VIATRIS PRIVATE LIMITED

**4.1 Therapeutic indications** - Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). - Management of acute pain in adults. - Treatment of primary dysmenorrhea. - Relief of signs and symptoms of ankylosing spondylitis (AS). - Management of chronic low back pain. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see Sections **4.3 Contraindications** and **4.4 Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), taking into consideration other available therapeutic options.

**4.1. Therapeutic indications** Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total-C/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease_ Eturion is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total-C to HDL-C ≥6, or premature family history of CHD. In adults with type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking or hypertension, Eturion is indicated to: - Reduce the risk of MI. - Reduce the risk of stroke. In adults with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI. - Reduce the risk of fatal and non-fatal stroke. - Reduce the risk for revascularization procedures. - Reduce the risk of hospitalization for congestive heart failure (CHF). - Reduce the risk of angina.

**4.1. Therapeutic indications** Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total-C/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease_ Eturion is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on HDL-C ≥6, or premature family history of CHD. In adults with type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking or hypertension, Eturion is indicated to: - Reduce the risk of MI. - Reduce the risk of stroke. In adults with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI. - Reduce the risk of fatal and non-fatal stroke. - Reduce the risk for revascularization procedures. - Reduce the risk of hospitalization for congestive heart failure (CHF). - Reduce the risk of angina.

**4.1 Therapeutic indications** Neuropathic pain Pregabalin is indicated for the treatment of neuropathic pain, which includes diabetic peripheral neuropathy and post-herpetic neuralgia, in adults. Epilepsy Pregabalin is indicated as adjunctive therapy of partial seizures, with or without secondary generalisation, in adults. Generalised anxiety disorder Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. Fibromyalgia Pregabalin is indicated for the management of fibromyalgia.

**4.1. Therapeutic indications** The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: **Amlodipine** _**Hypertension**_ The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. _**Coronary Artery Disease**_ Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs. Angiographically Documented Coronary Artery Disease In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. **Atorvastatin** _**Dyslipidemia**_ The atorvastatin component is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia (FH) or combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and in patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) when response to diet and other non-pharmacological measures is inadequate. The atorvastatin component also raises high-density lipoprotein cholesterol (HDL-C) and lowers the LDL-HDL and total-C/HDL ratios. The atorvastatin component is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total-C, LDL-C and apo B in patients with homozygous FH. _**Prevention of Cardiovascular Disease**_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD, such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD. In patients with Type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD, such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI - Reduce the risk of stroke In patients with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina

**4.1. Therapeutic indications** The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: **Amlodipine** _**Hypertension**_ The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. _**Coronary Artery Disease**_ Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs. Angiographically Documented Coronary Artery Disease In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. **Atorvastatin** _**Dyslipidemia**_ The atorvastatin component is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia (FH) or combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and in patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) when response to diet and other non-pharmacological measures is inadequate. The atorvastatin component also raises high-density lipoprotein cholesterol (HDL-C) and lowers the LDL-HDL and total-C/HDL ratios. The atorvastatin component is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total-C, LDL-C and apo B in patients with homozygous FH. _**Prevention of Cardiovascular Disease**_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD, such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD. In patients with Type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD, such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI - Reduce the risk of stroke In patients with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina

**4.1. Therapeutic indications** The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: **Amlodipine** _**Hypertension**_ The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. _**Coronary Artery Disease**_ Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs. Angiographically Documented Coronary Artery Disease In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. **Atorvastatin** _**Dyslipidemia**_ The atorvastatin component is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia (FH) or combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and in patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) when response to diet and other non-pharmacological measures is inadequate. The atorvastatin component also raises high-density lipoprotein cholesterol (HDL-C) and lowers the LDL-HDL and total-C/HDL ratios. The atorvastatin component is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total-C, LDL-C and apo B in patients with homozygous FH. _**Prevention of Cardiovascular Disease**_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD, such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD. In patients with Type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD, such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI - Reduce the risk of stroke In patients with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina

**4.1. Therapeutic indications** The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: **Amlodipine** _**Hypertension**_ The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. _**Coronary Artery Disease**_ Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal drugs. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy, or in combination with other antianginal drugs. Angiographically Documented Coronary Artery Disease In patients with recently documented coronary artery disease (CAD) by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. **Atorvastatin** _**Dyslipidemia**_ The atorvastatin component is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia (FH) or combined (mixed) hyperlipidemia ( _Fredrickson_ Types IIa and IIb), elevated serum TG levels ( _Fredrickson_ Type IV), and in patients with dysbetalipoproteinemia ( _Fredrickson_ Type III) when response to diet and other non-pharmacological measures is inadequate. The atorvastatin component also raises high-density lipoprotein cholesterol (HDL-C) and lowers the LDL-HDL and total-C/HDL ratios. The atorvastatin component is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total-C, LDL-C and apo B in patients with homozygous FH. _**Prevention of Cardiovascular Disease**_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD, such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of CHD. In patients with Type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD, such as retinopathy, albuminuria, smoking or hypertension, atorvastatin is indicated to: - Reduce the risk of MI - Reduce the risk of stroke In patients with clinically evident CHD, atorvastatin is indicated to: - Reduce the risk of non-fatal MI - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina

**4.1 Therapeutic Indications** **Hypertension** Eplerenone is indicated for the treatment of hypertension. In these patients, eplerenone may be used alone or in combination with other antihypertensive agents. **Heart Failure – Post-Myocardial Infarction (MI)** Eplerenone is indicated, in addition to standard therapy, to reduce the risk of cardiovascular mortality and cardiovascular hospitalization in stable patients with left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] ≤40%) and clinical evidence of heart failure after recent MI. **New York Heart Association (NYHA) Class II (Chronic) Heart Failure** Eplerenone is indicated, in addition to standard optimal therapy to reduce the risk of cardiovascular mortality and hospitalization in heart failure adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of >130 msec) (see section **5.1 Pharmacodynamic Properties** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**4.1. Therapeutic Indications** Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to another topical IOP lowering agent.