Olanzapine Pamoate - Relprevv (Zyprexa)

Trade Name : ZYPREXA

Eli Lilly and Company

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olanzapine Pamoate - Relprevv (Zyprexa) which is also known as ZYPREXA and Manufactured by Eli Lilly and Company. It is available in strength of per ml. Read more

Olanzapine Pamoate - Relprevv (Zyprexa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING: POST-INJECTION DELIRIUM/SEDATION SYNDROME and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.

Patients are at risk for severe sedation (including coma) and/or delirium after each injection and must be observed for at least 3 hours in a registered facility with ready access to emergency response services. Because of this risk, ZYPREXA RELPREVV is available only through a restricted distribution program called ZYPREXA RELPREVV Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment. (, , , , )
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA RELPREVV is not approved for the treatment of patients with dementia-related psychosis. (, , )

ZYPREXA RELPREVV is available only through a restricted distribution program . ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare facility, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV Patient Care Program. To enroll, call 1-877-772-9390.n
ZYPREXA RELPREVV is indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults .n
ZYPREXA RELPREVVu2122 is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia.u00a0()n
Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults.u00a0()n

150u00a0mg/2u00a0wks, 300u00a0mg/4u00a0wks, 210u00a0mg/2u00a0wks, 405u00a0mg/4u00a0wks, or 300u00a0mg/2u00a0wks. See for dosing recommendations. ()n
ZYPREXA RELPREVV is intended for deep intramuscular gluteal injection only.

Do not administer intravenously or subcutaneously. ()n
Be aware that there are two ZYPREXA intramuscular formulations with different dosing schedules. ZYPREXA IntraMuscular (10u00a0mg/vial) is a short-acting formulation and should not be confused with ZYPREXA RELPREVV. ()n
Establish tolerability with oral olanzapine prior to initiating treatment. ()n
ZYPREXA RELPREVV doses above 405u00a0mg every 4 weeks or 300u00a0mg every 2 weeks have not been evaluated in clinical trials. ()n
Use in specific populations (including renal and hepatic impaired, and pediatric population) has not been studied. ()n
Must be suspended using only the diluent for ZYPREXA RELPREVV provided in the convenience kit. ()n

ZYPREXA RELPREVV is a powder for suspension for intramuscular use only. ZYPREXA RELPREVV is present as a yellow solid in a glass vial equivalent to 210, 300, or 405u00a0mg olanzapine per vial. The diluent is a clear, colorless to slightly yellow solution in a glass vial . The reconstituted suspension will be yellow and opaque .n
Powder for suspension for intramuscular use only: 210u00a0mg/vial, 300u00a0mg/vial, and 405u00a0mg/vial. (, , )n

None.n
None.n

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Elderly Patients with Dementia-Related Psychosis:
Suicide:
Neuroleptic Malignant Syndrome:
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS):
Metabolic Changes:
Tardive Dyskinesia:
Orthostatic Hypotension:
Leukopenia, Neutropenia, and Agranulocytosis:
Seizures:
Potential for Cognitive and Motor Impairment:
Hyperprolactinemia:
Laboratory Tests:

Most common adverse reactions (u22655% in at least one of the treatment groups and greater than placebo) associated with ZYPREXA RELPREVV treatment: headache, sedation, weight gain, cough, diarrhea, back pain, nausea, somnolence, dry mouth, nasopharyngitis, increased appetite, and vomiting. ()n
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

CNS Acting Drugs:
Antihypertensive Agents:
Levodopa and Dopamine Agonists:
Diazepam:
Alcohol:
Carbamazepine:
Fluvoxamine:

No data

Pregnancy:
Pediatric Use:

In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15u00a0times the daily oral MRHD (20u00a0mg) and rhesus monkeys administered oral doses up to 8u00a0times the daily oral MRHD based on mg/m body surface area.n
Olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. Because ZYPREXA RELPREVV is to be administered by healthcare professionals, the potential for misuse or abuse by patients is low.n

No data

ZYPREXA RELPREVV is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 10H-thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-,4,4u2032-methylenebis[3-hydroxy-2-naphthalenecarboxylate] (1:1), monohydrate. The formula is CHNSu2022CHOu2022HO, which corresponds to a molecular weight of 718.8. The chemical structure is:n
ZYPREXA RELPREVV is a long-acting form of olanzapine and is intended for deep intramuscular gluteal injection only.n
ZYPREXA RELPREVV includes a vial of the drug product and a vial of the sterile diluent for ZYPREXA RELPREVV.n
The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405u00a0mg olanzapine base per vial. The diluent for ZYPREXA RELPREVV is a clear, colorless to slightly yellow solution in a glass vial and is composed of carboxymethylcellulose sodium, mannitol, polysorbateu00a080, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. The drug product is suspended in the diluent for ZYPREXA RELPREVV to a target concentration of 150u00a0mg olanzapine per mL prior to intramuscular injection.n

