Votrient 200 mg film-coated tablets, , Film-coated tablet. Capsule-shaped, pink, film-coated table, Medicine and Disease information

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Votrient 200 mg film-coated tablets overview

Votrient is indicated for the first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

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Related DrugsDrug Details

Votrient 200 mg film-coated tablets

Drug description :

Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).

Presentation :

Film-coated tablet. Capsule-shaped, pink, film-coated tablet with GS JT debossed on one side.

Indications :

Votrient is indicated for the first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

Adult Dosage :

Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer agents.

Adults
The recommended dose of pazopanib is 800 mg once daily.

Dose modifications
Dose modification should be in 200 mg increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The dose of pazopanib should not exceed 800 mg.

Paediatric population
Pazopanib is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Elderly
There are limited data of the use of pazopanib in patients aged 65 years and older. In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects. Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal impairment
Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites. Therefore, no dose adjustment is required in patients with creatinine clearance above 30 ml/min. Caution is advised in patients with creatinine clearance below 30 ml/min as there is no experience of pazopanib in this patient population.

Hepatic impairment
The safety and pharmacokinetics of pazopanib in patients with hepatic impairment have not been fully established. Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring due to potentially increased exposure to the medicinal product. Insufficient data a e available in patients with mild hepatic impairment to provide a dose adjustment recommendation but a reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment.

Pazopanib is contraindicated in patients with severe hepatic impairment.

Method of administration
Pazopanib should be taken without food, at least one hour before or two hours after a meal. Votrient film-coated tablets should be taken whole with water and not broken or crushed.

Special Precautions :

Hepatic effects
Cases of hepatic failure (including fatalities) have been reported during use of pazopanib. The safety and pharmacokinetics of pazopanib have not been fully established in patients with pre-existing hepatic impairment. Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring. A reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment.

Insufficient data are available in patients with mild hepatic impairment to provide a dose adjustment recommendation. Pazopanib is contraindicated in patients with severe hepatic impairment.

In clinical studies with pazopanib, increase in serum transaminases (ALT, AST) and bilirubin were observed. In the majority of the cases, isolated increases in ALT and AST have been reported, without concomitant elevations of alkaline phosphatase or bilirubin.

Monitor serum liver tests before initiation of treatment with pazopanib and at least once every 4 weeks for the first 4 months of treatment, and as clinically indicated. Periodic monitoring should then continue after this time period.

Patients with isolated transaminase elevations ≤ 8 X upper limit of normal (ULN) may be continued on pazopanib with weekly monitoring of liver function until transaminases return to Grade 1 or baseline.
Patients with transaminases of > 8 X ULN should have pazopanib interrupted until they return to Grade 1 or baseline. If the potential benefit for reinitiating pazopanib treatment is considered to outweigh the risk for hepatotoxicity, then reintroduce pazopanib at a reduced dose and measure serum liver tests weekly for 8 weeks. Following reintroduction of pazopanib, if transaminase elevations > 3 X ULN recur, then pazopanib should be discontinued.
If transaminase elevations > 3 X ULN occur concurrently with bilirubin elevations > 2 X ULN, bilirubin fractionation should be performed. If direct (conjugated) bilirubin is > 35 % of total bilirubin, pazopanib should be discontinued.

Hypertension
Blood pressure should be well controlled prior to initiating pazopanib. Patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.

Hypertension occurs early in the course of treatment (88 % occurring in first 18 weeks). In the case of persistent hypertension despite anti-hypertensive therapy, the pazopanib dose may be reduced (see section 4.2). Temporary suspension is recommended in patients if hypertension is severe and persists despite anti-hypertensive therapy and pazopanib dose reduction. Pazopanib treatment may be resumed once hypertension is appropriately controlled.

QT prolongation and Torsade de Pointes
In clinical studies with pazopanib, events of QT prolongation and Torsade de Pointes have occurred. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrythmics or other medicinal products that may prolong QT interval and those with relevant pre-existing cardiac disease. When using pazopanib, base line and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within normal range is recommended.

Arterial thrombotic events
In clinical studies with pazopanib, myocardial infarction, ischemic stroke, and transient ischemic attack were observed (see section 4.8). Pazopanib should be used with caution in patients who are at increased risk for any of these events. A treatment decision should be made based upon the assessment of individual patient’s benefit/risk.

Haemorrhagic events
In clinical studies with pazopanib haemorrhagic events have been reported. Pazopanib is not recommended in patients who had a history of haemoptysis, cerebral, or clinically significant gastrointestinal (GI) haemorrhage in the past 6 months. Pazopanib should be used with caution in patients with significant risk of haemorrhage.

Gastrointestinal perforations and fistula
In clinical studies with pazopanib, events of GI perforation or fistula have occurred. Pazopanib should be used with caution in patients at risk for GI perforation or fistula.

Wound healing
No formal studies on the effect of pazopanib on wound healing have been conducted. Since Vascular Endothelial Growth Factor (VEGF) inhibitors may impair wound healing, treatment with pazopanib should be stopped at least 7 days prior to scheduled surgery. The decision to resume pazopanib after surgery should be based on clinical judgement of adequate wound healing. Pazopanib should be discontinued in patients with wound dehiscence.

Heart failure
The safety and pharmacokinetics of pazopanib in patients with moderate to severe heart failure has not been studied.

Hypothyroidism
In clinical studies with pazopanib, events of hypothyroidism have occurred. Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism should be treated as per standard medical practice prior to the start of pazopanib treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on pazopanib treatment. Laboratory monitoring of thyroid function should be performed periodically and managed as per standard medical practice.

Proteinuria
In clinical studies with pazopanib, proteinuria has been reported. Baseline and periodic urinanalysis during treatment is recommended and patients should be monitored for worsening proteinuria. Pazopanib should be discontinued if the patient develops Grade 4 proteinuria.

Pregnancy
Pre-clinical studies in animals have shown reproductive toxicity. If pazopanib is used during pregnancy, or if the patient becomes pregnant whilst receiving pazopanib, the potential hazard to the foetus should be explained to the patient. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with pazopanib.

Interactions
Concomitant treatment with strong inhibitors of CYP3A4, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib. Selection of alternative concomitant medicinal products with no or minimal potential to inhibit CYP3A4, P-gp or BCRP should be considered.

Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to pazopanib.

Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1.

Grapefruit juice should be avoided during treatment with pazopanib.

Interactions :

Effects of other medicinal products on pazopanib

In vitro studies suggested that the oxidative metabolism of pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of pazopanib.

CYP3A4, P-gp, BCRP Inhibitors: Pazopanib is a substrate for CYP3A4, P-gp and BCRP.

Co-administration of pazopanib with strong inhibitors of the CYP3A4 family (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase pazopanib concentrations. Grapefruit juice contains an inhibitor of CYP3A4 and may also increase plasma concentrations of pazopanib.

Administration of 1,500 mg lapatinib (a substrate for and weak inhibitor of CYP3A4 and P-gp and a potent inhibitor of BCRP) with 800 mg pazopanib resulted in an approximately 50 % to 60 % increase in mean pazopanib AUC(0-24) and Cmax compared to administration of 800 mg pazopanib alone.

Inhibition of P-gp and/or BCRP by lapatinib likely contributed to the increased exposure to pazopanib.

Concurrent administration of a single dose of pazopanib eye drops (at a low dose of 400 μg (80 μl of 5 mg/ml)) with the strong CYP3A4 inhibitor and P-gp inhibitor, ketoconazole, in healthy volunteers resulted in a 2.2- and 1.5-fold increase in mean AUC(0-t) and Cmax values, respectively. Inhibition of P-gp and/or BCRP by ketoconazole likely contributed to the increased exposure to pazopanib. At present no dosing recommendations can be made for either potent specific inhibitors of CYP3A4 or ketoconazole.

Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will esult in an increase in plasma pazopanib concentrations. Co-administration with potent P-gp or BCRP inhibitors may also alter the exposure and distribution of pazopanib, including distribution into the central nervous systems (CNS).

Combination with strong CYP3A4, P-gp or BCRP inhibitors should therefore be avoided, or selection of an alternate concomitant medication with no or minimal potential to inhibit CYP3A4, P-gp or BCRP is recommended..

CYP3A4, P-gp, BCRP Inducers: CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations. Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the CNS. Selection of an alternate
concomitant medication with no or minimal enzyme or transporter induction potential is recommended.

Effects of pazopanib on other medicinal products
In vitro studies with human liver microsomes showed that pazopanib inhibited CYP enzymes 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, and 2E1. Potential induction of human CYP3A4 was demonstrated in an in vitro human PXR assay. Clinical pharmacology studies, using pazopanib 800 mg once daily, have demonstrated that pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients. Pazopanib resulted in an increase of approximately 30 % in the mean AUC and Cmax of midazolam (CYP3A4 probe substrate) and increases of 33 % to 64 % in the ratio of dextrometrophan to dextrophan concentrations in the urine after oral administration of dextromethorphan (CYP2D6 probe substrate). Co-administration of pazopanib 800 mg once daily and paclitaxel 80 mg/m2 (CYP3A4 and CYP2C8 substrate) once weekly resulted in a mean increase of 25 % and 31 % in paclitaxel AUC and Cmax, respectively.

Based on in vitro IC50 and in vivo plasma Cmax values, pazopanib metabolites GSK1268992 and GSK1268997 may contribute to the net inhibitory effect of pazopanib towards BCRP. Furthermore, inhibition of BCRP and P-gp by pazopanib in the gastrointestinal tract cannot be excluded. Care
should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates. In vitro, pazopanib inhibited human organic anion transporting polypeptide (OATP1B1). It cannot be excluded that pazopanib will affect the pharmacokinetics of substrates of OATP1B1 (e.g. rosuvastatin).

Effect of food on pazopanib
Administration of pazopanib with a high fat or low fat meal results in an approximately 2-fold increase in AUC and Cmax. Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.

Adverse Reactions :

Pooled data from the pivotal RCC study (VEG105192, n=290), extension study (VEG107769, n=71) and the supportive Phase II study (VEG102616, n=225) was evaluated in the overall evaluation of safety and tolerability of pazopanib (total n=586) in subjects with RCC.

The most important serious adverse reactions were transient ischaemic attack, ischaemic stroke, myocardial ischaemia, cardiac dysfunction, gastrointestinal perforation and fistula, QT prolongation and pulmonary, gastrointestinal and cerebral haemorrhage, all adverse reactions being reported in < 1 % of treated patients.

Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischemic stroke.

The most common adverse reactions (experienced by at least 10 % of the patients) of any grade included: diarrhoea, hair colour change, hypertension, nausea, fatigue, anorexia, vomiting, dysgeusia, elevated alanine aminotransferase and elevated aspartate aminotransferase.

Treatment related adverse reactions, all grades, which were reported in RCC patients are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency:

Very common 1/10

Common 1/100 to < 1/10

Uncommon 1/1,000 to < 1/100

Rare 1/10,000 to < 1/1,000

Very rare < 1/10,000

not known (cannot be estimated from the available data)

Categories have been assigned based on absolute frequencies in the clinical study data. Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.

Table 1: Treatment-related adverse reactions reported in RCC studies (n=586)

System Organ Class	Frequency (all grades)	Adverse Reactions	All Grades n (%)	Grade 3 n (%)	Grade 4 n (%)
Blood and lymphatic system disorders	Common	Thrombocytopenia	25 (4 %)	3 (< 1 %)	3 (< 1 %)
	Common	Neutropenia	17 (3 %)	4 (< 1 %)	2 (< 1 %)
	Common	Leukopenia	14 (2 %)	1 (< 1 %)	0
Endocrine disorders	Common	Hypothyroidism	23 (4 %)	0	0
Metabolism and nutrition disorders	Very common	Decreased appetite^e	122 (21 %)	6 (1 %)	0
	Uncommon	Hypophosphataemia	4 (< 1 %)	2 (< 1 %)	0
	Uncommon	Hypomagnesaemia	3 (< 1 %)	0	0
Nervous system disorders	Very common	Dysgeusia^c	92 (16 %)	0	0
	Common	Headache	41 (7 %)	0	0
	Common	Dizziness	19 (3 %)	0	1 (< 1 %)
	Common	Lethargy	12 (2 %)	1 (< 1 %)	0
	Common	Paraesthesia	12 (2 %)	2 (< 1 %)	0
	Uncommon	Peripheral sensory neuropathy	5 (< 1 %)	0	0
	Uncommon	Hypoaesthesia	4 (< 1 %)	0	0
	Uncommon	Transient ischaemic attack	3 (< 1 %)	2 (< 1 %)	0
	Uncommon	Cerebrovascular accident	1 (< 1 %)	0	1 (< 1 %)
	Uncommon	Ischaemic stroke	1 (< 1 %)	0	0
Eye disorders	Uncommon	Eyelash discolouration	3 (< 1 %)	0	0
Cardiac disorders	Uncommon	Bradycardia	3 (< 1 %)	0	0
	Uncommon	Cardiac dysfunction	4 (< 1 %)	1 (< 1 %)	1 (< 1 %)
	Uncommon	Myocardial infarction	2 (< 1 %)	0	2 (< 1 %)
	Uncommon	Myocardial ischaemia	1 (< 1 %)	1 (< 1 %)	0
Vascular disorders	Very common	Hypertension	225 (38 %)	34 (6%)	0
	Common	Hot flush	11 (2 %)	0	0
	Uncommon	Flushing	5 (< 1 %)	0	0
	Uncommon	Haemorrhage	1 (< 1 %)	0	0
	Uncommon	Hypertensive crisis	1 (< 1 %)	0	1 (< 1 %)
Respiratory, thoracic and mediastinal disorders	Common	Epistaxis	16 (3 %)	0	0
	Common	Dysphonia	15 (3 %)	0	0
	Uncommon	Pulmonary embolism	4 (< 1 %)	1 (< 1 %)	3 (< 1 %)
	Uncommon	Haemoptysis	3 (< 1 %)	0	0
	Uncommon	Pulmonary haemorrhage	1 (< 1 %)	0	0
Gastrointestinal disorders	Very common	Diarrhoea	286 (49 %)	19 (3 %)	2 (< 1 %)
	Very common	Nausea	161 (27 %)	3 (< 1 %)	0
	Very common	Vomiting	89 (15 %)	7 (1 %)	1 (< 1 %)
	Very common	Abdominal pain^a	60 (10 %)	8 (1 %)	0
	Common	Dyspepsia	24 (4 %)	2 (< 1 %)	0
	Common	Stomatitis	24 (4 %)	0	0
	Common	Flatulence	20 (3 %)	0	0
	Common	Abdominal distension	15 (3 %)	0	0
	Uncommon	Mouth ulceration	4 (< 1 %)	1 (< 1 %)	0
	Uncommon	Frequent bowel movements	3 (< 1 %)	0	0
	Uncommon	Gastrointestinal haemorrhage	3 (< 1 %)	1 (< 1 %)	0
	Uncommon	Rectal haemorrhage	3 (< 1 %)	1 (< 1 %)	0
	Uncommon	Large intestine perforation	2 (< 1 %)	1 (< 1 %)	0
	Uncommon	Mouth haemorrhage	2 (< 1 %)	0	0
	Uncommon	Enterocutaneous fistula	1 (< 1 %)	0	0
	Uncommon	Haematemesis	1 (< 1 %)	0	0
	Uncommon	Haematochezia	1 (< 1 %)	0	0
	Uncommon	Haemorrhoidal haemorrhage	1 (< 1 %)	0	0
	Uncommon	Ileal perforation	1 (< 1 %)	0	1 (< 1 %)
	Uncommon	Melaena	1 (< 1 %)	0	0
	Uncommon	Oesophageal haemorrhage	1 (< 1 %)	0	1 (< 1 %)
	Uncommon	Pancreatitis	1 (< 1 %)	0	0
	Uncommon	Peritonitis	1 (< 1 %)	0	0
	Uncommon	Retroperitoneal haemorrhage	1 (< 1 %)	0	0
	Uncommon	Upper gastrointestinal haemorrhage	1 (< 1 %)	0	0
Hepatobiliary disorders	Common	Hepatic function abnormal	20 (3 %)	6 (1 %)	0
	Common	Hyperbilirubinaemia	18 (3 %)	2 (< 1 %)	1 (< 1 %)
	Uncommon	Hepatotoxicity	5 (< 1 %)	3 (< 1 %)	0
	Uncommon	Jaundice	2 (< 1 %)	1 (< 1 %)	0
	Uncommon	Hepatic failure	1 (< 1 %)	0	1 (< 1 %)
	Uncommon	Hepatitis	1 (< 1 %)	1 (< 1 %)	0
Skin and subcutaneous disorders	Very common	Hair colour change	231 (39 %)	1 (< 1 %)	0
	Common	Rash	52 (9 %)	3 (< 1 %)	0
	Common	Alopecia	50 (9 %)	0	0
	Common	Palmar-plantar erythrodysaesthesia syndrome	43 (7 %)	7 (1 %)	0
	Common	Skin hypopigmentation	25 (4 %)	0	0
	Common	Erythema	15 (3 %)	0	0
	Common	Pruritus	13 (2 %)	0	0
	Common	Skin depigmentation	13 (2 %)	0	0
	Common	Dry skin	12 (2 %)	0	0
	Common	Hyperhidrosis	9 (2 %)	0	0
	Uncommon	Photosensitivity reaction	7 (1 %)	0	0
	Uncommon	Skin exfoliation	7 (1 %)	0	0
	Uncommon	Rash vesicular	3 (< 1 %)	0	0
	Uncommon	Pruritus generalised	2 (< 1 %)	1 (< 1 %)	0
	Uncommon	Rash papular	2 (< 1 %)	0	0
	Uncommon	Plantar erythema	1 (< 1 %)	0	0
	Uncommon	Rash erythematous	1 (< 1 %)	0	0
	Uncommon	Rash generalised	1 (< 1 %)	0	0
	Uncommon	Rash macular	1 (< 1 %)	0	0
	Uncommon	Rash pruritic	1 (< 1 %)	0	0
Musculoskeletal and connective tissue disorders	Common	Myalgia	15 (3 %)	2 (< 1 %)	0
Musculoskeletal and connective tissue disorders	Common	Muscle spasms	12 (2 %)	0	0
Renal and urinary disorders	Common	Proteinuria	40 (7 %)	5 (< 1 %)	0
Renal and urinary disorders	Uncommon	Haemorrhage urinary tract	1 (< 1 %)	0	0
Reproductive system and breast disorders	Uncommon	Menorrhagia	1 (< 1 %)	0	0
	Uncommon	Metrorrhagia	1 (< 1 %)	0	0
	Uncommon	Vaginal haemorrhage	1 (< 1 %)	0	0
General disorders and administration site conditions	Very common	Fatigue	139 (24 %)	16 (3 %)	0
	Common	Asthenia	41 (7 %)	8 (1 %)	0
	Common	Mucosal inflammation	27 (5 %)	2 (< 1 %)	0
	Common	Oedema^b	19 (3 %)	0	0
	Common	Chest pain	14 (2 %)	2 (< 1 %)	0
	Uncommon	Mucous membrane disorder	1 (< 1 %)	0	0
Investigations	Very common	Alanine aminotransferase increased	83 (14%)	28 (5 %)	4 (< 1 %)
	Very common	Aspartate aminotransferase increased	72 (12%)	17 (3 %)	3 (< 1 %)
	Common	Weight decreased	38 (6 %)	2 (< 1 %)	0
	Common	Blood creatinine increased	13 (2 %)	2 (< 1 %)	0
	Common	Blood bilirubin increased	11 (2 %)	1 (< 1 %)	1 (< 1 %)
	Common	White blood cell count decreased^d	10 (2 %)	1 (< 1 %)	0
	Common	Lipase increased	9 (2 %)	4 (< 1 %)	1 (< 1 %)
	Common	Blood pressure increased	6 (1 %)	0	0
	Common	Blood thyroid stimulating hormone increased	6 (1 %)	0	0
	Common	Gamma-glutamyltransferase increased	6 (1 %)	1 (< 1 %)	1 (< 1 %)
	Common	Hepatic enzyme increased	6 (1 %)	2 (< 1 %)	0
	Uncommon	Aspartate aminotransferase	5 (< 1 %)	2 (< 1 %)	0
	Uncommon	Blood urea increased	5 (< 1 %)	1 (< 1 %)	0
	Uncommon	Electrocardiogram QT prolonged	5(< 1 %)	1 (< 1 %)	0
	Uncommon	Blood amylase increased	4 (< 1 %)	0	0
	Uncommon	Blood glucose decreased	4 (< 1 %)	0	0
	Uncommon	Alanine aminotransferase	3 (< 1 %)	2 (< 1 %)	0
	Uncommon	Transaminase increased	3 (< 1 %)	1 (< 1 %)	0
	Uncommon	Blood pressure diastolic increased	2 (< 1 %)	0	0
	Uncommon	Thyroid function test abnormal	2 (< 1 %)	0	0
	Uncommon	Blood pressure systolic increased	1 (< 1 %)	0	0
	Uncommon	Liver function test abnormal	1 (< 1 %)	0	0
The following terms have been combined: ^a Abdominal pain, abdominal pain upper and abdominal pain lower ^b Oedema, oedema peripheral, eye oedema, localised oedema and face oedema ^c Dysgeusia, ageusia and hypogeusia ^d White cell count decreased, neutrophil count decreased and leukocyte count decreased ^e Decreased appetite and anorexia

Manufacturer :

Glaxo Group Ltd.

Drug Availability :

POM- Prescription Only Medicine

Drug Updated :

20 September 2010

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Benlysta 400 mg pulver till koncentrat till infusionsvätska, lösning. Benlysta 120 mg pulver till koncentrat till infusionsvätska, lösning. Qutenza 179 mg kutant plåster Onglyza 2,5 mg filmdragerade tabletter IRESSA 250 mg filmdragerade tabletter Mycamine 50 mg pulver till infusionsvätska, lösning Protopic 0,1% salva Cayston 75 mg pulver och vätska till lösning för nebulisator Xarelto 15 mg filmdragerade tabletter Xarelto 20 mg filmdragerade tabletter	Xarelto 10 mg filmdragerade tabletter Ketek 400 mg filmdragerade tabletter Tasigna 200 mg hårda kapslar Advate Injektionsvätska, lösning Axura 10 mg/g orala droppar, lösning Axura 10 mg filmdragerade tabletter Myozyme 50 mg, pulver till koncentrat till infusionsvätska, lösning Onbrez Breezhaler 300 mikrogram inhalationspulver, hårda kapslar Hepsera 10 mg tabletter Champix filmdragerade tabletter

French Drugs
Benlysta 120 mg poudre pour solution à diluer pour perfusion. Benlysta 400 mg poudre pour solution à diluer pour perfusion Qutenza 179 mg patch cutané. Onglyza 2,5 mg, comprimés pelliculés IRESSA 250 mg, comprimés pelliculés Mycamine 50 mg poudre pour solution pour perfusion Protopic 0,1% pommade VISTIDE 75 mg/ml, solution à diluer pour perfusion CANCIDAS 50 mg poudre pour solution à diluer pour perfusion Cubicin 350 mg poudre pour solution à diluer pour perfusion	ECALTA 100 mg poudre et solvant pour solution à diluer pour perfusion Altargo 1% pomada Protopic 0,03% pommade Xarelto 20 mg comprimé pelliculé Xarelto 15 mg comprimé pelliculé Xarelto 10 mg comprimé pelliculé Herceptin 150 mg poudre pour solution à diluer pour perfusion ACETYLCYSTEINE BIOGARAN CONSEIL 200 mg, poudre pour solution buvable en sachet ACETYLLEUCINE BIOGARAN 500 mg, comprimé ACETYLLEUCINE ZENTIVA 500 mg, comprimé

Portuguese Drugs
Benlysta 400 mg pó para concentrado para solução para perfusão Benlysta 120 mg pó para concentrado para solução para perfusão. Qutenza 179 mg adesivo cutâneo Onglyza 2,5 mg comprimidos revestidos por película IRESSA 250 mg comprimidos revestidos por película Protopic 0,1% pomada Mycamine 50 mg pó para solução para perfusão Vistide 75 mg/ml concentrado para solução para perfusão ECALTA 100 mg pó e solvente para concentrado para solução para perfusão CANCIDAS 50 mg pó para concentrado para solução para perfusão	Cubicin 350 mg pó para solução injetável ou para perfusão Protopic 0,03% pomada Xarelto 20 mg comprimidos revestidos por película Xarelto 15 mg comprimidos revestidos por película Xarelto 10 mg comprimidos revestidos por película Tredaptive Truvada Trevaclyn Trisenox Trizivir

Italian Drugs
Benlysta 400 mg polvere per concentrato per soluzione per infusione. Benlysta 120 mg polvere per concentrato per soluzione per infusione Qutenza 179 mg cerotto cutaneo Onglyza 2,5 mg compresse rivestite con film Mycamine 50 mg polvere per soluzione per infusione Vistide 75 mg/ml concentrato per soluzione per infusione CANCIDAS 50 mg polvere per concentrato per soluzione per infusione ECALTA 100 mg polvere e solvente per concentrato per soluzione per infusione Cubicin 350 mg polvere per soluzione iniettabile o per infusione Altargo 1% unguento	Protopic 0,03% unguento Xarelto 20 mg compresse rivestite con film Xarelto 15 mg compresse rivestite con film Xarelto 10 mg compresse rivestite con film MEPACT 4 mg polvere per sospensione per infusione FABLYN Testogel Nebido Levitra Xelevia 25 mg compresse rivestite con film

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