Bifogade filer
PR200404_Rybelsus_approval_EU
Kurs
+0,11%
Kalender
| Est. tid* | ||
| 2026-11-04 | 07:30 | Kvartalsrapport 2026-Q3 |
| 2026-08-05 | 07:30 | Kvartalsrapport 2026-Q2 |
| 2026-05-06 | - | Kvartalsrapport 2026-Q1 |
| 2026-03-27 | - | X-dag halvårsutdelning NOVO B 7.95 |
| 2026-03-26 | - | Årsstämma |
| 2026-02-04 | - | Bokslutskommuniké 2025 |
| 2025-11-14 | - | Extra Bolagsstämma 2025 |
| 2025-11-05 | - | Kvartalsrapport 2025-Q3 |
| 2025-08-15 | - | X-dag halvårsutdelning NOVO B 3.75 |
| 2025-08-06 | - | Kvartalsrapport 2025-Q2 |
| 2025-05-07 | - | Kvartalsrapport 2025-Q1 |
| 2025-03-28 | - | X-dag halvårsutdelning NOVO B 7.9 |
| 2025-03-27 | - | Årsstämma |
| 2025-02-05 | - | Bokslutskommuniké 2024 |
| 2024-11-06 | - | Kvartalsrapport 2024-Q3 |
| 2024-08-15 | - | X-dag halvårsutdelning NOVO B 3.5 |
| 2024-08-07 | - | Kvartalsrapport 2024-Q2 |
| 2024-05-02 | - | Kvartalsrapport 2024-Q1 |
| 2024-03-22 | - | X-dag halvårsutdelning NOVO B 6.4 |
| 2024-03-21 | - | Årsstämma |
| 2024-01-31 | - | Bokslutskommuniké 2023 |
| 2023-11-02 | - | Kvartalsrapport 2023-Q3 |
| 2023-09-13 | - | Split NOVO B 1:2 |
| 2023-08-18 | - | X-dag halvårsutdelning NOVO B 6 |
| 2023-08-10 | - | Kvartalsrapport 2023-Q2 |
| 2023-05-04 | - | Kvartalsrapport 2023-Q1 |
| 2023-03-24 | - | X-dag halvårsutdelning NOVO B 8.15 |
| 2023-03-23 | - | Årsstämma |
| 2023-02-01 | - | Bokslutskommuniké 2022 |
| 2022-11-02 | - | Kvartalsrapport 2022-Q3 |
| 2022-08-12 | - | X-dag halvårsutdelning NOVO B 4.25 |
| 2022-08-04 | - | Kvartalsrapport 2022-Q2 |
| 2022-05-04 | - | Kvartalsrapport 2022-Q1 |
| 2022-03-25 | - | X-dag halvårsutdelning NOVO B 6.9 |
| 2022-03-24 | - | Årsstämma |
| 2022-02-02 | - | Bokslutskommuniké 2021 |
| 2021-11-03 | - | Kvartalsrapport 2021-Q3 |
| 2021-08-16 | - | X-dag halvårsutdelning NOVO B 3.5 |
| 2021-08-05 | - | Kvartalsrapport 2021-Q2 |
| 2021-05-05 | - | Kvartalsrapport 2021-Q1 |
| 2021-03-26 | - | X-dag halvårsutdelning NOVO B 5.85 |
| 2021-03-25 | - | Årsstämma |
| 2021-02-03 | - | Bokslutskommuniké 2020 |
| 2020-10-30 | - | Kvartalsrapport 2020-Q3 |
| 2020-08-14 | - | X-dag halvårsutdelning NOVO B 3.25 |
| 2020-08-06 | - | Kvartalsrapport 2020-Q2 |
| 2020-05-06 | - | Kvartalsrapport 2020-Q1 |
| 2020-03-27 | - | X-dag halvårsutdelning NOVO B 5.35 |
| 2020-03-26 | - | Årsstämma |
| 2020-02-05 | - | Bokslutskommuniké 2019 |
| 2019-11-01 | - | Kvartalsrapport 2019-Q3 |
| 2019-08-21 | - | Kvartalsrapport 2019-Q2 |
| 2019-08-16 | - | X-dag halvårsutdelning NOVO B 3 |
| 2019-05-03 | - | Kvartalsrapport 2019-Q1 |
| 2019-03-22 | - | X-dag halvårsutdelning NOVO B 5.15 |
| 2019-03-21 | - | Årsstämma |
| 2019-02-01 | - | Bokslutskommuniké 2018 |
| 2018-08-18 | - | X-dag halvårsutdelning NOVO B 3 |
| 2018-08-08 | - | Kvartalsrapport 2018-Q2 |
| 2018-05-02 | - | Kvartalsrapport 2018-Q1 |
| 2018-03-23 | - | X-dag halvårsutdelning NOVO B 4.85 |
| 2018-03-22 | - | Årsstämma |
| 2018-02-01 | - | Bokslutskommuniké 2017 |
| 2017-11-01 | - | Kvartalsrapport 2017-Q3 |
| 2017-08-18 | - | X-dag halvårsutdelning NOVO B 3 |
| 2017-08-09 | - | Kvartalsrapport 2017-Q2 |
| 2017-05-03 | - | Kvartalsrapport 2017-Q1 |
| 2017-03-24 | - | X-dag ordinarie utdelning NOVO B 4.60 DKK |
| 2017-03-23 | - | Årsstämma |
| 2017-02-02 | - | Bokslutskommuniké 2016 |
| 2016-10-28 | - | Kvartalsrapport 2016-Q3 |
| 2016-08-12 | - | X-dag halvårsutdelning NOVO B 3 |
| 2016-08-05 | - | Kvartalsrapport 2016-Q2 |
| 2016-04-29 | - | Kvartalsrapport 2016-Q1 |
| 2016-03-21 | - | X-dag halvårsutdelning NOVO B 6.4 |
| 2016-03-18 | - | Årsstämma |
| 2016-02-03 | - | Bokslutskommuniké 2015 |
| 2015-10-29 | - | Kvartalsrapport 2015-Q3 |
| 2015-08-06 | - | Kvartalsrapport 2015-Q2 |
