Every EU marketing authorisation from the last 12 months - new medicines, biosimilars and generics approved centrally through the European Medicines Agency - plus CHMP positive opinions still awaiting a European Commission decision.
| Authorised | Medicine | Type | Marketing Authorisation Holder |
|---|---|---|---|
| 20 Jul 2026 | Etcamah
camizestrant · Endocrine therapy |
New Medicine | AstraZeneca AB |
| 15 Jul 2026 | Boey
trenibotulinumtoxinE · MUSCLE RELAXANTS;Other muscle relaxants, peripherally acting agents |
New Medicine | AbbVie Limited |
| 15 Jul 2026 | Jascayd
nerandomilast · Immunosuppressants |
New Medicine | Boehringer Ingelheim International GmbH |
| 30 Jun 2026 | Itvisma
onasemnogene abeparvovec · Other drugs for disorders of the musculo-skeletal system |
New Medicine | Novartis Europharm Limited |
| 19 Jun 2026 | Rexatilux
ranibizumab · Ophthalmologicals |
Biosimilar | Intas Third Party Sales 2005 S.L. |
| 19 Jun 2026 | Redemplo
plozasiran · Lipid modifying agents |
New MedicineOrphan | Arrowhead Pharmaceuticals Ireland Limited |
| 19 Jun 2026 | Cenrifki
tolebrutinib · Selective immunosuppressants |
New Medicine | Sanofi Winthrop Industrie |
| 19 Jun 2026 | Palbociclib Viatris
palbociclib · Antineoplastic agents |
Generic | Viatris Limited |
| 29 May 2026 | Bopediat
furosemide · Sulfonamides, plain;Diuretics |
New Medicine | Proveca Pharma Limited |
| 29 May 2026 | Imdylltra
tarlatamab · Antineoplastic agents |
New MedicineOrphan | Amgen Europe B.V. |
| 29 May 2026 | Zepzelca
lurbinectedin · Antineoplastic agents |
New MedicineOrphan | Pharma Mar S.A. |
| 28 May 2026 | Adstiladrin
nadofaragene firadenovec · Antineoplastic agents |
New MedicineATMP | Ferring Pharmaceuticals A/S |
| 21 May 2026 | Joenja
leniolisib · Antineoplastic agents |
New MedicineOrphan | Pharming Technologies B.V. |
| 06 May 2026 | Bysumlog
insulin lispro · Drugs used in diabetes |
Biosimilar | Gan & Lee Pharmaceuticals Europe GmbH |
| 27 Apr 2026 | Xolremdi
mavorixafor · Immunostimulants |
New MedicineOrphan | Norgine B.V. |
| 27 Apr 2026 | Tuyory
tocilizumab · Immunosuppressants |
Biosimilar | Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) |
| 27 Apr 2026 | Zandoriah
teriparatide · Calcium homeostasis |
Biosimilar | CinnaGen Co Unipessoal LDA |
| 27 Apr 2026 | Dazparda
insulin aspart · Drugs used in diabetes |
Biosimilar | Gan & Lee Pharmaceuticals Europe GmbH |
| 27 Apr 2026 | Onerji
levodopa;carbidopa · Anti-Parkinson drugs |
New Medicine | Tanabe Pharma GmbH |
| 23 Apr 2026 | Palsonify
paltusotine · Pituitary and hypothalamic hormones and analogues |
New MedicineOrphan | Crinetics Pharmaceuticals Europe GmbH |
| 23 Apr 2026 | Fubelv
etanercept · etanercept |
Biosimilar | Biosimilar Collaborations Ireland Limited |
| 23 Apr 2026 | Poherdy
pertuzumab · Antineoplastic agents |
Biosimilar | Organon N.V. |
| 23 Apr 2026 | Rhapsido
remibrutinib · Immunosuppressants |
New Medicine | Novartis Europharm Limited |
| 20 Apr 2026 | Ojemda
tovorafenib · Antineoplastic agents |
New MedicineOrphan | Ipsen Pharma |
| 20 Apr 2026 | mCombriax
influenza mRNA vaccine;COVID-19 mRNA vaccine · Vaccines |
New Medicine | Moderna Biotech Spain, S.L. |
| 15 Apr 2026 | Enflonsia
clesrovimab · Immune sera and immunoglobulins |
New Medicine | Merck Sharp Dohme Limited |
| 30 Mar 2026 | Supemtek
