Marketing-authorisation holder
Sebela Ireland Ltd
3 medicines in 1 country, as authorisation holder.
Medicines
Every medicine in the registers under its name, current ones first.
3 medicines
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| ONMEL200mg · Tablet | Itraconazole | United States | Not marketed | 2010 |
| PEXEVA10mg base | 20mg base | 30mg base | 40mg base · Tablet | Paroxetine | United States | Not marketed | 2003 |
| TRANDATE5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Injectable | Labetalol | United States | Not marketed | 1985 |
Countries
Where it holds or makes medicines, with how many are current.
| Country | Medicines | Current | Past | Companies |
|---|---|---|---|---|
| United States | 3 | 3 | 0 | CompaniesAll medicines |
Top substances
The active substances in most of its medicines.
Names in the registers
How the registers spell it, normalised: legal forms, accents and capitals removed.
- sebela ireland
Sources and licences
Compiled by Prognia from the public medicine and company registers below. Logos are not used.
U.S. Food and Drug Administration (Drugs@FDA, openFDA)
Source: U.S. FDA, Drugs@FDA / openFDA. FDA does not endorse this site.
Licence: Public domain (U.S. Government work)
Report an error or request removalCorrections from the company itself are welcome.
At a glance
- Type
- Marketing-authorisation holder
- Medicines
- 3
- Countries
- 1
- Roles
- Authorisation holder