Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Date of authorisation: 13/02/2017, Revision: 25, Status: Authorised

Olumiant RSS Authorised This medicine is authorised for use in the European Union baricitinib Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Olumiant is a medicine used for treating: adults with moderate to severe rheumatoid arthritis (a disease causing inflammation of the joints) when standard treatment with disease‑modifying anti‑rheumatic drugs (also known as ‘DMARDs’) has not worked well enough or if patients cannot tolerate them. Olumiant can be used either alone or in combination with the disease modifying drug methotrexate; adults and children from 2 years of age with moderate to severe atopic dermatitis (eczema) when treatments applied to the skin are not sufficient or appropriate; adults and adolescents from 12 years of age with severe alopecia areata (a disease causing hair loss of the scalp or other parts of the body); children aged 2 years and older with active juvenile idiopathic arthritis (inflammation of the joints in children) in whom DMARDs did not work or cannot be tolerated. Olumiant contains the active substance baricitinib. Expand section Collapse section How is Olumiant used? Olumiant can only be obtained with a prescription, and treatment must be started by a doctor who has experience in the diagnosis and treatment of the conditions for which it is used. Olumiant is available as tablets to be taken by mouth once a day. The tablet may be dissolved in water when given to children who are unable to swallow whole tablets. Treatment may be temporarily stopped in patients who develop an infection, which is a known side effect of the medicine, or in those with abnormal levels of red blood cells or certain white blood cells. For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist. How does Olumiant work? The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system). It works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the processes of inflammation and damage that occur in rheumatoid arthritis, atopic dermatitis, alopecia areata and juvenile idiopathic arthritis. By blocking these enzymes, baricitinib reduces joint, skin and hair follicle inflammation and other symptoms of these diseases. What benefits of Olumiant have been shown in studies? Rheumatoid arthritis Three studies in around 2,500 adults with rheumatoid arthritis showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous treatment with disease-modifying drugs have not worked well enough. In these studies, treatment with Olumiant (alone or with disease-modifying medicines such as methotrexate and adalimumab) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than treatment with comparator medicines and placebo (a dummy treatment). The results of the three studies after 12 weeks of treatment are as follows: in patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab and 40% (196 out of 488 patients) on placebo; in patients previously treated with conventional disease-modifying drugs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo; in patients previously treated with a class of disease-modifying drugs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo. Olumiant has also been studied in patients who had not received previous treatment. In one study involving 584 adults, Olumiant was more effective than methotrexate. However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients. Atopic dermatitis Three main studies in around 1,600 adults with atopic dermatitis for whom treatments applied to the skin had not worked well enough or were not suitable showed that Olumiant improved their symptoms. In 2 studies, 14 to 17% of those given Olumiant had skin clear or almost clear of inflammation after treatment for 16 weeks compared with 5% of those given placebo. In a study in which Olumiant or placebo were added to treatment with corticosteroid medicines applied to the skin, this was 31% with Olumiant and 15% with placebo. The benefits in those for whom Olumiant worked appeared to continue with longer-term treatment. An additional study involved 483 children from 2 years of age with moderate to severe atopic dermatitis for whom treatments applied to the skin had not worked well enough or were not suitable. Results showed that, after 16 weeks of treatment, skin was clear or almost clear of inflammation in 42% of patients given Olumiant, compared with 16% of those given placebo. Alopecia areata Two main studies in 1,200 adults with severe alopecia areata (experiencing loss of at least 50% of scalp hair) showed that Olumiant was effective at reducing hair loss compared to placebo. In these studies, after 36 weeks of treatment, the extent of hair loss improved from over 50% to under 20% of scalp hair in 34% of the participants taking 4 mg of Olumiant and in 20% of the participants taking 2 mg of Olumiant, compared with 4% of the participants taking placebo. The benefits of Olumiant appeared to continue with longer-term treatment. One main study in 257 adolescents from 12 years of age weighing at least 30 kg showed that Olumiant was also effective at reducing hair loss in this group, compared with placebo. After 36 weeks of treatment, the extent of hair loss improved from over 50% to under 20% of scalp hair in 42% of the participants taking Olumiant 4 mg and in 27% of the participants taking 2 mg of Olumiant, compared with around 5% of the participants taking placebo. Juvenile idiopathic arthritis A main study looked at the effect of Olumiant in 220 children and adolescents between 2 and 18 years of age