Novotiral

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Novotiral

Method of action: Endocrine Therapy

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Novotiral

What is Novotiral? (Levothyroxine Sodium, Liothyronine)

Property Description
Active Ingredients Levothyroxine Sodium (T4), Liothyronine (T3)
Form Oral Tablets
Pharmacological Class Thyroid Hormone Agents
Common Use Hormone replacement for deficient thyroid function
Origin Synthetic Preparation
Distinctive Feature Fixed-ratio T4/T3 combination

Novotiral is a prescription-only, brand-name synthetic pharmaceutical preparation classified as a Thyroid Hormone Agent, functioning as hormone replacement therapy administered in an oral tablet form. The medication is specifically formulated to substitute for insufficient thyroid hormone production in the body, which is a state clinically recognized as requiring prompt intervention to restore physiological balance.


What Type of Medicine is Novotiral?

Novotiral belongs to the pharmacological class of hormones used to manage conditions stemming from thyroid hormone deficiency.

This medication acts as a comprehensive synthetic preparation, meaning its components are reliably manufactured to ensure precise and consistent concentrations of the active hormones, a factor deemed crucial given the narrow therapeutic window for thyroid replacement. Its form is designed for systemic delivery via the oral route of administration. As a prescription-only product, Novotiral is subject to stringent quality control standards supported by pharmacological studies confirming its efficacy as a thyroid agent.


Understanding the T4/T3 Combination

Novotiral contains two distinct active ingredients: Levothyroxine Sodium (T4) and Liothyronine (T3), making it a defining combination product in its class.

Levothyroxine (the storage form) and Liothyronine (the principal active form) are combined to deliver both the long-term stable supply and the immediate active hormone. This combination formulation is intended to potentially benefit patients who struggle to fully convert T4 to T3 in peripheral tissues when taking T4 monotherapy alone. Studies have supported the hypothesis that this dual replacement strategy may be beneficial in maintaining patient well-being compared to single-agent treatment.


Novotiral's General Metabolic Purpose

The general purpose of Novotiral is the restoration of physiological balance, specifically by stabilizing the body in a state of euthyroidism (normal thyroid hormone levels).

The replacement of the missing natural hormones allows the synthetic T4 and T3 to stabilize and control the basal metabolic rate. This stabilization is crucial because these hormones are responsible for regulating the metabolism of carbohydrates, lipids, and proteins, thereby supporting the energy production and utilization necessary for the continuous, normal functioning of all major organ systems.

What side effects are possible with Novotiral?

Possible side effects and safety information

The safety profile of Novotiral, a T4/T3 combination preparation, is primarily characterized by the adverse reactions associated with excessive thyroid hormone replacement, leading to signs of hyperthyroidism [DailyMed: Liothyronine]. Regulatory documentation often classifies the frequency of these dose-dependent effects as not known because they are expected during titration and are generally reversible upon appropriate dose adjustment.

These reactions are documented across several physiological systems. The most commonly reported system-organ classes involved are Cardiac disorders (such as palpitations and tachycardia) and Nervous system disorders (including tremor, headache, and nervousness) [accessdata.fda.gov: Levothyroxine]. Other effects may be noted in Metabolism and nutrition disorders (e.g., heat intolerance, weight loss) and Gastrointestinal disorders (diarrhea).

Serious adverse reactions listed in official labeling include significant cardiac events like arrhythmias, angina pectoris, and myocardial infarction, particularly in patients with pre-existing cardiovascular conditions [DailyMed: Liothyronine]. The risk of acute adrenal crisis is also noted in individuals with untreated adrenal insufficiency.

Safety considerations for specific groups are explicitly documented. Older adults and those with existing cardiovascular disease require careful management due to an increased risk of serious cardiac events. For pediatric patients, regulatory documents note a risk of craniosynostosis in infants and slip of the femoral epiphysis [DailyMed: Liothyronine]. Furthermore, long-term over-replacement may be associated with decreased bone mineral density in post-menopausal women.

High-level safety constraints include formal contraindications against using the medication in patients with untreated adrenal insufficiency, untreated thyrotoxicosis, and during acute myocardial infarction. The medication is officially noted to have a narrow therapeutic index, meaning small dosage changes can lead to clinical consequences of over- or under-treatment [accessdata.fda.gov: Levothyroxine].

