Where it is registered
Each register and historical list with its number of registrations and a few of them.
Spain
AEMPS · 8 registrations
- Daxas 250 Microgramos Comprimidos250 µg · comprimido · Astrazeneca Ab
- Daxas 500 Microgramos Comprimidos Recubiertos con Pelicula500 µg · comprimido recubierto con película · Astrazeneca Ab
- Roflumilast Aurovitas 250 Microgramos Comprimidos Efg0,25 mg · comprimido · Aurovitas Spain, S.A.U.
- Roflumilast Aurovitas 500 Microgramos Comprimidos Efg0,5 mg · comprimido · Aurovitas Spain, S.A.U.
Canada
Health Canada · 5 registrations
- Daxas500 MCG · Tablet · Astrazeneca Canada INC
- Zoryve0.3 % / W/W · Cream · Arcutis Canada, INC.
- Zoryve0.3 % / W/W · Foam · Arcutis Canada, INC.
- Zoryve0.15 % / W/W · Cream · Arcutis Canada, INC.
United States
FDA · 4 registrations
At a glance
- Registers
- 8
- Historical lists
- 1
- Registrations
- 28
- With their own page
- 19
- Companies
- 15
All medicines with Roflumilast
Human medicines from every register that match Roflumilast by substance or by name, a page at a time, so the count can differ from the registrations above. Strengths and packs are on each medicine’s page.
28 search results
| Medicine | Register | Strength | Form | Status | Holder |
|---|---|---|---|---|---|
| Roflumilast | United States | 250MCG, 500MCG | tablet | Marketed | Alkem Labs LTD |
| Roflumilast Aurovitas 250 Microgramos Comprimidos Efg | Spain | 0,25 mg | comprimido | Marketed | Aurovitas Spain, S.A.U. |
| Roflumilast Aurovitas 500 Microgramos Comprimidos Efg | Spain | 0,5 mg | comprimido | Marketed | Aurovitas Spain, S.A.U. |
| Daliresp | United States | 250MCG, 500MCG | tablet | Marketed | Astrazeneca |
| Zoryve | United States | 0.3% | foam | Marketed | Arcutis |
| Zoryve | United States | 0.05%, 0.15%, 0.3% | cream | Marketed | Arcutis |
| Daxas 500 Microgramos Comprimidos Recubiertos con Pelicula | Spain | 500 µg | comprimido recubierto con película | Marketed | Astrazeneca Ab |
| Daxas | European Union | Authorised | AstraZeneca AB | ||
| Daxas 250 Microgramos Comprimidos | Spain | 250 µg | comprimido | Marketed | Astrazeneca Ab |
| Daxas 250 microgram tabletten | Netherlands | Tablet | Authorised | AstraZeneca AB | |
| Daxas 500 microgram filmomhulde tabletten | Netherlands | Filmomhulde tablet | Authorised | AstraZeneca AB | |
| Daxas® | Serbia | 500mcg | film tableta | Authorised | PredstavniŠTvo Astrazeneca UK Limited Beograd |
| Daxas | Canada | 500 MCG | Tablet | Marketed | Astrazeneca Canada INC |
| Zoryve | Canada | 0.3 % / W/W | Cream | Marketed | Arcutis Canada, INC. |
| Zoryve | Canada | 0.3 % / W/W | Foam | Marketed | Arcutis Canada, INC. |
| Zoryve | Canada | 0.15 % / W/W | Cream | Marketed | Arcutis Canada, INC. |
| Zoryve | Canada | 0.05 % / W/W | Cream | Marketed | Arcutis Canada, INC. |
| Daxas | Brazil | Authorised | Astrazeneca do Brasil Ltda | ||
| ROFLAST 500 mcg | Saudi Arabia | Authorised | Spimaco | ||
| Daxas | Croatia | Marketed | |||
| Daxas 500MCG F.C. Tablet | Saudi Arabia | Authorised | Takeda GMBH | ||
| Roflumilast Ferrer 250 Microgramos Comprimidos Efg | Spain | 0,25 mg | comprimido | Withdrawn | Ferrer Internacional S.A. |
| Roflumilast Ferrer 500 Microgramos Comprimidos Efg | Spain | 0,5 mg | comprimido | Withdrawn | Ferrer Internacional S.A. |
| Roflumilast Abdi 500 Microgramos Comprimidos Recubiertos con Pelicula Efg | Spain | 0,5 mg | comprimido recubierto con película | Withdrawn | Abdi Farma Unipessoal Lda. |
| Roflumilast Accord 500 Microgramos Comprimidos Recubiertos con Pelicula Efg | Spain | 0,5 mg | comprimido recubierto con película | Withdrawn | Accord Healthcare S.L.U. |