trivalent influenza vaccine (recombinant, prepared in cell culture) · Vaccines |
New Medicine | Sanofi Winthrop Industrie |
| 26 Mar 2026 | Kygevvi
doxecitine;doxribtimine · Other alimentary tract and metabolism products |
New MedicineOrphanPRIME | UCB Pharma |
| 26 Mar 2026 | Kayshild
semaglutide · Drugs used in diabetes |
New Medicine | Novo Nordisk A/S |
| 26 Mar 2026 | Fylrevy
estetrol · Sex hormones and modulators of the genital system |
New Medicine | Gedeon Richter Plc. |
| 26 Mar 2026 | Ilumira
lutetium (177Lu) chloride · Therapeutic radiopharmaceuticals |
New Medicine | Shine Europe B.V. |
| 24 Mar 2026 | Rezurock
belumosudil · Immunosuppressants |
New MedicineOrphan | Sanofi Winthrop Industrie |
| 16 Feb 2026 | Anktiva
nogapendekin alfa inbakicept · Immunostimulants |
New Medicine | Immunitybio Ireland Limited |
| 12 Feb 2026 | Exdensur
depemokimab · Drugs for obstructive airway diseases |
New Medicine | GlaxoSmithKline Trading Services Limited |
| 12 Feb 2026 | Myqorzo
aficamten |
New Medicine | Cytokinetics (Ireland) Limited |
| 12 Feb 2026 | mNexspike
COVID-19 mRNA vaccine · Vaccines |
New Medicine | Moderna Biotech Spain, S.L. |
| 12 Feb 2026 | Aumseqa
Aumolertinib · Antineoplastic agents |
New Medicine | SFL Pharmaceuticals Deutschland GmbH |
| 10 Feb 2026 | Gotenfia
golimumab · Immunosuppressants |
Biosimilar | Stada Arzneimittel AG |
| 10 Feb 2026 | Ranluspec
ranibizumab · Ophthalmologicals |
Biosimilar | Lupin Europe GmbH |
| 19 Jan 2026 | Aqneursa
L-acetylleucine · Other nervous system drugs |
New MedicineOrphan | Intrabio Ireland Limited |
| 19 Jan 2026 | Dawnzera
donidalorsen · Other hematological agents |
New Medicine | Otsuka Pharmaceutical Netherlands B.V. |
| 09 Jan 2026 | Ondibta
insulin glargine · Drugs used in diabetes |
Biosimilar | Gan & Lee Pharmaceuticals Europe GmbH |
| 09 Jan 2026 | Waskyra
etuvetidigene autotemcel · Other hematological agents |
New MedicineOrphanATMP | Fondazione Telethon ETS |
| 09 Jan 2026 | VacPertagen
pertussis vaccine (recombinant, acellular, component, adsorbed) · Vaccines |
New Medicine | BioNet Europe |
| 09 Jan 2026 | Inluriyo
imlunestrant · Endocrine therapy |
New Medicine | Eli Lilly Nederland B.V. |
| 08 Jan 2026 | Teduglutide Viatris
teduglutide · Other alimentary tract and metabolism products |
Generic | Viatris Limited |
| 08 Jan 2026 | Teizeild
teplizumab · Drugs used in diabetes |
New MedicinePRIME | Sanofi Winthrop Industrie |
| 08 Jan 2026 | Osqay
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Theramex Ireland Limited |
| 08 Jan 2026 | Austedo
deutetrabenazine · Other nervous system drugs |
New Medicine | Teva GmbH |
| 08 Jan 2026 | GalenVita
germanium (68Ge) chloride;gallium (68Ga) chloride · Diagnostic radiopharmaceuticals |
New Medicine | Curium Romania S.R.L. |
| 22 Dec 2025 | Wayrilz
rilzabrutinib · Not assigned yet |
New MedicineOrphan | Sanofi B.V. |
| 28 Nov 2025 | Imaavy
nipocalimab · Immunosuppressants |
New Medicine | Janssen Cilag International NV |
| 24 Nov 2025 | Kyinsu
insulin icodec;semaglutide · Insulins and analogues for injection, long-acting |
New Medicine | Novo Nordisk A/S |
| 21 Nov 2025 | Svariya (previously Rivaroxaban Koanaa)
rivaroxaban · Antithrombotic agents |
Generic | Koanaa Healthcare GmbH |
| 18 Nov 2025 | Brinsupri
Brensocatib |
New MedicinePRIME | Insmed Netherlands B.V. |
| 17 Nov 2025 | Usgena