who had juvenile idiopathic arthritis and had an insufficient response to at least one DMARD. In this study, all patients were first given Olumiant for 12 weeks, with 76% (167) of the patients showing an improvement in their symptoms after this period. In the second part of the study, 163 of these patients then either continued taking Olumiant or were given a placebo for up to 32 weeks. When patients continued on Olumiant, they were less likely to have a flare up (a sudden worsening of symptoms); 17% (14 out of 82) of patients on Olumiant had a flare up, compared with 51% (41 out of 81) of those given placebo. What are the risks associated with Olumiant? For the complete list of side effects and restrictions with Olumiant, see the package leaflet. In adults, the most common side effects with Olumiant used alone or in combination, which may affect more than 1 in 10 people, are increased blood cholesterol levels and, nose and throat infections. Common side effects (which may affect up to 1 in 10 people) include headache, herpes simplex infections (cold sores) and urinary tract infections (infection of the parts of the body that collect and pass out urine). In children and adolescents with juvenile idiopathic arthritis, side effects in the main study were consistent with those seen in adults with the exception of headache, which was a very common side effect. Common side effects (which may affect up to 1 in 10 people) included neutropenia (low levels of white blood cells) and pulmonary embolism (an obstruction in a blood vessel in the lung); in the main study these were seen in 1 patient each. In children and adolescents with atopic dermatitis, side effects were consistent with those seen in adults with the exception of neutropenia, which was a common side effect. In adolescents with alopecia areata, side effects were comparable to those seen in adults, although acne and neutropenia were more common in adolescents. Olumiant must not be used during pregnancy. Olumiant should only be used if no suitable treatment alternatives are available in patients aged 65 years or above, in patients with a history of cardiovascular disease (such as heart attack or stroke) or with risk factors for such a disease (such as current or previous long-term smokers), or in patients at increased risk of cancer. Why is Olumiant approved? The European Medicines Agency decided that Olumiant’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with disease‑modifying drugs has not worked well enough or if patients cannot tolerate them. The Agency also took into account the lack of treatment options for these patients, and the fact that Olumiant can be given by mouth, which is convenient for patients. Similarly, for patients with atopic dermatitis and alopecia areata whose other treatment options are limited, its benefits were clinically relevant, particularly in patients with atopic dermatitis when combined with corticosteroid treatment of the skin. In children and adolescents between 2 and 18 years of age, the medicine was effective at treating juvenile idiopathic arthritis and atopic dermatitis; it was also found to be effective at treating alopecia areata in adolescents from 12 years of age. Overall, its side effects are considered manageable, and several measures have been put in place to minimise the risks with this medicine, particularly infection. What measures are being taken to ensure the safe and effective use of Olumiant? The company that markets Olumiant will provide educational materials to healthcare professionals and patients with information about the risks with the medicine, particularly the risk of serious infections, blood clots, major cardiovascular events and cancer in certain patients. They will also include a reminder that Olumiant should not be taken during pregnancy and that women taking Olumiant must use contraception (birth control) during treatment and for at least one week after stopping treatment. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olumiant have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Olumiant are continuously monitored. Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients. Other information about Olumiant Olumiant received a marketing authorisation valid throughout the EU on 13 February 2017. This overview was last updated in 10-2023. Olumiant : EPAR - Medicine overview Reference Number: EMADOC-1829012207-45460 English (EN) (155.69 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Other languages (22) български (BG) (181.28 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View español (ES) (151.49 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View čeština (CS) (178.69 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View dansk (DA) (151.93 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Deutsch (DE) (157.22 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View eesti keel (ET) (147.15 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View ελληνικά (EL) (182.41 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View français (FR) (154.59 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View hrvatski (HR) (177.77 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View italiano (IT) (151.42 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View latviešu valoda (LV) (184.61 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View lietuvių kalba (LT) (175.97 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View magyar (HU) (178.72 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Malti (MT) (180.25 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Nederlands (NL) (156.32 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View polski (PL) (187.61 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View português (PT) (152.79 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View română (RO) (172.15 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View slovenčina (SK) (178.25 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View slovenščina (SL) (174.98 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Suomi (FI) (148.08 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View svenska (SV) (148.95 KB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Olumiant : EPAR - Risk management plan English (EN) (3.07 MB - PDF) First published: 27/10/2020 Last updated: 25/07/2025 View Product information Olumiant : EPAR - Product Information English (EN) (1.44 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Other languages (24) български (BG) (1.54 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View español (ES) (1.41 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View čeština (CS) (1.51 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View dansk (DA) (1.26 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Deutsch (DE) (1.28 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View eesti keel (ET) (1.12 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View ελληνικά (EL) (1.42 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View français (FR) (1.16 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View hrvatski (HR) (1.57 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View íslenska (IS) (1.22 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View italiano (IT) (1.27 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View latviešu valoda (LV) (1.59 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View lietuvių kalba (LT) (1.34 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View magyar (HU) (1.31 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Malti (MT) (1.51 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Nederlands (NL) (1.08 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View norsk (NO) (1.13 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View polski (PL) (1.4 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View português (PT) (1.28 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View română (RO) (1.51 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View slovenčina (SK) (1.31 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View slovenščina (SL) (1.31 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Suomi (FI) (1.59 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View svenska (SV) (1.01 MB - PDF) First published: 16/03/2017 Last updated: 10/04/2026 View Latest procedure affecting product information: VR/0000288098 30/03/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Olumiant : EPAR - All Authorised presentations English (EN) (63.22 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Other languages (24) български (BG) (76.98 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View español (ES) (56.79 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View čeština (CS) (56.83 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View dansk (DA) (51.61 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Deutsch (DE) (62.57 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View eesti keel (ET) (65.94 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View ελληνικά (EL) (71.84 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View français (FR) (72.37 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View hrvatski (HR) (78.5 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View íslenska (IS) (48.73 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View italiano (IT) (57.44 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View latviešu valoda (LV) (81.25 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View lietuvių kalba (LT) (85.26 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View magyar (HU) (78.71 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Malti (MT) (73.57 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Nederlands (NL) (59.81 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View norsk (NO) (50.05 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View polski (PL) (84.28 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View português (PT) (63.64 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View română (RO) (75.07 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View slovenčina (SK) (77.29 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View slovenščina (SL) (100.66 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Suomi (FI) (67.69 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View svenska (SV) (58.15 KB - PDF) First published: 16/03/2017 Last updated: 21/09/2023 View Product details Name of medicine Olumiant Active substance Baricitinib International non-proprietary name (INN) or common name baricitinib Therapeutic area (MeSH) Arthritis, Rheumatoid Anatomical therapeutic chemical (ATC) code L04AA37 Pharmacotherapeutic group Immunosuppressants Therapeutic indication Rheumatoid arthritis Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Atopic Dermatitis Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. Alopecia areata Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older. Juvenile idiopathic arthritis Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs: - Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), - Enthesitis related