did not measure pregnancy or live birth and does not provide a universal recovery deadline.[1]

  • Class-context evidence: mixed exposures cannot isolate any individual molecule or ester, and follow-up was too short to characterize all recovery.
  • Final hormone and semen denominators differ; attrition and resumed use limit recovery inference.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.

· Fresh source inspection and atomic assertion review; formulation, endpoints and limits reconciled in endocrine dossier. Prior history preserved; independent editorial review remains pending.

Pharmacokinetics

Regulatory recordSupporting passage inspected

A historical Pro-Viron SmPC formatted for the UK market (text revised May 2008) reported an oral mesterolone terminal half-life of 12-13 hours. The identical 12-13 hour terminal half-life figure appears in a current Bayer Proviron SmPC used in other markets (last renewed May 2023; text revised November 2023), giving independent-document corroboration of the same manufacturer-reported value. Historical therapeutic observations in either label do not establish absent endocrine suppression or a protective effect in an AAS combination.[2][3]

  • Historical formulation-specific label; current UK regulatory status has not been established by this record (see the separate general-proviron-regulatory-2026 claim).
  • The 2008 UK-formatted label could not be freshly reopened on this access date (publisher access blocked); its prior inspection record is preserved as historical input rather than upgraded.
  • The corroborating 2023 label is formatted for Gulf-region markets (UAE, Oman, Kuwait pharmacovigilance contacts), not the UK. Matching values across two manufacturer labels is not independent primary pharmacokinetic research; both derive from the same underlying data package.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.

· Attempted to freshly reopen the 2008 UK label; blocked by the publisher (HTTP 403) with no archived copy found. Located and inspected a current (2023) Bayer Proviron SmPC via a connected browser session that independently reports the identical 12-13 hour half-life, and added it as corroborating support. Independent editorial review pending; no qualified clinical review.

Interaction evidence

Human observational studySupporting passage inspected

Long-term illicit AAS exposure was associated with myocardial dysfunction and greater coronary plaque in male weightlifters. Concern about combining AAS follows from this class evidence; the incremental risk of any two steroids was not measured, and the paper does not name or compare specific steroid combinations.[4]

  • Observational, mixed self-reported exposure; no pair-specific causal estimate.
  • This is the same underlying study cited at full-text scope elsewhere in the site (general.ts "general-aas-cardiovascular-full"); it is one single source, not independent corroboration.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceSupporting passage inspected

FDA warns that people who “stack” steroid-like bodybuilding products with other products, including stimulants, may be at greater risk for serious and life-threatening reactions. This broad warning does not establish the effect or severity of an individual compound pair.[9]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceAbstract inspected

A review of testosterone-treatment studies found increased hemoglobin and hematocrit. Extrapolating to combined anabolic steroids suggests a possible overlapping effect, but the review did not establish pair-specific thrombosis risk.[10]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceAbstract inspected

Testosterone-related hematocrit increases and tamoxifen/raloxifene thromboembolic findings come from different study populations. They motivate a possible overlapping concern, not evidence of a measured thrombosis increase from the selected pair.[10][11]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceAbstract inspected

A controlled study in men given goserelin, testosterone gel and anastrozole linked estrogen deficiency to increased body fat and a contribution to reduced sexual function. Only anastrozole was studied; it does not establish the outcome of combining aromatase inhibitors generally, or of adding anastrozole specifically to a particular anabolic steroid.[12]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
  • Exemestane and letrozole were not administered in this trial and do not inherit this observation; the compound scope and the corresponding rule's applicable IDs are narrowed to anastrozole (see interactionsFileNotes).
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently re-read the abstract on 2026-09-09 and confirmed only anastrozole (not exemestane or letrozole) was used in this trial's second cohort; narrowed the claim's compound scope from all three aromatase inhibitors to anastrozole and flagged the corresponding rule restriction for the coordinator.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Narrowly supported passages published with study/product limits; remaining inherited assertions withheld from established-fact displays.

  • Not a comprehensive systematic review. Original monograph topics beyond the individual published claims—including monitoring schedules, contraindication lists, recovery assurances and detailed mechanisms—remain unverified.
  • No qualified clinician has reviewed these claims. Long-term outcomes and all marketed formulations have not been fully assessed.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. Disruption and recovery of testicular function during and after androgen abuse: the HAARLEM study.

    Smit DL, Buijs MM, de Hon O, den Heijer M, de Ronde W. Hum Reprod. 2021;36(4):880-890. DOI: 10.1093/humrep/deaa366. 2021-02-07. PMID:33550376 · DOI:10.1093/humrep/deaa366 Full text inspected.

    Inspected location: Smit 2022 thesis, chapter 6, printed pp. 95-112: methods, Tables 1-4, recovery results and discussion; PubMed 33550376 abstract; Amsterdam UMC publication record

    Study context and inspection record
  2. Pro-Viron mesterolone: historical UK SmPC

    2008-05-01. Product label.

    Inspected location: Section 5.2 and date-of-revision section

    Study context and inspection record
  3. Proviron 25 mg tablets: Summary of Product Characteristics (Gulf-region printing)

    2023-11-17. Product label.