ustekinumab · Immunosuppressants |
Biosimilar | Stada Arzneimittel AG |
| 17 Nov 2025 | Gobivaz
golimumab · Immunosuppressants |
Biosimilar | Advanz Pharma Limited |
| 17 Nov 2025 | Kefdensis
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Stada Arzneimittel AG |
| 17 Nov 2025 | Acvybra
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Reddy Holding GmbH |
| 17 Nov 2025 | Lynkuet
elinzanetant · Other gynecologicals |
New Medicine | Bayer AG |
| 17 Nov 2025 | Xbonzy
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Reddy Holding GmbH |
| 17 Nov 2025 | Vysribli (previously Denosumab Intas)
Vysribli · Drugs for treatment of bone diseases |
Biosimilar | Intas Third Party Sales 2005 S.L. |
| 17 Nov 2025 | Ponlimsi
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Teva GmbH |
| 17 Nov 2025 | Degevma
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Teva GmbH |
| 17 Nov 2025 | Zvogra
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Stada Arzneimittel AG |
| 17 Oct 2025 | Winlevi
clascoterone · Other anti-acne preparations for topical use |
New Medicine | Cassiopea S.p.A. |
| 24 Sep 2025 | Macitentan Accord
macitentan · Antihypertensives |
Generic | Accord Healthcare |
| 24 Sep 2025 | Macitentan AccordPharma
macitentan · Antihypertensives |
Generic | Accord Healthcare |
| 24 Sep 2025 | Kisunla
donanemab · Anti-dementia drugs;Other anti-dementia drugs |
New Medicine | Eli Lilly Nederland B.V. |
| 17 Sep 2025 | Voranigo
vorasidenib · Antineoplastic agents |
New MedicineOrphan | Les Laboratoires Servier |
| 17 Sep 2025 | Ekterly
sebetralstat · Other hematological agents |
New MedicineOrphan | Kalvista Pharmaceuticals (Ireland) Limited |
| 17 Sep 2025 | Bildyos
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Sciencepharma Sp. z o.o |
| 17 Sep 2025 | Bilprevda
denosumab · Drugs for treatment of bone diseases |
Biosimilar | Sciencepharma Sp. z o.o |
| 17 Sep 2025 | Usrenty
ustekinumab · Immunosuppressants |
Biosimilar | Biosimilar Collaborations Ireland Limited |
| 17 Sep 2025 | Romvimza
vimseltinib · Antineoplastic agents |
New MedicineOrphan | Deciphera Pharmaceuticals (Netherlands) B.V. |
| 17 Sep 2025 | Tryngolza
olezarsen · Lipid modifying agents |
New MedicineOrphan | Swedish Orphan Biovitrum AB (publ) |
| 15 Sep 2025 | Eyluxvi
aflibercept · Ophthalmologicals |
Biosimilar | Biolitec pharma Limited Zweigniederlassung Jena |
| 25 Aug 2025 | Zemcelpro
allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel · Other blood products |
New MedicineOrphanPRIMEATMP | Cordex Biologics International Limited |
| 25 Aug 2025 | Yeytuo
lenacapavir · Antivirals for systemic use |
New Medicine | Gilead Sciences Ireland Unlimited Company |
| 22 Aug 2025 | Nintedanib Viatris
nintedanib · Antineoplastic agents |
Generic | Viatris Limited |
| 21 Aug 2025 | Imreplys
sargramostim · Immunostimulants |
New Medicine | Partner Therapeutics Limited |
| 19 Aug 2025 | Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris
emtricitabine;rilpivirine;tenofovir alafenamide · Antivirals for systemic use |
Generic | Viatris Limited |
| 18 Aug 2025 | Rezdiffra
resmetirom · Bile and liver therapy |
New Medicine | Madrigal Pharmaceuticals EU Limited |
| 18 Aug 2025 | Afiveg
aflibercept · Ophthalmologicals |
Biosimilar | STADA Arzneimittel AG |
| 18 Aug 2025 | Mynzepli
aflibercept · Ophthalmologicals |
