Digest del 19/09/2026 – Osservatorio Regolatorio Pharma

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Pubblicazioni dal 18/09/2026 06:25 a ora — 66 news

AIFA (2)

Epatite C: aggiornamento del 14 settembre 2026 sui pazienti arruolati

L'Agenzia Italiana del Farmaco rende disponibile l’aggiornamento settimanale dei dati relativi ai trattamenti con i nuovi farmaci ad azione antivirale diretta di seconda generazione (DAAs) per la cura dell’epatite C cronica, raccolti dai Registri di monitoraggio AIFA.

Esiti runione Commissione Scientifica e Economica del Farmaco (CSE)

L'Agenzia Italiana del Farmaco rende disponibile gli esiti dei lavori della riunione della Commissione Scientifica e Economica (CSE) del 7-11 settembre 2026.

Gazzetta Ufficiale – Serie Generale (1)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO

Revoca, su rinuncia, dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Eribulina Viatris». (26A04852)

EMA – News & press releases (1)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026

12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.The committee recommended…, CHMP statistics Key figures from the September 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency, CHMP statistics:…, Positive recommendations on new medicines, Frehemgo International non-proprietary name (INN) denecimig Marketing authorisation applicant Novo Nordisk A/S Therapeutic…

EMA – Regulatory & procedural guidelines (1)

Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1

EMA – What's new (55)

Summary of opinion: Ocrevus, 17/09/2026 Positive

Summary of opinion: Cosentyx Positive

Summary of opinion: Anzupgo, 17/09/2026 Positive

EMA concludes review of ipidacrine-containing medicines

Benefits of sodium oxybate continue to outweigh risks in people with alcohol dependency

Summary of opinion: Abiraterone Mylan, 17/09/2026 Positive

Withdrawn application: Kaftrio, 01/09/2026

Withdrawn application: Kalydeco, 01/09/2026

Summary of opinion: Tecvayli, 17/09/2026 Positive

Summary of opinion: Jyseleca Positive

Summary of opinion: Pradaxa, 17/09/2026 Positive

Summary of opinion: Keytruda, 17/09/2026 Positive

Withdrawn application: Alhemo, 10/09/2026

Summary of opinion: Sogroya, 17/09/2026 Positive

Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence, sodium oxybate Article 31 referrals CHMP opinion, 17/09/2026, 18/09/2026

Referral: Ipidacrine-containing medicinal products, ipidacrine Article 31 referrals CHMP opinion, 17/09/2026, 18/09/2026

Summary of opinion: Padcev, 17/09/2026 Positive

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026

Summary of opinion: Enhertu, 17/09/2026 Positive

Antimicrobial Sales and Use (ASU) - Use data template

Antimicrobial Sales and Use (ASU) - Sales data template

Clinical investigation of medicinal products for the treatment of systemic sclerosis

Draft reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis

Questions and answers on post approval change management protocols (veterinary) - Scientific guideline

Questions and answers on post approval change management protocols for veterinary medicinal products

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline

Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)

Organisation chart: Human Medicines

User safety of topically administered products - Scientific guideline

Draft guideline on user safety of topically administered veterinary medicinal products - Revision 1

Highlight report - Combination Products Operational Group (COMBO) - Medical Devices stream - July 2026

Antimicrobial Sales and Use (ASU) Platform: Release notes

MedDRA important medical event terms list - version 29.1

User safety for pharmaceutical veterinary medicinal products - Scientific guideline

Draft guideline on user safety for pharmaceutical veterinary medicinal products - Revision 2

Human medicines European public assessment report (EPAR): Zeydovio, glepaglutide, Status: Opinion

Human medicines European public assessment report (EPAR): Sepalna, senaparib, Status: Opinion

Human medicines European public assessment report (EPAR): Ruxolitinib Zentiva, ruxolitinib, Status: Opinion

Human medicines European public assessment report (EPAR): Povofortay, povorcitinib, Status: Opinion

Human medicines European public assessment report (EPAR): Pebrilzo, pertuzumab, Status: Opinion

Human medicines European public assessment report (EPAR): Lifyorli, relacorilant, Status: Opinion

Human medicines European public assessment report (EPAR): Inijaq, tofacitinib, Status: Opinion

Human medicines European public assessment report (EPAR): Frehemgo, denecimig, Status: Opinion

Human medicines European public assessment report (EPAR): Adcomfo, omalizumab, Status: Opinion

Human medicines European public assessment report (EPAR): VaxRabeo, rabies vaccine (inactivated) for human, Status: Opinion

Human medicines European public assessment report (EPAR): Xervyteg, Allogeneic faecal microbiota, pooled, Status: Opinion

Veterinary good pharmacovigilance practices (VGVP)

Regulatory sandboxes: Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 21 September 2026, 13:30 (CEST) to 21 September 2026, 17:00 (CEST)

EMA annual call with General Practitioner Organisations' representatives, Online, European Medicines Agency, Amsterdam, the Netherlands, from 20 November 2026, 13:00 (CET) to 20 November 2026, 15:00 (CET)

Workshop on advancing proof-of-concept data in paediatric oncology drug development , Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 13:00 (CEST) to 21 September 2026, 16:00 (CEST)

Human medicines European public assessment report (EPAR): Avtozma, tocilizumab, Date of authorisation: 14/02/2025, Revision: 8, Status: Authorised

Programme of the 2026 annual meeting of the European network of paediatric research at EMA (EnprEMA)

Human medicines European public assessment report (EPAR): Steqeyma, ustekinumab, Date of authorisation: 22/08/2024, Revision: 10, Status: Authorised

EU Union Register of Medicinal Products (5)

Zyprexa (CHEPLAPHARM Registration GmbH)

Zyprexa (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2026) 6619 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMAYU0000360644

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Yearly update - Commission Decision (2026) 6624 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000365887

Skytrofa (Ascendis Pharma Endocrinology Division A/S)

Skytrofa (Active substance: Lonapegsomatropin) - Centralised - Renewal - Commission Decision (2026) 6631 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000339532

Tepmetko (Merck Europe B.V.)

Tepmetko (Active substance: tepotinib) - Centralised - Renewal - Commission Decision (2026) 6633 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000339701

IMBRUVICA (Janssen-Cilag International NV)

IMBRUVICA (Active substance: Ibrutinib) - PSUSA - Modification - Commission Decision (2026) 6630 of Mon, 14 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000336107

AboutPharma – Legal & Regulatory (1)

Chmp di settembre: parere positivo per 12 nuovi medicinali. Tra le indicazioni anche emofilia, tumori e miastenia

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