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Active substance: NAPROXEN

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Naproxen EC 500mg Tablets


Naproxen EC 500mg Tablets: each tablet contains 500mg naproxen.
For the full list of excipients, see section 6.1.


Gastro-resistant film-coated tablets.
Naproxen EC 500mg Tablets: an oblong, biconvex, white or almost white, filmcoated tablet with a smooth surface containing 500mg of naproxen




Therapeutic indications
Naproxen EC is indicated in adults for the treatment of rheumatoid arthritis,
osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute musculoskeletal
disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical
spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.


Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4).
Naproxen EC tablets should be swallowed whole and not broken or crushed.
Therapy should be started at the lowest recommended dose, especially in elderly

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

The usual dose is 500mg to 1g daily taken in 2 doses at 12-hour intervals. Where 1g
per day is needed either one 500mg tablet twice daily or two 500mg tablets in a single
administration (morning or evening) is recommended. In the following cases a
loading dose of 750mg or 1g per day for the acute phase is recommended:
a) In patients reporting severe night-time pain/or morning stiffness.
b) In patients being switched to Naproxen from a high dose of another anti-rheumatic
c) In osteoarthrosis where pain is the predominant symptom.
Acute musculoskeletal disorders and dysmenorrhoea
500mg initially followed by 250mg at 6 - 8 hour intervals as needed, with a maximum
daily dose after the first day of 1250mg.
Studies indicate that although total plasma concentration of naproxen is unchanged,
the unbound plasma fraction of naproxen is increased in the elderly. The implication
of this finding for Naproxen EC dosing is unknown. As with other drugs used in the
elderly it is prudent to use the lowest effective dose and for the shortest possible
duration as elderly patients are more prone to adverse events. The patient should be
monitored regularly for GI bleeding during NSAID therapy. For the effect of reduced
elimination in the elderly see section 4.4.
Paediatric population
Naproxen EC is not recommended for use in children under 16 years of age.
Renal/hepatic impairment
A lower dose should be considered in patients with renal or hepatic impairment.
Naproxen EC is contraindicated in patients with baseline creatinine clearance less
than 30 ml/minute because accumulation of naproxen metabolites has been seen in
patients with severe renal failure or those on dialysis (see section 4.3).
Treatment should be reviewed at regular intervals and discontinued if no benefit is
Method of Administration
For oral administration.
To be taken preferably with or after food.


Active or history of peptic ulceration or active gastrointestinal bleeding, (two or more
distinct episodes of proven ulceration or bleeding). History of gastrointestinal
bleeding or perforation related to previous NSAIDs therapy
Hypersensitivity to the active substance or to any of the excipients listed in section
Since the potential exists for cross-sensitivity reactions, Naproxen EC should not be
given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic
drugs induce asthma, rhinitis, nasal polyps or urticaria. These reactions have the
potential of being fatal. Severe anaphylactic-like reactions to naproxen have been
reported in such patients.
Severe renal, hepatic or heart failure.

Naproxen is contraindicated during the last trimester of pregnancy (see section 4.6).


Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.2, and
gastro-intestinal and cardiovascular risks below).
Patients treated with NSAIDs long-term should undergo regular medical
supervision to monitor for adverse events.
Elderly and/or debilitated patients are particularly susceptible to the adverse
events of NSAIDs. Especially gastrointestinal bleeding and perforation, which
may be fatal. Prolonged use of the NSAIDs in the elderly is not recommended.
Where prolonged therapy is required, patients should be reviewed regularly.
The antipyretic and anti-inflammatory activities of Naproxen EC may reduce
fever and inflammation, thereby diminishing their utility as diagnostic signs.
Bronchospasm may be precipitated in patients suffering from, or with a history
of, bronchial asthma or allergic disease.
As with other non-steroidal anti-inflammatory drugs, elevations of one or
more liver function tests mayoccur. Hepatic abnormalities may be the result of
hypersensitivity rather than direct toxciity. Severe hepatic reactions, including
jaundice and hepatitis (some cases hepatitis have been fatal) have been
reported with this drug as with other non-steroidal anti-inflammatory drugs.
Cross reactivity has been reported.
Naproxen decreases platelet aggregation and prolongs bleeding time. This
effect should be kept in mind when bleeding times are determined.
Although sodium retention has not been reported in metabolic studies, it is
possible that patients with questionable or compromised cardiac function may
be at a greater risk when taking Naproxen EC.
Gastrointestinal (GI) bleeding, ulceration and perforation
Gastro-intestinal bleeding, ulceration or perforation which can be fatal has
been reported with all NSAIDs at any time during treatment, with or without
warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation, is higher with increasing
NSAID doses, in patients with a history of ulcer, particularly if complicated
with haemorrhage or perforation (see section 4.3), and in the elderly. These
patients should commence treatment on the lowest dose available.
Combination therapy with protective agents (e.g. misoprostol or proton pump
inhibitors) should be considered for these patients, and also for patients

