- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Legal category
Adults:Major depressive episodes.Obsessive-compulsive disorder.Bulimia nervosa: PROZAC is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Children and Adolescents Aged 8 Years and Above:Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
Major depressive episodesAdults and the elderly: The recommended dose is 20mg daily. Dosage should be reviewed and adjusted if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Obsessive-compulsive disorderAdults and the elderly: The recommended dose is 20mg daily. Although there may be an increased potential for undesirable effects at higher doses, in some patients, if after two weeks there is insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg.If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy.Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.Bulimia nervosa: Adults and the elderly: A dose of 60mg/day is recommended. Long-term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa.All indications: The recommended dose may be increased or decreased. Doses above 80mg/day have not been systematically evaluated.
Paediatric population - Children and adolescents aged 8 years and above (moderate to severe major depressive episode):Treatment should be initiated and monitored under specialist supervision. The starting dose is 10mg/day given as 2.5ml of PROZAC oral solution. Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.After one to two weeks, the dose may be increased to 20mg/day. Clinical trial experience with daily doses greater than 20mg is minimal. There is only limited data on treatment beyond 9 weeks.Lower-weight children: Due to higher plasma levels in lower-weight children, the therapeutic effect may be achieved with lower doses (see section 5.2).For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.Elderly patients: Caution is recommended when increasing the dose, and the daily dose should generally not exceed 40mg. Maximum recommended dose is 60mg/day.Patients with hepatic impairment: A lower or less frequent dose (e.g., 20mg every second day) should be considered in patients with hepatic impairment (see section 5.2), or in patients where concomitant medication has the potential for interaction with PROZAC (see section 4.5).Withdrawal symptoms seen on discontinuation of PROZAC: Abrupt discontinuation should be avoided. When stopping treatment with PROZAC the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4 and section 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Method of administrationFor oral administration. Fluoxetine may be administered as a single or divided dose, during or between meals.When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. The capsule and oral solution forms are bioequivalent.
Rash and allergic reactionsRash, anaphylactoid events and progressive systemic events, sometimes serious (involving skin, kidney, liver or lung), have been reported. Upon the appearance of rash or of other allergic phenomena for which an alternative aetiology cannot be identified, fluoxetine should be discontinued.
SeizuresSeizures are a potential risk with antidepressant drugs. Therefore, as with other antidepressants, fluoxetine should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures or where there is an increase in seizure frequency. Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy and patients with controlled epilepsy should be carefully monitored.
ManiaAntidepressants should be used with caution in patients with a history of mania/hypomania. As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase.
Hepatic/Renal functionFluoxetine is extensively metabolised by the liver and excreted by the kidneys. A lower dose, e.g., alternate day dosing, is recommended in patients with significant hepatic dysfunction. When given fluoxetine 20mg/day for 2 months, patients with severe renal failure (GFR <10ml/min) requiring dialysis showed no difference in plasma levels of fluoxetine or norfluoxetine compared to controls with normal renal function.
TamoxifenFluoxetine, a potent inhibitor of CYP2D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, fluoxetine should whenever possible be avoided during tamoxifen treatment (see section 4.5).
Cardiovascular EffectsCases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period (see sections 4.5, 4.8 and 4.9). Fluoxetine should be used with caution in patients with conditions such as congenital long QT syndrome, a family history of QT prolongation or other clinical conditions that predispose to arrhythmias (e.g., hypokalemia and hypomagnesemia, bradycardia, acute myocardial infarction or uncompensated heart failure) or increased exposure to fluoxetine (e.g., hepatic impairment).If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started. If signs of cardiac arrhythmia occur during treatment with fluoxetine, the treatment should be withdrawn and an ECG should be performed.
Weight lossWeight loss may occur in patients taking fluoxetine, but it is usually proportional to baseline body weight.
DiabetesIn patients with diabetes, treatment with an SSRI may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Suicide/suicidal thoughts or clinical worseningDepression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.Other psychiatric conditions for which PROZAC is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.Patients with a history of suicide-related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.Close supervision of patients, and in particular those at high risk, should accompany drug therapy especially in early treatment, and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present.Akathisia/psychomotor restlessnessThe use of fluoxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Withdrawal symptoms seen on discontinuation of SSRI treatmentWithdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8). In clinical trials, adverse events seen on treatment discontinuation occurred in approximately 60% of patients in both the fluoxetine and placebo groups. Of these adverse events, 17% in the fluoxetine group and 12% in the placebo group were severe in nature.The risk of withdrawal symptoms may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor, and headache are the most commonly reported reactions. Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment. Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that PROZAC should be gradually tapered when discontinuing treatment over a period of at least one to two weeks, according to the patient's needs (see 'Withdrawal symptoms seen on discontinuation of PROZAC', section 4.2).
