Every direct healthcare professional communication (DHPC) the European Medicines Agency has published: the letters that tell doctors and pharmacists about new safety information, quality defects or supply problems.
The EMA has published 170 direct healthcare professional communications since January 2020, 19 of them in the last 12 months. The most recent, on 20 Aug 2026, concerned Jentadueto (quality defect). A DHPC is sent by the company to doctors and pharmacists, agreed with the EMA or national regulators. Patients should not stop or change a medicine because of a DHPC without speaking to their doctor or pharmacist.
| Medicine | Type | Therapeutic area | Published |
|---|---|---|---|
| Jentadueto linagliptin, metformin hydrochloride · ATC A10BD11 |
Quality defect | Diabetes Mellitus, Type 2 | 20 Aug 2026 |
| Litfulo ritlecitinib tosilate · ATC L04AF08 |
Adverse event, Post-authorisation measure, Restriction of indication Variation |
Alopecia Areata | 10 Aug 2026 |
| Desogestrel / etonogestrel desogestrel, etonogestrel |
Adverse event, Post-authorisation measure Variation |
— | 6 Aug 2026 |
| Vyvgart efgartigimod alfa · ATC L04AA58 |
Quality defect | Myasthenia Gravis, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | 23 Jul 2026 |
| Tavneos avacopan · ATC L04 4 clinical trials → |
Referral - Article 20 procedure Revocation |
Microscopic Polyangiitis, Wegener Granulomatosis | 16 Jul 2026 |
| Ixchiq Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated · ATC J07BP01 |
Adverse event, Restriction of indication Variation |
Chikungunya virus | 14 Jul 2026 |
| Evrysdi risdiplam · ATC M09AX10 6 clinical trials → |
Quality defect | Muscular Atrophy, Spinal | 12 Jun 2026 |
| Ontozry cenobamate · ATC N03AX 4 clinical trials → |
Adverse event, Post-authorisation measure Variation |
Epilepsy | 12 May 2026 |
| Tecovirimat SIGA tecovirimat monohydrate · ATC J05AX24 2 clinical trials → |
Restriction of indication Variation |
Poxviridae Infections, Cowpox, Monkeypox, Vaccinia, Smallpox | 11 May 2026 |
| Savene dexrazoxane · ATC V03AF02 8 clinical trials → |
Quality defect | Extravasation of Diagnostic and Therapeutic Materials | 23 Apr 2026 |
| Levamisole levamisole |
Adverse event Withdrawal |
— | 16 Apr 2026 |
| Avtozma tocilizumab · ATC L04AC07 71 clinical trials → |
Medication error, Quality defect | Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Cytokine Release Syndrome, COVID-19 virus infection | 3 Apr 2026 |
| Arixtra fondaparinux sodium · ATC B01AX05 |
Quality defect | Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Angina, Unstable | 6 Feb 2026 |
| Tranexamic acid tranexamic acid 45 clinical trials → |
Adverse event Variation |
— | 11 Dec 2025 |
| Remsima infliximab · ATC L04AB02 39 clinical trials → |
New contraindication Variation |
Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid | 8 Dec 2025 |
| Libtayo cemiplimab · ATC L01XC33 68 clinical trials → |
Quality defect | Carcinoma, Squamous Cell | 10 Nov 2025 |
| Lenalidomide Mylan lenalidomide · ATC L04AX07 167 clinical trials → |
Quality defect | Multiple Myeloma | 29 Oct 2025 |
| Crysvita burosumab · ATC M05BX05 |
Adverse event Variation |
Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant, Osteomalacia | 9 Oct 2025 |
| Caspofungin caspofungin 2 clinical trials → |
Post-authorisation measure Variation |
— | 9 Oct 2025 |
| Leqembi Lecanemab · ATC N06DX04 13 clinical trials → |
Post-authorisation measure Variation |
