Drugs / SELVACOVATEIN
SELVACOVATEIN
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Bimervax | — | 2023-03-30 | europa.eu ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05981846 | Sep → Oct 2023 | COVID-19, influenza | Hipra Scientific, S.L.U | Completed | No outcome recorded |
| Phase 2 | NCT06234956 | Jun 2023 → Sep 2025 | COVID-19 | Hipra Scientific, S.L.U | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Hipra Scientific, S.L.U | Regulatory HIPRA receives European Commission marketing authorisation for its COVID-19 vaccine adapted to the XFG.1.1 variant hipra.com ↗
HIPRA has received European Commission marketing authorisation for its recombinant protein adjuvanted COVID-19 vaccine 1 , BIMERVAX®, adapted to the XFG.1.1 variant. |
| 2026-07-24 | Hipra Scientific, S.L.U | Regulatory HIPRA receives positive CHMP opinion from the European Medicines Agency for its COVID-19 vaccine adapted to XFG.1.1 variant hipra.com ↗
HIPRA has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Product for Human Use (CHMP) for its recombinant protein COVID-19 vaccine, BIMERVAX®, adapted to the XFG.1.1 variant. |
| 2025-09-23 | Hipra Scientific, S.L.U | Regulatory HIPRA receives European Commission approval for the commercialization of its COVID-19 vaccine adapted to the LP.8.1 variant hipra.com ↗
HIPRA has received approval from the European Commission to market BIMERVAX® , its COVID-19 vaccine adapted to the LP.8.1 variant, developed and fully produced in Spain. |
| 2025-09-19 | Hipra Scientific, S.L.U | Regulatory HIPRA receives positive opinion from the European Medicines Agency for its COVID-19 vaccine adapted to the LP.8.1 variant for this autumn hipra.com ↗ |
| 2024-06-26 | Hipra Scientific, S.L.U | Regulatory Significant advancements and a fifteen-month extension for the RBDCOV Project hipra.com ↗ |
| 2023-10-18 | Hipra Scientific, S.L.U | Regulatory BIMERVAX® becomes the first COVID-19 vaccine approved by WHO hipra.com ↗
HIPRA's vaccine has received WHO prequalification, which is the world organization's seal of approval |
| 2023-07-17 | Hipra Scientific, S.L.U | Regulatory AEMPS authorizes the clinical trial to study the joint vaccination of HIPRA's COVID-19 vaccine with an influenza vaccine hipra.com ↗
The clinical trial has been authorised by the Spanish Agency for Medicines and Health Products (AEMPS). |
| 2023-05-29 | Hipra Scientific, S.L.U | Regulatory AEMPS authorizes the clinical trial to study HIPRA's COVID-19 vaccine in adolescents between 12 and 17 years old hipra.com ↗ |
| 2023-04-11 | Hipra Scientific, S.L.U | Regulatory The Spanish Prime Minister defines HIPRA’s vaccine as a 'historic milestone' that reinforces the country's leadership in the European health sector hipra.com ↗ |
| 2023-03-31 | Hipra Scientific, S.L.U | Regulatory BIMERVAX® has also obtained the approval of the European Commission to be marketed hipra.com ↗
Therefore, HIPRA’s vaccine against COVID-19 now has the green light to be marketed in the European Union. |
| 2023-03-30 | Hipra Scientific, S.L.U | Regulatory HIPRA receives positive opinion from European Medicines Agency for its BIMERVAX® COVID-19 Vaccine hipra.com ↗
HIPRA has received the positive opinion of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorisation in the European Union of BIMERVAX®, the COVID-19 vaccine developed by the biotechnological pharmaceutical company. |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SELVACOVATEIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314796 ↗ |
| Known as | BIMERVAX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06234956 ↗ |
| Known as | Selvacovateina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314796 ↗ |
| Known as | Selvacovateine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314796 ↗ |
| Modality | Vaccine | “One dose of booster vaccine” NCT05981846 ↗ |