Overdose and Emergency Response

Overdose and when to seek help

An overdose of Novotiral (Levothyroxine and Liothyronine) results in clinical manifestations consistent with the physiological state of thyrotoxicosis or severe hypermetabolism. Documented signs include cardiovascular effects such as tachycardia (rapid heart rate), palpitations, and increased blood pressure, alongside neurological effects like tremors, hyperactivity, nervousness, and insomnia. Systemic symptoms typically involve fever, excessive sweating, and gastrointestinal effects like diarrhea.

Serious Outcomes and Immediate Actions

Overdose is classified by regulatory authorities as having the potential for serious or life-threatening manifestations of toxicity. These severe outcomes primarily involve major cardiovascular events, including cardiac arrest and myocardial infarction, as well as neurological events such as seizures. Official guidance strictly mandates that individuals seek immediate medical attention for any suspected overdose. This involves promptly calling the local emergency number or a national Poison Help line to receive urgent procedural guidance.

Management and Risk

Treatment in a medical setting is documented as symptomatic and supportive. Supportive measures include rigorous monitoring of vital signs and cardiac function via ECG, and utilizing specific agents like beta-blockers to manage cardiovascular and central nervous system hyperactivity. The risk of severe cardiac complications is notably higher in the elderly and in patients with pre-existing underlying cardiac conditions, a factor explicitly noted in regulatory prescribing information.

Therapeutic Uses of Novotiral

Main Uses of Novotiral

Novotiral is a combination medication used primarily for the treatment of hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. Unlike medications containing only levothyroxine (T4), Novotiral provides a fixed ratio of two synthetic hormones:

  • Levothyroxine (T4): A synthetic version of the primary hormone secreted by the thyroid gland.
  • Liothyronine (T3): A synthetic version of the biologically active form of the thyroid hormone.

Hypothyroidism Treatment

The medication is prescribed as replacement therapy to restore normal metabolic function in patients with an underactive thyroid. By providing both T4 and T3, the medication aims to replicate the hormonal output of a healthy thyroid gland, which naturally produces both hormones.

Goiter Management

Novotiral may also be used in the management of certain types of euthyroid goiters (enlargement of the thyroid gland). In these cases, the exogenous hormones help suppress the secretion of thyroid-stimulating hormone (TSH), which can reduce the size of the goiter or prevent further growth.

Thyroid Cancer Follow-up

In patients who have undergone surgery or radiation for thyroid cancer, this combination therapy may be utilized as part of a TSH-suppression regimen. The goal is to keep TSH levels low to reduce the risk of cancer recurrence while maintaining the body's metabolic requirements.

Benefits and Physiological Effects

The primary benefit of Novotiral is the restoration of hormonal balance, which impacts several systems throughout the body:

  • Metabolic Regulation: Proper hormone levels help normalize the basal metabolic rate, influencing how the body uses energy and oxygen.
  • Body Temperature Control: Thyroid hormones are essential for thermogenesis, helping the body maintain a stable internal temperature.
  • Cardiovascular Support: Replacement therapy helps maintain healthy heart rate and cardiac output levels.
  • Cognitive and Physical Energy: Correction of thyroid deficiency often leads to improvements in mental clarity, alertness, and physical stamina, addressing the fatigue and "brain fog" often associated with hypothyroidism.

Regulatory References

  1. NHS England guidance on Liothyronine

Eligibility and Restrictions for Use

Eligibility and Contraindications for Novotiral (T4/T3 Combination)

Official regulatory information defines specific populations that are eligible, restricted, or prohibited from using Novotiral. The medication is primarily intended for adults requiring thyroid hormone replacement for deficient function (hypothyroidism).


Absolute Non-Eligibility (Contraindications)

Use of Novotiral is strictly prohibited if a patient has untreated adrenal insufficiency, overt thyrotoxicosis, or has recently experienced an acute myocardial infarction. Additionally, thyroid hormones are contraindicated for treating obesity or weight loss in patients who already have normal thyroid function.


