Active ingredients: Mianserina
LANTANON 30 mg film-coated tablets
Indications Why is Lantanon used? What is it for?
LANTANON is an antidepressant medicine.
LANTANON is recommended in the treatment of cases of depression in which treatment with antidepressants is indicated (endogenous depression, reactive depression, anxious depression, involutional melancholy, depression associated with somatic disorders).
Contraindications When Lantanon should not be used
- Mania
- Severe liver disease
- Hypersensitivity to mianserinor to any of the excipients
- Concomitant use of monoamine oxidase inhibitors MAOIs (see "Interactions")
- Pregnancy and breastfeeding (see "Pregnancy and breastfeeding")
Precautions for use What you need to know before taking Lantanon
- For use by children and adolescents under the age of 18.
Lantanon should not be used for the treatment of children and adolescents under 18 years of age.
Suicidal behaviors (suicide attempts and suicidal ideation) and hostility (essentially aggression, oppositional behavior and anger) were observed more frequently in clinical trials in children and adolescents treated with antidepressants than in those treated with placebo. If, based on medical needs, a decision to treat is made, the patient should be carefully monitored for the appearance of suicidal symptoms. Furthermore, long-term safety data for children and adolescents are not available with regard to growth, maturation and cognitive and behavioral development.
- Suicide / suicidal thoughts Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (or suicide-related events).
This risk persists until significant remission occurs. As improvement may not occur during the first or immediate weeks of treatment, patients should be monitored closely until improvement occurs. It is generally clinical experience that the risk of suicide may increase in the early stages of improvement.
Other psychiatric conditions for which Lantanon is prescribed may also be associated with an increased risk of suicidal behavior. Furthermore, these pathologies can be associated with major depressive disorder. Therefore, the same precautions followed when treating patients with other psychiatric disorders should be observed when treating patients with major depressive disorders.
Patients with a history of suicidal behavior or thoughts, or who exhibit a significant degree of suicidal ideation prior to initiation of treatment, are at increased risk of suicidal thoughts or suicidal thoughts, and should be closely monitored during treatment. of clinical trials conducted with antidepressants in comparison with placebo in the therapy of psychiatric disorders, showed an increased risk of suicidal behavior in the age group below 25 years of patients treated with antidepressants compared to placebo.
Drug therapy with antidepressants should always be associated with close surveillance of patients, particularly those at high risk, especially in the initial stages of treatment and after dose changes. Patients (or caregivers) should be advised of the need to monitor and report immediately to their treating physician any clinical worsening, the onset of suicidal behavior or thoughts, or changes in behavior. suicide, particularly at the start of treatment, give the patient only a limited number of Lantanon tablets.
- Cases of bone marrow depression with thrombocytopenia, agranulocytosis or granulocytopenia have been reported with Lantanon therapy. These reactions mostly occurred after 4-6 months of treatment and were generally reversible on discontinuation of treatment.
For this reason it is advisable to have periodic haematological checks, especially during the first 3 months of treatment, as required for other antidepressants that can cause similar side effects. In patients treated for the first time, haematological checks should be performed once a week, for the first 2 months.
If a patient experiences symptoms of infection (fever, stomatitis, sore throat or other inflammatory phenomena) treatment with Lantanon should be discontinued and a complete blood count performed immediately. This side effect has been observed in patients of all ages but appears more common in the elderly. Therefore in elderly patients it is advisable to restrict the use of the drug to subjects with glaucoma, prostatic hypertrophy, serious cardiological problems.
- Lantanon, like other antidepressant medicines, could aggravate a hypomanic state in subjects predisposed to bipolar affective forms. In such cases, Lantanon treatment should be discontinued.
- Patients who, in addition to the depressive picture, present a hepatic, renal or cardiac insufficiency, must be particularly followed during the whole period of therapy with the periodic execution of the pertinent laboratory tests. Also check the dosages of any other concomitant therapy. Carefully monitor patients with recent myocardial infarction or heart block.
- QT prolongation and ventricular arrhythmias (including torsades de pointes) have been reported during post-marketing use of Lantanon (see Undesirable Effects). Lantanon should be used with caution in patients with risk factors for QT prolongation / torsades. spike including congenital long QT syndrome, age> 65 years, female, structural heart disease / left ventricular (LV) dysfunction, renal or hepatic disease, use of medicinal products that inhibit the metabolism of Lantanon and concomitant use of other medicinal products that prolong the QTc (see Interactions). Hypokalaemia and hypomagnesaemia should be corrected prior to treatment. Consideration should be given to stopping Lantanon treatment or reducing the dose if the QTc interval is> 500ms or increases by> 60ms.
