Marketing-authorisation holder · United States
Hoffmann-La Roche Inc.
17 medicines in 1 country, as authorisation holder.
Loading your page…
Loading your page…
Marketing-authorisation holder · United States
17 medicines in 1 country, as authorisation holder.
One free account for the Prognia apps: Ward to study, Osler for clinical answers with their sources, and the network to find your colleagues.
Groups are put together by Prognia from the names regulators publish and from company links; they are not an official corporate structure.
Every medicine in the registers under its name, current ones first.
17 medicines
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| ACCUTANE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule | Isotretinoin | United States | Not marketed | 1982 |
| ALECENSA150mg base · Capsule | Alectinib | United States | Marketed | 2015 |
| BONIVA150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet | Ibandronic acid | United States | Not marketed | 2003 |
| FORTOVASE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule | Saquinavir | United States | Not marketed | 1997 |
| INVIRASE200mg base · Capsule | Saquinavir | United States | Not marketed | 1995 |
| INVIRASE500mg base · Tablet | Saquinavir | United States | Not marketed | 2004 |
| ROCEPHIN10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1GM BASE/VIAL | 250MG BASE/VIAL | 2GM BASE/VIAL | 500MG BASE/VIAL · Injectable | Ceftriaxone | United States | Not marketed | 1984 |
| ROCEPHIN1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · Injectable | Ceftriaxone | United States | Not marketed | 1984 |
| ROCEPHIN KIT1gm base/vial,n/a; 1% | 500mg base/vial,n/a; 1% · Injectable | Ceftriaxone, N/a, Lidocaine n/a,1% | United States | Not marketed | 1984 |
| ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Injectable | Ceftriaxone | United States | Not marketed | 1987 |
| ROMAZICON0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Injectable | Flumazenil | United States | Not marketed | 1991 |
| ZELBORAF240mg · Tablet | Vemurafenib | United States | Marketed | 2011 |
| Pegasys Copegus Combination Pack180mcg/0.5ml & 1200mg | Peginterferon alfa-2b, Ribavirin | United States | Withdrawn | 2004 |
| Pegasys Copegus Combination Pack180mcg/0.5ml & 800mg | Peginterferon alfa-2b, Ribavirin | United States | Withdrawn | 2004 |
| Pegasys Copegus Combination Pack180mcg/0.5ml &1000mg | Peginterferon alfa-2b, Ribavirin | United States | Withdrawn | 2004 |
| Roferon-A3miu/0.5ml · For Injection | Interferon alfa-2b | United States | Withdrawn | 1986 |
| Zenapax25mg/5ml · Injection | Daclizumab | United States | Withdrawn | 1997 |
Where it holds or makes medicines, with how many are current.
| Country | Medicines | Current | Past | Companies |
|---|---|---|---|---|
| United States | 17 | 12 | 5 | CompaniesAll medicines |
The active substances in most of its medicines.
How the registers spell it, normalised: legal forms, accents and capitals removed.
Compiled by Prognia from the public medicine and company registers below. Logos are not used.
Source: U.S. FDA, Drugs@FDA / openFDA. FDA does not endorse this site.
Licence: Public domain (U.S. Government work)
FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.
Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions
Report an error or request removalCorrections from the company itself are welcome.
Other companies in the same group.
Ranked by their number of medicines.