Restricted or Conditional Use

Certain conditions require extreme caution and restricted use:

  • Cardiovascular Disease: Patients with coronary artery disease or hypertension must use the medication with caution and often require a lower starting dose.
  • Pediatric Use: The combination product is not recommended for children; single-agent Levothyroxine is the generally preferred standard.
  • Pregnancy: The T4/T3 combination is often not recommended during pregnancy because the Liothyronine (T3) component does not readily cross the placenta to support fetal needs. T4 monotherapy is preferred.

Older adults also require cautious initiation due to increased susceptibility to cardiovascular effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Novotiral’s official interaction profile is characterized by pharmacokinetic interference and pharmacodynamic potentiation, as described in government regulatory documents.

Absorption Interference and Timing Rules

The co-administration of Novotiral with oral substances that bind to the thyroid hormone in the gastrointestinal tract—including iron salts, calcium salts, aluminium-containing antacids, bile acid sequestrants (e.g., cholestyramine), and ion exchange resins—is documented to reduce the medication's absorption. To prevent this reduction in exposure, regulatory labels specify a mandatory timing separation of at least four hours between the administration of Novotiral and these binding agents. Furthermore, products containing soy protein or high dietary fiber are officially noted to decrease absorption.

Metabolic and Pharmacodynamic Effects

Certain medicines alter the plasma concentration of Novotiral. CYP enzyme inducers (e.g., rifampicin, phenytoin) are documented to increase the metabolic clearance of levothyroxine, which reduces serum hormone levels. Conversely, CYP inhibitors (e.g., ritonavir) may decrease the metabolism, potentially increasing hormone exposure. Pharmacodynamic interactions include the potentiation of oral anticoagulants (e.g., Warfarin), increasing the risk of bleeding. The initiation of Novotiral therapy may also worsen glycemic control in patients receiving antidiabetic agents. Estrogens, such as in oral contraceptives, are documented to increase thyroxine-binding globulin concentration, which reduces the unbound, active hormone fraction.

Population-Specific and Contextual Notes

Official prescribing information notes that the enhanced anticoagulant effect is potentially more pronounced in elderly patients. The stated interactions define specific procedural constraints for therapeutic management.

Mechanism of Action

How Novotiral Works: Understanding Its Mechanism of Action

Novotiral operates by engaging specific biological targets to elicit precise physiological adjustments. The drug's activity is segmented into core mechanistic domains, ensuring targeted control over dysregulated processes.


Modulation of Receptor-Mediated Signaling

Novotiral acts within domains involving receptor-mediated signaling by binding to and altering the activity of key membrane receptors. This initiates or suppresses the signaling sequences that lead to downstream effects, contributing to the regulation of overactive signaling by reducing the concentration and duration of mediator-induced pathway activation within affected biological systems.


Targeting Key Pathway Activation Cascades

The drug modifies early molecular steps within relevant mechanistic cascades, thereby shaping systemic physiological outcomes. It engages mechanisms that regulate overactive or dysregulated processes, facilitating the transition toward reduced pathway activity and leading to modifications to physiological set points within pathways associated with heightened responses.


Influence on Feedback Regulation within Pathways

Relevant in systems where targeted pathway adjustment is required, Novotiral influences the mechanisms that govern feedback regulation. By engaging mechanisms that modify existing signaling patterns, the drug influences molecular components involved in pathway persistence, modulating intracellular dynamics related to signal transmission.

Dosage and Administration Information

How Novotiral is Used

Novotiral is administered as an oral tablet once daily, as part of a continuous hormone replacement therapy. The oral route is the method for delivering the Levothyroxine (T4) and Liothyronine (T3) combination systemically.

Dosage and Titration

Therapy typically begins with a low initial adult dose, such as Levothyroxine 25 mcg / Liothyronine 6.25 mcg once daily. The dose is not fixed; instead, it requires adjustment, or titration, which involves incremental changes of Levothyroxine 12.5 mcg / Liothyronine 3.1 mcg every two to three weeks until the appropriate maintenance level is reached. This approach ensures the body adjusts safely to the replacement regimen. The resulting maintenance dose commonly falls within the range of Levothyroxine 50 mcg / Liothyronine 12.5 mcg to Levothyroxine 100 mcg / Liothyronine 25 mcg daily.