HaemorrhageThere have been reports of cutaneous bleeding abnormalities, such as ecchymosis and purpura with SSRIs. Ecchymosis has been reported as an infrequent event during treatment with fluoxetine. Other haemorrhagic manifestations (e.g., gynaecological haemorrhages, gastro-intestinal bleedings and other cutaneous or mucous bleedings) have been reported rarely. Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, drugs known to affect platelet function (e.g., atypical antipsychotics, such as clozapine, phenothiazines, most TCAs, aspirin, NSAIDs), or other drugs that may increase risk of bleeding, as well as in patients with a history of bleeding disorders.
MydriasisMydriasis has been reported in association with fluoxetine; therefore, caution should be used when prescribing fluoxetine in patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma.
Electroconvulsive therapy (ECT)There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment; therefore, caution is advisable.
St John's WortAn increase in serotonergic effects, such as serotonin syndrome, may occur when selective serotonin reuptake inhibitors and herbal preparations containing St John's Wort (Hypericum perforatum) are used together.
Serotonin syndrome or neuroleptic malignant syndrome-like eventsOn rare occasions, development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of fluoxetine, particularly when given in combination with other serotonergic (among others, L-tryptophan) and/or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions, treatment with fluoxetine should be discontinued if such events (characterised by clusters of symptoms, such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes, including confusion, irritability, extreme agitation, progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
PROZAC oral solution contains sucrosePatients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
PregnancySome epidemiological studies suggest an increased risk of cardiovascular defects associated with the use of fluoxetine during the first trimester. The mechanism is unknown. Overall the data suggest that the risk of having an infant with a cardiovascular defect following maternal fluoxetine exposure is in the region of 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population.Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.Furthermore, although fluoxetine can be used during pregnancy, caution should be exercised, especially during late pregnancy or just prior to the onset of labour since some other effects have been reported in neonates: irritability, tremor, hypotonia, persistent crying, difficulty in sucking or in sleeping. These symptoms may indicate either serotonergic effects or a withdrawal syndrome. The time to occur and the duration of these symptoms may be related to the long half-life of fluoxetine (4-6 days) and its active metabolite, norfluoxetine (4-16 days).
Breast-feedingFluoxetine and its metabolite norfluoxetine, are known to be excreted in human breast milk. Adverse events have been reported in breastfeeding infants. If treatment with fluoxetine is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
FertilityAnimal data have shown that fluoxetine may affect sperm quality (see section 5.3).Human case reports with some SSRI's have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.
|Blood and lymphatic system disorders|
|Immune system disorders|
|Anaphylactic reaction Serum sickness|
|Inappropriate antidiuretic hormone secretion|
|Metabolism and nutrition disorders|
|Insomnia2||Anxiety Nervousness Restlessness Tension Libido decreased3Sleep disorder Abnormal dreams4||Depersonalisation Elevated mood Euphoric mood Thinking abnormal Orgasm abnormal5Bruxism Suicidal thoughts and behaviour 6||Hypomania Mania Hallucinations Agitation Panic attacks Confusion Dysphemia|
|Nervous system disorders|
|Headache||Disturbance in attention Dizziness Dysgeusia Lethargy Somnolence7Tremor||Psychomotor hyperactivity Dyskinesia Ataxia Balance disorder Myoclonus Memory impairment||Convulsion Akathisia Buccoglossal syndrome Serotonin syndrome|
|Ear and labyrinth disorders|
|Palpitations||Ventricular arrhythmia including torsade de pointes Electrocardiogram QT prolonged|
|Respiratory, thoracic and mediastinal disorders|
|Yawning||Dyspnoea Epistaxis||Pharyngitis Pulmonary events (inflammatory processes of varying histopathology and/or fibrosis) 9|
|Diarrhoea Nausea||Vomiting Dyspepsia Dry mouth||Dysphagia Gastrointestinal haemorrhage10||Oesophageal pain|
|Skin and subcutaneous tissue disorders|
|Rash11Urticaria Pruritus Hyperhidrosis||Alopecia Increased tendency to bruise Cold sweat||Angioedema Ecchymosis Photosensitivity reaction Purpura Erythema multiforme12|
|Musculoskeletal and connective tissue disorders|
|Renal and urinary disorders|
|Frequent urination13||Dysuria||Urinary retention Micturition disorder|
|Reproductive system and breast disorders|
|Gynaecological bleeding14Erectile dysfunction Ejaculation disorder15||Sexual dysfunction||Galactorrhoea Hyperprolactinemia Priapism|
|General disorders and administration site conditions|
|Fatigue16||Feeling jittery Chills||Malaise Feeling abnormal Feeling cold Feeling hot||Mucosal haemorrhage|
|Weight decreased||Abnormal liver function tests|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard.