Cognitive Dysfunction, Alzheimer Disease | 26 Sep 2025 |
| Ixchiq Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated |
Referral - Article 20 procedure | Chikungunya virus | 23 Sep 2025 |
| Rapamune sirolimus 32 clinical trials → |
Quality defect | Graft Rejection, Kidney Transplantation | 19 Sep 2025 |
| Finasteride / dutasteride Finasteride, dutasteride |
Post-authorisation measure Variation |
— | 12 Sep 2025 |
| Clozapine clozapine 8 clinical trials → |
Safety signal Variation |
— | 8 Sep 2025 |
| Evrysdi risdiplam · ATC M09AX10 6 clinical trials → |
Quality defect | Muscular Atrophy, Spinal | 21 Aug 2025 |
| Rybelsus semaglutide · ATC A10BJ06 110 clinical trials → |
Medication error Variation |
— | 1 Aug 2025 |
| Mysimba bupropion hydrochloride, naltrexone hydrochloride · ATC A08AA |
Adverse event Variation |
— | 29 May 2025 |
| Ixchiq Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated |
Adverse event Variation |
Chikungunya virus | 22 May 2025 |
| Opzelura ruxolitinib phosphate · ATC D11AH 70 clinical trials → |
Quality defect | Vitiligo | 24 Apr 2025 |
| Emblaveo avibactam, aztreonam · ATC J01DF51 |
Quality defect Suspension |
Gram-Negative Bacterial Infections, Urinary Tract Infections, Healthcare-Associated Pneumonia, Soft Tissue Infections | 14 Mar 2025 |
| Kisqali ribociclib · ATC L01EF02 64 clinical trials → |
Post-authorisation measure | Breast Neoplasms | 19 Feb 2025 |
| Veoza fezolinetant · ATC G02CX06 2 clinical trials → |
Adverse event Variation |
Menopause, Hot Flashes | 13 Jan 2025 |
| Alofisel darvadstrocel · ATC L04 |
Lack of effect Withdrawal |
Rectal Fistula | 19 Dec 2024 |
| Keppra levetiracetam · ATC N03AX14 13 clinical trials → |
Medication error | Epilepsy | 16 Dec 2024 |
| Cyanokit hydroxocobalamin · ATC V03AB33 |
Medicine shortage, Quality defect | Poisoning | 9 Dec 2024 |
| Ibandronic acid Accord ibandronic acid · ATC M05BA06 |
Quality defect | Wounds and Injuries, Breast Diseases, Neoplastic Processes, Calcium Metabolism Disorders, Water-Electrolyte Imbalance | 5 Dec 2024 |
| Metamizole metamizole 2 clinical trials → |
Adverse event Variation |
— | 3 Dec 2024 |
| Pegasys peginterferon alfa-2a · ATC L03AB11 |
Medicine shortage | Hepatitis C, Chronic, Hepatitis B, Chronic, Polycythemia Vera, Thrombocythemia, Essential | 8 Nov 2024 |
| 5 fluorouracil 5 fluorouracil |
Periodic safety update single assessment | Neoplasms | 24 Oct 2024 |
| Vabysmo Faricimab · ATC S01L 16 clinical trials → |
Quality defect | Wet Macular Degeneration, Macular Edema, Diabetes Complications | 17 Oct 2024 |
| Infanrix Hexa Diphtheria toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide, tetanus toxoid · ATC J07CA09 |
Quality defect | Hepatitis B, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, Tetanus | 10 Oct 2024 |
| Synflorix Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F · ATC J07AL52 |
Quality defect | Pneumococcal Infections, Immunization | 10 Oct 2024 |
| Oxbryta voxelotor · ATC B06AX03 |
Referral - Article 20 procedure Suspension |
Anemia, Anemia, Hemolytic, Anemia, Sickle Cell | 7 Oct 2024 |
| Medroxyprogesterone acetate medroxyprogesterone acetate 3 clinical trials → |
Safety signal Variation |
— | 3 Oct 2024 |
| Privigen human normal immunoglobulin (IVIg) · ATC J06BA02 |
Quality defect | Purpura, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome | 22 Aug 2024 |
| NovoSeven eptacog alfa (activated) · ATC B02BD08 |
Medicine shortage, Quality defect | Hemophilia B, Thrombasthenia, Factor VII Deficiency, Hemophilia A | 19 Aug 2024 |
