IBUPROFEN VELFARM, Pedmarqsi and AYUNA AMA CARE: Safety Measures — 13 October 2026

PharmExpert’s review dated 13 October covers 20 topic groups from official regulator communications and documents. They include batch actions, safety-information changes, additional risk-minimisation measures, device corrective actions and pharmacovigilance operations. Not every publication represents a new clinical signal.

Actions concerning specific medicine batches

In its letter dated 9 October, Roszdravnadzor reported stopping circulation of IBUPROFEN VELFARM 200 mg batch 2000724 because it failed the dissolution specification. The action concerns this batch, which differs from the batches PharmExpert covered previously. Official card and letter 01И-1163/26.

On 12 October, MHRA issued a Class 2 recall for Pedmarqsi 80 mg/mL batches 458273 and 475287 because of particles. Stock should be quarantined and returned; no related suspected adverse reactions had been received at the date of the communication. Official MHRA notice.

TGA’s action commencing on 9 October is a Class I consumer recall for AYUNA AMA CARE batch 2038, linked to the association between Andrographis and anaphylaxis. Consumers should stop use and return the product. Official TGA card RC-2026-RN-00791-1.

On 12 October, HSA announced a Class 2 retail recall covering 31 Clonotril 0.5 mg batches following out-of-specification stability results. The notice does not identify a particular impurity or report patient harm. Official HSA notice.

Ukraine SEC: Eylea and Padcev

Ukraine SEC’s 12 October aflibercept/Eylea communication recommends adding retinal vasculitis as a rare adverse reaction and retinal occlusive vasculitis with an unknown frequency. The benefit-risk balance for the approved indications remains unchanged. Official SEC material.

Its 12 October enfortumab vedotin/Padcev material describes updates concerning opportunistic and fungal infections, leukopenia and urinary-tract infections. Official SEC material.

On 12 October, SEC also posted an Eylea additional risk-minimisation package: a healthcare-professional guide, patient guide and illustrated intravitreal-injection procedure material. It covers asepsis, correct preparation and dose, intraocular-pressure monitoring and warning signs requiring urgent contact. This is one educational package, not three new signals. Official SEC card.

Medical devices and continuity of treatment

ANSM’s 12 October card concerns an AMS 700 CX/LGX packaging mix-up: packs labelled 0.5 cm could contain a 1.5 cm rear-tip extender. The manufacturer’s 9 October letter describes four complaints detected before implantation. The most likely consequence is negligible procedural delay; an undetected longer component could cause erosion or tissue dehiscence requiring further intervention. The estimated likelihood is very low, and no patient consequences had been reported at the date of the letter. Official ANSM notice.

For the SCORE tibial base, ANSM reported a size-engraving mismatch with correct labelling and traceability. The manufacturer’s 6 October letter explicitly states that patient safety is not affected and that implanted devices require no special follow-up; exchange of unused components is optional. Official ANSM notice.

On its duloxetine-shortage page, updated on 12 October, ANSM advises limiting new treatment starts, preserving continuity and avoiding abrupt discontinuation. Official ANSM source.

EMA, PEI and Swissmedic

EMA’s 12 October updates cover five topics: refining adverse-reaction presentation for Rhokiinsa/Roclanda; Duvyzat enteral-tube instructions; Lazcluze dispersion and nasogastric-tube administration without crushing; Altuvoct multi-vial dose preparation and polysorbate 80 allergy wording; and extending an Ofev paediatric-study milestone to 30 October 2026. Rhokiinsa and Roclanda, Duvyzat, Lazcluze, Altuvoct, Ofev.

In its 9 October notice, PEI explained that some online adverse-reaction reports had not been transferred to the database during a 7–9 October technical failure. Affected reporters are asked to resubmit them. Mandatory reporting by the relevant organisations was not affected. Official PEI notice.

Swissmedic’s index dates the Xgeva, Aspaveli and Mounjaro risk-management-plan summaries to 12 October. Xgeva’s Swiss summary version 1.0 is dated October 2026 and based on EU RMP 37.1 of 19 September 2025; Aspaveli’s summary is dated 10 December 2025 and Mounjaro’s 8 October 2026. These are RMP publications; their risks are not presented as newly emerging on 12 October. Xgeva, Aspaveli, Mounjaro.

SEC also published a new PSUR submission cover-letter template on 12 October, an operational pharmacovigilance update. Official SEC material.

Practical relevance for QPPV, LQPPV and LCPPV

For QPPV, LQPPV and LCPPV, these materials can support assessment of the official measures applicable to their portfolio: checking affected products and batches, approved product information, risk-minimisation plans and educational materials. Actions should be determined from the official primary source and applicable local requirements.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by Roszdravnadzor, MHRA, Ukraine SEC, TGA, HSA, PEI, ANSM, EMA and Swissmedic and current as of 13 October 2026. It is not medical or legal advice, does not replace the official source, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.