Marketing authorisation

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on: 
Sunday, March 10, 2024
Capsule, HPRA, EXP, NAAM, Pi, CS, ATMP, Table, Unicode, Health education, Potassium iodide, Syringe, VIAL, Inn, Potassium, NRG, Powder, Translation, Blister, Patient, Guideline, Abbreviation, SIDC, WHO, COPD, ISO, Compilation, Diabetes, DA, Prohibition, Times New Roman, Excipient, Narcotic, FAQ, Approximation error, Sodium chloride, PI, Cmax, Microsoft Word, NOT, Veterinary medicine, European Medicines Agency, Council, PFU, QRD, Helicobacter pylori, Tablet, Microsoft, Total, Medication package insert, European, DIE, Language, Single Supervisory Mechanism, Plaque, Vaccine, MAH, Safety, Printing, International standard, Sodium, Osteoporosis, Reproduction, Name, Marketing authorisation, Marketing, Caregiver, Imperial, NCA, Food, EDQM, Confusion, Risk, Cell, Medicine, Disease, Public, Medical device

29 February 2024

Key Points: 
    • 29 February 2024
      EMA/25090/2002 rev.23*
      Human Medicines Division

      Compilation of QRD decisions on stylistic matters in product information
      Issues
      Abbreviations

      Connected problems
      Subscript and superscript

      QRD Suggestions
      Acronyms must be written in their standard form; e.g.

    • Cmax, Cmax
      Abbreviations and

      Not always understood,

      Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.

    • The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
      i.e.
    • critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 2/23

      Issues

      Connected problems

      QRD Suggestions

      emphasise in the labelling
      the special handling prior
      to administration of the
      product.

    • Consistency

      Inconsistencies in style are

      Once a particular style or house style has been selected, it must be used consistently throughout the text.

    • Tradename 150 mg solution for injection in pre-filled syringe
      Tradename 150 mg solution for injection in pre-filled pen

      information annexes?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 3/23

      Issues
      Desiccant

      Connected problems

      QRD Suggestions

      For medicinal products

      The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

      packaged with a desiccant

      the desiccant.

    • For bottles containing a desiccant, a similar statement should also be considered provided there

      mistake the desiccant for a

      is available space.

    • It can only be included in brackets in section 3 of the

      where can this be

      SmPC and section 4 of the labelling.

    • Direct speech should only
      be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
    • The term ?drug? though can be used in the product information annexes when it is part of a standard set of
      terms (e.g.
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 5/23

      Issues
      Foreign terms

      Connected problems

      QRD Suggestions

      Foreign terms, particularly

      Foreign terms must be written in italics; e.g.

    • Patients can be referred to as ?he? or

      physician is often referred

      as ?she? when the medicinal product is exclusively for use by males or females.

    • if the product in question might be

      measurements are

      used by elderly patients), in brackets after the metric measures in the English text.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 6/23

      Issues

      Connected problems

      QRD Suggestions

      product name is composed
      of MAH+INN?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 7/23

      Issues

      Connected problems

      QRD Suggestions
      MT: English
      BG: Bulgarian
      NL: Dutch
      CZ: Czech or English at applicant?s discretion.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 14/23

      Issues

      Connected problems

      QRD Suggestions
      considered, e.g.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 16/23

      Issues
      Symbols: Non-Unicode

      Connected problems

      QRD Suggestions

      The use of non-Unicode

      Only Unicode symbols must be used in submitted product information annexes.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 20/23

      Issues

      Connected problems

      Units: SI base units -

      International Standard

      litre

      base units have been
      introduced in the European
      Union with Council
      Directive 80/181/EEC of
      20.12.79 (O.J.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 23/23

Anavex Life Sciences Reports Fiscal 2024 First Quarter Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 7, 2024
Clinical trial, Marketing authorisation, FDA, Expanded access, Genome, Frontotemporal dementia, Safety, Food, OLE, Real, CNS, Medicine, Publication, Committee, RTT, Rett syndrome, Patent, Marketing, CHMP, European, Human, DSM-IV codes, Research, Patient, Drug development, Pharmacokinetics, Pharmacology, Central nervous system, Webcast, Conference call, Doctor of Philosophy, Treatment, EDGAR, MECP2, Union, Therapy, EMA, RWE, Alzheimer's disease, European Medicines Agency, Neurodevelopmental disorder, Bank statement, Conference, Pharmaceutical industry

NEW YORK, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended December 31, 2023.