arthritis, and - Juvenile psoriatic arthritis. Baricitinib may be used as monotherapy or in combination with methotrexate. Authorisation details EMA product number EMEA/H/C/004085 Marketing authorisation holder Eli Lilly Nederland B.V. Orteliuslaan 1000 3528 BD Utrecht Netherlands Opinion adopted 14/12/2016 Marketing authorisation issued 13/02/2017 Revision 25 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Olumiant : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (132.44 KB - PDF) First published: 19/12/2025 Last updated: 10/04/2026 View Olumiant : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (140.89 KB - PDF) First published: 20/10/2017 Last updated: 25/07/2025 View CHMP post-authorisation summary of positive opinion for Olumiant (VR/0000288098) Adopted Reference Number: EMADOC-1700519818-2937601 English (EN) (172.48 KB - PDF) First published: 27/02/2026 View Olumiant-H-C-004085-II-0046 : EPAR - Assessment report Adopted Reference Number: EMA/275928/2024 English (EN) (565.27 KB - PDF) First published: 05/07/2024 View Olumiant-H-C-004085-II-0037 : EPAR - Assessment report - variation Adopted Reference Number: EMA/436396/2023 English (EN) (3.67 MB - PDF) First published: 30/10/2023 View Olumiant-H-C-4085-X-0035-G : EPAR - Assessment report - Variation Adopted Reference Number: EMA/365746/2023 English (EN) (2.98 MB - PDF) First published: 21/09/2023 View CHMP post-authorisation summary of positive opinion for Olumiant (II-37) Adopted Reference Number: EMA/CHMP/343776/2023 English (EN) (150.27 KB - PDF) First published: 14/09/2023 View CHMP post-authorisation summary of opinion for Olumiant (X-35-G) Adopted Reference Number: EMA/CHMP/311719/2023 English (EN) (93.87 KB - PDF) First published: 21/07/2023 View Olumiant : EPAR - Scientific conclusions for Article 20 referral - Divergent positions of CHMP English (EN) (126.74 KB - PDF) First published: 15/06/2023 View Olumiant-H-C-4085-A20-0032 : EPAR – Scientific conclusions - Article 20 English (EN) (139.86 KB - PDF) First published: 15/06/2023 View Other languages (24) български (BG) (203.66 KB - PDF) First published: 15/06/2023 View español (ES) (180.84 KB - PDF) First published: 15/06/2023 View čeština (CS) (217.54 KB - PDF) First published: 15/06/2023 View dansk (DA) (182.81 KB - PDF) First published: 15/06/2023 View Deutsch (DE) (192.42 KB - PDF) First published: 15/06/2023 View eesti keel (ET) (172.43 KB - PDF) First published: 15/06/2023 View ελληνικά (EL) (202.37 KB - PDF) First published: 15/06/2023 View français (FR) (178.06 KB - PDF) First published: 15/06/2023 View hrvatski (HR) (208.34 KB - PDF) First published: 15/06/2023 View íslenska (IS) (189.22 KB - PDF) First published: 15/06/2023 View italiano (IT) (180.64 KB - PDF) First published: 15/06/2023 View latviešu valoda (LV) (202.23 KB - PDF) First published: 15/06/2023 View lietuvių kalba (LT) (225.26 KB - PDF) First published: 15/06/2023 View magyar (HU) (215.29 KB - PDF) First published: 15/06/2023 View Malti (MT) (226.94 KB - PDF) First published: 15/06/2023 View Nederlands (NL) (185.49 KB - PDF) First published: 15/06/2023 View norsk (NO) (180 KB - PDF) First published: 15/06/2023 View polski (PL) (211.18 KB - PDF) First published: 15/06/2023 View português (PT) (181.57 KB - PDF) First published: 15/06/2023 View română (RO) (221.05 KB - PDF) First published: 15/06/2023 View slovenčina (SK) (199.58 KB - PDF) First published: 15/06/2023 View slovenščina (SL) (222.12 KB - PDF) First published: 15/06/2023 View Suomi (FI) (169.26 KB - PDF) First published: 15/06/2023 View svenska (SV) (182.3 KB - PDF) First published: 15/06/2023 View Olumiant-H-C-4085-A20-0032 : EPAR - Assessment Report - Article 20 Adopted Reference Number: EMA/586384/2022 English (EN) (751.5 KB - PDF) First published: 15/06/2023 View Olumiant-H-C-4085-P46-012.1 : EPAR - Assessment report Adopted Reference Number: EMA/CHMP/607/2023 English (EN) (1.07 MB - PDF) First published: 22/02/2023 View Olumiant-H-C-4085-II-0029-G : EPAR - Assessment report - Variation Adopted Reference Number: EMA/572597/2022 English (EN) (3.88 MB - PDF) First published: 29/06/2022 View CHMP post-authorisation summary of positive opinion for Olumiant (II-29-G) Adopted Reference Number: EMA/CHMP/260143/2022 English (EN) (150.39 KB - PDF) First published: 20/05/2022 View Olumiant-PSUSA-000010578/202002 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/635532/2020 English (EN) (157.08 KB - PDF) First published: 15/12/2020 View Olumiant-H-C-4085-II-0016 : EPAR - Assessment report - Variation Adopted Reference Number: EMA/520470/2020 English (EN) (6.68 MB - PDF) First published: 27/10/2020 View CHMP post-authorisation summary of positive opinion for Olumiant (II-16) Adopted Reference Number: EMA/CHMP/267941/2020 English (EN) (143.21 KB - PDF) First published: 18/09/2020 View Olumiant-PSUSA-00010578-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/648109/2019 English (EN) (130.98 KB - PDF) First published: 03/12/2019 View Initial marketing authorisation documents Olumiant : EPAR - Public assessment report Adopted Reference Number: EMA/13493/2017 English (EN) (2.27 MB - PDF) First published: 16/03/2017 Last updated: 16/03/2017 View CHMP summary of positive opinion for Olumiant English (EN) (74.21 KB - PDF) First published: 16/12/2016 Last updated: 16/12/2016 View News on Olumiant Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2026 27/02/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023 21/07/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022 16/12/2022 EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders 28/10/2022 