Marketing-authorisation holder
Hoffmann-La Roche Inc.
17 medicines in 1 country, as authorisation holder and manufacturer.
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Marketing-authorisation holder
17 medicines in 1 country, as authorisation holder and manufacturer.
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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| ACCUTANE10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule | Isotretinoin | United States | Not marketed | 1982 |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| BONIVA150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet | Ibandronic acid | United States | Not marketed | 2003 |
| FORTOVASE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Capsule | Saquinavir | United States | Not marketed | 1997 |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| ROCEPHIN10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1GM BASE/VIAL | 250MG BASE/VIAL | 2GM BASE/VIAL | 500MG BASE/VIAL · Injectable | Ceftriaxone | United States | Not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| ROCEPHIN1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · Injectable | Ceftriaxone | United States | Not marketed | 1984 |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 |
Also in the registers of Colombia
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)
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia, CUM vencidos; source update 2026-09-16; acquired 2026-10-08.
Licence: CC BY-SA 4.0
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
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