Biosimilar | Advanz Pharma Limited |
| 18 Aug 2025 | Vivlipeg
pegfilgrastim · Immunostimulants |
Biosimilar | Biosimilar Collaborations Ireland Limited |
| 14 Aug 2025 | Ogsiveo
nirogacestat · Other antineoplastic agents |
New MedicineOrphan | Merck Europe B.V. |
| 14 Aug 2025 | Usymro
ustekinumab · Immunosuppressants |
Biosimilar | Gedeon Richter Plc. |
| 14 Aug 2025 | Eiyzey
aflibercept · Ophthalmologicals |
Biosimilar | Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
| 14 Aug 2025 | Vgenfli
aflibercept · Ophthalmologicals |
Biosimilar | Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
| Opinion | Medicine | Type | Applicant |
|---|---|---|---|
| 23 Jul 2026 | Cavoley
pegfilgrastim |
Biosimilar | CuraTeQ Biologics s.r.o |
| 23 Jul 2026 | Evlarco
obicetrapib;ezetimibe |
New Medicine | A. Menarini International Licensing S.A. |
| 23 Jul 2026 | Icotyde
icotrokinra hydrochloride |
New Medicine | Janssen-Cilag International N.V. |
| 23 Jul 2026 | Lynavoy
Linerixibat |
New MedicineOrphan | GlaxoSmithKline Trading Services Limited |
| 23 Jul 2026 | Lyrokaul
lerodalcibep |
New Medicine | LIB Therapeutics B.V. |
| 23 Jul 2026 | Nezglyal
leriglitazone |
New MedicineOrphan | Minoryx Therapeutics S.L. |
| 23 Jul 2026 | Susvimo
ranibizumab |
New Medicine | Roche Registration GmbH |
| 23 Jul 2026 | Ubeslo
obicetrapib |
New Medicine | A. Menarini International Licensing S.A. |
| 23 Jul 2026 | Tafamidis Accord
tafamidis |
Generic | Accord Healthcare S.L.U. |
| 23 Jul 2026 | Ruxolitinib Viatris
ruxolitinib hemifumarate |
Generic | Viatris Limited |
| 23 Jul 2026 | Riociguat Accord
riociguat |
Generic | Accord Healthcare S.L.U. |
| 25 Jun 2026 | Daybu
trofinetide |
New MedicineOrphan | Acadia Pharmaceuticals B.V. |
| 25 Jun 2026 | Aujemflu
Influenza vaccine (surface antigen, inactivated, adjuvanted, prepared in cell culture) |
New Medicine | Seqirus Netherlands B.V. |
| 25 Jun 2026 | Denosumab Ascend
denosumab |
Biosimilar | Ascend GmbH |
| 25 Jun 2026 | Hopledo
levodopa;carbidopa |
New Medicine | Zambon SpA |
| 25 Jun 2026 | Nylaspeg
pegfilgrastim |
Biosimilar | Qilu Pharma Spain S.L. |
| 25 Jun 2026 | Onswik
Insulin efsitora alfa |
New Medicine | Eli Lilly Nederland B.V. |
| 23 Jun 2026 | Zokovea
ensitrelvir |
New Medicine | Shionogi B.V. |
| 21 May 2026 | Colchicine Agepha Pharma
colchicine |
New Medicine | Agepha Pharma s.r.o. |
| 21 May 2026 | Ablymico
liraglutide |
New Medicine | STADA Arzneimittel AG |
| 21 May 2026 | Liraglutide STADA
liraglutide |
New Medicine | STADA Arzneimittel AG |
| 21 May 2026 | Vijoice
alpelisib |
New MedicineOrphan | Novartis Europharm Limited |
| 21 May 2026 | Vislyfa
ranibizumab |
Biosimilar | Lupin Europe GmbH |
| 30 Jan 2025 | Skojoy
aflibercept |
Biosimilar | Amgen Technology (Ireland) UC |
A CHMP positive opinion is the scientific recommendation of the EMA's Committee for Medicinal Products for Human Use. The European Commission normally issues the legally binding marketing authorisation within 67 days of the opinion.
Source: European Medicines Agency medicines data - centrally authorised human medicines only; nationally authorised products are not included. Compare the US market in our FDA Approvals Tracker and FDA Recall Tracker, see the EU Clinical Trials Tracker for the trials behind these approvals, or cross-reference the Irish market in the Irish Medicines Database.