Key Points: 
  • The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • We intend to further assess the results and discuss with the regulatory authorities next steps.
  • General and administrative expenses for the quarter of $2.6 million compared to $3.3 million for the comparable first quarter of fiscal 2023.
  • Research and development expenses for the fourth quarter of $8.7 million compared to $12.1 million for the comparable first quarter of fiscal 2023.

Anavex Life Sciences Reports Fiscal 2023 Year End Financial Results and Provides Business Update

Retrieved on: 
Monday, November 27, 2023
Psychiatry, MLS, Agitation, EDGAR, Marketing, Conference call, Patent, Barrow Neurological Institute, Marketing authorisation, Conference, Insomnia, Plasma, European, Publication, American Academy, Dementia, Therapy, Neuroscience, Medicine, Rett syndrome, EMA, Anxiety, CNS, Biomarker, Patient, Senior, DSM-IV codes, Alzheimer's disease, Memory, MD, Doctor of Philosophy, Research, Clinical trial, Schizophrenia, Neurobiology of Aging, European Medicines Agency, Regulatory affairs, Pathology, Central nervous system, Webcast, Pharmaceutical industry

NEW YORK, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2023.

Key Points: 
  • “There is a high demand from Alzheimer’s disease patients and families for easy access and scalable treatment options.
  • The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • On November 22, 2023, the Company announced that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No.
  • The financial information for the fiscal year ended September 30, 2023, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com .

Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)

Retrieved on: 
Monday, November 20, 2023
DSM-IV codes, Senior, Authorization, Alzheimer's disease, Dementia, MRI, MLS, Amyloid-related imaging abnormalities, Marketing, EMA, WHO, European, Brain, Doctor of Philosophy, World Health Organization, Cerebral edema, ARIA, European Medicines Agency, Regulatory affairs, Marketing authorisation, Pathology, Amyloid, Patient, Therapy, Medical imaging

These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

Key Points: 
  • These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.
  • Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
  • Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Retrieved on: 
Monday, December 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Retrieved on: 
Monday, December 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

EQS-News: CHEPLAPHARM opens presence in Tokyo

Retrieved on: 
Tuesday, November 7, 2023
United States federal executive departments, Marketing authorisation, Dean, Cheplapharm Arzneimittel, Medication, Toronto Metropolitan University, Business development, Medicines and Healthcare products Regulatory Agency, Ministry, Ministry of Health, Labour and Welfare, Business administration, Marketing, Business, Strategic planning, Temple, Aerospace engineering, Patient, Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry, Novartis, Health

CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.

Key Points: 
  • CHEPLAPHARM Arzneimittel GmbH, based in Greifswald/Germany, has opened a presence in the Japanese capital Tokyo and obtained the pharmaceutical licence for Japan.
  • The managing director of the founded CHEPLAPHARM KK is Kentaro Ichimori, who most recently held a leading position for Sandoz in Japan.
  • Establishing a presence in Japan and launching CHEPLAPHARM as a local brand is important to further build trust with local business partners, doctors and patients.
  • The opening of an office in Tokyo and the presence on the Japanese market serves to establish CHEPLAPHARM as a brand in Japan and make it better known, thus leveraging further growth potential.