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The short-term effectiveness of ZYPREXA RELPREVV was established in an 8-week, placebo-controlled trial in adult patients (n=404) who were experiencing psychotic symptoms and met DSM-IV or DSM-IV-TR criteria for schizophrenia. Patients were randomized to receive injections of ZYPREXA RELPREVV 210u00a0mg every 2 weeks, ZYPREXA RELPREVV 405u00a0mg every 4 weeks, ZYPREXA RELPREVV 300u00a0mg every 2 weeks, or placebo every 2 weeks. Patients were discontinued from their previous antipsychotics and underwent a 2-7 day washout period. No oral antipsychotic supplementation was allowed throughout the trial. The primary efficacy measure was change from baseline to endpoint in total Positive and Negative Syndrome Scaleu00a0(PANSS) score (mean baseline total PANSS score 101). Total PANSS scores showed statistically significant improvement from baseline to endpoint with each dose of ZYPREXA RELPREVV (210u00a0mg every 2 weeks, 405u00a0mg every 4 weeks, and 300u00a0mg every 2 weeks) as compared to placebo. The effectiveness of ZYPREXA RELPREVV in the treatment of schizophrenia is further supported by the established effectiveness of the oral formulation of olanzapine.n
A longer-term trial enrolled patients with schizophrenia (n=1065) who had remained stable for 4 to 8 weeks on open-label treatment with oral olanzapine (mean baseline total PANSS score 56) and were then randomized to continue their current oral olanzapine dose (10, 15, or 20u00a0mg/day); or to ZYPREXA RELPREVV 150u00a0mg every 2 weeks (405u00a0mg every 4 weeks, 300u00a0mg every 2 weeks, or 45u00a0mg every 4 weeks). No oral antipsychotic supplementation was allowed throughout the trial. The primary efficacy measure was time to exacerbation of symptoms of schizophrenia defined in terms of increases in Brief Psychiatric Rating Scaleu00a0(BPRS) positive symptoms or hospitalization. ZYPREXA RELPREVV doses of 150u00a0mg every 2 weeks, 405u00a0mg every 4 weeks, and 300u00a0mg every 2 weeks were each statistically significantly superior to low dose ZYPREXA RELPREVV (45u00a0mg every 4 weeks).n

No data

ntttttttAdvise the patient to read the FDA-approved patient labeling ().ntttttt
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking ZYPREXA RELPREVV. Patients should be advised to call their doctor if they do not think they are getting better or have concerns about their condition.n
Post-Injection Delirium/Sedation Syndrome
During premarketing clinical studies, reactions that presented with signs and symptoms consistent with olanzapine overdose have been reported in patients following an injection of ZYPREXA RELPREVV. It is mandatory that patients be enrolled in the ZYPREXA RELPREVV Patient Care Program to receive ZYPREXA RELPREVV treatment. Patients should be advised of the risk of post-injection delirium/sedation syndrome each time they receive an injection . Patient and caregivers should be advised that after each ZYPREXA RELPREVV injection, patients must be observed at the healthcare facility for at least 3 hours and must be accompanied to their destination upon leaving the facility. The Medication Guide should be distributed each time patients receive an injection.
Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke
Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with ZYPREXA had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.
ZYPREXA RELPREVV is not approved for elderly patients with dementia-related psychosis .
Neuroleptic Malignant Syndrome (NMS)
Array
Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including ZYPREXA. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) .
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Patients should be advised to report to their health care provider at the earliest onset of any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) .
Hyperglycemia and Diabetes Mellitus
Patients should be advised of the potential risk of hyperglycemia-related adverse reactions related to ZYPREXA RELPREVV. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctoru2019s instructions about how often to check their blood sugar while taking ZYPREXA RELPREVV .
Dyslipidemia
Patients should be counseled that dyslipidemia has occurred during treatment with ZYPREXA RELPREVV. Patients should have their lipid profile monitored regularly .
Weight Gain
Patients should be counseled that weight gain has occurred during treatment with ZYPREXA RELPREVV. Patients should have their weight monitored regularly .
Orthostatic Hypotension
Patients should be advised of the risk of orthostatic hypotension, and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA RELPREVV, e.g., diazepam or alcohol . Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better. Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with orthostatic hypotension: dizziness, fast or slow heartbeat, or fainting.
Potential for Cognitive and Motor Impairment
Because ZYPREXA RELPREVV has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ZYPREXA RELPREVV therapy does not affect them adversely. Additionally, due to the risk of post-injection delirium/sedation syndrome, patients should not drive or operate heavy machinery for the remainder of the day of each injection .
Body Temperature Regulation
Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine .
Concomitant Medication
Patients should be advised to inform their healthcare providers if they are taking, or plan to take, ZYPREXA or Symbyax (olanzapine/fluoxetine combination). Patients should also be advised to inform their healthcare providers if they are taking, plan to take, or have stopped taking any prescription or over-the-counter drugs, including herbal supplements, since there is a potential for interactions .
Alcohol
Patients should be advised to avoid alcohol while taking ZYPREXA RELPREVV .
Use in Specific Populations
Pregnancyn- [see Use in Specific Populations ()]
Lactationn- [see Use in Specific Populations ()]
Infertilityn- [see Use in Specific Populations ()]
Pediatric Usen- [see Use in Specific Populations ()]
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.n
ZYPR-0009-USPI-201910n

