No |
Name |
Active substance |
Therapeutic area |
Date of authorisation |
Status |
1 |
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
| Split influenza virus, inactivated, containing antigen* : A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
* produced in eggs |
ImmunizationDisease OutbreaksInfluenza, Human |
19/10/2009 |
Authorised |
2 |
Pandemic Influenza Vaccine H5N1 Baxter
| Whole virion, inactivated containing antigen*: A/Vietnam/1203/2004 (H5N1)
* produced in Vero cells |
ImmunizationInfluenza, HumanDisease Outbreaks |
16/10/2009 |
Authorised |
3 |
Pandemrix
| Split influenza virus inactivated, containing antigen equivalent to:
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms*
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80
* haemagglutinin |
ImmunizationDisease OutbreaksInfluenza, Human |
20/05/2008 |
Authorised |
4 |
Panretin
| alitretinoin |
Sarcoma, Kaposi |
11/10/2000 |
Authorised |
5 |
Pantecta Control
| pantoprazole |
Gastroesophageal Reflux |
12/06/2009 |
Authorised |
6 |
Pantoloc Control
| pantoprazole |
Gastroesophageal Reflux |
12/06/2009 |
Authorised |
7 |
Pantozol Control
| pantoprazole |
Gastroesophageal Reflux |
12/06/2009 |
Authorised |
8 |
Parareg
| cinacalcet |
HypercalcemiaHyperparathyroidismParathyroid Neoplasms |
22/10/2004 |
Withdrawn |
9 |
Patrex
| sildenafil |
Erectile Dysfunction |
15/09/1998 |
Withdrawn |
10 |
Paxene
| paclitaxel |
Sarcoma, KaposiCarcinoma, Non-Small-Cell LungOvarian NeoplasmsBreast Neoplasms |
19/07/1999 |
Withdrawn |
11 |
PecFent
| fentanyl |
PainCancer |
31/08/2010 |
Authorised |
12 |
Pedea
| ibuprofen |
Ductus Arteriosus, Patent |
29/07/2004 |
Authorised |
13 |
Pegasys
| peginterferon alfa-2a |
Hepatitis B, ChronicHepatitis C, Chronic |
20/06/2002 |
Authorised |
14 |
PegIntron
| peginterferon alfa-2b |
Hepatitis C, Chronic |
25/05/2000 |
Authorised |
15 |
Pelzont
| laropiprant / nicotinic acid |
Dyslipidemias |
03/07/2008 |
Authorised |
16 |
Pergoveris
| follitropin alfa /?lutropin alfa |
Infertility, Female |
25/06/2007 |
Authorised |
17 |
Peyona (previously Nymusa)
| caffeine citrate |
Apnea |
02/07/2009 |
Authorised |
18 |
PhotoBarr
| porfimer sodium |
Barrett Esophagus |
25/03/2004 |
Authorised |
19 |
Plavix
| clopidogrel hydrogen sulfate |
StrokeAcute Coronary SyndromePeripheral Vascular DiseasesMyocardial InfarctionAtrial Fibrillation |
15/07/1998 |
Authorised |
20 |
Plenadren
| hydrocortisone |
Adrenal Insufficiency |
03/11/2011 |
Authorised |
21 |
Posaconazole SP
| posaconazole |
AspergillosisCoccidioidomycosisCandidiasisMycoses |
25/10/2005 |
Withdrawn |
22 |
Possia
| ticagrelor |
Peripheral Vascular DiseasesAcute Coronary Syndrome |
03/12/2010 |
Authorised |
23 |
Potactasol
| topotecan |
Uterine Cervical NeoplasmsSmall Cell Lung Carcinoma |
06/01/2011 |
Authorised |
24 |
Pradaxa
| dabigatran etexilate mesilate |
Arthroplasty, ReplacementVenous Thromboembolism |
18/03/2008 |
Authorised |
25 |
Pramipexole Accord
| pramipexole dihydrochloride monohydrate |
Parkinson Disease |
30/09/2011 |
Authorised |
26 |
Pramipexole Teva
| pramipexole dihydrochloride monohydrate |
Parkinson Disease |
18/12/2008 |
Authorised |
27 |
Prandin
| repaglinide |
Diabetes Mellitus, Type 2 |
29/01/2001 |
Authorised |
28 |
Pravafenix
| fenofibrate / pravastatin |
Dyslipidemias |
14/04/2011 |
Authorised |
29 |
Preotact
| parathyroid hormone (rdna) |
Osteoporosis, Postmenopausal |
24/04/2006 |
Authorised |
30 |
Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic
| Influenza virus surface antigens*, inactivated:
