Frontiers | Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment
An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and Clinical Development Conditions - Dominik Sawicki-Wrzask, Mikael Thomsen, Ole J. Bjerrum, 2015
STRATEGIC APPROACHES OF UTILIZING BA/BE STUDIES TO OBTAIN APPROVAL FROM DIFFERENT REGULATORY AGENCIES FOR FIXED DOSE COMBINATION - BioPharma Services
EMA accepts Otsuka and Astex's marketing authorisation application for acute myeloid leukaemia treatment - PMLiVE
Frontiers | A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe
EMA Adopts Updated Guideline on Fixed Dose Combination Drugs | RAPS
Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing | SpringerLink
Certifying Pharmaceutical Exports A Roadmap To EMA's Certificate Of Medicinal Product
Combination treatment for AML closer to approval following EMA nod - Drug Discovery World (DDW)
![PDF] Fixed dose combination product : A Review | Semantic Scholar](https://d3i71xaburhd42.cloudfront.net/f43d4f1c5e14ec71949aed625321a7b65a618eb0/8-Table3-1.png "PDF] Fixed dose combination product : A Review | Semantic Scholar")
PDF] Fixed dose combination product : A Review | Semantic Scholar
An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014: A Focus on Benefit-Risk and Clinical Development Conditions - Dominik Sawicki-Wrzask, Mikael Thomsen, Ole J. Bjerrum, 2015
Strategies in Designing Clinicals for Fixed-Combination Drug
Guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. - ESPL Regulatory Consulting
CMDh press release - November 2020
Pharmaceutical application and development of fixed-dose combination: dosage form review | SpringerLink
Topical Fixed-Dose Combinations: A Way of Progress for Pain Management? - ScienceDirect
PDF) A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013
Topical fixed-dose combinations: Current in vitro methodologies for pre-clinical development - ScienceDirect
The European Medicines Agency's approval of new medicines for type 2 diabetes - Blind - 2018 - Diabetes, Obesity and Metabolism - Wiley Online Library
EMA revises fixed combination product guideline | Healthcare Packaging
FDC GDL _overview of comments
Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs | PLOS Medicine
EU Medicines Agency on Twitter: "What is EMA's advice on the use of non-steroidal anti-inflammatories like #ibuprofen for #COVID19? #NSAIDs #SafetyOfMedicines 👉https://t.co/qFidQE4e3w https://t.co/S7YVHRFhlF" / Twitter
EMA to review oral fixed-dose combination for acute leukaemia - European Pharmaceutical Manufacturer
EMA: show clinical justification for combination drugs