requiring concomitant low dose aspirin, or other drugs likely to increase
gastrointestinal risk (see section 4.5).
Patients with a history of GI toxicity, particularly when elderly, should report
any unusual abdominal symptoms (especially GI bleeding) particularly in the
initial stages of treatment.
Caution should be advised in patients receiving concomitant medications
which could increase the risk of ulceration or bleeding, such as oral
corticosteroid, anticoagulants such as warfarin, selective serotonin-reuptake
inhibitors or anti-platelet agents such as aspirin (see Section 4.5).
When GI bleeding or ulceration occurs in patients receiving Naproxen EC, the
treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn's disease) as these conditions may be
exacerbated (see Section 4.8).
Renal effects
There have been reports of impaired renal function, renal failure, acute
interstitial nephritis, haematuria, proteinuria, renal papillary necrosis and
occasionally nephrotic syndrome associated with naproxen.
Renal failure linked to reduced prostaglandin production
The administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. Patients at greatest risk
of this reaction are those with impaired renal function, cardiac impairment,
liver dysfunction, those taking diuretics, angiotensin converting enzyme
inhibitors, angiotensin-II receptor antagonists and the elderly. Renal function
should be monitored in these patients (see also Section 4.3)
Use in patients with impaired renal function
As naproxen is eliminated to a large extent (95%) by urinary excretion via
glomerular filtration, it should be used with great caution in patients with
impaired renal function and the monitoring of serum creatinine and/or
creatinine clearance is advised and patients should be adequately hydrated.
Naproxen EC is contraindicated in patients having a baseline creatinine
clearance of less than 30ml/minute.
Haemodialysis does not decrease the plasma concentration of naproxen
because of the high degree of protein binding.
Certain patients, specifically those whose renal blood flow is compromised,
such as in extracellular volume depletion, cirrhosis of the liver, sodium
restriction, congestive heart failure, and pre-existing renal disease, should have
renal function assessed before and during Naproxen EC therapy. Some elderly
patients in whom impaired renal function may be expected, as well as patients
using diuretics, may also fall within this category. A reduction in daily dosage

should be considered to avoid the possibility of excessive accumulation of
naproxen metabolites in these patients.
Use in patients with impaired liver function
Chronic alcoholic liver disease and probably also other forms of cirrhosis
reduce the total plasma concentration of naproxen, but the plasma
concentration of unbound naproxen is increased. The implication of this
finding for Naproxen EC dosing is unknown but it is prudent to use the lowest
effective dose.
Patients who have coagulation disorders or are receiving drug therapy that
interferes with haemostasis should be carefully observed if naproxencontaining products are administered.
Patients at high risk of bleeding or those on full anti-coagulation therapy (e.g.
dicoumarol derivatives) may be at increased risk of bleeding if given
naproxen-containing products concurrently.
Anaphylactic (anaphylactoid) reactions
Hypersensitivity reactions may occur in susceptible individuals. Anaphylactic
(anaphylactoid) reactions may occur both in patients with and without a
history of hypersensitivity or exposure to aspirin, other non-steroidal antiinflammatory drugs or naproxen-containing products. They may also occur in
individuals with a history of angioedema, bronchospastic reactivity (e.g.
asthma), rhinitis and nasal polyps.
Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
If steroid dosage is reduced or eliminated during therapy, the steroid dosage
should be reduced slowly and the patients must be observed closely for any
evidence of adverse effects, including adrenal insufficiency and exacerbation
of symptoms of arthritis.
Ocular effects
Studies have not shown changes in the eye attributable to naproxen
administration. In rare cases, adverse ocular disorders including papillitis,
retrobulbar optic neuritis and papilloedema, have been reported in users of
NSAIDs including naproxen, although a cause-and-effect relationship cannot
be established; accordingly, patients who develop visual disturbances during
treatment with naproxen-containing products should have an ophthalmological
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of
hypertension and/or mild to moderate congestive heart failure as fluid
retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of coxibs and some
NSAIDs (particularly at high doses and in long term treatment) may be

associated with a small increased risk of arterial thrombotic events (for
example myocardial infarction or stroke). Although data suggest that the use
of naproxen (1000 mg daily) may be associated with a lower risk, some risk
cannot be excluded.
Patients with uncontrolled hypertension, congestive heart failure, established
ischaemic heart disease, peripheral arterial disease and/or cerebrovascular
disease should only be treated with naproxen after careful consideration.
Similar consideration should be made before initiating longer-term treatment
of patients with risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking).

