This review brings together 20 verified groups of official communications from Australia, the European Union, Japan and Russia. Current publications of 11–12 November are supplemented by four explicitly identified retrospective Japanese groups. Topics include avacopan restrictions, contraception after CellCept, ARIA risk management, renal replacement therapy dosing and targeted recalls. Document and action dates are shown separately from publication dates.
For QPPV, LQPPV and LCPPV: assess each communication within the responsibilities and requirements of the relevant jurisdiction.
Current communications and updates
Avacopan: PMDA English notice and Japanese switching materials
On 12 November PMDA posted the English version of the MHLW notice dated 21 October. The regulator could not conclude that benefits outweigh risks because of concerns about trial-data reliability. Treatment should not be started in new patients; discontinuation or switching should be considered individually for existing patients. May Blue Letter precautions remain applicable while treatment continues. Japanese planned-withdrawal/switching materials posted on 5 November were checked as a retrospective companion.
Paracetamol: one batch recalled for dissolution noncompliance
Roszdravnadzor · Document: 01И-1291/26 · Publication or update: 2026-11-11 12:23 (site time) · Document or action date: 2026-11-09
Roszdravnadzor reports the manufacturer's recall of batch 2210424 of paracetamol 500 mg,10 tablets, because a tested portion did not meet the dissolution specification. The letter refers to a September quality finding but documents a subsequent recall and measures addressing a threat to life and health. The action concerns the identified batch.
TGA · Document: RC-2026-RN-00920-1 · First observed in the database: 2026-11-12 · Document or action date: 2026-11-10
TGA records a Class III recall after the courier delivered the wrong box, which did not meet the customer's activity and dose requirements. Clinical sites received an immediate notice; stock was returned and replaced. The source documents a shipment error and does not report an adverse outcome.
TGA · Document: RC-2026-RN-00903-1 · First observed in the database: 2026-11-12 · Document or action date: 2026-11-10
The Australian Class III correction revises compound concentrations relevant to barbiturate-assay interpretation. Incorrect values may contribute to false-positive or false-negative results. Users should discuss the appropriate action, including previous results, with their medical director. This is a local follow-up to the Siemens correction already reviewed in the preceding package.
TGA · Document: RC-2026-RN-00919-1 · First observed in the database: 2026-11-12 · Document or action date: 2026-11-10
The Class II correction adds information on intrauterine adhesions and Asherman syndrome following intrauterine procedures, particularly those involving mechanical endometrial trauma. TGA describes patient, procedural and clinical factors that may influence risk. Users should review the revised warnings.
Xpert MRSA/SA SSTI: batch recalled for false negatives
TGA · Document: RC-2026-RN-00926-1 · First observed in the database: 2026-11-12 · Document or action date: 2026-11-10
The Class II recall concerns batch1001489295(lot 17701). False-negative results may delay or misdirect treatment, with potential progression to bloodstream infection and sepsis. TGA instructs users to stop using affected kits, dispose of remaining product and request replacements. Its regulatory classification remains Class II.
EMA · Document: EMA/VR/0000365313 · Publication or update: 2026-11-11 · Document or action date: 2026-10-15
The updated CellCept information extends contraception after treatment for women of childbearing potential from six weeks to six months. SmPC sections 4.4/4.6 and the leaflet were updated. The 15 October procedure mentions submission of RMP 3.0; the current published file is version 3.1. Updated information was published on 11 November.
EMA · Document: VR/0000386673; VR/0000386383; EPITT20255 · Publication or update: 2026-11-11 · Document or action date: 2026-11-11
Updated Braftovi and Mektovi information lists neutropenia as a common adverse reaction for the relevant combined use. This implements the previously reviewed PRAC recommendation on signalEPITT 20255 and is not a new independent signal. The cards and current product information are dated 11 November; the combination is counted once.
Emblaveo: dosing during continuous renal replacement therapy
EMA · Document: EMA/VR/0000340764 · Publication or update: 2026-11-11 · Document or action date: 2026-10-15
Sections 4.2/5.2 clarify continuous renal replacement therapy dosing according to effluent flow and assuming no residual renal function. The recommendations are based on an ex-vivo study and pharmacokinetic simulations. Specific doses should be taken from the current official product information.
EMA · Document: EMA/VR/0000341324 · Publication or update: 2026-11-11 · Document or action date: 2026-10-15
Sections 4.2/5.2 add initial CRRT dosing recommendations based on effluent flow and assuming no residual renal function, supported by in-vitro data and pharmacokinetic modelling. This is a dosing update rather than a newly identified adverse reaction.
