Medicine and device safety updates: 19 October 2026

Roszdravnadzor

Romiplostim: Stimplate educational materials support safe preparation and dosing. (Official source; Document 1; Document 2) Elranatamab: the Ilreksi patient card addresses CRS/ICANS and required monitoring. (Official source; Document 1) Tafamidis: the Alufamidis guide covers ATTR-CM diagnosis and pregnancy precautions. (Official source; Document 1)

Pembrolizumab: the Pembroblokin card addresses immune-mediated reactions and should be retained for at least four months after the last dose. (Official source; Document 1) AMLODIPINE-PRANA 10 mg, batch 220525: Roszdravnadzor ordered cessation of circulation and removal because of non-compliance for related impurities. The action concerns the specified batch rather than the manufacturer’s entire portfolio. (Official source; Document 1)

Ukraine SEC

Epcoritamab: Ukraine’s Tepkinly card explains urgent action for symptoms of CRS/ICANS. (Official source; Document 1) Desogestrel/etonogestrel: Ukraine’s NuvaRing, Marvelon and Implanon NXT communication addresses a small meningioma risk with prolonged use and contraindication in current or previous meningioma. (Official source; Document 1)

EMA

Cibinqo: severe baseline atopic dermatitis was removed as a herpes zoster risk factor after review of long-term data; the herpes zoster risk remains. (Official source; Document 1; Document 2; Document 3) Ocrevus: final EMA information incorporates drug-induced liver injury and liver monitoring, implementing previously communicated measures. Use from age 10 concerns the 300 mg IV formulation; 1800 mg SC remains for adults. (Official source; Document 1; Document 2; Document 3) Stelara: information was added on serious hypersensitivity in patients with alpha-gal syndrome, meat allergy or anti-alpha-gal IgE, usually with the first dose. (Official source; Document 1; Document 2)

Plegridy: paediatric data identify ALT elevation as very common. Publication of these data does not establish a new paediatric approval. (Official source; Document 1; Document 2) Afstyla and Idelvion: polysorbate 80 warnings were updated in professional and patient information. (Official source; Document 1; Document 2; Official source; Document 1; Document 2) Remicade: the risk management plan was updated, including DEVELOP follow-up and additional risk minimisation measures. (Official source; Document 1; Document 2)

Padcev: information and RMP 6.3 were updated for perioperative use with pembrolizumab in resectable muscle-invasive bladder cancer. EMA’s assessment identified no new safety concerns; a polysorbate 20 warning was added. (Official source; Document 1; Document 2; Document 3; Document 4) HyQvia: the assessment of Japanese study TAK-771-3005, involving 15 participants including five children, identified no new safety concerns. (Official source; Document 1; Document 2) Strimvelis: publication of RMP 8.0, signed in 2025, updates the pharmacovigilance plan. The historical leukaemia risk is not a new 2026 signal. (Official source; Document 1; Document 2)

Mylotarg: EMA did not support the proposed use in children aged 1–<18 with mitoxantrone/cytarabine because of insufficient benefit evidence and limitations in safety data. The existing approval from age 15 with daunorubicin/cytarabine remains. (Official source; Document 1) Yartemlea: re-examination confirmed refusal of narsoplimab for HSCT-TMA because benefit, safety and dosing evidence was insufficient. This is not a recall of an authorised medicine. (Official source; Document 1) Nyxoid: CHMP recommended non-prescription status for emergency naloxone in opioid overdose; this is a recommendation rather than confirmation of national supply arrangements. (Official source)

EMA: 2028 dates were added to the standard and ATMP timetables for responses to requests for supplementary information in signal assessment. (Official source; Official source) EMA: historical March 2026 CHMP minutes and an annex were published. Interim discussions should be read alongside subsequent decisions. (Official source; Document 2) EMA: historical CHMP PROM minutes from 1 December 2025 were published, covering PRAC, real-world evidence and incident management. (Official source)

EMA: consultation on a kidney transplantation trial concept covers immunosuppression safety and long-term follow-up; comments close 31 January 2027. (Official source; Document 1)