- Alterations of the glycemic load curve have been observed during treatment with Lantanon in patients with unstable diabetes mellitus; it is therefore advisable in such patients a periodic control of the glycaemia.
- Epileptic patients treated with Lantanon should be followed with particular care.
- Discontinue treatment if jaundice, even mild, hypomania or convulsions occur.
Specially performed human studies have shown that Lantanon reduces psychomotor activity only during the first few days of treatment.
The product must be used under the direct supervision of the doctor.
Interactions Which drugs or foods can modify the effect of Lantanon
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
- Lantanon may potentiate the depressing effect of alcohol on the central nervous system, therefore patients should be advised to avoid ingesting alcohol during therapy.
- Mianserin should not be administered concomitantly with monoamine oxidase inhibitors (MAOIs) (such as moclobemide, tranylcypromine and linezolid) or within two weeks of stopping treatment with these substances. If not, at least two weeks must elapse before patients treated with mianserin are treated with MAO inhibitors (see Contraindications).
- Lantanon does not interact with betanidine, guanethidine, clonidine, methyldopa, propranolol alone or associated with hydralazine. However, it is recommended that blood pressure be monitored periodically in patients receiving concomitant antihypertensive therapy.
- concomitant treatment with antiepileptic medicinal products that are CYP3A4 inducers (such as phenytoin and carbamazepine) may result in reduced plasma levels of mianserin. Dosage adjustments should be considered upon initiation or discontinuation of concomitant treatment with such drugs.
- Like other antidepressants, Lantanon can influence the metabolism of coumarin derivatives such as, for example, warfarin, thus requiring control.
- The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician, to avoid unexpected undesirable effects from interaction.
- Concomitant use of other medicines that prolong the QTc interval (eg some antipsychotics and antibiotics) may increase the risk of QT prolongation and / or ventricular arrhythmias (eg torsades de pointes). Check the product information of the other medicines administered for information on their effects on the QTc interval.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Although animal experiments and limited human data indicate that mianserin does not cause fetal or neonatal harm and that mianserin is excreted in breast milk only in very small quantities, the product should not be used in cases of confirmed or suspected pregnancy and l Breastfeeding should be discontinued if Lantanon treatment is deemed essential.
Effects on ability to drive and use machines
Lantanon may reduce psychomotor activity during the first days of treatment. In general, depressed individuals treated with antidepressants should avoid engaging in potentially hazardous activities such as driving motor vehicles or operating machinery.
Dose, Method and Time of Administration How to use Lantanon: Posology
The tablets should be swallowed without being chewed, if necessary with a little liquid
Adults: Dosage should be determined on an individual basis. For all patients, both hospitalized and outpatient, and in any case in general medical practice, it is recommended to start treatment with a daily dose of 30-40 mg and to subsequently adapt the dosage according to the clinical response. The dose can be gradually increased until an optimal clinical response is achieved.The effective daily dose is usually 30-90 mg. In most cases, the dose of 60 mg per day is sufficient; however, dosages up to 120 mg per day are well tolerated. Elderly: In the treatment of elderly patients, the dosage should be carefully established by the physician, who will have to evaluate a possible reduction of the dosages indicated above. Dosage should be determined on an individual basis. A lower dose than that usually used for adult patients may be sufficient to provide a satisfactory clinical response.
Children: Lantanon should not be used to treat children and adolescents under 18 years of age (see "Special warnings").
- The entire daily dose should be divided into appropriate administrations or preferably taken in a single evening dose (given the favorable effect on sleep), up to a maximum of 60 mg, at bedtime
- Treatment with an adequate dose should result in a positive response within 2-4 weeks. In case of insufficient response, the dose can be increased. If there is no response within the next 2-4 weeks, treatment should be stopped.
- It is recommended that antidepressant treatment be maintained for several months after initial clinical improvement.
- Abrupt discontinuation of Lantanon treatment may rarely cause a discontinuation syndrome.
Overdose What to do if you have taken too much Lantanon
Symptoms of acute overdose are usually confined to prolonged sedation. Cardiac arrhythmias, seizures, severe hypotension and respiratory depression may rarely occur. Cases of QT prolongation on electrocardiogram and torsades de pointes have also been reported. ECG monitoring should be performed. There is no specific antidote for Lantanon; in case of accidental or intentional overdose of the drug, the stomach should be freed as soon as possible. possible and institute symptomatic therapy to support vital functions.In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Lantanon, ask your doctor or pharmacist.
Side Effects What are the side effects of Lantanon
Like all medicines, this can cause side effects, although not everybody gets them.