Arriello appoints experienced biotech expert, Kate Coleman, as VP of Quality & Compliance

Retrieved on: 
Wednesday, September 20, 2023
Trinity College, Industrial microbiology, Microbiology, Senior, Face, Administration, Culture, Bachelor, Fear, Risk management, Quality management, University College Dublin, ATMP, Kate, Research Quality Association, Marketing, Trinity College Dublin, QP, QRM, Quality control, Risk, QA, Master of Science, Quality assurance, Growth, Dublin Institute of Technology, Regulatory affairs, API, Vaccine, Marketing authorisation, Conference, Regulation, QMC, Audit, Pharmaceutical industry, Nursing, EU, Pharmacovigilance, Quality, Sanofi

DUBLIN, Sept. 20, 2023 /PRNewswire-PRWeb/ -- Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has announced that industrial microbiology and quality risk management specialist Kate Coleman, will join the company in September as VP of Quality & Compliance. She joins from PharmaLex, where she was Senior Director/Principal Consultant for Quality Management and Compliance and QMC Head of the UK/Ireland region.

Key Points: 
  • DUBLIN, Sept. 20, 2023 /PRNewswire-PRWeb/ -- Arriello , a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has announced that industrial microbiology and quality risk management specialist Kate Coleman , will join the company in September as VP of Quality & Compliance.
  • She joins from PharmaLex, where she was Senior Director/Principal Consultant for Quality Management and Compliance and QMC Head of the UK/Ireland region.
  • This last accomplishment, gained in 2009, means Kate can act as a Qualified Person (QP) for clients in the EU.
  • Here she will present on the theme of "QRM and Quality - Making sure fear doesn't undermine your QRM programme" - exploring the purpose of Quality Risk Management.

Reacta Healthcare appoints Kevin Hawkins as Head of Regulatory Affairs

Retrieved on: 
Monday, June 26, 2023
Teva Pharmaceuticals, Inhalation, Teva, Marketing authorisation, Food allergy, Head, Regional health authorities in Manitoba, Marketing, Senior, Growth, Regulatory affairs, Nasal spray, Oral food challenge, Pharmaceutical industry, Management

DEESIDE, Wales, June 26, 2023 /PRNewswire/ -- Reacta Healthcare , an early-stage food allergy diagnostic company specialising in the development and manufacturing of pharmaceutical grade challenge materials for Oral Food Challenges, announces the appointment of industry executive Kevin Hawkins as Head of Regulatory Affairs.

Key Points: 
  • DEESIDE, Wales, June 26, 2023 /PRNewswire/ -- Reacta Healthcare , an early-stage food allergy diagnostic company specialising in the development and manufacturing of pharmaceutical grade challenge materials for Oral Food Challenges, announces the appointment of industry executive Kevin Hawkins as Head of Regulatory Affairs.
  • Mr. Hawkins is a pharma veteran with leadership experience spanning R&D, regulatory affairs, analytical development, and project leadership.
  • Mr. Hawkins previously served as Senior Director and Head of Development at Teva Pharmaceuticals for over 10 years covering a broad range of R&D, analytical development, and regulatory affairs.
  • Kevin is a highly skilled and respected senior leader with a strong track record in R&D and Regulatory Affairs.

Successful capital increase for Biophytis with €2.3 million raised

Retrieved on: 
Thursday, May 11, 2023
Euronext Growth, CET, Therapy, COVID-19, Ageing, Mass meeting, Annual general meeting, Marketing, Marketing authorisation, Patient, Transaction, ISIN, Respiratory failure, Pharmaceutical industry, Security (finance), Cryptocurrency

Funds raised to finance the Marketing Authorisation Applications of Sarconeos (BIO101) for the treatment of severe forms of COVID-19.

Key Points: 
  • Funds raised to finance the Marketing Authorisation Applications of Sarconeos (BIO101) for the treatment of severe forms of COVID-19.
  • Stanislas Veillet, CEO of Biophytis stated: “On behalf of Biophytis team, I would like to warmly thank all of the professional investors, hitorical Company’s investors, for their support, and retail investors through PrimaryBid who participated in this fundraising.
  • The settlement-delivery of the new shares and their admission to Euronext Growth Paris under ISIN code FR0012816825 will take place on May 15 2023.
  • Following the Transaction, the Company's share capital will represent an amount of €4,267,650, split into 426,764,954 ordinary shares with a par value of €0.01, all of the same category.