What’s new
- Veterinary medicines European public assessment report (EPAR): Porcilis ColiClos, vaccine to provide passive immunity to the progeny against Escherichia coli and Clostridium perfringens in pigs, Status: Authorised
- Agenda of the COMP meeting 5-7 November 2024
- Nominations to the Network Portfolio Advisory Group
- Veterinary medicines European public assessment report (EPAR): Hiprabovis IBR Marker Live, live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis, Status: Authorised
- PSUSA/00000007/202312
- Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027
- EVVet3 EVWeb Production - Release notes
- PSUSA/00002170/202403
- PSUSA/00010802/202403
- Minutes of the CHMP meeting 27-30 May 2024
- PDCO minutes of the 3-6 September 2024 meeting
- Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda, Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated,Dengue virus, serotype 2, live, attenuated, Dengue, 13/10/2022 Positive opinion
- Questions and answers on Article 82 referral procedures
- Questions and answers on Article 82 referral procedures based on Article 129(3)
- PSUSA/00009162/202403
News and press releases
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024
- EMA closed 1 November
- Fostering regulatory collaboration to improve access to mpox medicines
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)14-17 October 2024
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 October 2024
- Handling of competing interests: revised rules for committee members and experts
- Seizing opportunities in a changing medicines landscape
- EMA Management Board: highlights of October 2024 meeting
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October 2024
- Improving efficiency of approval process for new medicines in the EU
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024
- EMA recommends extending indication of mpox vaccine to adolescents
- EMA’s human medicines committee elects new Chair
- New chair elected for EMA’s Orphan Medicinal Products Committee
Human Medicines Highlights newsletter
- Human medicines highlights - April 2024
- Human medicines highlights - March 2024
- Human medicines highlights - February 2024
- Human medicines highlights - January 2024
- Human medicines highlights - November-December 2023
- Human medicines highlights - October 2023
- Human medicines highlights - September 2023
- Human medicines highlights - August 2023
- Human medicines highlights - August 2022
- Human medicines highlights - June 2022
- Human medicines highlights - May 2022
- Human medicines highlights - April 2022
- Human medicines highlights - March 2022
- Human medicines highlights - February 2022
- Human medicines highlights - January 2022
Events
- 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 15 November 2024, 09:30 (CET) to 15 November 2024, 13:30 (CET)
- EMA risk management information day 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 November 2024, 13:30 (CET) to 21 November 2024, 17:30 (CET)
- SPOR Status Update, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 January 2025, 10:00 (CET) to 22 January 2025, 12:00 (CET)
- Advancing regulatory science research, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2024, 13:30 (CET) to 18 November 2024, 17:30 (CET)
- Linkedin Live session: A call to action against antimicrobial resistance , European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 11 November 2024, 11:30 (CET) to 11 November 2024, 12:30 (CET)
- Workshop with Notified Bodies on the Mandatory Scope of the CECP and PECP, Online, European Medicines Agency, Amsterdam, the Netherlands, 22 April 2024
- Highlights from the first Expert Panels and Notified Bodies workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, 22 April 2024
- Human variation electronic application form (eAF) training session and Q&A clinic, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 November 2024, 10:00 (CET) to 8 November 2024, 11:00 (CET)
- Pharmacovigilance Risk Assessment Committee (PRAC): 23 - 26 November 2026, European Medicines Agency, Amsterdam, the Netherlands, from 23 November 2026 to 26 November 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 26 - 29 October 2026, European Medicines Agency, Amsterdam, the Netherlands, from 26 October 2026 to 29 October 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 28 September - 1 October 2026, European Medicines Agency, Amsterdam, the Netherlands, from 28 September 2026 to 1 October 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 31 August - 3 September 2026, European Medicines Agency, Amsterdam, the Netherlands, from 31 August 2026 to 3 September 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 3 - 6 August 2026, European Medicines Agency, Amsterdam, the Netherlands, from 3 August 2026 to 6 August 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 6 - 9 July 2026, European Medicines Agency, Amsterdam, the Netherlands, from 6 July 2026 to 9 July 2026
- Pharmacovigilance Risk Assessment Committee (PRAC): 8 - 11 June 2026, European Medicines Agency, Amsterdam, the Netherlands, from 8 June 2026 to 11 June 2026
Regulatory and procedural guidelines (human and veterinary)
- Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections
- Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections
- Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
- Introduction to the Compilation of Union procedures on inspections and exchange of information
- PRIME eligibility requests: 2025 deadlines for submission and timetable for assessment
- List of centrally authorised products with safety-related changes to the Product Information
- EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
- Management of rapid alerts arising from quality defects risk assessment
- History of changes to the compilation of procedures
- Superseded - EMA guidance on the use of medicinal products for the treatment of patients exposed to terrorist attacks with chemical agents
- EMA guidance on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare
- Superseded - EMA guidance on use of medicinal products for the treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism
- EMA guidance on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfare
- Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances which are essential for the treatment of equine species and for which the withdrawal period for equine species shall be six
- Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
Scientific guidelines (human and veterinary)
- Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
- Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
- Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
- Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers
- Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
- Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application
- Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)
- ICH guideline E11A on pediatric extrapolation Step 5
- Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
- ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate realworld evidence, with a focus on effectiveness of medicines
- Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance
- Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
- Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline
- Guideline on the clinical evaluation of anticancer medicinal products - Revision 6
Agendas and Minutes
- Agenda of the COMP meeting 5-7 November 2024
- Minutes of the CHMP meeting 27-30 May 2024
- PDCO minutes of the 3-6 September 2024 meeting
- Minutes of the PRAC meeting 2-5 September 2024
- Agenda of the PRAC meeting 28-31 October 2024
- Minutes of the CAT meeting 17-19 July 2024
- Minutes of the CAT meeting 19-21 June 2024
- Minutes of the CAT meeting 22-24 May 2024
- Minutes of the COMP meeting 10-12 September 2024
- Agenda - PDCO agenda of the 15-18 October 2024 meeting
- Agenda of the CHMP meeting 14-17 October 2024
- Agenda of the CAT meeting 9-11 October 2024
- Agenda of the CVMP meeting 8-10 October 2024
- Minutes of the HMPC meeting 22-24 July 2024
- PDCO minutes of the 23-26 July 2024 meeting
European Union reference dates (EURD) list
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
Fees
- New Fee Regulation: webinar on Regulation (EU) 2024/568 and changes foreseen for industry stakeholders (H)
- Decision of the Executive Director on fee incentives for scientific advice, marketing authorisation applications and pre-authorisation inspections in the ATMP support pilot for academia
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests for medicines for COVID-19 not covered by Article 16(2) of Regulation (EU) 2022/123
- Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2022
- Fees payable to the European Medicines Agency
- Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
- How to pay
Herbal medicines for human use
- Herbal medicinal product: Prunus avium peduncleArray,Array, D: Draft under discussion
- Herbal medicinal product: Ricini oleum, Ricini oleum, F: Assessment finalised
- Herbal medicinal product: Rosae flos, Rosae flos, F: Assessment finalised
- Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
- Call for scientific data for the periodic review of the monograph on Symphyti radix - Revision 1
- Call for scientific data for the periodic review of the monograph on Sisymbrii officinalis herba - Revision 1
- Call for scientific data for the periodic review of the monograph on Sideritis herba - Revision 1
- Herbal medicinal product: Sisymbrii officinalis herba, Sisymbrii officinalis herba, F: Assessment finalised
- Herbal medicinal product: Symphyti radix, Symphyti radix, F: Assessment finalised
- Herbal medicinal product: Sideritis herba, Sideritis herba, F: Assessment finalised
- Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
- Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
- Herbal medicinal product: Aloes folii succus siccatus, Aloes folii succus siccatus, F: Assessment finalised
- Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
- Herbal medicinal product: Urticae radix, Urticae radix, F: Assessment finalised
Human medicines: European public assessment reports (EPARs) and summaries of opinion
- Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), para-aminosalicylic acid, Date of authorisation: 07/04/2014, Revision: 13, Status: Authorised
