Search clinical trials for: Post authorization safety study

Total 177904 results

GlaxoSmithKline
Harvard Pilgrim Health Care Institute

Not yet recruiting

Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions

Herpes Zoster
AstraZeneca
Parexel

Recruiting

Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States (PASSAGE)

Asthma

United States
AstraZeneca

Recruiting

Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

Neoplasms | Asthma

Sweden, United Kingdom
Novartis Pharmaceuticals

Recruiting

Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent

Multiple Sclerosis

United States
Novartis Pharmaceuticals

Recruiting

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis (SPRING)

Multiple Sclerosis

Taiwan
Regeneron Pharmaceuticals
Sanofi

Recruiting

Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

Asthma | Atopic Dermatitis (AD)

United States
Kyowa Kirin, Inc.

Recruiting

Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Cutaneous T Cell Lymphoma | ATLL | Leukemia/Lymphoma

United States
Bayer

Active, not recruiting

Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib (JPMS-DTC)

Thyroid Carcinoma

Japan
Bayer

Completed

Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) (JPMS-CTEPH)

Hypertension, Pulmonary

Japan
Swedish Orphan Biovitrum

Active, not recruiting

A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients

Primary Hemophagocytic Lymphohistiocytosis

China
Bayer

Completed

Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH) (JPMS-PAH)

Hypertension, Pulmonary

Japan
Advanced Accelerator Applications

Completed

Post-Authorization Safety Study (PASS) of LysaKare® in Adult Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

Gastroenteropancreatic Neuroendocrine Tumors

United Kingdom, Italy, Netherlands, Poland
PT Bio Farma
National Advisory Immunization Committee Indonesia

Completed

Post Authorization Safety Study Moderna COVID-19 Primary Vaccine

COVID-19

Indonesia
Sun Pharmaceutical Industries Limited

Active, not recruiting

Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma (NISSO)

Basal Cell Carcinoma

Spain, Germany, Italy, Switzerland
Advanced Accelerator Applications

Active, not recruiting

Post-Authorization Long-Term Safety Study of LUTATHERA (SALUS)

Neuroendocrine Tumors

United Kingdom, Portugal, Spain, France, United States
Bristol-Myers Squibb

Active, not recruiting

A Post-Authorization, Long-term Study of Ozanimod Real-world Safety (ORION)

Multiple Sclerosis, Relapsing-Remitting

United States
Celgene

Completed

Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)

Myelodysplastic Syndromes | Beta-thalassemia

Austria
Celgene

Completed

Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) (PASS MDS del5q)

Myelodysplastic Syndrome

Spain, United Kingdom, Denmark, Germany, France, Greece, Italy, Sweden, Belgium, United States, Luxembourg, Norway
BioMarin Pharmaceutical

Completed

Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency (KAMPER)

Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency

Sweden, France, Italy, Spain, Germany, Netherlands, Austria, Slovakia, Portugal
Organon and Co

Completed

Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

Ankylosing Spondylitis
Boehringer Ingelheim

Completed

Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration

Diabetes Mellitus, Type 2

Saudi Arabia
Organon and Co

Completed

Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)

Schizophrenia | Bipolar Disorder
Target PharmaSolutions, Inc.

Completed

Direct Acting Antiviral-Post Authorization Safety Study

Hepatocellular Carcinoma | Hepatitis C

United States, Spain, Germany, France, Italy
Celgene

Completed

An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide. (REVIEW)

Multiple Myeloma
ViiV Healthcare
GlaxoSmithKline

Completed

PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)

Infection, Human Immunodeficiency Virus I
Celgene

Completed

Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in Korea

Myelodysplastic Syndrome

Korea, Republic of
Biogen
AMS Advanced Medical Services GmbH

Completed

A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis (PERFECT)

Multiple Sclerosis, Relapsing-Remitting

Germany
Bayer

Completed

YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China

Contraception

China
Bayer

Completed

Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid Pregnancy

Contraception

Mexico
Bayer
Regeneron Pharmaceuticals

Completed

Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO) (JPMS-CRVO)

Retinal Vein Occlusion

Japan
Hikma Pharmaceuticals LLC

Completed

Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan (MyOra-PASS)

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Jordan
Professor Saad Shakir
Bayer

Completed

An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®). (ROSE)

Atrial Fibrillation | Deep Vein Thrombosis | Pulmonary Embolism

United Kingdom
GlaxoSmithKline

Completed

Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom (H1N1 PASS UK)

Influenza

United Kingdom
Celgene

Completed

A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea

Multiple Myeloma

Korea, Republic of
Sandoz
Hexal AG

Completed

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. (EPO-PASS)

Chronic Kidney Disease

Poland, Germany, Romania, Italy, Austria, Bulgaria, France, Macedonia, The Former Yugoslav Republic of, Russian Federation, Ukraine
Sanofi Pasteur, a Sanofi Company

Completed

Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults

Influenza | Swine-Origin A/H1N1 Influenza Virus

France
UCB Pharma

Completed

Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures (PASS)

Epilepsies, Partial

France, Germany, United Kingdom, Spain, Netherlands
LG Life Sciences

Unknown

Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

Hepatitis B | Pertussis | Tetanus | Diphtheria | Haemophilus Influenza Type B
Janssen-Cilag B.V.

Completed

VALEO: A Post Authorization Study, Designed to Learn More About the Safety and Effectiveness of the Use of Bortezomib in the Netherlands

Multiple Myeloma | Hematological Neoplasms

Netherlands
Pfizer

Completed

Post-Authorization Study Evaluating Safety Of Tigecycline (HORUS)

Intra-Abdominal Infections | Skin Disease, Infectious | Soft Tissues Infections
B. Braun Melsungen AG

Completed

Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

Surgery

Germany, Austria, Czech Republic, Italy, Netherlands
Octapharma

Not yet recruiting

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Significant Bleeding Risk | Vitamin K-Dependent Coagulation Defect
Ionis Pharmaceuticals, Inc.

Not yet recruiting

ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)

Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
Pharmosa Biopharm Inc.
Novotech (New Zealand) Limited

Not yet recruiting

Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

Pulmonary Arterial Hypertension

New Zealand
Novartis Pharmaceuticals

Not yet recruiting

Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation (ASC4INDIA)

Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
Bostal Drug Delivery Co., Ltd

Not yet recruiting

A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

Diabetes Mellitus, Type 2
Tianjin Medical University Cancer Institute and...

Recruiting

The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

General Anesthesia Gastrointestinal Cancer Surgery

China
Serum Institute of India Pvt. Ltd.

Recruiting

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

Hepatitis B Immunization | Diptheria Immunization | Tetanus Immunization | Pertussis Immunization | Haemophilus Influenzae Type B Immunization | Polio Immunization

Bangladesh, India
mAbxience Research S.L.

Recruiting

A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders (MB04-A-01-23)

Healthy Volunteers

Netherlands
Wishbone SA
EVAMED; Pharmalex; Advimago

Recruiting

Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Safety Issues | Bone Regeneration

Belgium

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