№ lp_1_2_46564
File format: docx
Character count: 2841
File size: 37 KB
Regulatory guidance text defining the required structure and content of a Summary of Product Characteristics as part of the WHO Public Assessment Report for medicines under the WHO Prequalification Programme.
Document type:
Regulatory guidance document
Subject:
Medicinal product information
Program:
WHO Prequalification of Medicines
Issuing organization:
World Health Organization
Responsible unit:
WHO Prequalification Team: medicines (PQTm)
Scope:
Summary of Product Characteristics for medicinal products
Regulatory context:
WHO Public Assessment Report (WHOPAR)
Intended use:
Prequalification assessment of medicines
Sections covered:
Quality, clinical particulars, pharmacological properties, pharmaceutical particulars
Reference system:
WHO Prequalification reference number
Related resources:
WHO guidelines and referenced literature
Language:
English
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Date:
21/02/2025
Reference number:
EMA/457563/2023
Department:
Therapeutic Areas Department
Subject:
Antimicrobial susceptibility testing
Type of document:
Regulatory text for SmPC
Issuing body:
European Medicines Agency
Responsible committee:
European Committee on Antimicrobial Susceptibility Testing (EUCAST)
Related substance:
{INN}
Applicable section:
SmPC Section 5.1
Language versions:
Multiple EU languages
Source link:
https://www.ema.europa.eu/documents/other/minimum-inhibitory-concentration-mic-breakpoints_en.xlsx
Year:
2021
Region / City:
Global
Topic:
Medicine/Pharmaceuticals
Document Type:
Pharmaceutical Product Information
Organization:
N/A
Author:
N/A
Target Audience:
Healthcare Professionals
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Note:
Year
Target Audience:
Parents and guardians of multilingual children entering kindergarten
Year:
2011
Region / City:
Washington, D.C.
Topic:
Educational characteristics of prisoners
Document Type:
Working Paper
Organization / Institution:
U.S. Census Bureau
Author:
Stephanie Ewert, Tara Wildhagen
Target Audience:
Researchers, policymakers, and individuals concerned with incarceration and educational attainment
Period of Validity:
N/A
Date of Approval:
N/A
Date of Changes:
N/A
Note:
Year
Year:
2026
Region / City:
European Union
Subject:
Pharmaceutical Product Information
Document Type:
Pharmaceutical Summary
Organization:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Period of validity:
Ongoing
Approval Date:
2026
Date of Modifications:
2026
Contextual Description:
The document outlines the product characteristics, indications, dosage, administration guidelines, and precautions for the pharmaceutical product Tysabri, as approved by the European Medicines Agency.
Year:
Not specified
Region / City:
Not specified
Subject:
Gypsum fiber roof board, building materials
Document Type:
Product specification / technical datasheet
Manufacturer / Organization:
USG Corporation
Standards and Certifications:
ASTM C1278, ASTM D3273, ASTM E84, ASTM E661, ASTM C518, UL Classified Type FRX-G, FM Approved (FM 4450, FM 4470, FM Class 1)
Material Composition:
97% recycled material
Performance Attributes:
Moisture and mold resistance, wind-uplift performance, compressive strength 1800 psi
Dimensions:
Thickness [1/4” (66.4) – 5/8” (15.9)], Length [4’-0” (1219) – 8’-0” (2438)], Width 48" (1219), Bending radius [25’-0” (7620) – 30’-0” (9144)]
Target Audience:
Architects, engineers, contractors, building code officials
Year:
2026
Region / City:
EMEA
Subject:
Pharmaceutical Information
Document Type:
Product Information
Organization / Institution:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare Professionals, Medical Practitioners
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Document type:
Product Information
Organ / institution:
European Medicines Agency
Target audience:
Healthcare professionals, patients
Year:
2026
Region / City:
European Union
Subject:
Pharmaceutical product information
Document type:
Summary of Product Characteristics
Organization / Institution:
European Medicines Agency (EMA)
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Note:
Year
Year:
2014
Region / City:
-
Topic:
Address validation process for service address
Document type:
Technical specification
Organization / Institution:
-
Author:
-
Target audience:
Technical professionals involved in address validation systems
Period of validity:
-
Approval date:
-
Date of changes:
-
Document No:
FDA/DNC/TEM-01
Year:
2024
Region / City:
Accra, Ghana
Subject:
Immunological Veterinary Medicinal Products
Document Type:
Guideline
Organization / Institution:
Food and Drugs Authority
Author:
Food and Drugs Authority
Target Audience:
Pharmaceutical manufacturers, regulatory authorities
Validity Period:
Not specified
Approval Date:
1st February 2013
Revision Date:
30th January 2024
Year:
2023
Region / City:
European Union
Subject:
Pharmaceutical Product Information
Document Type:
Product Information
Organization / Institution:
European Medicines Agency
Author:
Eliquis Manufacturer
Target Audience:
Healthcare Professionals
Effective Period:
Not specified
Approval Date:
Not specified
Date of Last Change:
Not specified
Year:
2026
Region / City:
Europe
Topic:
Medicine Information
Document Type:
Pharmaceutical Product Information
Organization / Institution:
European Medicines Agency
Author:
European Medicines Agency
Target Audience:
Healthcare professionals
Period of Validity:
Ongoing
Approval Date:
2026
Date of Changes:
2026
Year:
2023
Note:
Region / city
Topic:
Wireless LANs, QoS Characteristics
Document type:
Technical proposal
Organization / institution:
IEEE
Author:
Duncan Ho, Abhishek Patil, Gaurang Naik, George Cherian, Alfred Asterjadhi, Yanjun Sun, Abdel Karim
Target audience:
Technical experts, IEEE 802.11 working group
Document type:
Educational laboratory activity
Subject area:
Chemistry and environmental science
Educational level:
Secondary education
Curriculum expectations:
Scientific investigation skills, waste management, environmental challenges
Activities:
Polymer synthesis, material testing, data analysis
Polymers produced:
Starch-based polymer, milk-based polymer
Assessment type:
Summative laboratory work
Time allocation:
Four instructional periods
Materials:
Laboratory chemicals, glassware, heating equipment, testing apparatus
Geographic context:
Canada
Referenced resources:
Educational articles and videos on plastics and bioplastics
Curriculum framework:
Science curriculum with environmental focus
Year:
2024
Region / city:
United Kingdom
Theme:
Organic food certification
Document type:
Form
Organization / institution:
Soil Association
Author:
Soil Association
Target audience:
Companies submitting products for certification
Effective period:
From September 2025
Approval date:
Not specified
Amendment date:
March 2024
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
Note:
Year
Document Type:
Procedure
Organization / Institution:
Canberra Health Services