A/Viet Nam/1194/2004 (H5N1) – like strain used (NIBRG-14)
* produced in eggs |
ImmunizationInfluenza, HumanDisease Outbreaks |
29/11/2010 |
Authorised |
31 |
Prepandemic influenza vaccine GlaxoSmithKline Biologicals
| Split influenza virus, inactivated, containing antigen*: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
* produced in eggs |
Influenza, HumanDisease OutbreaksImmunization |
26/09/2008 |
Authorised |
32 |
Prepandrix
| purified antigen fractions of inactivated split virions a/vietnam/1194/2004 nibrg-14 (h5n1), split influenza virus, inactivated, containing antigen: a/indonesia/05/2005 (h5n1) like strain used (pr8-ibcdc-rg2) (produced in eggs) |
ImmunizationInfluenza, HumanDisease Outbreaks |
14/05/2008 |
Authorised |
33 |
Prevenar
| Pneumococcal polysaccharide serotype 4* Pneumococcal polysaccharide serotype 6B* Pneumococcal polysaccharide serotype 9V* Pneumococcal polysaccharide serotype 14* Pneumococcal oligosaccharide serotype 18C* Pneumococcal polysaccharide serotype 19F* Pneumococcal polysaccharide serotype 23F*
* Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg) |
Pneumococcal InfectionsImmunization |
02/02/2001 |
Authorised |
34 |
Prevenar 13
| pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, 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, protein, crm197 |
ImmunizationPneumococcal Infections |
09/12/2009 |
Authorised |
35 |
Prezista
| darunavir |
HIV Infections |
12/02/2007 |
Authorised |
36 |
Prialt
| ziconotide |
PainInjections, Spinal |
21/02/2005 |
Authorised |
37 |
Primavax
| diphtheria toxoid purified, hepatitis B, recombinant surface antigen, tetanus toxoid purified |
TetanusHepatitis BDiphtheriaImmunization |
05/02/1998 |
Withdrawn |
38 |
Pritor
| telmisartan |
Hypertension |
11/12/1998 |
Authorised |
39 |
PritorPlus
| telmisartan / hydrochlorothiazide |
Hypertension |
22/04/2002 |
Authorised |
40 |
Privigen
| human normal immunoglobulin (ivig) |
Guillain-Barre SyndromeMucocutaneous Lymph Node SyndromeImmunologic Deficiency SyndromesBone Marrow TransplantationPurpura, Thrombocytopenic, Idiopathic |
25/04/2008 |
Authorised |
41 |
Procomvax
| polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC
outer membrane protein complex of Neisseria meningitides (B11 strain, subgroup B)
adsorbed hepatitis B surface antigen |
ImmunizationMeningitis, HaemophilusHepatitis B |
07/05/1999 |
Withdrawn |
42 |
Procoralan
| ivabradine |
Angina Pectoris |
25/10/2005 |
Authorised |
43 |
Prolia
| denosumab |
Bone ResorptionOsteoporosis, Postmenopausal |
26/05/2010 |
Authorised |
44 |
Prometax
| rivastigmine |
DementiaParkinson DiseaseAlzheimer Disease |
04/12/1998 |
Authorised |
45 |
Proquad
| virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella |
ImmunizationMumpsChickenpoxMeaslesRubella |
06/04/2006 |
Authorised |
46 |
Protaphane
| insulin human |
Diabetes Mellitus |
07/10/2002 |
Authorised |
47 |
Protelos
| strontium ranelate |
Osteoporosis, Postmenopausal |
21/09/2004 |
Authorised |
48 |
Protopic
| tacrolimus |
Dermatitis, Atopic |
28/02/2002 |
Authorised |
49 |
Protopy
| tacrolimus |
Dermatitis, Atopic |
28/02/2002 |
Withdrawn |
50 |
Pumarix
| pandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted)? |
Influenza, HumanImmunizationDisease Outbreaks |
04/03/2011 |
Authorised |
51 |
Puregon
| follitropin beta |
InfertilityHypogonadism |
03/05/1996 |
Authorised |
52 |
Pylobactell
| 13C-urea |
Breath TestsHelicobacter Infections |
07/05/1998 |
Authorised |
53 |
Pylori-Chek
| 13C-urea |
Helicobacter InfectionsBreath Tests |
15/06/1998 |
Withdrawn |