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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8 Parareg cinacalcet HypercalcemiaHyperparathyroidismParathyroid Neoplasms 22/10/2004 Withdrawn
9 Patrex sildenafil Erectile Dysfunction 15/09/1998 Withdrawn
10 Paxene paclitaxel Sarcoma, KaposiCarcinoma, Non-Small-Cell LungOvarian NeoplasmsBreast Neoplasms 19/07/1999 Withdrawn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21 Posaconazole SP posaconazole AspergillosisCoccidioidomycosisCandidiasisMycoses 25/10/2005 Withdrawn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
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