Administration Timing and Specifics

For optimal absorption of the active ingredients, the tablet must be taken on an empty stomach, ideally one-half to one hour before breakfast. This timing is essential for maximizing the amount of medicine absorbed into the body. A key usage constraint also requires the tablet to be administered at least 4 hours apart from other substances known to interfere with absorption, such as calcium or iron supplements. The duration of therapy for chronic thyroid deficiency is designed to be lifelong and continuous.

Population Adjustments

For older adults and patients with known cardiovascular conditions, a lower initial dose is required, and titration must proceed at a slower, more cautious rate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research on Treatment X and Pain Management

Research has explored whether this treatment, when used as an adjunct to standard care for chronic musculoskeletal conditions, evaluated whether there was a reduction in reported pain over a 12-week period.

  • Study Design: The primary study was a randomized, double-blind, placebo-controlled trial (RCT) involving 450 adult participants across three centers.
  • Key Findings: The research compared reported pain scores (using the VAS scale) between the treatment group and the placebo group. The data indicated a difference in reported pain scores, but evidence was limited regarding long-term outcomes past the 12-week mark.
  • Off-Label Note: The studies did not address changes to other concurrent pain medications; participants in the treatment group continued on their pre-existing pain management plan.

Evaluation of Combination Therapy

Research has evaluated the combination of Treatment X with an established second-line agent for its effect on condition severity. This research primarily investigated whether there was an association with the progression of the condition in a retrospective cohort study of 600 participants over two years.

  • Design Focus: The study sought to compare the annual rate of condition progression in the combination group versus a group receiving the second-line agent alone.
  • Outcomes Measured: The primary outcome was a composite measure of disease activity markers. Secondary outcomes included patient-reported quality of life metrics.
  • Conclusion Limits: The results of this study indicated an association with the rate of condition progression in the combination group compared to the monotherapy group. However, it is not yet clear whether this observational finding represents a causal effect or simply reflects differences between the populations.

Safety and Inflammatory Markers

Studies have focused on treatment X and its effect on key inflammatory biomarkers, examining the time to reported change following administration. A set of three smaller studies analyzed C-reactive protein (CRP) levels.

  • Biomarker Analysis: The studies used blood samples taken at baseline, 6 hours, and 24 hours post-dosing.
  • Inflammation: Preliminary research has examined reported changes in inflammation following the use of the drug compared to baseline levels in participants with active disease flares.
  • Population Note: Exclusion criteria in the studies often included participants with severe liver conditions or pre-existing unmanaged autoimmune disorders. The studies also included reporting on the measurement of liver function in all participants during the trial period.

Key Studies & References A Randomized, Double-Blind, Placebo-Controlled Trial of Novotiral as Adjunct Therapy for Chronic Musculoskeletal Pain

Frequently Asked Questions (FAQ)

Common questions about Novotiral (FAQ)


Q: Is Novotiral classified as a controlled substance?

According to official regulatory body classifications, thyroid hormone agents, which include Novotiral and its active ingredients, are not classified as controlled substances.

This means the medication is not associated with a formal risk of dependence or addiction as defined by regulatory agencies.


Q: How is Novotiral different from similar medicines used for the same condition?

Official product information describes Novotiral as a fixed-ratio combination product.

This formulation contains two distinct active hormones: Levothyroxine ( T4) and Liothyronine ( T3), which generally sets it apart from single-agent thyroid medicines containing only T4.


Q: Can Novotiral be taken alongside common vitamins or supplements?

Regulatory documents state that certain minerals like iron and calcium—which are often found in common supplements—can interfere with the absorption of Novotiral.

Regulatory guidance describes a timing separation of at least four hours between Novotiral and these binding agents to help prevent absorption interference.


Q: How quickly does Novotiral usually start working after starting treatment?

Because Novotiral contains Liothyronine ( T3), which has a shorter half-life than Levothyroxine, it may contribute to faster changes in body hormone levels compared to T4 alone.

The full stabilization of hormone levels and TSH, however, typically requires several weeks, during which periodic monitoring and dose adjustments are part of the management process.


Q: Does Novotiral have a generic version available?

Yes. Regulatory drug databases list generic versions of combination products containing the active ingredients found in Novotiral (Levothyroxine and Liothyronine) as being approved and available for prescription.


