Drugs / Hepatitis B
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Primavax | — | 1998-02-05 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00505063 | Jul 2007 → Jun 2025 | childhood malignant neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06038617 | Oct 2023 → Apr 2025 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02868970 | Feb 2017 → Jul 2021 | — | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase 4 | NCT00329251 | Apr 2003 → Mar 2006 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03180359 | Jan 2016 → Oct 2019 | disease related to transplantation | Hospices Civils de Lyon | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2021-01-07 | LG Life Sciences | Regulatory LG Chem to contribute to global polio eradication with Eupolio, the first Sabin Inactivated Polio Vaccine to receive WHO prequalification lgchem.com ↗
LG Chem announced today that its Sabin-Inactivated Polio Vaccine (Sabin-IPV) Eupolio ™ received World Health Organization (WHO) prequalification effective December 21st, 2020, enabling it to be supplied globally as early as this month. |
| 2020-08-28 | GlaxoSmithKline | Results GSK presents promising phase 2a data for chronic hepatitis B treatment gsk.com ↗
We have observed promising early-stage results showing antiviral activity with our anti-sense oligonucleotide, a key investigational medicine in our growing infectious diseases portfolio. |
| 2020-04-24 | AJ Vaccines A/S | Regulatory World Immunization Week 2020 ajvaccines.com ↗
Thus, we were particularly happy to announce the WHO prequalification of our new inactivated polio vaccine this week |
| 2017-11-13 | PT Bio Farma | Regulatory Bio Farma Daftarkan Pentabio ke WHO co.id ↗
PT. Bio Farma (Company) is registering a vaccine product of Pentabio which is the combination of Diphtheria, Tetanus, Pertusiss, recombinant hepatitis B, Haemophilus Influenza type B to the World Health Organization (WHO). |
| 2013-02-20 | Daiichi Sankyo | Regulatory Announcement of application for approval in Japan of DPT-IPV vaccine for prevention of Diphtheria, Pertussis, Tetanus, and acute Poliomyelitis daiichisankyo.com ↗ |
All press releases naming this drug 18 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hepatitis B | “Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines” NCT06038617 ↗ |
| Modality | Vaccine | “Hepatitis A vaccine is indicated for immunization against infections caused by hepatitis A virus; Hepatitis B vaccine is indicated for immunization against infection caused by...” NCT02868970 ↗ |