BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, August 15, 2025
Home » Topics » Regulatory » Danish Medicines Agency

Danish Medicines Agency
Danish Medicines Agency RSS Feed RSS

Ozempic pen and packaging

EMA warns Ozempic linked to ‘very rare’ side effect

June 6, 2025
By Nuala Moran
No Comments
The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.
Read More

EMA investigating potential semaglutide link to eye disease

Jan. 17, 2025
By Nuala Moran
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
Read More
Ozempic pen and packaging

Danish regulators question possible Ozempic link to rare eye condition

Dec. 17, 2024
By Nuala Moran
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).
Read More

Danish Medicines Agency approves AJ Vaccines' polio vaccine

July 1, 2019

Danish clearance for Oncology Venture's study of APO-010 in multiple myeloma

March 23, 2017

Avexxin cleared to conduct study of AVX-001 in Denmark

Feb. 8, 2013

Almirall launches aclidinium in Europe

Sep. 21, 2012

First European approval granted for Sumavel DosePro for migraine

Dec. 9, 2010

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Aug. 14, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for August 14, 2025.
  • NME Digest: Q2 2025

    BioWorld
    A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications...
  • Microscopic image of blood cells, chronic myeloid leukemia and thrombocytosis

    Scemblix ticks Novartis earnings box; more ahead in CML

    BioWorld
    Novartis AG’s financial update included good news about Scemblix (asciminib), the first and only U.S. FDA-approved allosteric inhibitor for chronic myeloid...
  • Mirugen co-founders Keith Martin (L) and Raymond Wong (R)

    Aussie gene therapy company emerges from stealth

    BioWorld
    Aussie gene therapy company Mirugen Pty Ltd. has emerged from stealth mode from the Center for Eye Research Australia in Melbourne, toting a AU$4.5 million...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing