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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

Immunization
Disease Outbreaks
Influenza, 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

Immunization
Influenza, Human
Disease 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

Immunization
Disease Outbreaks
Influenza, Human
20/05/2008 Authorised
4 Panretin alitretinoin Sarcoma, Kaposi
HIV Infections
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 Hypercalcemia
Hyperparathyroidism
Parathyroid Neoplasms
22/10/2004 Withdrawn
9 Patrex sildenafil Erectile Dysfunction 15/09/1998 Withdrawn
10 Paxene paclitaxel Sarcoma, Kaposi
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Breast Neoplasms
19/07/1999 Withdrawn
11 PecFent fentanyl Pain
Cancer
31/08/2010 Authorised
12 Pedea ibuprofen Ductus Arteriosus, Patent 29/07/2004 Authorised
13 Pegasys peginterferon alfa-2a Hepatitis B, Chronic
Hepatitis 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 Stroke
Acute Coronary Syndrome
Peripheral Vascular Diseases
Myocardial Infarction
15/07/1998 Authorised
20 Posaconazole SP posaconazole Aspergillosis
Coccidioidomycosis
Candidiasis
Mycoses
25/10/2005 Withdrawn
21 Possia ticagrelor Peripheral Vascular Diseases
Acute Coronary Syndrome
03/12/2010 Authorised
22 Potactasol topotecan Uterine Cervical Neoplasms
Small Cell Lung Carcinoma
06/01/2011 Authorised
23 Pradaxa dabigatran etexilate mesilate Arthroplasty, Replacement
Venous Thromboembolism
18/03/2008 Authorised
24 Pramipexole Teva pramipexole dihydrochloride monohydrate Parkinson Disease 18/12/2008 Authorised
25 Prandin repaglinide Diabetes Mellitus, Type 2 29/01/2001 Authorised
26 Preotact parathyroid hormone (rdna) Osteoporosis, Postmenopausal 24/04/2006 Authorised
27 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
Immunization
Influenza, Human
Disease Outbreaks
29/11/2010 Authorised
28 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, Human
Disease Outbreaks
Immunization
26/09/2008 Authorised
29 Prepandrix Split influenza virus, inactivated, containing antigen*: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

* produced in eggs

Immunization
Influenza, Human
Disease Outbreaks
14/05/2008 Authorised
30 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 Infections
Immunization
02/02/2001 Authorised
31 Prevenar 13 pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) Immunization
Pneumococcal Infections
09/12/2009 Authorised
32 Prezista darunavir HIV Infections 12/02/2007 Authorised
33 Prialt ziconotide Pain
Injections, Spinal
21/02/2005 Authorised
34 Primavax diphtheria toxoid purified, hepatitis B, recombinant surface antigen, tetanus toxoid purified Tetanus
Hepatitis B
Diphtheria
Immunization
05/02/1998 Withdrawn
35 Pritor telmisartan Hypertension 11/12/1998 Authorised
36 PritorPlus telmisartan / hydrochlorothiazide Hypertension 22/04/2002 Authorised
37 Privigen human normal immunoglobulin (ivig) Guillain-Barre Syndrome
Mucocutaneous Lymph Node Syndrome
Immunologic Deficiency Syndromes
Bone Marrow Transplantation
Purpura, Thrombocytopenic, Idiopathic
25/04/2008 Authorised
38 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

Immunization
Meningitis, Haemophilus
Hepatitis B
07/05/1999 Withdrawn
39 Procoralan ivabradine Angina Pectoris 25/10/2005 Authorised
40 Prolia denosumab Bone Resorption
Osteoporosis, Postmenopausal
26/05/2010 Authorised
41 Prometax rivastigmine Dementia
Parkinson Disease
Alzheimer Disease
04/12/1998 Authorised
42 Proquad virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella Immunization
Mumps
Chickenpox
Measles
Rubella
06/04/2006 Authorised
43 Protaphane insulin human Diabetes Mellitus 07/10/2002 Authorised
44 Protelos strontium ranelate Osteoporosis, Postmenopausal 21/09/2004 Authorised
45 Protopic tacrolimus Dermatitis, Atopic 28/02/2002 Authorised
46 Protopy tacrolimus Dermatitis, Atopic 28/02/2002 Withdrawn
47 Puregon follitropin beta Infertility
Hypogonadism
03/05/1996 Authorised
48 Pylobactell 13C-urea Breath Tests
Helicobacter Infections
07/05/1998 Authorised
49 Pylori-Chek 13C-urea Helicobacter Infections
Breath Tests
15/06/1998 Withdrawn
themecategory
 
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