Depressed patients exhibit a number of symptoms associated with the disease itself (dry mouth, stubborn constipation, accommodation disturbances). Therefore, it is sometimes difficult to determine which symptoms are a consequence of the disease and which are a consequence of Lantanon treatment.
Influenza-like syndrome, abnormal liver function data, gynaecomastia have been reported.
Cases of suicidal ideation and suicidal behaviors have been reported during mianserin therapy or early after discontinuation (see "Precautions for use").
Rare side effects: suicidal ideation / behavior.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
See the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date shown on the package
Lantanon 30 mg film-coated tablets: store at a temperature not exceeding 30 ° C, in the original container to keep it away from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Other Information
COMPOSITION
LANTANON 30 mg film-coated tablets:
One tablet of Lantanon 30 mg contains:
Active ingredient: mianserin HCl 30 mg.
Excipients: Core: potato starch, precipitated silica, magnesium stearate, methylcellulose, dibasic calcium phosphate. Coating: hypromellose, macrogol 8000, titanium dioxide.
PHARMACEUTICAL FORM AND CONTENT
Film-coated tablets. 30 mg film-coated tablets - Pack of 30 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
LANTANON 30 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet of Lantanon 30 mg contains:
Active principle: mianserin HCl 30 mg.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Film-coated tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Lantanon is recommended in the treatment of cases of depression, in which treatment with antidepressant drugs is indicated and in particular in the following clinical forms:
- endogenous depression,
- reactive depression,
- anxious depression,
- involutional melancholy,
- depression associated with somatic disorders.
04.2 Posology and method of administration
Dosage
The tablets should be swallowed without being chewed, if necessary with a little liquid.
Adults
The dose should be determined on an individual basis. For all patients, both hospitalized and outpatient, and in any case in general medical practice, it is recommended to start treatment with a daily dose of 30 mg and subsequently to adapt the dosage according to the clinical response. The dose can be gradually increased until an optimal clinical response is achieved. The effective daily dose is usually 30-90 mg. In most cases, a dose of 60 mg per day is sufficient; however, dosages up to 120 mg per day are well tolerated.
§ The entire daily dose should be divided into appropriate administrations or preferably taken in a single evening dose (given the favorable effect on sleep), up to a maximum of 60 mg at bedtime.
§ Treatment with an adequate dose should result in a positive response within 2-4 weeks. In case of insufficient response, the dose can be increased. If there is no response within the next 2-4 weeks, treatment should be stopped.
§ It is recommended that antidepressant treatment be maintained for several months after initial clinical improvement.
Abrupt discontinuation of Lantanon treatment may rarely cause a discontinuation syndrome.
Senior citizens
In the treatment of elderly patients, the posology must be carefully established by the physician, who will have to evaluate a possible reduction of the aforementioned dose. The dose should be determined on an individual basis. A lower dose than that usually used for adult patients may be sufficient to provide a satisfactory clinical response.
Pediatric population
Lantanon should not be used for the treatment of children and adolescents under 18 years of age (see section 4.4).
04.3 Contraindications
• Mania.
• Severe liver disease
• Hypersensitivity to mianserin or to any of the excipients listed in section 6.1
• Concomitant use of MAOIs monoamine oxidase inhibitors (see section 4.5)
• Children and adolescents under 18 years of age (see section 4.4.)
• Pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
§ Suicide / suicidal ideation
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (or suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first or immediately following weeks of treatment, patients should be monitored closely until improvement occurs. Clinical experience generally indicates that the risk of suicide may increase in the early stages of improvement.
Other psychiatric conditions for which Lantanon is prescribed can increase the risk of suicidal behavior. Furthermore, these pathologies can be associated with major depressive disorder. Therefore, the same precautions followed when treating patients with other psychiatric disorders should be observed when treating patients with major depressive disorders.
Patients with a history of suicidal behavior or thoughts, or who exhibit a significant degree of suicidal ideation prior to initiation of treatment, are at increased risk of suicidal thoughts or suicidal thoughts, and should be closely monitored during treatment. of clinical trials conducted with antidepressants in comparison with placebo in the therapy of psychiatric disorders, showed an increased risk of suicidal behavior in the age group below 25 years of patients treated with antidepressants compared to placebo.
Drug therapy with antidepressants should always be associated with close surveillance of patients, particularly those at high risk, especially in the initial stages of treatment and after dose changes. Patients (or their carers) should be advised of the need to monitor and report immediately to their treating physician any clinical worsening, the onset of suicidal behavior or thoughts, or changes in behavior.
Regarding the possibility of suicide, especially at the start of treatment, give the patient only a limited number of Lantanon tablets.