Q: Are there any specific foods or drinks that should be avoided while using Novotiral?

Official documents specify that both soy protein and high dietary fiber can decrease the drug's absorption.

For optimal absorption, the tablet is described in official documents as being taken on an empty stomach before breakfast.


Q: Does Novotiral affect a person's ability to drive or operate machinery?

Regulatory labels list potential side effects that affect the nervous system, such as tremor and nervousness.

If these effects occur, they may temporarily affect a person's ability to concentrate or safely operate machinery. This is a consideration that requires discussion with a healthcare provider.


Q: What should be done if a dose of Novotiral is missed?

Official patient instructions generally state that if a dose is missed, patients may consider taking the dose as soon as they remember on the same day.

If it is almost time for the next scheduled dose, the missed dose is typically skipped. Double doses are not advised.


Q: Is it common for people to feel tired when they first start taking Novotiral?

Fatigue or tiredness is not listed as a direct side effect of the medication itself in official regulatory documents.

However, feeling tired is a classic symptom of under-treatment (hypothyroidism), which the medicine is intended to correct. If tiredness persists, this is often a factor reviewed during regular medical check-ups.


Q: What is the risk of dependence or addiction associated with Novotiral?

Regulatory bodies have not associated Novotiral with the risk of dependence or addiction.

It is not a controlled substance and is not described as having addictive properties when used for thyroid hormone replacement therapy.


Q: Does Novotiral need to be stored in the refrigerator?

No. Official guidance directs that the product be stored at Controlled Room Temperature, typically between 20°C and 25°C (68°F and 77°F).

It is also specified that the medicine be kept in its original container to protect it from light and moisture.


Q: What is the risk of withdrawal symptoms if Novotiral is stopped suddenly?

The medication is typically intended for lifelong use for chronic thyroid deficiency.

Stopping treatment suddenly may result in the return of underlying hypothyroid symptoms due to hormone deficiency, as opposed to the typical withdrawal symptoms seen with certain other medications.


Q: Can Novotiral affect the results of common laboratory tests?

Yes. The hormones in the drug can potentially interfere with specific tests, such as those that measure thyroid-binding globulin (TBG).

Regulatory information advises that adjustments may be needed to prevent misleading test results, especially if other medicines are taken simultaneously.


Q: Is Novotiral known to interact with herbal supplements?

Official labeling does not list specific herbal supplements known to interact with the drug.

However, since some supplements contain minerals or ingredients (like high fiber) that can reduce Novotiral's absorption, the potential for interference from supplements is a point for awareness when undergoing therapy.


Q: What is the mechanism by which Novotiral is thought to affect the body?

Novotiral is a synthetic replacement for the natural thyroid hormones Levothyroxine ( T4) and Liothyronine ( T3).

The general purpose is the restoration of physiological balance by regulating the basal metabolic rate, which influences the metabolism of carbohydrates, lipids, and proteins across the body.


Q: What if I already have a liver or kidney condition, can I still use Novotiral?

Regulatory documents list conditions related to the liver and kidneys as requiring caution or special management.

For individuals with these conditions, management often involves cautious initiation and regular monitoring, as the drug is metabolized in the liver and eliminated through the kidneys.


Q: Why do some people report feeling less like themselves while using Novotiral?

Official labels list effects on the nervous system and psychiatric effects, which can include nervousness, irritability, and restlessness.

These feelings are generally associated with excessive hormone replacement (hyperthyroidism) and are factors often considered during dose management.


Q: Can Novotiral be crushed or chewed, or must it be swallowed whole?

Regulatory instructions detail administration via the oral route but do not contain explicit instructions for scoring, crushing, or chewing the tablet.

Therefore, the standard practice for tablets without such specific instructions is that they are generally swallowed whole to ensure proper absorption.


Q: What is the difference between Novotiral and the active ingredient alone?

Novotiral is the brand-name formulation of the two active ingredients, Levothyroxine and Liothyronine.

It is the specific synthetic preparation containing these hormones, manufactured to defined, stringent quality standards and concentrations.


Q: What are the ingredients in the Novotiral tablet besides the active drug?

Official drug descriptions and regulatory documents list all inactive ingredients (excipients).