| 2015-04-30 | - | Kvartalsrapport 2015-Q1 |
| 2015-03-20 | - | X-dag ordinarie utdelning NOVO B 5.00 DKK |
| 2015-03-19 | - | Årsstämma |
| 2015-01-30 | - | Bokslutskommuniké 2014 |
| 2014-10-30 | - | Kvartalsrapport 2014-Q3 |
| 2014-08-07 | - | Kvartalsrapport 2014-Q2 |
| 2014-05-01 | - | Kvartalsrapport 2014-Q1 |
| 2014-03-21 | - | X-dag ordinarie utdelning NOVO B 4.50 DKK |
| 2014-03-20 | - | Årsstämma |
| 2014-02-03 | - | Bokslutskommuniké 2013 |
| 2014-01-02 | - | Split NOVO B 1:5 |
| 2013-10-31 | - | Kvartalsrapport 2013-Q3 |
| 2013-08-08 | - | Kvartalsrapport 2013-Q2 |
| 2013-05-01 | - | Kvartalsrapport 2013-Q1 |
| 2013-03-21 | - | X-dag ordinarie utdelning NOVO B 18.00 DKK |
| 2013-03-20 | - | Årsstämma |
| 2013-02-04 | - | Bokslutskommuniké 2012 |
| 2012-10-31 | - | Kvartalsrapport 2012-Q3 |
| 2012-08-09 | - | Kvartalsrapport 2012-Q2 |
| 2012-04-27 | - | Kvartalsrapport 2012-Q1 |
| 2012-03-22 | - | X-dag ordinarie utdelning NOVO B 14.00 DKK |
| 2012-03-21 | - | Årsstämma |
| 2012-02-02 | - | Bokslutskommuniké 2011 |
| 2011-10-27 | - | Kvartalsrapport 2011-Q3 |
| 2011-08-04 | - | Kvartalsrapport 2011-Q2 |
| 2011-04-28 | - | Kvartalsrapport 2011-Q1 |
| 2011-03-24 | - | X-dag ordinarie utdelning NOVO B 10.00 DKK |
| 2011-03-23 | - | Årsstämma |
| 2011-02-02 | - | Bokslutskommuniké 2010 |
| 2010-03-25 | - | X-dag ordinarie utdelning NOVO B 7.50 DKK |
| 2007-12-03 | - | Split NOVO B 1:2 |
| 2001-04-04 | - | Split NOVO B 1:5 |
| 1997-01-02 | - | Split NOVO B 1:2 |
Beskrivning
| Land | Danmark |
|---|---|
| Lista | Large Cap Copenhagen |
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
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Bagsværd, Denmark, 4 April 2020 - Novo Nordisk today announced that the European Commission (EC) has granted marketing authorisation for Rybelsus® (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. The marketing authorisation applies to all 27 European Union member states and the United Kingdom.
Rybelsus® is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist. The approval is based on the results from 10 PIONEER clinical trials, in which Rybelsus® after 52 weeks demonstrated statistically significant reductions in HbA1c vs sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg weight reduction. Across the PIONEER programme, Rybelsus® demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished over time.
“We are very excited about the approval of Rybelsus® as we can now offer people in Europe living with type 2 diabetes the first and only GLP-1 in a tablet,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer. “Based on its strong clinical profile, we believe Rybelsus® has the potential to set a new standard for the treatment of type 2 diabetes, as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”
The launch of Rybelsus® is expected to take place in the first EU countries in the second half of 2020.
About Rybelsus®
Rybelsus® (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1. Rybelsus® is approved in the US, Switzerland and EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg.
Rybelsus® is currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.
Further information
| Media: | ||
| Mette Kruse Danielsen | +45 3079 3883 | mkd@novonordisk.com |
| Ken Inchausti (US) | +1 609 240 9429 | kiau@novonordisk.com |
| Investors: | ||
| Daniel Muusmann Bohsen | +45 3075 2175 | dabo@novonordisk.com |
| Valdemar Borum Svarrer | +45 3079 0301 | jvls@novonordisk.com |
| Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
| Mark Joseph Root | +45 3079 4211 | mjhr@novonordisk.com |
| Kristoffer Due Berg (US) | +1 609 235 2989 | krdb@novonordisk.com |
Company announcement No 21 / 2020