SLE and mixed connective tissue disease
In patients with systemic lupus erythematous (SLE) and mixed connective
tissue disorders there may be an increased risk of aseptic meningitis (see
section 4.8).
Serious skin reactions, some of them fatal, including exfoliative dermatitis,
Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported
very rarely in association with the use of NSAIDs(see section 4.8). Patients
appear to be at highest risk for these reactions early in the course of therapy:
the onset of teh reactions occurring in the majority of cases within the first
month of treatment. Naproxen should be discontinued at the first appearance
of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Combination with other NSAIDs
The combination of naproxen-containing products and other NSAIDs,
including cyclooxygenase-2 selective inhibitors, is not recommended, because
of the cumulative risks of inducing serious NSAID-related adverse events

Interaction with other medicinal products and other forms of interaction
Concomitant administration of antacid or colestyramine can delay the absorption of
naproxen but does not affect its extent. Concomitant administration of food can delay
the absorption of naproxen, but does not affect its extent.
Due to the high plasma protein binding of naproxen, patients simultaneously
receiving hydantoins, anticoagulants other NSAIDs, aspirin or a highly protein-bound
sulphonamide should be observed for signs of overdosage of these drugs. Patients
simultaneously receiving Naproxen EC and hydantoin, suplonamide or sulphnylurea
should be observed for adjustment or dose if required.
It is considered unsafe to take NSAIDs in combination with warfarin or heparin
unless under direct medical supervision as NSAIDs may enhance the effects of anticoagulants (see section 4.4).

Other analgesics including cyclooxygenase-2 selective inhibitors: the concomitant
administration of two or more NSAIDs (including aspirin) should be avoided, as this
may increase the risk of adverse effects (see section 4.4).
No interactions have been observed in clinical studies with naproxen and
anticoagulants or sulphonylureas, but caution is nevertheless advised since interaction
has been seen with other non-steroidal agents of this class.
Caution is advised when Naproxen EC is co-administered with diuretics as there can
be a decreased diuretic effect. The natriuretic effect of furosemide has been reported
to be inhibited by some drugs of this class. Diuretics can increase the risk of
nephrotoxicity of NSAIDs.
Inhibition of renal lithium clearance leading to increases in plasma lithium
concentrations has also been reported.
Naproxen and other non-steroidal anti-inflammatory drugs can reduce the
antihypertensive effect of antihypertensives. Concomitant use of NSAIDs with ACE
inhibitors or angiotensin-II receptor antagonists may increase the risk of renal
impairment, especially in patients with pre-existing poor renal function (see section
Probenecid given concurrently increases naproxen plasma levels and extends its halflife considerably.

Caution is advised where methotrexate is administered concurrently because of
possible enhancement of its toxicity, since naproxen, in common with other nonsteroidal anti-inflammatory drugs, has been reported to reduce the tubular secretion of
methotrexate in an animal model.
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac
glycoside levels when co-administered with cardiac glycosides.
As with all NSAIDs caution is advised when ciclosporin is co-administered because
of the increased risk of nephrotoxicity.
NSAIDs should not be used for 8 - 12 days after mifepristone administration as
NSAIDs can reduce the effects of mifepristone.
As with all NSAIDs, caution should be taken when co-administering with
corticosteroids because of the increased risk of gastrointestinal ulceration or bleeding.
Animal data indicate that NSAIDs can increase the risk of convulsions associated
with quinolone antibiotics. Patients taking quinolones may have an increased risk of
developing convulsions.

There is an increased risk of gastrointestinal bleeding (see Section 4.4) when antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) are combined with
There is a possible risk of nephrotoxicity when NSAIDs are given with tacrolimus.
There is an increased risk of haematological toxicity when NSAIDs are given with
zidovudine. There is evidence of an increased risk of haemarthroses and haematoma
in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and
It is suggested that Naproxen EC therapy be temporarily discontinued 48 hours before
adrenal function tests are performed, because naproxen may artifactually interfere
with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with
some assays of urinary 5-hydroxyindoleacetic acid.