| Glatiramer acetate Glatiramer acetate · ATC L03AX13 |
Adverse event Variation |
Multiple Sclerosis | 14 Aug 2024 |
| Ozempic / Victoza semaglutide, liraglutide · ATC A10BJ06;A10BJ02 |
Medicine shortage | Diabetes Mellitus, Diabetes Mellitus, Type 2 | 9 Aug 2024 |
| Ocaliva obeticholic acid · ATC A05AA04 |
Post-authorisation measure Revocation |
Liver Cirrhosis, Biliary | 31 Jul 2024 |
| Vabysmo Faricimab · ATC S01L 16 clinical trials → |
Quality defect | Wet Macular Degeneration, Macular Edema, Diabetes Complications | 25 Jul 2024 |
| Abecma / Breyanzi / Carvykti / Kymriah / Tecartus / Yescarta idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, brexucabtagene autoleucel, axicabtagene ciloleucel, ciltacabtagene autoleucel · ATC L01;L01XL05;L01XL04;L01X;L01XX70 |
Adverse event Variation |
Multiple Myeloma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Mediastinal Neoplasms, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Mantle-Cell | 18 Jul 2024 |
| Hydroxyprogesterone caproate hydroxyprogesterone caproate |
Post-authorisation measure Suspension |
— | 17 Jul 2024 |
| Zypadhera olanzapine pamoate monohydrate · ATC N05AH03 |
Quality defect | Schizophrenia | 19 Jun 2024 |
| Giapreza angiotensin II acetate · ATC C09 3 clinical trials → |
Quality defect | Hypotension, Shock | 23 May 2024 |
| Paxlovid nirmatrelvir, ritonavir · ATC J05AE30 |
Adverse event Maintenance |
COVID-19 virus infection | 21 Mar 2024 |
| Valproate valproate · ATC N03AG01 2 clinical trials → |
Post-authorisation measure Variation |
Epilepsy, Bipolar Disorder, Migraine Disorders | 19 Feb 2024 |
| Pseudoephedrine pseudoephedrine · ATC R01BA02 |
Referral - Article 31 Variation |
Nasal Decongestants | 9 Feb 2024 |
| Voxzogo vosoritide · ATC M05BX 9 clinical trials → |
Change in dosing recommendation Variation |
Achondroplasia | 23 Jan 2024 |
| Leqvio inclisiran · ATC C10AX 11 clinical trials → |
Quality defect Maintenance |
Hypercholesterolemia, Dyslipidemias | 21 Dec 2023 |
| Ozempic / Victoza semaglutide, liraglutide · ATC A10BJ06;A10BJ02 |
Medicine shortage | Diabetes Mellitus, Type 2 | 21 Nov 2023 |
| Omega-3 fatty acid ethyl esters omega-3 fatty acid ethyl esters |
Adverse event Variation |
Cardiovascular Diseases | 8 Nov 2023 |
| Integrilin eptifibatide · ATC B01AC16 |
Medicine shortage Withdrawal |
Angina, Unstable, Myocardial Infarction | 2 Nov 2023 |
| Topiramate / phentermine topiramate, phentermine · ATC N03AX11 |
Restriction of indication Variation |
Epilepsy, Migraine Disorders | 1 Nov 2023 |
| Vaxneuvance Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed) · ATC J07AL02 |
Quality defect Maintenance |
Pneumococcal Infections | 20 Sep 2023 |
| RoActemra / Hemlibra / Herceptin / Kadcyla / MabThera / Phesgo / Tecentriq tocilizumab, emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab · ATC L04AC07;B02BX06;L01XC03;L01XC14;L01XC02;L01XY |
Quality defect | Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Cytokine Release Syndrome, Giant Cell Arteritis, COVID-19 virus infection, Hemophilia A, Stomach Neoplasms, Breast Neoplasms, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Small Cell Lung Carcinoma | 17 Aug 2023 |
| Advate / Rixubis octocog alfa, Factor VIII Inhibitor Bypassing Activity, nonacog gamma |
Quality defect Variation |
— | 14 Aug 2023 |
| Simponi golimumab · ATC L04AB06 6 clinical trials → |
Quality defect Variation |
Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid | 9 Aug 2023 |