SymptomsCases of overdose of fluoxetine alone usually have a mild course. Symptoms of overdose have included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic arrhythmias (including nodal rhythm and ventricular arrhythmias) or ECG changes indicative of QTc prolongation to cardiac arrest (including very rare cases of Torsade de Pointes), pulmonary dysfunction, and signs of altered CNS status ranging from excitation to coma. Fatality attributed to overdose of fluoxetine alone has been extremely rare.
ManagementCardiac and vital signs monitoring are recommended, along with general symptomatic and supportive measures. No specific antidote is known.Forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage. In managing overdosage, consider the possibility of multiple drug involvement. An extended time for close medical observation may be needed in patients who have taken excessive quantities of a tricyclic antidepressant if they are also taking, or have recently taken, fluoxetine.
Mechanism of actionFluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α1-, α2-, and β-adrenergic; serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.
Clinical efficacy and safetyMajor depressive episodes: Clinical trials in patients with major depressive episodes have been conducted versus placebo and active controls. PROZAC has been shown to be significantly more effective than placebo, as measured by the Hamilton Depression Rating Scale (HAM-D). In these studies, PROZAC produced a significantly higher rate of response (defined by a 50% decrease in the HAM-D score) and remission compared to placebo.Dose response: In the fixed-dose studies of patients with major depression there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses. However, it is clinical experience that uptitrating might be beneficial for some patients.Obsessive-compulsive disorder: In short-term trials (under 24 weeks), fluoxetine was shown to be significantly more effective than placebo. There was a therapeutic effect at 20mg/day, but higher doses (40 or 60mg/day) showed a higher response rate. In long-term studies (three short-term studies extension phase and a relapse prevention study), efficacy has not been shown.Bulimia nervosa: In short-term trials (under 16 weeks), in out-patients fulfilling DSM-III-R-criteria for bulimia nervosa, fluoxetine 60mg/day was shown to be significantly more effective than placebo for the reduction of bingeing, vomiting and purging activities. However, for long-term efficacy no conclusion can be drawn.Pre-Menstrual Dysphoric Disorder: Two placebo-controlled studies were conducted in patients meeting pre-menstrual dysphoric disorder (PMDD) diagnostic criteria according to DSM-IV. Patients were included if they had symptoms of sufficient severity to impair social and occupational function and relationships with others. Patients using oral contraceptives were excluded. In the first study of continuous 20mg daily dosing for 6 cycles, improvement was observed in the primary efficacy parameter (irritability, anxiety and dysphoria). In the second study, with intermittent luteal phase dosing (20mg daily for 14 days) for 3 cycles, improvement was observed in the primary efficacy parameter (Daily Record of Severity of Problems score). However, definitive conclusions on efficacy and duration of treatment cannot be drawn from these studies.
Paediatric populationMajor depressive episodes: Clinical trials in children and adolescents aged 8 years and above have been conducted versus placebo. PROZAC, at a dose of 20mg, has been shown to be significantly more effective than placebo in two short-term pivotal studies, as measured by the reduction of Childhood Depression Rating Scale-Revised (CDRS-R) total scores and Clinical Global Impression of Improvement (CGI-I) scores. In both studies, patients met criteria for moderate to severe MDD (DSM-III or DSM-IV) at three different evaluations by practising child psychiatrists. Efficacy in the fluoxetine trials may depend on the inclusion of a selective patient population (one that has not spontaneously recovered within a period of 3-5 weeks and whose depression persisted in the face of considerable attention). There is only limited data on safety and efficacy beyond 9 weeks. In general, efficacy of fluoxetine was modest. Response rates (the primary endpoint, defined as a 30% decrease in the CDRS-R score) demonstrated a statistically significant difference in one of the two pivotal studies (58% for fluoxetine versus 32% for placebo, P = 0.013; and 65% for fluoxetine versus 54% for placebo, P = 0.093). In these two studies, the mean absolute changes in CDRS-R from baseline to endpoint were 20 for fluoxetine versus 11 for placebo, P = 0.002; and 22 for fluoxetine versus 15 for placebo, P <0.001.Effects on growth, see sections 4.4 and 4.8: After 19 weeks of treatment, paediatric subjects treated with fluoxetine in a clinical trial gained an average of 1.1 cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than subjects treated with placebo.In a retrospective matched control observational study with a mean of 1.8 years of exposure to fluoxetine, paediatric subjects treated with fluoxetine had no difference in growth adjusted for expected growth in height from their matched, untreated controls (0.0 cm, p=0.9673).
Special populationsElderly: Kinetic parameters are not altered in healthy elderly when compared to younger subjects.Paediatric population: The mean fluoxetine concentration in children is approximately 2-fold higher than that observed in adolescents and the mean norfluoxetine concentration 1.5-fold higher. Steady-state plasma concentrations are dependent on body weight and are higher in lower-weight children (see section 4.2). As in adults, fluoxetine and norfluoxetine accumulated extensively following multiple oral dosing; steady-state concentrations were achieved within 3 to 4 weeks of daily dosing.Hepatic insufficiency: In case of hepatic insufficiency (alcoholic cirrhosis), fluoxetine and norfluoxetine half-lives are increased to 7 and 12 days, respectively. A lower or less frequent dose should be considered.Renal insufficiency: After single-dose administration of fluoxetine in patients with mild, moderate, or complete (anuria) renal insufficiency, kinetic parameters have not been altered when compared to healthy volunteers. However, after repeated administration, an increase in steady-state plateau of plasma concentrations may be observed.
Adult animal studiesIn a 2-generation rat reproduction study, fluoxetine did not produce adverse effects on the mating or fertility of rats, was not teratogenic, and did not affect growth, development, or reproductive parameters of the offspring.The concentrations in the diet provided doses approximately equivalent to 1.5, 3.9, and 9.7 mg fluoxetine/kg body weight.Male mice treated daily for 3 months with fluoxetine in the diet at a dose approximately equivalent to 31 mg/kg showed a decrease in testis weight and hypospermatogenesis. However, this dose level exceeded the maximum-tolerated dose (MTD) as significant signs of toxicity were seen.
Juvenile animal studiesIn a juvenile toxicology study in CD rats, administration of 30 mg/kg/day of fluoxetine hydrochloride on postnatal days 21 to 90 resulted in irreversible testicular degeneration and necrosis, epididymal epithelial vacuolation, immaturity and inactivity of the female reproductive tract and decreased fertility. Delays in sexual maturation occurred in males (10 and 30 mg/kg/day) and females (30 mg/kg/day). The significance of these findings in humans is unknown. Rats administered 30 mg/kg also had decreased femur lengths compared with controls and skeletal muscle degeneration, necrosis and regeneration. At 10 mg/kg/day, plasma levels achieved in animals were approximately 0.8 to 8.8 fold (fluoxetine) and 3.6 to 23.2 fold (norfluoxetine) those usually observed in paediatric patients. At 3 mg/kg/day, plasma levels achieved in animals were approximately 0.04 to 0.5 fold (fluoxetine) and 0.3 to 2.1 fold (norfluoxetine) those usually achieved in paediatric patients.A study in juvenile mice has indicated that inhibition of the serotonin transporter prevents the accrual of bone formation. This finding would appear to be supported by clinical findings. The reversibility of this effect has not been established. Another study in juvenile mice (treated on postnatal days 4 to 21) has demonstrated that inhibition of the serotonin transporter had long-lasting effects on the behaviour of the mice. There is no information on whether the effect was reversible. The clinical relevance of this finding has not been established.
The oral solution contains:Benzoic acidSucroseGlycerineMint flavour (containing 0.23 % ethanol (alcohol))Purified water
The capsules contain:Maize starch flowableDimeticone
Capsule components:Patent blue V (E131) Yellow iron oxide (E172)Titanium dioxide (E171)GelatinPharmaceutical grade edible printing ink: containing shellac, hydrated ferric oxide (black) E172, propylene glycol and may contain ammonium hydroxide and potassium hydroxide.
|Oral solution:||PL 00006/0272|
|Date of first authorisation:||25 November 1988|
|Date of latest renewal:||01 April 2013|
|Date of first authorisation:||25 November 1988|
|Date of latest renewal:||01 April 2013|
Eli Lilly and Company Limited
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL
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+44 (0)1256 775 569
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