- Human medicines European public assessment report (EPAR): Agamree, Vamorolone, Date of authorisation: 14/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn
- Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, Date of authorisation: 23/08/2018, Revision: 8, Status: Authorised
- Human medicines European public assessment report (EPAR): Gefzuris, gefapixant, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Lutholaz, Status: Withdrawn application
- Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), pomalidomide, Date of authorisation: 05/08/2013, Revision: 24, Status: Authorised
- Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), human normal immunoglobulin, Date of authorisation: 23/07/2007, Revision: 19, Status: Authorised
- Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Psoriasis, Date of authorisation: 24/03/2023, Status: Authorised
- Human medicines European public assessment report (EPAR): Ammonaps, sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease;Citrullinemia;Carbamoyl-Phosphate Synthase I Deficiency Disease, Date of authorisation: 07/12/1999, Revision: 21, Status: Authorised
- Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests;Helicobacter Infections, Date of authorisation: 14/08/1997, Revision: 18, Status: Authorised
- Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, Date of authorisation: 30/05/2017, Revision: 6, Status: Authorised
- Human medicines European public assessment report (EPAR): Evoltra, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 29/05/2006, Revision: 31, Status: Authorised
Inspections
- Good Manufacturing Practice (GMP)/Distribution Practice Practice (GDP) Inspectors Working Group
- Good Clinical Practice Inspectors Working Group
- Quality systems framework for Good Manufacturing Practice (GMP) inspectorates
- Union format for a good manufacturing practice (GMP) certificate
- History of changes to the compilation of procedures
- Union format for registration of manufacturer, importer or distributor of active substance
- Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA
- Statement of non-compliance with good distribution practice of a distributor of active substances for use as starting materials in medicinal products
- Statement of non-compliance with good distribution practice
- Good distribution practice (GDP) inspection report – Union format
- Union format for a good distribution practice (GDP) certificate for active substances to be used as starting materials in medicinal products
- Union format for a wholesale distribution authorisation
- Notification of serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations
- Statement of non-compliance with good manufacturing practice (GMP)
- Union format for a good distribution practice (GDP) certificate
Maximum residue limits and opinions on maximum residue limits
- Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - CVMP
- Lidocaine (porcine species): European Public MRL Assessment Report (EPMAR) - CVMP
- Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
- Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
- Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel
- Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP
- Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP
- Opinion of the CVMP on the establishment of maximum residue limits: Sodium salicylate
- Rafoxanide (Bovine and ovine milk) - Summary opinion of the CVMP on the establishment of maximum residue limits
- Praziquantel (all ruminants except bovine, Equidae, fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits
- Bambermycin (poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP
- Ketoprofen (poultry) - Summary opinion of the CVMP on the extension of maximum residue limits
- Toltrazuril (poultry eggs) - Summary opinion of the CVMP on the extension of maximum residue limits
New medicines: human
- Summary of opinion: Metalyse, 14/12/2023 Positive
- Human medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Status: Opinion
- Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion
- Human medicines European public assessment report (EPAR): Casgevy, Exagamglogene autotemcel, Status: Opinion
- Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion
- Human medicines European public assessment report (EPAR): Velsipity, Etrasimod, Status: Opinion
- Summary of opinion: Zinplava, 14/12/2023 Positive
- Summary of opinion: Frontpro (previously known as Afoxolaner Merial), 07/12/2023 Positive
- Human medicines European public assessment report (EPAR): Rimmyrah, ranibizumab, Status: Opinion
- Human medicines European public assessment report (EPAR): Omjjara, momelotinib, Status: Opinion
- Human medicines European public assessment report (EPAR): Rystiggo, Rozanolixizumab, Status: Opinion
- Summary of opinion: Talzenna, 09/11/2023 Positive
- Summary of opinion: Jardiance, 09/11/2023 Positive
- Summary of opinion: Evkeeza, 09/11/2023 Positive
- Human medicines European public assessment report (EPAR): Uzpruvo, ustekinumab, Status: Opinion
Orphan designations
- Orphan designation: Rivoceranib (mesilate) Treatment of hepatocellular carcinoma, 27/09/2024 Positive