| Gavreto pralsetinib · ATC L01XE 6 clinical trials → |
Adverse event, Post-authorisation measure Variation |
Carcinoma, Non-Small-Cell Lung | 16 Jun 2023 |
| Adakveo Crizanlizumab · ATC B06AX01 4 clinical trials → |
Lack of effect, Referral - Article 20 procedure Revocation |
Anemia, Sickle Cell | 15 Jun 2023 |
| Fluoroquinolones Fluoroquinolones |
Post-authorisation measure Variation |
Anti-Bacterial Agents | 8 Jun 2023 |
| Simulect basiliximab · ATC L04AC02 3 clinical trials → |
Quality defect | Graft Rejection, Kidney Transplantation | 21 Apr 2023 |
| Menotropin Menotropin · ATC G03GA02 |
Medicine shortage | — | 12 Apr 2023 |
| Pholcodine Pholcodine |
Referral - Article 107i procedure Revocation |
Cough | 27 Mar 2023 |
| Ozempic semaglutide · ATC A10BJ06 110 clinical trials → |
Medicine shortage | Diabetes Mellitus | 13 Mar 2023 |
| Myalepta Metreleptin · ATC A16AA 5 clinical trials → |
Medicine shortage | Lipodystrophy, Familial Partial | 3 Mar 2023 |
| Caprelsa vandetanib · ATC L01XE 3 clinical trials → |
Restriction of indication Variation |
Thyroid Neoplasms | 28 Feb 2023 |
| Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz abrocitinib, filgotinib, baricitinib, upadacitinib, tofacitinib · ATC D11AH08;L04AA45;L04AA37;L04AA44;L04AA29 |
Referral - Article 20 procedure Variation |
Arthritis, Rheumatoid, Dermatitis, Atopic | 21 Feb 2023 |
| Xalkori crizotinib · ATC L01ED01 21 clinical trials → |
Adverse event Variation |
Carcinoma, Non-Small-Cell Lung | 21 Feb 2023 |
| Spikevax (previously COVID-19 Vaccine Moderna) CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2) · ATC J07BX03 |
Adverse event Variation |
COVID-19 virus infection | 21 Feb 2023 |
| Neofordex dexamethasone · ATC H02AB02 325 clinical trials → |
Change in dosing recommendation Variation |
Multiple Myeloma | 17 Feb 2023 |
| Fasturtec rasburicase · ATC V03AF07 |
Medicine shortage | Hyperuricemia | 17 Feb 2023 |
| Zolgensma onasemnogene abeparvovec · ATC M09AX09 |
Adverse event Variation |
Muscular Atrophy, Spinal | 16 Feb 2023 |
| Cystagon mercaptamine bitartrate · ATC A16AA04 |
Quality defect | Cystinosis | 15 Feb 2023 |
| Adakveo Crizanlizumab · ATC B06AX01 4 clinical trials → |
Referral - Article 20 procedure | Anemia, Sickle Cell | 14 Feb 2023 |
| Amfepramone amfepramone · ATC A08AA03 |
Referral - Article 31 Revocation |
Obesity | 8 Feb 2023 |
| Lymphoseek tilmanocept · ATC V09IA09 |
Medicine shortage | Radionuclide Imaging | 31 Jan 2023 |
| Pazenir paclitaxel · ATC L01CD01 400 clinical trials → |
Medicine shortage | Breast Neoplasms | 24 Jan 2023 |
| Insuman insulin human · ATC A10AB01;A10AC01 |
Medicine shortage Maintenance |
Diabetes Mellitus | 14 Jan 2023 |
| Terlipressin terlipressin · ATC H01BA04 4 clinical trials → |
Referral - Article 31 Variation |
Vasopressins | 1 Dec 2022 |
| Zoely nomegestrol, chlormadinone · ATC G03 |
Adverse event, Referral - Article 31 Variation |
— | 8 Nov 2022 |
| Imbruvica Ibrutinib · ATC L01EL01 44 clinical trials → |
Post-authorisation measure Variation |
Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell | 3 Nov 2022 |
| Ozempic semaglutide · ATC A10BJ06 110 clinical trials → |
Medicine shortage Maintenance |
Diabetes Mellitus | 19 Oct 2022 |
| Natpar parathyroid hormone · ATC H05AA03 |
Medicine shortage Maintenance |
Hypoparathyroidism | 4 Oct 2022 |
| Nulojix belatacept · ATC L04AA28 7 clinical trials → |
Medicine shortage Maintenance |
Graft Rejection, Kidney Transplantation | 28 Sep 2022 |
