Advanz Pharma Limited
9 products tracked · names used in filings: Advanz Pharma Limited
Upcoming milestones
Mon 23 Nov 2026🇪🇺 Expected EC decisionestimatein 9 days
Adcomfo (omalizumab): expected EC decision
Estimated as CHMP opinion (2026-09-17) + 67 days, the standard Commission decision period. Not an official date. · Advanz Pharma Limited · source
Recent milestones
Thu 17 Sep 2026🇪🇺 CHMP positive opinion
Adcomfo (omalizumab): CHMP positive opinion
Advanz Pharma Limited; Biosimilar · source
Mon 17 Nov 2025🇪🇺 EU approval (EC decision)
Gobivaz (golimumab) approved in the EU
Marketing authorisation to Advanz Pharma Limited; Biosimilar, Additional monitoring · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Zektayos - Hepjuvo obeticholic acid | Application withdrawn | |
| 🇪🇺 | Adcomfo omalizumab | Opinion | |
| 🇪🇺 | Nugalviq govorestat | Application withdrawn | |
| 🇪🇺 | Gobivaz golimumab | Authorised | 2025-11-17 |
| 🇪🇺 | Mynzepli aflibercept | Authorised | 2025-08-18 |
| 🇪🇺 | Exblifep cefepime;enmetazobactam | Authorised | 2024-03-21 |
| 🇪🇺 | Ocaliva obeticholic acid | Revoked | 2016-12-12 |
| 🇪🇺 | Brinavess vernakalant hydrochloride | Authorised | 2010-09-01 |
| 🇪🇺 | Zavesca miglustat | Authorised | 2002-11-20 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.