Información de medicamentos

MEDICAMENTOS AUTORIZADOS EN AGENCIAS REGULADORAS DE PAÍSES DE ALTA VIGILANCIA
(Fichas técnicas e insertos)
ALEMANIA

AUSTRALIA
AUSTRIA
BELGICA
CBIP

CANADA
COREA
DINAMARCA
ESPAÑA
ESTADOS UNIDOS
Dailymed

FDA Label

Medguide

FRANCIA

Base De Donnés Publique
Des Médicaments

HOLANDA
HUNGRIA
IRLANDA
ITALIA
JAPON

OTC (Japón)
NORUEGA
PORTUGAL
REINO UNIDO
EMC

SUECIA
SUIZA
 

LINKS OMS

MEDICAMENTOS Y BIOLOGICOS PRECALIFICADOS

PRECALIFICACION

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MEDICAMENTOS

HEALTH PRODUCTS POLICY AND STANDARDS

ATC

INN (DCI)

Specifications for Pharmaceuticals Products

WHO Model List of Essential Medicines

WHO model formulary for children 

WHO model formulary

The Selection and Use of Essential Medicines

Model List of Essential Medicines

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VACUNAS

OMS Vacunas precalificadas

OMS Precalificados

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BIOLOGICOS

Expert Committee on Biological Standardization

Biotherapeutic products

Similar Biotherapeutic products

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​DISPOSITIVOS MEDICOS

Priority Medical devices information system (MeDevIS)

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LINKS DE MEDICAMENTOS  DE VENTA SIN RECETA MEDICA
AUSTRALIA

DINAMARCA

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ESTADOS UNIDOS

CFR
Dailymed

OTC Monograps

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CANADA

Health Canada
Category IV Monographs

Drug Facts
 

HOLANDA

IRLANDA

SUECIA

REINO UNIDO

NORUEGA

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PERU

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Association of the European Self-Care Industry

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GUIAS

Unión Europea

HMA

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LINKS DE UTILIDAD PERU

Fichas técnicas de especialidades farmacéuticas

Fichas técnicas de Biológicos

Listado de medicamentos intercambiables

Registro Sanitario de Medicamentos

Petitorio Nacional de Medicamentos Esenciales

Listado de Autoridades competentes para emisión de CPP

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Formulario de Medicamentos Esenciales

OTROS
EMA
Drugs
HMA MRI Product Index
 

EUDRAGMDP

Documentos Red PARF

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DIETETICOS
Health Claim EU
Health Claim FDA
Health Claim UK

Dietary Supplement Label Database (USA)

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NATURALES

Medline Plus: Herbs and Supplements

WHO monographs on selected medicinal plants

Volume 1

Volume 2

Volume 3

Volume 4

HEALTH CANADA

Natural health products ingredients database

Single Ingredients Monographs

Product Monographs

Search License Natural Health Products

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BIOLÓGICOS
EMA
Búsqueda de biologicos autorizados

Guidelines Multidisciplinary Biosimilar

Interchangeability of biosimilar medicines in the EU

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FDA
Drugs@FDA: FDA-Approved Drugs

Biosimilar Product Information

Purple Book

Search for FDA Guidance Documents

Approved Vaccine Products

Approved Blood Products

Emergency Use Authorization 

CANADA
Biosimilar biologic drugs

The Drug and Health Product Register

COREA

Biosimilar

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OMS

Precalificación

OMS Vacunas precalificadas

OMS Vacunas COVID

OMS Precalificados

Biosimilar

Biotherapeutic Products

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UE Biológicos

OTROS BIOLOGICOS DE ORIGEN NO RECOMBINANTE

HMA Questions and answers on biologicals 

SUBSTITUTION / INTERCHANGEABILITY

Suecia

Dinamarca

Noruega

Australia

Hungria

EMA

Documentos Red PARF

ICH (Guidelines)

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PERU

Fichas técnicas Biológicos

Biosimilares autorizados

EXCIPIENTES
Drugs: Inactive Drug Ingredient

Inactive Ingredient Search for Approved Drug Products (USA)
Listado excipientes (Perú)

Excipients (EMA)
Pharma Excipients
Excipientes críticos

Considerations and recommendations on traditional and non-traditional uses of excipients in oral drug products

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INTERCAMBIABILIDAD DE MEDICAMENTOS