| Metalyse tenecteplase · ATC B01AD11 22 clinical trials → |
Medicine shortage Maintenance |
Myocardial Infarction | 23 Sep 2022 |
| Nulojix belatacept · ATC L04AA28 7 clinical trials → |
Medication error Maintenance |
Graft Rejection, Kidney Transplantation | 12 Sep 2022 |
| Visudyne verteporfin · ATC S01LA01 3 clinical trials → |
Medicine shortage Maintenance |
Myopia, Degenerative, Macular Degeneration | 12 Aug 2022 |
| Rubraca rucaparib camsylate · ATC L01XX |
Referral - Article 20 procedure, Restriction of indication Variation |
Ovarian Neoplasms | 12 Aug 2022 |
| Cetrotide cetrorelix (as acetate) · ATC H01CC02 |
Medicine shortage Maintenance |
Ovulation, Ovulation Induction | 9 Aug 2022 |
| Hydroxyethyl starch hydroxyethyl starch |
Post-authorisation measure Suspension |
— | 30 Jun 2022 |
| Imlygic talimogene laherparepvec · ATC L01XX51 2 clinical trials → |
Adverse event, Quality defect Variation |
Melanoma | 16 Jun 2022 |
| Dexdor Dexmedetomidine hydrochloride · ATC N05CM18 144 clinical trials → |
Safety signal Maintenance |
Conscious Sedation | 16 Jun 2022 |
| Defitelio defibrotide · ATC B01AX01 |
Lack of effect, Safety signal Maintenance |
Hepatic Veno-Occlusive Disease | 13 Jun 2022 |
| Ocaliva obeticholic acid · ATC A05AA04 |
New contraindication Variation |
Liver Cirrhosis, Biliary | 9 Jun 2022 |
| Lymphoseek tilmanocept · ATC V09IA09 |
Medicine shortage Maintenance |
Radionuclide Imaging | 30 May 2022 |
| Rubraca rucaparib camsylate · ATC L01XX |
Referral - Article 20 procedure Variation |
Ovarian Neoplasms | 5 May 2022 |
| Natpar parathyroid hormone · ATC H05AA03 |
Medicine shortage Maintenance |
Hypoparathyroidism | 29 Apr 2022 |
| Remicade / Flixabi / Inflectra / Remsima / Zessly infliximab · ATC L04AB02 39 clinical trials → |
New contraindication Variation |
Spondylitis, Ankylosing, Arthritis, Rheumatoid, Psoriasis, Crohn Disease, Arthritis, Psoriatic, Colitis, Ulcerative | 7 Mar 2022 |
| Xagrid anagrelide · ATC L01XX35 2 clinical trials → |
Safety signal Variation |
Thrombocythemia, Essential | 22 Feb 2022 |
| Mavenclad cladribine · ATC L04AA40 7 clinical trials → |
Adverse event Variation |
Multiple Sclerosis | 14 Feb 2022 |
| Nulojix belatacept · ATC L04AA28 7 clinical trials → |
Medicine shortage Maintenance |
Graft Rejection, Kidney Transplantation | 17 Jan 2022 |
| Briviact (in Italy: Nubriveo) Brivaracetam · ATC N03AX23 2 clinical trials → |
Quality defect Maintenance |
Epilepsy | 18 Dec 2021 |
| Lymphoseek tilmanocept · ATC V09IA09 |
Medicine shortage Maintenance |
Radionuclide Imaging | 7 Dec 2021 |
| Forxiga dapagliflozin propanediol monohydrate · ATC A10BK01 |
Type II variation Variation |
Diabetes Mellitus, Type 2 | 11 Nov 2021 |
| Kevzara sarilumab · ATC L04AC14 9 clinical trials → |
Medicine shortage Variation |
Arthritis, Rheumatoid | 9 Nov 2021 |
| Beovu Brolucizumab · ATC S01 |
Type II variation Variation |
Wet Macular Degeneration | 5 Nov 2021 |
| Visudyne verteporfin · ATC S01LA01 3 clinical trials → |
Medicine shortage | Myopia, Degenerative, Macular Degeneration | 5 Nov 2021 |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) ChAdOx1-SARS-COV-2 · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 13 Oct 2021 |
| Jcovden (previously COVID-19 Vaccine Janssen) adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 13 Oct 2021 |
| Champix varenicline · ATC N07BA03 4 clinical trials → |
Medicine shortage Variation |
Tobacco Use Cessation | 30 Sep 2021 |