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022 20/05/2022 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022 11/02/2022 EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen 29/04/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020 18/09/2020 New oral treatment for moderate to severe atopic dermatitis 18/09/2020 New oral treatment for rheumatoid arthritis 16/12/2016 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016 16/12/2016 Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Olumiant : EPAR – Product information - tracked changes English (EN) (633.99 KB - DOCX) First published: 19/12/2025 View Other languages (24) български (BG) (683.33 KB - DOCX) First published: 19/12/2025 View español (ES) (653 KB - DOCX) First published: 19/12/2025 View čeština (CS) (693.85 KB - DOCX) First published: 19/12/2025 View dansk (DA) (1003.5 KB - DOC) First published: 19/12/2025 View Deutsch (DE) (674.03 KB - DOCX) First published: 19/12/2025 View eesti keel (ET) (653.7 KB - DOCX) First published: 19/12/2025 View ελληνικά (EL) (683.9 KB - DOCX) First published: 19/12/2025 View français (FR) (775.6 KB - DOCX) First published: 19/12/2025 View hrvatski (HR) (693.47 KB - DOCX) First published: 19/12/2025 View íslenska (IS) (1011.5 KB - DOC) First published: 19/12/2025 View italiano (IT) (1020.5 KB - DOC) First published: 19/12/2025 View latviešu valoda (LV) (687.73 KB - DOCX) First published: 19/12/2025 View lietuvių kalba (LT) (607.2 KB - DOCX) First published: 19/12/2025 View magyar (HU) (667.52 KB - DOCX) First published: 19/12/2025 View Malti (MT) (670.24 KB - DOCX) First published: 19/12/2025 View Nederlands (NL) (560.67 KB - DOCX) First published: 19/12/2025 View norsk (NO) (702.99 KB - DOCX) First published: 19/12/2025 View polski (PL) (676.21 KB - DOCX) First published: 19/12/2025 View português (PT) (601.63 KB - DOC) First published: 19/12/2025 View română (RO) (705.4 KB - DOCX) First published: 19/12/2025 View slovenčina (SK) (682.21 KB - DOCX) First published: 19/12/2025 View slovenščina (SL) (549.54 KB - DOCX) First published: 19/12/2025 View Suomi (FI) (754.78 KB - DOCX) First published: 19/12/2025 View svenska (SV) (492.49 KB - DOCX) First published: 19/12/2025 View Related content Clinical data (initial marketing authorisation) More information on Olumiant EMEA-001220-PIP01-11-M10 - paediatric investigation plan EMEA-001220-PIP03-16-M02 - paediatric investigation plan EMEA-001220-PIP05-19 - paediatric investigation plan EMEA-001220-PIP07-20-M01 - paediatric investigation plan Janus kinase inhibitors (JAKi) - referral EMEA-001220-PIP08-20 - paediatric investigation plan Olumiant - withdrawal of application for variation to marketing authorisation Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz - direct healthcare professional communication (DHPC) Baricitinib Drug Utilisation Study: Assessment of Effectiveness of New Recommendations for Use Based on Secondary Data Sources in France, Germany, The Netherlands, and Sweden (I4V-MC-B038) - post-authorisation study Rheumatologist and Dermatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant (baricitinib), a JAK1/2 inhibitor (I4V-MC-B025) - post-authorisation study Observational study of exposure to baricitinib during pregnancy in US-based administrative claims data (I4V-MC-B036) - post-authorisation study Cross-Sectional Survey of Rheumatologists and Dermatologists to Assess the Effectiveness of the Baricitinib Additional Risk Minimization Measures in Canada - post-authorisation study Post-Marketing Safety Study on Olumiant (Baricitinib) Use Among Moderate to Severe Active Rheumatoid Arthritis Patients in China - post-authorisation study Spanish Registry of Atopic Dermatitis (BIOBADATOP) - post-authorisation study Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant® (baricitinib) a JAK1/2 inhibitor (I4V-MC-B010) - post-authorisation study A Retrospective Cohort Study to Assess the Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Rheumatoid Arthritis in Nordic Countries (I4V-MC-B011) - post-authorisation study A Prospective Observational Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults in the United States with Moderate-to-Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B003) - post-authorisation study Shortening the time to confirm or to rebut Adverse events of interest related to innovative Therapies for immune-mediated inflammATory dIseases: cross-talking between different data sOURces. SATURATIOn study. - post-authorisation study The UK-Irish Atopic Eczema Systemic Therapy Register (A-STAR): Eli Lilly Engagement with A-STAR - post-authorisation study Comparative Assessment of VTE and Other Risks among Patients with Rheumatoid Arthritis treated with Baricitinib versus Tumor Necrosis Factor Inhibitors: A Multi-database Observational Cohort Study - post-authorisation study Assessment of off-label use of baricitinib in the paediatric population (Paediatric use of baricitinib) - post-authorisation study A Retrospective Cohort Study to Assess the Long-Term Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Adults with Moderate to Severe Rheumatoid Arthritis in the Course of Routine Clinical Care (I4V-MC-B004) - post-authorisation study An Observational Cohort Study to Investigate the Risk of Malignancies Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (I4V-JE-B020) - post-authorisation study An Observational Cohort Study to Investigate the Risk of Serious Infections Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (4V-JE-B019) - post-authorisation study Topics Medicines This page was last updated on 10/04/2026 Share this page