WHO Guidance Documents

WHO Technical Report Series

EMA Scientific Guidelines

FDA Guidance Documents

ICH Multidisciplinary

FDA Product specific guidances for generic drug development

EMA Product Specific bioequivalence guidance

EMA Questions&Answers

CANADA Pharmaceutical quality of Aqueous solutions

Canada Submissions for generic parenteral drugs

Canada Guidances Bioavailability and Bioequivalence

Canada Draft Guidance Document: Generic Drug Equivalence: Medicinal Ingredients

ANVISA Equivalencia Terapéutica

ANVISA Regulación

ANVISA buscador normas

DIGEMID

BCS 

FIP Biowaiver Monographs

Online BCS Database

Dissolution Methods Database with BCS and BE

OMS Informe 40 Anx 8

OMS Informe 54 Anx 12

PQT/MED-specific Annotations for the ICH M9 Guideline (24 January 2023)

Current Knowledge Gaps and Regulatory Challenges in the Evaluation of Biowaivers for BCS Class III

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CENTROS AUTORIZADOS

WHO Public Inspection Reports

ANVISA

FDA

ANMAT Vademecum

TAMAÑO DE MUESTRA

TUTORIAL IN BIOSTATISTICS Sample sizes for clinical trials with Normal data

FARTSSIE

PRODUCTOS DE REFERENCIA

OMS

IPRP Bioequivalence Group

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PUBLIC ASSESSMENT REPORT

Australia

Suiza

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SEGURIDAD

BASES DE DATOS DE RAMs

WHO Vigiaccess

European Database of suspected  adverse drug reaction reports

FDA Adverse Event Reporting System (FAERS)

Canada Vigilance Adverse Reaction Online Database

Risk Management Plans and Periodic Safety Update Reports (PAHO)​

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PGR

Suiza

Dinamarca

Alemania

PGR HMA

PSURs EMA

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MHRA

Safety Public Assessment Reports

Drug Safety Update

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JAPON

Revision of Precautions

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WHO Pharmacovigilance

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EMA Safety

Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC recommendations on safety signals

Periodic safety update report single assessment (PSUSA)

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FDA Safety

Drug Safety-related Labeling Changes (SrLC)

Approved Risk Evaluation and Mitigation Strategies (REMS)

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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CAMBIOS

EMA

WHO General Guidance on variations to multisource pharmaceutical products

WHO Guidelines on variations to a prequalified product

WHO Guidelines for changes to approved biotherapeutic products

WHO Guidelines for changes to approved vaccines

Australian Variations

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FDA

MEDICAMENTOS Y BIOLOGICOS AUTORIZADOS

Drugs@FDA: FDA-Approved Drugs

FDA Label

Dailymed

Approved Vaccine Products

Approved Blood Products

Emergency Use Authorization 

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GUIAS CIENTIFICAS

FDA Guidance Documents

CFR

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MEDICAMENTOS GENERICOS

Orange book

FDA Product specific guidances for generic drug development

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BIOSIMILARES

Biosimilar Product Information

Purple Book

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OTC

OTC Monograps

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ESTABLECIMIENTOS

Drug Establishments Current Registration Site

Inspections

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DISPOSITIVOS MEDICOS

Medical Device Databases

Devices@FDA

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EMA

Medicamentos y Biologicos autorizados

Listado de medicamentos autorizados en la UE

Guías científicas

Product-specific bioequivalence guidance

Clinical pharmacology and pharmacokinetics: questions and answers

Product-specific biosimilar guidelines

Product Information Requirements

CMDh Questions & Answers on Biologicals

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European database of suspected adverse drug reaction reports

Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC recommendations on safety signals

Periodic safety update report single assessment (PSUSA)

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Authenticity verification for electronic certificates

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UNION EUROPEA

Comisión Europea

Union Register

EUDRA LEX - EU Legislation

Heads of Medicines Agency (HMA)

MRI Product Index

OVERVIEW OF BIOLOGICAL ACTIVE SUBSTANCES OF NON-RECOMBINANT ORIGIN

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EUDRA GMP

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Autoridades reguladoras de paises de UE

Monografias OTC​

Noruega

Suecia

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Medicamentos OTC

Holanda

Irlanda

Irlanda (Legal Status)

Reino Unido

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EDQM

CEP

Standard Terms EDQM

Melclass

Australian Manufacturers

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BUSQUEDA 6S (Medicina Basada en evidencias)
PubMed
LILACS
ACP Journal Club
BMJ Evidence based medicine
Colaboración Cochrane
Uptodate
SIGN
NICE
Tripdatabase
Accesss
Medscape
Epistemonikos
Web-based Sample Size/Power Calculations
Search MEDLINE/PubMed via PICO with Spelling Checker
Dr Chris Cates' EBM Website
Manual Merck

EVALUACION DE NUEVOS MEDICAMENTOS

Navarra

FARMACOPEAS
Farmacopea Internacional
Farmacopea Japonesa
Farmacopea Coreana

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BPM

Unión Europea

Australia

Canada

Reino Unido