| Jcovden (previously COVID-19 Vaccine Janssen) adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 19 Jul 2021 |
| Comirnaty / Spikevax (previously COVID-19 Vaccine Moderna) single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2) · ATC J07BX;J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 19 Jul 2021 |
| Champix varenicline · ATC N07BA03 4 clinical trials → |
Quality defect | Tobacco Use Cessation | 15 Jul 2021 |
| Xeljanz tofacitinib citrate · ATC L04AA29 32 clinical trials → |
Safety signal Variation |
Arthritis, Rheumatoid | 6 Jul 2021 |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) ChAdOx1-SARS-COV-2 · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 23 Jun 2021 |
| Venclyxto venetoclax · ATC L01XX52 204 clinical trials → |
Type II variation Variation |
Leukemia, Lymphocytic, Chronic, B-Cell | 10 Jun 2021 |
| INOmax nitric oxide · ATC R07AX 4 clinical trials → |
Quality defect Maintenance |
Hypertension, Pulmonary, Respiratory Insufficiency | 3 Jun 2021 |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) ChAdOx1-SARS-COV-2 · ATC J07BX03 |
Type II variation Variation |
COVID-19 virus infection | 2 Jun 2021 |
| Jcovden (previously COVID-19 Vaccine Janssen) adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 26 Apr 2021 |
| Eylea aflibercept · ATC S01LA05 42 clinical trials → |
Adverse event Variation |
Wet Macular Degeneration, Macular Edema, Diabetes Complications | 15 Apr 2021 |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) ChAdOx1-SARS-COV-2 · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 13 Apr 2021 |
| Respreeza human alpha1-proteinase inhibitor · ATC B02AB02 |
Medicine shortage | Genetic Diseases, Inborn, Lung Diseases | 26 Mar 2021 |
| Tecentriq atezolizumab · ATC L01FX06 173 clinical trials → |
Adverse event Variation |
Carcinoma, Transitional Cell, Carcinoma, Non-Small-Cell Lung, Urologic Neoplasms, Breast Neoplasms, Small Cell Lung Carcinoma | 25 Mar 2021 |
| Xeljanz tofacitinib citrate · ATC L04AA29 32 clinical trials → |
Safety signal | Arthritis, Rheumatoid | 24 Mar 2021 |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S) · ATC J07BX03 |
Safety signal Variation |
COVID-19 virus infection | 24 Mar 2021 |
| Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells · ATC L03 |
Adverse event Maintenance |
Severe Combined Immunodeficiency | 22 Mar 2021 |
| Zolgensma onasemnogene abeparvovec · ATC M09AX09 |
Type II variation Variation |
— | 18 Mar 2021 |
| Lojuxta Lomitapide · ATC C10AX12 |
Post-authorisation measure Maintenance |
Hypercholesterolemia | 17 Feb 2021 |
| Respreeza alpha1-proteinase inhibitor (human) · ATC B02AB02 |
Quality defect | Lung Diseases | 12 Feb 2021 |
| Alkindi hydrocortisone · ATC H02AB09 18 clinical trials → |
Safety signal Variation |
Adrenal Insufficiency | 4 Feb 2021 |
| Nucala Mepolizumab · ATC R03DX09 16 clinical trials → |
Medicine shortage | Asthma | 23 Jan 2021 |
| Kaletra lopinavir, ritonavir |
Quality defect | HIV Infections | 23 Dec 2020 |
| Zerbaxa ceftolozane, tazobactam · ATC J01 |
Quality defect | Bacterial Infections | 23 Dec 2020 |
| Metamizole metamizole · ATC N02BB02 2 clinical trials → |
Periodic safety update report Variation |
— | 15 Dec 2020 |
| Gliolan 5-aminolevulinic acid hydrochloride · ATC L01XD04 |
Type II variation Variation |
Glioma | 1 Dec 2020 |
| Tecfidera dimethyl fumarate · ATC L04AX07 7 clinical trials → |
Type II variation Variation |
Multiple Sclerosis | 12 Nov 2020 |
