№ files_lp_3_process_7_046800
File format: docx Character count: 10156 File size: 28 KB
This document provides a detailed pharmaceutical profile of Solimax-Q, a medication for treating overactive bladder, including dosage instructions, side effects, and contraindications.
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
Price: 8 / 10 USD
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Susceptibility testing breakpoints MIC interpretive criteria for inclusion in SmPC Section 5.1
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
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
Topics: Solimax-Q 5mg SmPC