Fertility, pregnancy and lactation
Congenital abnormalities have been reported in association with NSAID
administration in man; however, these are low in frequency and do not appear to
follow any discernible pattern. As with other drugs of this type, naproxen produces
delay in parturition in animals and also affects the human foetal cardiovascular
system (closure of ductus arteriosus). Use of Naproxen EC in the last trimester of
pregnancy is contraindicated (see Section 4.3). NSAIDs should not be used during
the first two trimesters of pregnancy unless clearly needed, and unless the potential
benefit to the patient outweighs the potential risk to the foetus.
Labour and delivery
Naproxen containing products are not recommended in labour and delivery because,
through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect
foetal circulation and inhibit contractions, thus with an increased bleeding tendency in
both mother and child.

Naproxen has been found in the milk of lactating women. The use of Naproxen EC
should therefore be avoided in patients who are breast-feeding.
The use of naproxen, as with any drug known to inhibit
cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended
in women attempting to conceive. In women who have difficulty conceiving or are
undergoing investigation of infertility, withdrawal of naproxen should be considered.


Effects on ability to drive and use machines
Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visial
disturbances or depression with the use of Naproxen. If patients experience these or
similar undesirable effects, they should not drive or operate machinery.


Undesirable effects
The following adverse events have been reported with NSAIDs and with naproxen.
Blood and lymphatic system disorders: Neutropenia, thrombocytopenia,
granulocytopenia including agranulocytosis, eosinophilia, leucopenia, aplastic
anaemia and haemolytic anaemia.
Immune system disorders: Hypersensitivity reactions have been reported following
treatment with NSAIDs in patients with, or without, a history of previous
hypersensitivity reactions to NSAIDs. These may consist of
(a) non-specific allergic reactions and anaphylaxis
(b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm
or dyspnoea, or
(c) assorted skin disorders, including rashes of various types, pruritus, urticaria,
purpura, angio-oedema and more rarely exfoliative and bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
Metabolism and nutrition disorders: hyperkalaemia.
Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and
Nervous system disorders: Convulsions, dizziness, headache, lightheadedness,
drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and
cognitive dysfunction have been reported. Aseptic meningitis(especially in patients
with existing auto-immune disorders, such as systemic lupus erythematosus, mixed
connective tissue disease), with symptoms such as stiff neck, headache, nausea,
vomiting, fever or disorientation (see section 4.4),
Eye disorders: Visual disturbances, corneal opacity, papillitis, and papilloedema.
Ear and labyrinth disorders: Tinnitus, hearing disturbances including impairment
and vertigo.
Cardiac disorders: Oedema, palpitations, cardiac failure, congestive heart failure
have been reported with NSAID treatment.
Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs
(particularly at high doses and in long term treatment) may be associated with a small

increased risk of arterial thrombotic events (for example myocardial infarction or
stroke) (see section 4.4).
Vascular disorders: Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, asthma, eosinophilic
pneumonitis and pulmonary oedema.
Gastrointestinal disorders: The most commonly observed adverse reactions are
gastrointestinal in nature. Heartburn, nausea, vomiting, constipation, diarrhoea,
flatulence, dyspepsia, abdominal discomfort and epigastric distress. More serious
reactions which may occur are gastro-intestinal bleeding, which is sometimes fatal,
particularly in the elderly (see section 4.4), inflammation, ulceration, perforation, and
obstruction of the upper and lower gastrointestinal tract, melaena, haematemesis,
stomatitis, exacerbation of ulcerative colitis and Crohn’s disease (see section 4.4),
oesophagitis, gastritis and pancreatitis.
Hepatobiliary disorders: Jaundice, fatal hepatitis and abnormal liver function tests.
Skin and subcutaneous tissue disorders: Skin rashes including fixed drug eruption,
itching (pruritis), urticaria, ecchymoses, purpura, sweating. Alopecia, erythema
multiforme, Stevens Johnson syndrome, erythema nodosum, lichen planus, pustular
reaction, SLE, epidermal necrolysis, very rarely toxic epidermal necrolysis and
photosensitivity reactions (including cases in which the skin resembles porphyria
cutanea tarda, "pseudoporphyria") or epidermolysis bullosa-like reactions may occur
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur,
treatment should be discontinued and the patient monitored.
Musculoskeletal and connective tissue disorders: Myalgia, muscle weakness.
Renal and urinary disorders: Including but not limited to glomerular nephritis,
interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal
papillary necrosis and renal failure.
Reproductive system and breast disorders: Female infertility.
General disorders and administration site conditions: Thirst, pyrexia, fatigue and
Reporting of suspected adverse reactions
Reporting 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 the Yellow Card Scheme at