| Gilenya Fingolimod · ATC L04AA27 8 clinical trials → |
Periodic safety update report Variation |
Multiple Sclerosis | 10 Nov 2020 |
| Ondexxya andexanet alfa · ATC V03AB |
Adverse event Variation |
Drug-Related Side Effects and Adverse Reactions | 4 Nov 2020 |
| Esbriet Pirfenidone · ATC L04AX05 13 clinical trials → |
Type II variation Variation |
Idiopathic Pulmonary Fibrosis | 29 Oct 2020 |
| Quofenix / Quinsair Delafloxacin, levofloxacin · ATC J01MA23;J01MA12 |
Safety signal Variation |
— | 29 Oct 2020 |
| Cabazitaxel Accord cabazitaxel · ATC L01CD 11 clinical trials → |
Medication error | Prostatic Neoplasms, Castration-Resistant | 28 Oct 2020 |
| Leuprorelin leuprorelin 9 clinical trials → |
Referral - Article 31 Variation |
— | 2 Oct 2020 |
| Nulojix belatacept · ATC L04AA28 7 clinical trials → |
Medicine shortage | Graft Rejection, Kidney Transplantation | 23 Sep 2020 |
| Prevymis Letermovir · ATC J05 9 clinical trials → |
Variation |
Cytomegalovirus Infections | 11 Sep 2020 |
| RoActemra tocilizumab · ATC L04AC07 71 clinical trials → |
Medicine shortage | Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Cytokine Release Syndrome | 3 Sep 2020 |
| Insuman insulin human · ATC A10AB01;A10AC01 |
Type II variation | Diabetes Mellitus | 20 Jul 2020 |
| Myalepta Metreleptin · ATC A16AA 5 clinical trials → |
Quality defect | Lipodystrophy, Familial Partial | 18 Jun 2020 |
| Suboxone buprenorphine, naloxone · ATC N07BC51 |
Quality defect | Opioid-Related Disorders | 18 Jun 2020 |
| Ondexxya andexanet alfa · ATC V03AB |
Safety signal Variation |
Drug-Related Side Effects and Adverse Reactions | 17 Jun 2020 |
| Flucytosine flucytosine · ATC J02AX01 |
Referral - Article 31 Variation |
— | 4 Jun 2020 |
| Xeloda / Capecitabine Accord / Capecitabine Medac / Capecitabine Teva / Ecansya (previously Capecitabine Krka) / Teysuno Fluorouracil, capecitabine, tegafur · ATC L01BC06;L01BC53;L01BC02 |
Referral - Article 31 Variation |
— | 4 Jun 2020 |
| Tepadina thiotepa · ATC L01AC01 11 clinical trials → |
Quality defect | Hematopoietic Stem Cell Transplantation | 1 Jun 2020 |
| Brivudine brivudine · ATC J05AB15 |
Periodic safety update single assessment Variation |
— | 12 May 2020 |
| Polivy polatuzumab vedotin · ATC L01FX06 23 clinical trials → |
Quality defect | Lymphoma, B-Cell | 4 May 2020 |
| Cyproterone cyproterone |
Referral - Article 31 Variation |
Androgen Antagonists | 29 Apr 2020 |
| Esmya / Ulipristal Acetate Gedeon Richter ulipristal acetate |
Interim measures Suspension |
Leiomyoma | 23 Mar 2020 |
| Mepact mifamurtide · ATC L03AX15 2 clinical trials → |
Quality defect | Osteosarcoma | 25 Feb 2020 |
| Estradiol estradiol · ATC G03CA03 11 clinical trials → |
Referral - Article 31 Variation |
— | 20 Feb 2020 |
| Ecalta anidulafungin · ATC J02AX06 |
Quality defect Variation |
Candidiasis | 14 Feb 2020 |
| Picato Ingenol mebutate · ATC D06BX02 |
Interim measures, Referral - Article 20 procedure Suspension |
Keratosis, Actinic | 27 Jan 2020 |
Each medicine links to the EMA's DHPC page with the full letter. This register reports what the EMA published; it is not medical advice.
Every row is copied from the EMA's DHPC data, reproduced with acknowledgement of the source. Veterinary communications are excluded.
A daily job downloads the EMA's DHPC JSON report and lists every human-medicine communication, newest first. No AI drafting and no editorial pass. See our editorial standards. The the EMA data on this page was last retrieved on 27 Sep 2026.