Medicine and device safety updates: 21 October 2026
- 21-10-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Thirty official sources were reviewed. Fifty-six materials are curated into 34 updates from eight regulators. They cover product information, safety actions, risk-management plans and pharmacovigilance methods. The number of groups is not the number of new signals.
This review is for QPPV, LQPPV, LCPPV and PV specialists. Role names and responsibilities vary by jurisdiction.
EMA — European Medicines Agency
Imuldosa — alignment with reference product
Indication, use and safety information and RMP were aligned with Stelara. Opinion 17 September; Commission decision 15 October. This is not presented as a new signal.
Deferasirox Accord — paediatric iron overload
Sections 4.4, 4.8 and 5.1 were updated for non-transfusion-dependent paediatric iron overload, aligned with Exjade.
Tosmova — RMP and patient card
The current RMP 1.1 changes the list of important risks and reduces additional minimisation to a Patient Card. Existing SmPC warnings remain; excipient information was also aligned.
Kanjinti — polysorbate 20 information
Product information and leaflet now include polysorbate 20 excipient warnings; this is an information update.
Prevenar 20 — assessment report published
The Article 46 B7471024 assessment appeared on 20 October, although the report is dated 20 August. It found no new signal, PI change or regulatory action.
Afqlir — retinal vasculitis class information
Product information implements the known aflibercept class assessment on retinal vasculitis, with or without occlusion. This is implementation of an earlier assessment.
Bimervax — coadministration evidence
HIPRA-HH-11 results and RMP 3.2 address use in adults over 65 with a prior COVID-19 vaccine and adjuvanted inactivated influenza vaccine. The separate shelf-life change is a quality matter.
Enhertu — confirmatory study deadline
Annex II.E and RMP 14.0 move the confirmatory DL04 D967 SC00001 study deadline from Q4 2026 to Q2 2027.
Skyclarys — interaction and extension data
Product information includes extension-study data and a CYP2C19 interaction: omaveloxolone reduced omeprazole AUC by about 34% and is a weak CYP2C19 inducer. Follow the current approved information.
Exjade — PI and RMP changes
Sections 4.3 and 4.5 remove the contraindication on combining Exjade with other iron chelators. Separately, RMP 24.1 removes five important-risk groups and special follow-up forms after review. Relevant SmPC warnings and monitoring remain; removal from the RMP summary does not mean the risks disappeared.
Jivi — paediatric use and proposed follow-up
The assessment covers previously untreated patients aged 7 years and older, including a regimen for ages 7 to under 12. RMP 4.1 proposes factor VIII inhibitor monitoring through EUHASS/PedNet.
Polivy — grouped variation
A grouped variation covers clinical and quality/stability changes.
Poteligeo — warning update
Section 4.4 was updated after real-world studies, postmarketing data and literature.
Beyonttra — reproductive data
Sections 4.6 and 5.3 add rat placenta/milk findings. Human milk excretion is unknown; the approved information says the medicine should not be used during breastfeeding.
Columvi — HLH/IEC-HS warning
A warning covers haemophagocytic lymphohistiocytosis (HLH)/immune effector cell-associated HLH-like syndrome (IEC-HS), including fatal cases. Consider it with atypical or prolonged cytokine release syndrome (CRS); monitor, interrupt and treat as the approved information directs.
Ontozry — older paediatric assessment published
An 11-page report appeared on 20 October but is dated 21 May. It identifies no new safety information, PI change or new approved paediatric indication.
Arikayce liposomal — leaflet wording
The leaflet presents an adverse effect in patient-friendly wording and updates an instruction figure; this is an information and use update.
EMA RSI response timelines
Revision 7 of the EMA signal response timetable, dated 16 October, adds 2028 dates for 30-, 60- and 90-day responses. It is procedural, not a new signal.
DMD workshop — real-world data methods
The summary dated 16 October and accompanying workshop presentations address data quality, core outcomes and long-term safety methods. They set out discussion and future work, not binding new requirements.
Bacteriophage therapy workshop agenda
An updated agenda for the 30 October workshop includes pharmacovigilance and traceability. An agenda does not itself create a new requirement.
Companion diagnostic Operational Group agenda
The agenda dated 15 October for the Operational Group meeting on 21 October includes discussion of Summary of Safety and Performance template guidance, companion diagnostic consultations, and class/group labelling. An agenda is not a final guideline.
MHRA — United Kingdom
IXCHIQ — UK marketing authorisation withdrawn
Following a safety review, MHRA found the UK benefit–risk balance unfavourable and withdrew the authorisation. Do not prescribe, supply or administer IXCHIQ; handle stock under local procedures. People previously vaccinated without adverse effects need no extra action solely because of the withdrawal.
AEMPS — Spain
Pedmarqsi — particles and batch measures
AEMPS confirmed particles in three early-access batches and withdrew those batches. Five named Spanish-market batches have no confirmed particles; where clinically needed, inspect and use an appropriate filter under the official instructions. No associated adverse reactions were reported.
