№ lp_1_2_30429
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Regulatory reference text defining EUCAST-established minimum inhibitory concentration interpretive criteria for antimicrobial susceptibility testing intended for inclusion in the clinical particulars section of a medicinal product summary.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Summary of Product Characteristics (SmPC) Template
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
SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) Solimax-Q (Solifenacin Succinate) 5mg film-coated Tablets
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
General Instructions and Cover Sheet Requirements for MIC Mark Package Submittal
Document type: Instructional form and submission guidelines
Subject: MIC Mark Package documentation requirements
Intended use: Submission of manufacturing and inspection documentation
Applicable items: Single part per package with associated serial numbers
Standards referenced: Critical Safety Item requirements per drawings and standards
Organization: GA-EMS and U.S. Government
Scope: Supplier submittals under government contracts
Related documentation: CSI documentation and supplemental documentation
Standardized Etest Method for MIC Determination of Antimicrobial Susceptibility
Note: Year
Topic: Antimicrobial Susceptibility Testing
Document Type: Standard Operating Procedure
Context: Standard operating procedure for antimicrobial susceptibility testing using Etest for determining MIC values of pathogenic bacteria.
Special MIC – Distributed Energy Resources (DER)
Year: 2017
Location: PJM Conference and Training Center
Topic: Distributed Energy Resources
Document Type: Meeting Agenda
Organization: PJM
Author: Andrew Gledhill
Target Audience: Stakeholders of the PJM
Period of Validity: April 10, 2017
Approval Date: April 10, 2017
Date of Changes: None
HOWL! NOW!! The Red Moon Howl Virtual Open Mic Event
Year: 2022
Region / City: New York, EST
Theme: Menstrual cycle, performance art
Document type: Event announcement
Organization: Society for Menstrual Cycle Research (SMCR), Our Bodies Ourselves Today (OBOS Today)
Author: Not specified
Target audience: Individuals interested in menstrual cycle research, performance art, and virtual events
Event date: January 19, 2022
Submission deadline: Not specified
Event format: Virtual, Zoom
Recording format: Pre-recorded or live performances
Technical requirements: Video under 5 minutes, landscape mode preferred
Press Release Announcing the Album Peach Blossom Youth by Mic Harrison and The High Score, August 6, 2025
Title: Peach Blossom Youth
Artist: Mic Harrison and The High Score
Release date: October 3, 2025
Label: Deaf Goat/Real Much Records
Document type: Press release
Publication date: August 6, 2025
Genre: Americana, roots rock, bluegrass-influenced rock
Producer: Eric “Roscoe” Ambel
Band members: Mic Harrison; Robbie Trosper; Vance Hillard; Kevin Abernathy; Mark T. Dunn
Guest musicians: Eric “Roscoe” Ambel; Mary Lee Kortes
Region: East Tennessee, United States
Author: Lee Zimmerman
2026 - U15 Tier 2 Provincial Championship – July 31st – August 2nd Windsor, Ontario (Mic Mac Park) - Hotel Block
Year: 2026
Region / City: Windsor, Ontario
Theme: Hotel Accommodation
Document Type: Event Information
Organization: PWSA
Author: Rod Drouillard
Target Audience: Tournament participants and teams
Period of Validity: July 31st – August 2nd, 2026
Approval Date: N/A
Date of Changes: N/A
Topics: breakpoints SmPC MIC