KemSu (sufentanil;ketamine)

Where it stands

KemSu (sufentanil;ketamine), from Proveca Pharma Limited, received a negative CHMP opinion on 2026-07-23 in the EU. The records list its status as Refused and show no approval date. The proposed indication was the treatment of acute pain in children aged 1 to less than 18 years.

The negative opinion is the only milestone on record, and it is marked as an official source. The records contain no detail on the grounds for the opinion, the vote, or any earlier steps such as clock-stops or oral explanations. Any statement about why the CHMP reached this view would therefore be speculation.

Regulatory pathway and designations

A CHMP opinion is the scientific recommendation the EMA issues in the centralised procedure. The European Commission then adopts a legally binding decision based on it. A negative opinion means the CHMP recommends against granting a marketing authorisation. The records show the product as Refused and do not separately document a Commission decision.

No designations are recorded for KemSu. That means none appear in the data provided, not that the product was confirmed to have none. The records do not mention priority-medicines status, orphan designation, a paediatric investigation plan or accelerated assessment.

Under general EU procedure, an applicant that receives a negative opinion can request a re-examination. It must give written notice within 15 days of receiving the opinion, and must submit detailed grounds within 60 days. The records do not say whether Proveca has taken or intends to take this step.

Safety and pharmacovigilance

The records contain no safety or pharmacovigilance information for KemSu. They give no adverse-event data, risk-management plan, benefit-risk discussion or post-authorisation commitments.

It would be unsupported to link the negative opinion to any safety concern, or to any efficacy, quality or other issue. Those grounds can only be taken from the EMA's published assessment documentation, which is not part of the data provided.

What to watch

The first point is whether the applicant requests re-examination within the procedural timelines. The second is whether the Commission decision formalising the refusal is recorded. The third is whether the EMA publishes its refusal documentation, which normally sets out the CHMP's scientific reasoning. That would be the first reliable source for the grounds of the opinion.

For business-development and medical teams, the product has no EU authorisation on the basis of the current records. Any plans that depend on an EU paediatric acute-pain option based on this sufentanil and ketamine combination should wait for the published reasoning and any outcome of re-examination.