Symptoms include headache, heartburn, nausea, vomiting, epigastric pain,
gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation,
drowsiness, dizziness, tinnitus, fainting, indigestion. In case of significant
poisoning acute renal failure and liver damage are possible.
Respiratory depression and coma may occur after the ingestion of NSAIDs but
are rare.
In one case of naproxen overdose, transient prolongation of the prothrombin
time due to hypotrhrombinaemia may have been due to selective inhibition of
the synthesis of vitamin-K dependent clotting factors.
A few patients have experienced seizures, but it is not known whether these
were naproxen-related or not. It is not known what dose of the drug would be
Patients should be treated symptomatically as required. Within one hour of
ingestion of a potentially toxic amount activated charcoal should be
considered. Alternatively in adults gastric lavage should be considered within
one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially
toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous
Other measures may be indicated by the patient's clinical condition.
Haemodialysis does not decrease the plasma concentration of naproxen
because of the high degree of protein binding. However, haemodialysis may
still be appropriate in a patient with renal failure who has taken naproxen.




Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products,
nonsteroids. ATC code: M01AE02

Naproxen has been shown to have anti-inflammatory, analgesic and antipyretic
properties when tested in classical animal test systems. It exhibits its antiinflammatory effect even in adrenalectomised animals, indicating that its action is not
mediated through the pituitary-adrenal axis. It inhibits prostaglandin synthetase, as do
other non-steroidal anti-inflammatory agents. As with other agents, however, the
exact mechanism of its anti-inflammatory action is not known.


Pharmacokinetic properties
Naproxen is completely absorbed from the gastro-intestinal tract, and peak plasma
levels are reached in 2 to 4 hours. Naproxen is present in the blood mainly as
unchanged drug, extensively bound to plasma proteins. The plasma half-life is
between 12 and 15 hours, enabling a steady state to be achieved within 3 days of
initiation of therapy on a twice daily dose regimen. The degree of absorption is not
significantly affected by either foods or most antacids. Excretion is almost entirely
via the urine, mainly as conjugated naproxen, with some unchanged drug.
Metabolism in children is similar to that in adults. Chronic alcoholic liver disease
reduces the total plasma concentration of naproxen but the concentration of unbound
naproxen increases. In the elderly, the unbound plasma concentration of naproxen is
increased although total plasma concentration is unchanged.
When naproxen is administered in the enteric-coated form, the peak plasma levels are
delayed compared to those seen with standard tablets. However, the mean areas under
the plasma concentration-time curves, and hence bioavailability, are equivalent. The
tablets, therefore, perform as one would anticipate for a drug which does not
disintegrate until it reaches the small intestine, where dissolution is rapid and


Preclinical safety data
Naproxen was administered with food to Sprague-Dawley rats for 24 months at doses
of 8, 16 and 24mg/kg/day. Naproxen was not carcinogenic in rats.
Mutagenicity was not seen in Salmonella typhimurium (5 cell lines), Sachharomyces
cerevisisae (1 cell line) and mouse lymphoma tests.
Naproxen did not affect the fertility of rats when administered orally at doses of
30mg/kg/day to males and 20mg/kg/day to females.
Naproxen was not teratogenic when administered orally at doses of 20mg/kg/day
during organogenesis to rats and rabbits.
Perinatal/Postnatal Reproduction
Oral administration of naproxen to pregnant rats at doses of 2, 10 and 20mg/kg/day
during the third trimester of pregnancy resulted in difficult labour. These are known
effects of this class of compounds and were demonstrated in pregnant rats with
aspirin and indometacin.




List of excipients
Tablet core : polyvidone, colloidal silicon dioxide, microcrystalline cellulose,
croscarmellose sodium, magnesium stearate
Tablet coating : triethyl citrate, glycerol monostearate, methacrylic acid copolymer
(type C), talc, titanium dioxide (E171)


Not applicable.


Shelf life
48 months.


Special precautions for storage
Store below 25°C.
Blisters : keep blister in the outer carton in order to protect from light


Nature and contents of container
Transparent or coloured PVC/PVDC blister with aluminium foil in cartons containing
56 tablets.


Special precautions for disposal
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.


Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE

United Kingdom


PL 14894/0535





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Source: Medicines and Healthcare Products Regulatory Agency

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