Flixabi: post-authorisation study programme updated
EMA · Document: EMA/VR/0000358948; RMP15.0 · Publication or update: 2026-11-11 · Document or action date: 2026-10-29
The variation covers final ARTIS and RABBIT-RA safety-study reports and a waiver request for the final BSRBR-RA report; its summary mentions RMP 15.0. The current published RMP is version 15.1 dated 1 October and identifies changed additional BSRBR-RA pharmacovigilance activities. This does not establish a new risk or the end of all monitoring.
EMA · Document: EMA/PAM/0000362957; EMADOC-1700519818-3353205 · Publication or update: 2026-11-11 · Document or action date: 2026-10-15
CHMP assessed V920-007 long-term follow-up submitted under Article 46 of the paediatric regulation. The limited descriptive immunogenicity and safety data identified no new safety concern, required no product-information update and left the benefit–risk balance unchanged. This is a study assessment, not a recall or new signal.
PMDA/MHLW · Document: MHLW1112No.1 · Publication or update: 2026-11-12 · Document or action date: 2026-11-12
The MHLW guideline sets patient-selection, facility, safety-information and adverse-event response/reporting requirements. It identifies severe component hypersensitivity as a contraindication and requires attention to serious allergic reactions. These are proper-use conditions rather than a newly identified signal.
Donanemab: ARIA management and consideration of APOE testing
PMDA/MHLW · Document: MHLW1112No.2 · Publication or update: 2026-11-12 · Document or action date: 2026-11-12
The change table adds consideration of APOE testing, generally before treatment, using an approved diagnostic test with explanation and consent. Suspected ARIA calls for prompt clinical assessment and MRI. The document does not require mandatory genotyping of every patient.
Lecanemab: ARIA, anaphylaxis and subcutaneous self-administration
PMDA/MHLW · Document: MHLW1112No.3 · Publication or update: 2026-11-12 · Document or action date: 2026-11-12
The guideline adds consideration of APOE testing for ARIA management and specifies MRI monitoring for the subcutaneous formulation. Anaphylaxis requires discontinuation without rechallenge. Self-administration requires suitability assessment, training and physician oversight; treatment initiation takes place at a medical facility.
Pembrolizumab: proper use of the subcutaneous combination
PMDA/MHLW · Document: MHLW1112No.4 · Publication or update: 2026-11-12 · Document or action date: 2026-11-12
MHLW revised optimal-use guidelines to cover the newly approved subcutaneous pembrolizumab/berahyaluronidase-alfa combination. The document defines applicable patients and facility requirements and refers to current product information and the RMP. The formulation update is not presented as a new safety signal.
PMDA/MHLW · Document: No separate document number; PMDA PDF000283500 · Publication or update: 2026-11-10 · Document or action date: 2026-11 (day not stated)
In its PMDA-hosted communication, Towa reports N-nitrososertraline detection. Some lots exceeded the calculated lifetime limit of 1 ppm, by at most 1.4-fold, while all were below the interim 6.7 ppm value. The company reports continued supply following discussion with MHLW and advises against independent treatment cessation. This is a retrospective review, not a recall.
PMDA/MHLW · Document: No separate numbers; PMDA PDFs000283499/000283425/000283426/000283360 · Publication or update: 2026-11-10 (Felsen; other entries November) · Document or action date: 2026-11 (day not stated)
Manufacturer communications hosted by PMDA describe N-nitrosomeglumine up to 2.7times 100 ng/day, below the interim 670 ng/day value. The authors do not consider immediate recall or prescription cessation necessary and advise patients against changing treatment independently. These values and conclusions concern the identified products and are reviewed retrospectively.
PMDA/MHLW · Document: Approval22400BZX00453000; PMDA PDF000283495 · Publication or update: 2026-11-06 · Document or action date: 2026-11-06
MHLW/Tokyo report a recall of 24,300 ARROW PIC kits because the guidewire's hydrophilic coating may swell unevenly, aggregate or detach when wetted. No serious harm in Japan had been reported at the communication date. This is a retrospectively checked Japanese action; foreign notices are not merged without component and lot comparison.
PMDA/MHLW · Document: 1-2506 · Publication or update: 2026-11-09 · Document or action date: 2026-11-09; recall commenced 2026-11-02
The Japanese Red Cross recalled one unit after information that the donor had used a medicine potentially affecting blood-product quality. The unit had not been used; the source explicitly states that no patient harm occurred. The Class I recall began on 2 November and the card was published on 9 November. This was checked retrospectively.
