| Gripovac 3 |
Veterinary |
inactivated influenza-A virus |
inactivated influenza-A virus |
EMEA/V/C/000157 |
Merial S.A.S. |
2010/01/14
|
Withdrawn |
| Scintimun |
Human |
besilesomab |
besilesomab |
EMEA/H/C/001045 |
Telix Innovations |
2010/01/11
|
Authorised |
| Leflunomide Zentiva (previously Leflunomide Winthrop) |
Human |
leflunomide |
leflunomide |
EMEA/H/C/001129 |
Zentiva k.s. |
2010/01/08
|
Authorised |
| Firdapse (previously Zenas) |
Human |
amifampridine |
amifampridine |
EMEA/H/C/001032 |
SERB SA |
2009/12/23
|
Authorised |
| Sildenafil ratiopharm |
Human |
sildenafil |
sildenafil |
EMEA/H/C/001080 |
Ratiopharm GmbH |
2009/12/23
|
Authorised |
| Rivastigmine Hexal |
Human |
rivastigmine |
rivastigmine |
EMEA/H/C/001182 |
Hexal AG |
2009/12/11
|
Authorised |
| Rivastigmine 1 A Pharma |
Human |
rivastigmine |
rivastigmine |
EMEA/H/C/001181 |
1 A Pharma GmbH |
2009/12/11
|
Authorised |
| Olazax |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001087 |
Glenmark Pharmaceuticals s.r.o. |
2009/12/11
|
Authorised |
| Rivastigmine Sandoz |
Human |
rivastigmine |
rivastigmine |
EMEA/H/C/001183 |
Sandoz GmbH |
2009/12/10
|
Authorised |
| Sildenafil Actavis |
Human |
sildenafil |
sildenafil |
EMEA/H/C/001090 |
Actavis Group PTC ehf |
2009/12/10
|
Authorised |
| Lamivudine Teva Pharma B.V. |
Human |
lamivudine |
lamivudine |
EMEA/H/C/001111 |
Teva B.V. |
2009/12/10
|
Authorised |
| Olazax Disperzi |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001088 |
Glenmark Pharmaceuticals s.r.o. |
2009/12/10
|
Authorised |
| Prevenar 13 |
Human |
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F |
EMEA/H/C/001104 |
Pfizer Europe MA EEIG |
2009/12/09
|
Authorised |
| Olanzapine Glenmark Europe |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001086 |
Glenmark Arzneimittel GmbH |
2009/12/03
|
Authorised |
| Olanzapine Glenmark |
Human |
olanzapine |
olanzapine |
EMEA/H/C/001085 |
Glenmark Arzneimittel GmbH |
2009/12/03
|
Authorised |
| Hirobriz Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001211 |
Novartis Europharm Limited |
2009/11/30
|
Authorised |
| Zutectra |
Human |
human hepatitis B immunoglobulin |
human hepatitis B immunoglobulin |
EMEA/H/C/001089 |
Biotest Pharma GmbH |
2009/11/30
|
Authorised |
| Nevirapine Teva |
Human |
nevirapine |
nevirapine |
EMEA/H/C/001119 |
Teva B.V. |
2009/11/30
|
Withdrawn |
| Sildenafil Teva |
Human |
sildenafil |
sildenafil |
EMEA/H/C/001073 |
Teva B.V. |
2009/11/30
|
Authorised |
| Oslif Breezhaler |
Human |
indacaterol |
indacaterol maleate |
EMEA/H/C/001210 |
Novartis Europharm Limited |
2009/11/29
|
Authorised |