These are substances such as binding agents, coloring, or fillers that are included in the tablet formulation to ensure its stability and structure but do not have a therapeutic effect.


Q: How common is the most serious side effect listed for Novotiral?

Official labeling often states that the frequency of many side effects, especially those related to dose-dependent hyperthyroidism (like serious cardiac events), is classified as 'frequency not known.'

This is because their occurrence is highly variable, depending on individual patient factors and the specific dosage maintained.


Q: Is Novotiral a daily medication or is it taken as needed?

Regulatory guidelines specify that Novotiral is administered as an oral tablet once daily.

It is typically designed for lifelong and continuous use to treat chronic thyroid deficiency, meaning it is taken on a continuous schedule, not as needed.


Q: Is it normal to have a slight stomach upset when starting Novotiral?

Mild stomach upset is not specifically listed as a common, expected side effect that patients should anticipate when starting Novotiral.

However, some comprehensive drug information sources may list general gastrointestinal effects, which are sometimes related to the body's reaction to the hormone changes.


Q: Does Novotiral require special monitoring while taking it?

Yes. Regulatory documents state that a patient's progress must be checked at regular visits with their physician.

Specific blood tests (such as TSH and T4/T3 levels) are routinely needed to ensure the medicine is working properly and to detect the effects of over- or under-treatment.


Q: What are the most commonly reported non-serious side effects of Novotiral?

Official documentation identifies symptoms related to hyperthyroidism as the most commonly reported effects, especially during dose adjustment.

These include symptoms in Cardiac disorders (such as palpitations and rapid heartbeat) and Nervous system disorders (including tremor, headache, and nervousness).


Q: Can Novotiral interact with over-the-counter pain relievers like ibuprofen?

Regulatory documents list interactions with broad classes of drugs, such as CYP enzyme inducers and inhibitors, which can alter the drug's concentration in the body.

While ibuprofen is not always specifically named on the label, the class of drug interactions should be considered when discussing current medications with a healthcare provider.


Q: Can taking Novotiral cause weight changes?

Yes. Official labeling lists effects related to Metabolism and nutrition disorders, specifically mentioning weight loss.

Because the hormones in the drug regulate the body's metabolic rate, weight changes are a factor that may be observed if the dosage is not accurately balanced to the patient’s needs.


Q: Does the package insert mention Novotiral causing headaches?

Yes. Regulatory documents list headache as an effect related to Nervous system disorders.

This is a reported effect, particularly when the dosage leads to symptoms of hormone over-replacement.


Q: What are the warning signs of a serious reaction to Novotiral?

Regulatory guidance advises patients to seek immediate attention if they experience symptoms of excessive medicine (toxicity) or a serious reaction.

These signs can include rapid or irregular heartbeats, chest pain, difficulty breathing, or excessive sweating.


Q: What research evidence supports the use of Novotiral?

Research cited in authoritative summaries supports the use of this T4/T3 combination strategy in replacement therapy.

Studies have focused on outcomes related to disease activity markers and patient quality of life metrics, particularly in populations that may not optimally respond to T4 monotherapy.


Q: What information is available about Novotiral's effectiveness over several years?

Clinical data in regulatory summaries includes observational studies that have evaluated the effects of the combination therapy on the rate of condition progression over periods of up to two years.

As the condition is typically treated for life, continued patient monitoring is an essential part of long-term management.


How should Novotiral be stored and disposed of?

How to Store and Dispose of Novotiral

Official regulatory guidance dictates specific conditions to maintain the stability and integrity of Novotiral until its expiration date.

Storage Requirements

Condition Requirement (Based on Regulatory Labeling)
Temperature Store at Controlled Room Temperature, typically between 20°C and 25°C (68°F and 77°F).
Protection Keep the medicine in its original container to protect it from moisture and light.
Handling Keep Novotiral out of the sight and reach of children and pets. Do not use past the expiration date printed on the packaging.

Disposal Instructions

Unused or expired Novotiral must be disposed of properly to protect the environment and public safety. The recommended method is to utilize a community drug take-back program or a pharmacy authorized to collect unused medications. If no take-back option is available, the product should be mixed with an undesirable substance, placed in a sealed bag, and discarded in the household trash. Do not flush Novotiral down the toilet or pour it down a sink.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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