§ Cases of bone marrow depression with thrombocytopenia, agranulocytosis or granulocytopenia have been reported with Lantanon therapy. These reactions mostly occurred after 4-6 months of treatment and were generally reversible on discontinuation of treatment.
For this reason it is advisable to have periodic haematological checks, especially during the first three months of treatment, as required for other antidepressants that can cause similar side effects. In patients treated for the first time, haematological checks should be performed once a week for the first two months.
§ If a patient experiences symptoms of infection (fever, stomatitis, sore throat or other inflammatory phenomena) treatment with Lantanon should be discontinued and a complete blood count performed immediately. These side effects have been seen in patients of all ages, but appear more common in the elderly. For this reason, the use of the medicine should be limited in elderly patients with the following conditions: glaucoma, prostatic hypertrophy, serious cardiological problems .
§ Lantanon, like other antidepressants, could aggravate a hypomanic state in subjects predisposed to bipolar affective forms. In such cases, Lantanon treatment should be discontinued.
§ Patients who, in addition to the depressive picture, present a hepatic, renal or cardiac insufficiency must be particularly followed during the whole period of therapy with the periodic execution of pertinent laboratory tests. Also check the dosages of any other concomitant therapy. Carefully monitor patients with recent myocardial infarction or heart block.
§ QT prolongation and ventricular arrhythmias (including torsades de pointes) have been reported during post-marketing use of Lantanon (see section 4.8). Lantanon should be used with caution in patients with risk factors for QT prolongation / torsion including congenital long QT syndrome, age> 65 years, female, structural heart disease / left ventricular (LV) dysfunction, renal or hepatic disease, use of medicinal products that inhibit the metabolism of Lantanon and concomitant use of other medicinal products that prolong QTc (see section 4.5). Hypokalaemia and hypomagnesaemia should be corrected prior to treatment. Consideration should be given to stopping Lantanon treatment or reducing the dose if the QTc interval is> 500ms or increases by> 60ms.
§ Slight changes in the glycemic load curve have been observed during treatment with Lantanon in patients with unstable diabetes mellitus; it is therefore advisable, in such patients, a periodic control of the glycaemia.
§ Epileptic patients treated with Lantanon should be followed with particular care.
§ Discontinue treatment if jaundice, even mild, hypomania or convulsions occur.
Specially performed human studies have shown that Lantanon reduces psychomotor activity only during the first few days of treatment.
The product must be used under the direct supervision of the doctor.
Pediatric population
§ For use by children and adolescents under the age of 18.
Lantanon should not be used for the treatment of children and adolescents under 18 years of age.
Suicidal behaviors (suicide attempts and suicidal ideation) and hostility (essentially aggression, oppositional behavior and anger) were observed more frequently in clinical trials in children and adolescents treated with antidepressants than in those treated with placebo. If, based on medical needs, a decision to treat is made, the patient should be carefully monitored for the appearance of suicidal symptoms. Furthermore, long-term safety data for children and adolescents are not available with regard to growth, maturation and cognitive and behavioral development.
04.5 Interactions with other medicinal products and other forms of interaction
§ Lantanon may potentiate the depressing effect of alcohol on the central nervous system, therefore patients should be advised to avoid ingesting alcohol during therapy.
§ Mianserin should not be administered concomitantly with monoamine oxidase (iMAO) inhibitors (such as moclobemide, tranylcypromine and linezolid) or within two weeks of stopping treatment with these substances. Otherwise at least two weeks must elapse before patients treated with mianserin are treated with MAO inhibitors (see section 4.3).
§ Lantanon does not interact with betanidine, guanethidine, clonidine, methyldopa, propranolol alone or combined with hydralazine. However, it is recommended that blood pressure be monitored periodically in patients receiving concomitant antihypertensive therapy.
§ Concomitant treatment with antiepileptic medicinal products that are CYP3A4 inducers (such as phenytoin and carbamazepine) may result in reduced plasma levels of mianserin. Dosage adjustments should be considered upon initiation or discontinuation of concomitant treatment with such medicinal products.
§ Like other antidepressants, Lantanon can influence the metabolism of coumarin derivatives such as, for example, warfarin, thus requiring monitoring.
§ The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected undesirable effects from interaction.
§ Concomitant use of other medicines that prolong the QTc interval (eg some antipsychotics and antibiotics) may increase the risk of QT prolongation and / or ventricular arrhythmias (eg torsades de pointes). Check the product information of the other medicines administered for information on their effects on the QTc interval.