Health Canada

Canada: ARCHITECT i2000SR module 03M74-02/ISR64041 is affected by a local arcing, smoke and operator burn risk; no injuries were reported. (Official source) Canada: NICO Myriad 19×21.5 MHP Paediscope NN8520, in four specified lots, is affected by an adapter fit problem. (Official source) Canada: SIGNA Architect PG75M2300263SC may produce incorrect MR Touch liver stiffness results. (Official source)

TGA

Australia: three product recalls of Andrographis medicines implement action for the known anaphylaxis risk. Check the precise products and batches in each notice. (Official source; Official source; Official source) Calcium Breakthrough B5317.120: soy protein presents a risk for people with soy allergy; no associated adverse reactions had been reported as of 13 October. (Official source) Cefazolin 6000 mg Surefuser BB26101785: leakage was detected before treatment; remaining devices in the batch should be inspected. (Official source)

Ifosfamide/Mesna BB26103194: the supplied component doses were reversed relative to the order. The discrepancy was detected before use and the product was discarded. (Official source) LULA 0 mg/mL: low nicotine levels were detected in two batches. Significant effects are considered unlikely, mild effects cannot be excluded, and no adverse events were reported. (Official source) ORTHO Sera Anti-Fyb V283670/V279053: false-positive results may occur; remove affected lots and review previous results. (Official source)

RayStation 4.7–2026: loss of part of a deformed dose distribution can underestimate accumulated dose. Australian and New Zealand notices address the same issue. (Official source; Official source) Senographe Pristina VIA: differing anode/filter configurations in manual 3D+2D mode may cause a minor additional dose and artefacts; follow the manufacturer’s instructions pending correction. (Official source; Official source) Safe-T-Seal/Maquet sevoflurane vaporizers: specified serial numbers are being recalled and replaced because components may deteriorate in performance. Follow the customer letter until replacement. (Official source)

TruSystem 7000/7500: a main lift column problem may cause injury and procedural complications. Stop use and contact the supplier if unusual noise occurs. (Official source) TAVNEOS: avacopan withdrawal from the Australian market is planned by 31 March 2027. Do not initiate new patients; existing patients should not stop without medical advice, and liver monitoring remains necessary. (Official source)

Medsafe

ESENTA: paste 183910, lot 5L00431, is affected by a foreign material issue. (Official source) Cooper Apple Hunts: cannula CO-900-800, lot 550034148 has a length issue preventing trocar protrusion, detectable before use. (Official source) Abre: partial venous stent deployment may require additional intervention; instructions and manual deployment guidance are being updated. (Official source)

Atellica CH/CI: assay carryover can cause falsely elevated HbA1c and, on CI, falsely low direct bilirubin. (Official source) INKA Sims: instructions for curette INK16378.01 are being updated with an Asherman syndrome warning. (Official source) MiniCap R5C4482/R5C4483/R5C4484: the manufacturer is assessing a potential silicone tubing risk and provides interim guidance, including prioritising shorter sets for young infants when alternatives are unavailable. (Official source)

Philips Radiography 7000 M, model 712010: the manufacturer reports a potential safety issue involving failure to drive immediately after exposure; a software update is planned. (Official source)

ANSM

cobas c303: vacuum tube damage may cause undetected incorrect results. Perform daily quality control before releasing results; stop use and contact support if a persistent deviation occurs. (Official source; Document 1) Centricity High Acuity: omitted doses in certain views and omitted orders on printouts may lead to therapy errors; verify the original chart as instructed by the manufacturer. (Official source; Document 1) ANSM: the 2026–2027 winter plan publication was updated, covering prevention of misuse, safe substitutions and coordination of vigilance networks. (Official source; Document 1)

NMPA/CDE

Chinese Journal of Pharmacovigilance 23(10): research, case reports and translated communications. The issue is not a new NMPA decision or proof of causality for each reported case. (Official source)

CDSCO/PvPI

PvPI: the 30 September alert lists suspected associations of levetiracetam with gingival hypertrophy and xylometazoline/oxymetazoline with rebound nasal congestion; monitoring and adverse reaction reporting are advised. (Official source; Document 1)