ANSM — France
Intersurgical — selected spirometry kits
ANSM notice R2630930 concerns specified French references and lots with incorrect measurements or waveforms. Quarantine and return or destroy affected stock as instructed. The notice does not expect impaired ventilation or oxygenation.
eMAG — heating timeout with SP4 Patch 2
SP4 Patch 2 can cause a heating timeout and invalid extraction cycle, potentially delaying testing; it does not create false results. Follow the notice and arrange technician rollback to Patch 1.
TGA — Australia
Evoke CLS — charging and impedance alert
TGA warns of unintended stimulation during charging or impedance checks and possible charging failure or therapy interruption. The notice does not recommend prophylactic explant or replacement.
i-STAT hs-TnI — potential false-high result
Affected lots can yield falsely high troponin results; the notice reports no evidence of falsely low results. Interpret in clinical context and retest discordant results using the specified unaffected lot or another validated assay.
Philips Lumify — registration and USB connection
Unexpected re-registration and an unstable or interrupted USB connection between probe and phone/tablet can delay imaging. Do not use outside readily available Wi-Fi or cellular coverage; have backup imaging. The notice reports deaths and serious injuries associated with the issue, without establishing causality.
Thompson’s Immunofort — consumer recall
TGA recalled all unexpired lots of the named andrographis product in light of anaphylaxis risk. Stop use and follow return or disposal instructions.
Kyrgyzstan — medicines and devices authority
Kyrgyzstan — medicine dispensing process
Letter 12/3922 of 21 October addresses dispensing and prohibits accepting or returning medicines from individuals for resale where quality, safety and efficacy cannot be assured. It is a process measure, not a product recall.
Ukraine State Expert Center
20 published RMP summaries
The web items appeared on 21 October. The underlying RMPs have different, sometimes older, dates and versions; posting their summaries does not mean 20 new signals. Check risk lists and measures against each product’s current approved information. An empty “important risks” list is not proof that all warnings are absent.
| Product / substance | RMP version | Document date | Official item |
|---|---|---|---|
| Propolis tincture — propolis | RMP 1.1 | Not printed in the primary PDF | Source |
| Copaxone 40 / Copaxone-Teva — glatiramer acetate | RMP 9.0 | Not printed in the primary PDF | Source |
| Klofan 2% — clotrimazole | RMP 2.0 | 2024-07-08 | Source |
| Gynex / Gynex Forte — metronidazole + miconazole | RMP 2.2 | 2024-01-26 | Source |
| Montular Kids 4 mg — montelukast | RMP 2.0 | 2025-04-11 | Source |
| Montular Kids 5 mg — montelukast | RMP 2.0 | 2025-04-11 | Source |
| Montular 10 mg — montelukast | RMP 2.0 | 2025-06-12 | Source |
| Pascal Trio — olmesartan medoxomil + amlodipine + hydrochlorothiazide | RMP 0.3 | Not printed in the primary PDF | Source |
| Rinox — mometasone furoate | RMP 0.3 | 2026-07-03 | Source |
| Vaxigrip — trivalent inactivated split influenza vaccine | RMP (version not printed) | Not printed in the primary PDF | Source |
| AC-Help — acetylcysteine | RMP (version not printed) | Not printed in the primary PDF | Source |
| Atorvastatin-Teva — atorvastatin | RMP UA 1.3 | Not printed in the primary PDF | Source |
| Micafungin-Teva — micafungin | RMP 2.1 | Not printed in the primary PDF | Source |
| Valsartan Trio-Teva — amlodipine + valsartan + hydrochlorothiazide | RMP UA 0.1 | Not printed in the primary PDF | Source |
| Angi.Net mint — flurbiprofen | RMP (version not printed) | Not printed in the primary PDF | Source |
| Banbact — clindamycin | RMP 4.1 | 2025-09-30 | Source |
| Abrol — ambroxol | RMP 2.1 | 2026-02-20 | Source |
| Oxybutynin Geneim — oxybutynin | RMP 2.0 | Not printed in the primary PDF | Source |
| Orgil — ornidazole | RMP 1.0 | 2019-10-17 | Source |
| Klofan 1% — clotrimazole | RMP 2.0 | 2024-07-08 | Source |
Some published RMPs list risk categories for glatiramer, atorvastatin, micafungin, metronidazole/miconazole, clindamycin and ornidazole. These are entries in the respective RMP versions, not evidence of new signals on 21 October.
NMPA/CDR/CDE — China
Alopecia areata trial guidance
CDE guidance published 20 October describes long-term adverse-event and laboratory monitoring, including infection and malignancy assessment for immunomodulators. It is trial guidance, not a new product signal.
Adolescent weight-management trial guidance
CDE posted guidance on 20 October; its signed notice is dated 15 October. It addresses GLP-1 receptor agonist trials in ages 12 to under 18 and safety monitoring, without announcing a new signal.
Pharmacovigilance training and capacity
Four CDR items cover UMC training, Yunnan sentinel hospitals, Sichuan–Chongqing staff and a Fujian professional skills event. Web dates are 19–20 October. These are capacity updates, not new medicine risks.