04.6 Pregnancy and breastfeeding
Although animal experiments and limited human data indicate that mianserin does not cause fetal or neonatal harm and that mianserin is excreted in breast milk only in very small quantities, the product should not be used in cases of confirmed or suspected pregnancy and l Breastfeeding should be discontinued if Lantanon treatment is deemed essential.
04.7 Effects on ability to drive and use machines
Lantanon can reduce psychomotor activity during the first days of treatment. In general, depressed individuals treated with antidepressants should avoid carrying out potentially dangerous activities such as driving or operating machinery.
04.8 Undesirable effects
Depressed patients exhibit a number of symptoms associated with the disease itself (dry mouth, stubborn constipation, accommodation disturbances). Therefore, it is sometimes difficult to determine which symptoms are a consequence of the disease and which are a consequence of Lantanon treatment.
Influenza-like syndrome, abnormal liver function data, gynaecomastia have been reported.
Rare: suicidal ideation / behavior (see section 4.4 Special warnings and precautions for use).
Cases of suicidal ideation and suicidal behaviors have been reported during mianserin therapy or early after discontinuation (see section 4.4).
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms of acute overdose are usually confined to prolonged sedation. Cardiac arrhythmias, seizures, severe hypotension and respiratory depression may rarely occur. There have also been reports of QT prolongation on electrocardiography and torsades de pointes. ECG monitoring should be performed.
There is no specific antidote for Lantanon; in case of accidental or intentional overdose of the drug, it is necessary to free the stomach as soon as possible and to institute symptomatic therapy to support vital functions.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants. ATC code: N06AX03.
Mianserin, the active ingredient of Lantanon, belongs to a series of compounds, piperazino-azepines, whose chemical structure differs from that of commonly used tricyclic antidepressants (TCAs: tricyclic antidepressants); in fact, the basic side chain to which the anticholinergic activity of the tricyclic compounds is linked is missing. Lantanon increases central noradrenergic neurotransmission by blocking alpha2 autoreceptors and inhibiting noradrenaline reuptake. Furthermore, interactions with serotonin receptors in the central nervous system have been shown. Human drug-EEG studies have confirmed the antidepressant profile of Lantanon. The antidepressant efficacy of Lantanon has been demonstrated in placebo-controlled studies. In addition, Lantanon possesses anxiolytic and sleep-enhancing properties, which are important in the treatment of patients with anxiety or sleep disturbances associated with depressive illness. The sedative properties are believed to derive from the H1 and alpha1 histamine antagonist activity.
Lantanon is well tolerated, including by elderly patients and those with cardiovascular disease. At therapeutic doses Lantanon is virtually devoid of anticholinergic activity. Lantanon does not antagonize the action of sympathomimetic agents and antihypertensive drugs that interact with adrenergic receptors (eg betanidine) or alpha2-receptors (eg clonidine, methyldopa).
05.2 Pharmacokinetic properties
After oral administration of Lantanon, the active ingredient, mianserin, is rapidly and well absorbed, reaching peak plasma levels within 3 hours. Bioavailability is about 20%. Plasma protein binding of mianserin is approximately 95%. The elimination half-life (21-61 hours) is sufficient to warrant once-daily dosing. Steady-state plasma levels are achieved in 6 days. Mianserin is extensively metabolised and eliminated in the urine and faeces in 7-9 days. The major pathways of biotransformation are demethylation and oxidation followed by conjugation.
05.3 Preclinical safety data
After chronic treatment with mianserin in animals, a hyposensitivity of post-synaptic receptors is observed, accompanied by a reduction in their number. The LD50 after oral administration is 325 mg / kg in mice and 1,450 mg / kg in male rats. chronic toxicity, carried out in dogs (4 - 10 - 40 mg / kg per day) and in rhesus monkeys (2.5 - 10 - 40 mg / kg per day) did not show alterations in haematological, haematochemical and urinary parameters; pathological changes were found in the macromicroscopic structure of the various organs and tissues.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lantanon 30 mg tablets contain:
Nucleus: potato starch, precipitated silica, magnesium stearate, methylcellulose, dibasic calcium phosphate.
Coating: hypromellose, macrogol 8000, titanium dioxide (E171).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years
06.4 Special precautions for storage
Lantanon 30 mg film-coated tablets: Do not Store above 30 ° C. Store in the original package to protect from light and moisture.
06.5 Nature of the immediate packaging and contents of the package
PVC / Aluminum blister.
Pack of 30 mg film-coated tablets, 30 tablets
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
08.0 MARKETING AUTHORIZATION NUMBER
Lantanon 30 mg film-coated tablets, 30 tablets: AIC n ° 023695036.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
11.11.82 - May 2010
10.0 DATE OF REVISION OF THE TEXT
June 2015