    Inspected location: Sections 1-10 via connected-browser rendering (direct automated retrieval was blocked, HTTP 403; see correctionCheck): Section 2 composition (25 mg mesterolone, lactose monohydrate excipient); Section 4.1-4.9 clinical particulars, including adverse-event reporting contacts for the United Arab Emirates, Oman and Kuwait; Section 5.1-5.2 pharmacological/pharmacokinetic properties (absorption, distribution, biotransformation, and an Elimination paragraph stating "the serum levels of mesterolone decrease with a terminal half-life of 12-13 hours"); Section 7 Marketing Authorisation Holder (Bayer AG, Leverkusen, Germany); Section 8 Registration No. 824 24 04; Section 9 (first authorisation 9 October 1970, last renewal 22 May 2023); Section 10 date of revision 17/11/2023.

    Study context and inspection record
  4. Cardiovascular Toxicity of Illicit Anabolic-Androgenic Steroid Use

    Baggish AL, Weiner RB, Kanayama G, Hudson JI, Lu MT, Hoffmann U, Pope HG Jr. Circulation. 2017;135(21):1991-2002. DOI: 10.1161/circulationaha.116.026945. 2017-05-23. PMID:28533317 · PMCID:PMC5614517 · DOI:10.1161/CIRCULATIONAHA.116.026945 Full text inspected.

    Inspected location: Methods: design, recruitment, primary outcomes and adjustment; Results Cardiac Structure/Function and Coronary Atherosclerosis; Discussion and Limitations; table references 2-4

    This page cites a second record of the same publication. They are listed together so one study is not read as separate supporting evidence.

    Same publication, separate inspection record: Methods: participant recruitment and blinding, and an ancillary non-weightlifter comparison group used to isolate weightlifting from AAS effects; Results: LV systolic/diastolic function and coronary artery plaque volume, including the on-drug (n=58) versus off-drug (n=28) subgroup comparison; Discussion Limitations paragraph on residual confounding, exposure misclassification and survivorship bias Full text inspected. Inspection record

    Study context and inspection record
  5. Anabolic Androgenic Steroids Induce Reversible Left Ventricular Hypertrophy and Cardiac Dysfunction. Echocardiography Results of the HAARLEM Study

    Smit DL, Voogel AJ, den Heijer M, de Ronde W. Front Reprod Health. 2021;3:732318. DOI: 10.3389/frph.2021.732318. 2021-09-01. PMID:36304014 · DOI:10.3389/frph.2021.732318 Full text inspected.

    Inspected location: Methods; followup disposition; Table 1; Left Ventricle and Diastolic Function results; Discussion and Limitations

    Study context and inspection record
  6. electronic medicines compendium (emc): search results for "mesterolone" and "proviron"

    undated. Regulatory document.

    Inspected location: Search results pages for the queries "mesterolone" (https://www.medicines.org.uk/emc/search?q=mesterolone) and "proviron" (https://www.medicines.org.uk/emc/search?q=proviron), both returning "No search results" with no discontinued-medicine listing surfaced either.

    Study context and inspection record
  7. Mesterolone tablets - Pro-Viron (patient information reference page)

    2019-11-21. Full text inspected.

    Inspected location: Page statement: "Pro-Viron® tablets were discontinued in the UK in September 2018. At the time of review there are no branded or generic products containing mesterolone available in the UK. Mesterolone may still be available in other countries."

    Study context and inspection record
  8. List of nationally authorised medicinal products: mesterolone (PSUSA/00010551/202501)

    European Medicines Agency. European Medicines Agency, Human Medicines Division, EMADOC-1700519818-2498333, dated 02 October 2025. 2025-10-02. PSUSA/00010551/202501 · EMADOC-1700519818-2498333 Regulatory document.

    Inspected location: Full 3-page document: table of nationally authorised mesterolone products, listing Proviron 25 mg comprimidos (Bayer Hispania SL, Spain, national authorisation 48.881), Proviron (Bayer Hellas SA, Greece, authorisation 21964/29-3-2012) and Proviron 25 mg comprimidos (Bayer Portugal Lda, Portugal, authorisations 8242404 and 8242412).

    Study context and inspection record
  9. FDA: Caution - Bodybuilding Products Can Be Risky

    undated. Regulatory document.

    Inspected location: Opening paragraphs; adverse-reaction lists; "stacking" paragraph naming stimulants; "What to Do"; footer "Content current as of: 09/20/2024"

    Study context and inspection record
  10. Adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis

    2010-06. PMID:20525906 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record
  11. Selective oestrogen receptor modulators in prevention of breast cancer: an updated meta-analysis of individual participant data

    2013-05-25. PMID:23639488 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record
  12. Gonadal steroids and body composition, strength, and sexual function in men

    2013-09-12. PMID:24024838 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • Fresh PubMed EUtils retrieval for inherited lead PMID 6539197; identity, abstract and linked corrections checked where an abstract existed.
  • https://pubmed.ncbi.nlm.nih.gov/33550376/ — abstract; PubMed abstract: Main results: testosterone and sperm outcomes during recovery; Limitations: duration and mixed AAS exposure
  • https://www.bayer.com/sites/default/files/proviron-smpc-may-2008-1.pdf — label; Section 5.2 and date-of-revision section
  • https://pmc.ncbi.nlm.nih.gov/articles/PMC5614517/ — full-text; Methods: study design and cardiovascular assessment; Results: Tables 2 and 3; Discussion: Limitations
  • https://www.frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2021.732318/full — full-text; Methods: echocardiography and analysis; Results: Table 1, follow-up disposition, Left Ventricle and Diastolic Function; Limitations

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