The ELPENHALER® was initially developed for the administration of medications in the treatment of asthma and COPD.
European Registration of our Fluticasone + Salmeterol ELPENHALER® is shown below:
|
DCP1 Approval
|
Czech Rep. |
Germany |
Hungary |
Italy |
Portugal |
Slovakia |
Sweden |
| National Approvals |
Greece |
Malta |
Cyprus |
|
More DCPs and National registrations are going in Europe and in other countries
.
The ELPENHALER® product pipeline is as follows:
|
Product Name,
API
|
Presentation
(strength x doses)
|
Product status
Indication
|
Dossier
Availability |
Formopen®
Formoterol fumarate |
12 mcg x 60
|
Launched in GR (04.07)
Asthma and COPD
|
Dossier in CTD format
Available for Licensing
|
Fluticapen®
Fluticasone propionate |
250mcg x 60
500mcg x 60
|
Launched in GR (03.08)
Asthma and COPD
|
Dossier in CTD format
Available for Licensing
|
|
Rolenium®
Fluticasone propionate
Salmeterol xinafoate
|
100/50 mcg x 60
250/50 mcg x 60
500/50 mcg x 60
|
Launched in GR (11.09)
Asthma and COPD
|
Dossier in CTD format
Available for Licensing
|
Pulmoton®
Budesonide
Formoterol fumarate |
100/6 mcg x 120
200/6 mcg x 120
400/12 mcg x 60
|
Clinical Development
Asthma and COPD
|
Expected EU filing
Q1 2012
|
| Tiotropium |
18 mcg x 30 |
Analytical Development
COPD
|
Expected EU filing
Q4 2012
|