- Orphan designation: efineptakin alfa Treatment of acute radiation syndrome, 30/09/2024 Positive
- Orphan designation: Humanised anti-folate receptor 1 monoclonal antibody conjugated to maytansinoid DM4 Treatment of ovarian cancer, 19/03/2015 Positive
- Orphan designation: Heterologous human adult liver-derived progenitor cells Treatment of argininosuccinic aciduria, 17/07/2013 Positive
- Orphan designation: Heterologous human adult liver-derived progenitor cells Treatment of ornithine-translocase deficiency, 17/07/2013 Positive
- Orphan designation: milademetan tosilate monohydrate Treatment of soft tissue sarcoma, 20/03/2017 Positive
- Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome), 12/01/2017 Positive
- Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F Treatment of multiple myeloma, 16/10/2017 Positive
- Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN6 gene Treatment of neuronal ceroid lipofuscinosis, 21/08/2019 Positive
- Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene Treatment of neuronal ceroid lipofuscinosis, 21/08/2019 Positive
- Orphan designation: 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene Treatment of primary myelofibrosis, 25/08/2010 Positive
- Orphan designation: 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene Treatment of post-polycythaemia vera myelofibrosis, 25/08/2010 Positive
- Orphan designation: 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene Treatment of post-essential thrombocythaemia myelofibrosis, 25/08/2010 Positive
- Orphan designation: Losmapimod treatment of facioscapulohumeral muscular dystrophy, 24/03/2020 Positive
- Orphan designation: idebenone Treatment of Friedreich's ataxia, 08/03/2004 Positive
Public consultations
- Draft consolidated 3-year rolling work plan for the Vaccine Working Party (VWP) - 2025-2027
- EMA policy on handling of competing interests of scientific committee members and experts: Draft for public consultation
- Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (draft)
- Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
- Consolidated 3-year rolling work plan for the Haematology Working Party (HAEMWP) : January 2025 - December 2027
- Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027
- Draft 3-year rolling work plan for the Rheumatology and Immunology Working Party (RIWP) : 2025-2027
- Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1
- Draft Central Nervous System Working Party (CNSWP) consolidated 3-year rolling work plan 2025-2027
- Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats
- Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees
- Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/2000-Rev.4)
- Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
- Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance
- Draft guideline on the chemistry of active substances - Revision 1
Withdrawn applications
- Human medicines European public assessment report (EPAR): Epixram, levetiracetam, Status: Withdrawn application (before opinion)
- Withdrawn application: Sialanar, 06/09/2024
- Human medicines European public assessment report (EPAR): Durysta, bimatoprost, Status: Withdrawn application (before opinion)
- Withdrawn application: Ontilyv, 12/03/2024
- Human medicines European public assessment report (EPAR): Upstelda, ustekinumab, Status: Withdrawn application (before opinion)
- Withdrawn application: Scenesse, 24/04/2024
- Withdrawn application: Ongentys, 12/03/2024
- Withdrawn application: Orencia, 19/02/2024
- Withdrawn application: Adcetris, 23/02/2024
- Withdrawn application: Iclusig, 11/08/2023
- Withdrawn application: Bylvay, odevixibat, Date of withdrawal: 22/10/2023, Post-authorisation
- Withdrawn application: Vijoice, alpelisib, Date of withdrawal: 30/10/2023, Initial authorisation
- Withdrawn application: RoActemra, 13/09/2023
- Withdrawn application: RoActemra, tocilizumab, Date of withdrawal: 13/09/2023, Post-authorisation
- Withdrawn application: Vivjoa, Oteseconazole, Date of withdrawal: 24/08/2023, Initial authorisation
Paediatric investigation plans
- EMEA-001043-PIP01-10-M03
- Opinion/decision on a Paediatric investigation plan (PIP): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0377/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0391/2023
- EMEA-001776-PIP03-17-M01
- Opinion/decision on a Paediatric investigation plan (PIP): Rukobia, fostemsavir (tromethamine), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0380/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Stelara, ustekinumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0341/2023
- EMEA-003319-PIP02-22
- EMEA-003328-PIP01-22
- EMEA-003232-PIP01-22-M01
- Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), elasomeran,imelsomeram,davesomeran, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0373/2023
- Opinion/decision on a Paediatric investigation plan (PIP): Comirnaty, Tozinameran,Tozinameran / famtozinameran, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0393/2023
- EMEA-002827-PIP01-20-M02
- EMEA-002681-PIP01-19-M02
- EMEA-002722-PIP01-19-M03
- EMEA-002485-PIP01-18-M01