Date

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 April 2024, 09:00 (CEST) to 23 April 2024, 10:00 (CEST)

Retrieved on: 
Tuesday, April 23, 2024
Safety, Date, European Medicines Agency, Shortage

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024

Key Points: 
  • Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024
    EventHumanVeterinaryMedicine shortagesMedicines
    Date
    Location
    The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) was established under Regulation 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.
  • The MSSG will be ensuring a robust response to issues impacting the quality, safety, efficacy and supply of medicinal products during major events or public health emergencies.

Product Management Service (PMS) Product UI and API training (access & navigation), Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 June 2024, 10:00 (CEST) to 3 June 2024, 11:30 (CEST)

Retrieved on: 
Friday, April 19, 2024
Network, API, PMS, Date, UI, Application

Product Management Service (PMS) Product UI and API training (access & navigation)

Key Points: 
  • Product Management Service (PMS) Product UI and API training (access & navigation)
    EventHumanMedicines
    Date
    Location
    Following the go-live of the Product Management Service (PMS) Product User Interface (UI) and Application Programming Interface (API) taking place at the end of May 2024, the PMS team will host a training session to explain & showcase the access and navigation for both the Product UI and API.
  • The participation is recommended to Industry and Network stakeholders working on regulatory affairs of their respective organisations.

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Retrieved on: 
Thursday, April 18, 2024
Eucalyptus oil, Bronchitis, Spasm, Seizure, System, Risk, Inflammation, Patient, Lung, Monograph, Committee, Inhalation, Steam, Herbal medicine, Date, Asthma, Heart failure, Plant, Mouth, Infection, Skin, Fever, Myalgia, Water, Larynx, Medicine, Dietary supplement

Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Key Points: 


Herbal medicinal product: Eucalypti aetheroleumArray,Array,Array, F: Assessment finalised

Herbal medicinal product: Pilosellae herba cum radiceArray, F: Assessment finalised

Retrieved on: 
Thursday, April 18, 2024
Cerastium, Date, Urinary system, System, Patient, Monograph, Committee, Urine, Mouth, Heart, Herbal medicine, Flower, Medicine, Dietary supplement

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
  • Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
  • Key facts
    - Latin name
    - Pilosellae herba cum radice
    - English common name
    - Mouse-ear hawkweed
    - Botanical name
    Hieracium pilosella L.
    - Therapeutic area
    - Urinary tract and genital disorders
    - Status
    - F: Assessment finalised
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph

Committee for Orphan Medicinal Products (COMP): 16-18 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 16 April 2024 to 18 April 2024

Retrieved on: 
Thursday, April 18, 2024
Diagnosis, Date, Committee, COMP, Pharmaceutical industry

Committee for Orphan Medicinal Products (COMP): 16-18 April 2024

Key Points: 

Committee for Orphan Medicinal Products (COMP): 16-18 April 2024
EventHumanRare diseases
Date
Location
The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.

Committee for Advanced Therapies (CAT): 17-19 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 17 April 2024 to 19 April 2024

Retrieved on: 
Thursday, April 18, 2024
Date, Committee, CAT, Safety

Committee for Advanced Therapies (CAT): 17-19 April 2024

Key Points: 

Committee for Advanced Therapies (CAT): 17-19 April 2024
EventHumanAdvanced therapiesInnovation
Date
Location
The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

Joint HMA/EMA Big Data Steering Group workshop on RWE methods, Online, European Medicines Agency, Amsterdam, the Netherlands, 14 June 2024

Retrieved on: 
Thursday, April 18, 2024
RWE, Patient, Joint, Date, EMA, Industrial design

Joint HMA/EMA Big Data Steering Group workshop on RWE methods

Key Points: 
  • Joint HMA/EMA Big Data Steering Group workshop on RWE methods
    EventHumanData on medicines
    Date
    Location
    This one-day hybrid Big Data Steering Group (BDSG) workshop will bring together representatives of regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:
    You can register for the workshop at the following link:
    Registration for the Joint HMA/EMA Big Data Steering Group Workshop on RWE methods

EQS-News: Announcement on the payment of the cash distribution from the capital reduction of STRABAG SE (ISIN AT000000STR1) resolved on 16 June 2023 via a value right (ISIN AT0000A36HK3)

Retrieved on: 
Wednesday, April 10, 2024
Exercise, Date, Sale, Disclosure, Risk, DSG, Policy, Lawyer, Privacy, Person, Proxy, Custodian bank, GDPR, Acquisition, Aktiengesellschaft, Publication, STRABAG, KMG, Microsoft Excel, Erste Group, EUR, European, Security (finance)

The shares of STRABAG SE with ISIN AT000000STR1 will be traded "ex claim for cash distribution" from Friday, 22 March 2024.

Key Points: 
  • The shares of STRABAG SE with ISIN AT000000STR1 will be traded "ex claim for cash distribution" from Friday, 22 March 2024.
  • The Depositing Agent acts exclusively as an agent of STRABAG SE and does not assume any obligations towards the holders of value rights.
  • The submission of the value rights for Cash Distribution must be declared to the custodian bank using the submission form provided.
  • Customary bank charges may be incurred for processing the payment of the Cash Distribution by way of value rights.

ANNOUNCEMENT OF INVITATION TO VOLUNTARY TENDER OFFER TO THE HOLDERS OF X5 RETAIL GROUP N.V., GLOBAL DEPOSITARY RECEIPTS – ISIN US98387E2054

Retrieved on: 
Wednesday, April 10, 2024
Offer and acceptance, Date, Form, DTC, Issuer, Security (finance), Cryptocurrency

The date and time by which holders must validly tender Securities in order to be eligible to receive an Acceptance Notice and instruct a settlement.

Key Points: 
  • The date and time by which holders must validly tender Securities in order to be eligible to receive an Acceptance Notice and instruct a settlement.
  • As soon as reasonably possible from receipt of an Acceptance Form, that is confirmed by the Offeror to be valid.
  • Holders that wish to accept the Offer are requested to complete the Form of Acceptance and send this directly to the Offeror via email to [email protected] .
  • Forms of Acceptance received by the 6th of May 2024 will receive a Confirmation Notice.

ANNOUNCEMENT OF INVITATION TO VOLUNTARY TENDER OFFER TO THE HOLDERS OF GLOBALTRANS INVESTMENT PLC GDR's - US37949E2046

Retrieved on: 
Wednesday, April 10, 2024
Offer and acceptance, Date, Form, DTC, Issuer, Settlement date, Security (finance)

The date and time by which holders must validly tender Securities in order to be eligible to receive the relevant Purchase Price on the Settlement Date.

Key Points: 
  • The date and time by which holders must validly tender Securities in order to be eligible to receive the relevant Purchase Price on the Settlement Date.
  • As soon as reasonably possible from receipt of an Acceptance Form, that is confirmed by the Offeror to be valid.
  • Holders that wish to accept the Offer are requested to complete the Form of Acceptance and send this directly to the Offeror via email to [email protected] .
  • Forms of Acceptance received by the 6th of May 2024 will receive a Confirmation Notice.