Medication Guide
ZYPREXAn- Arrayn- RELPREVVu2122 (zy-PREX-a REL-prev)
(olanzapine)
For Extended Release Injectable Suspension
Read the Medication Guide that comes with ZYPREXA RELPREVV before you start taking it and each time before you get an injection. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor if there is something you do not understand or you want to learn more about ZYPREXA RELPREVV.n
What is the most important information I should know about ZYPREXA RELPREVV?
Before you receive ZYPREXA RELPREVV treatment you must:
ZYPREXA RELPREVV may cause serious side effects, including:
These serious side effects are described below.
What is ZYPREXA RELPREVV?
ZYPREXA RELPREVV is a long-acting prescription medicine given by injection and used to treat schizophrenia in adults. The symptoms of schizophrenia include:n
Some of your symptoms of schizophrenia may improve with treatment with ZYPREXA RELPREVV. If you do not think you are getting better, call your doctor.n
It is not known if ZYPREXA RELPREVV is safe and effective in children under 18 years of age.n
What should I tell my doctor before taking ZYPREXA RELPREVV?
ZYPREXA RELPREVV may not be right for you. Before starting ZYPREXA RELPREVV, tell your doctor if you have or had:n
Tell your doctor if you exercise a lot or are in hot places often.n
The symptoms of schizophrenia may include or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.n
Tell your doctor about all the medicines that you take,
How should I receive ZYPREXA RELPREVV?
What should I avoid while receiving ZYPREXA RELPREVV?
What are the possible side effects of ZYPREXA RELPREVV?
Serious side effects may happen when you take ZYPREXA RELPREVV, including:
Common side effects of ZYPREXA RELPREVV include:
Tell your doctor about any side effect that bothers you or that does not go away.n
These are not all the possible side effects with ZYPREXA RELPREVV. For more information, ask your doctor or pharmacist.n
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
General information about ZYPREXA RELPREVV
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.n
This Medication Guide summarizes the most important information about ZYPREXA RELPREVV. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA RELPREVV that was written for healthcare professionals. For more information about ZYPREXA RELPREVV call 1-800-Lilly-Rx (1-800-545-5979) or visit www.zyprexarelprevv.com.n
What are the ingredients in ZYPREXA RELPREVV?
Active ingredient: olanzapinen
Inactive ingredients: carboxymethylcellulose sodium, mannitol, polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injectionn
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guide revised October 22, 2019n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
www.zyprexarelprevv.com
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.n
ZYPR-0002-MG-20191022n

No data

PACKAGE LABEL - ZYPREXA Relprevv 210 mg
NDC 0002-7635-11n
Medication Guide is to be dispensed to patients.n
VL7635/VL7622n
ZYPREXA Relprevvn
(olanzapine)n
For Extended Release Injectable Suspensionn
210 mg/vial Convenience kitn
Convenience kit includes:n
One vial of Zyprexa Relprevv 210 mg/vialn
One 3-mL vial of diluentn
One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro needle with needle protection devicen
Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection devicen
Hypodermic Needle-Pro is a registered trademark of Smiths Medical.n
Reconstitute each vial with 1.3 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.n
Rx onlyn
tttttttFOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.ttttttn
tttttttDosing Frequency: Once every two weeksttttttn
www.zyprexarelprevv.comn
Lillyn

PACKAGE LABEL - ZYPREXA Relprevv 300 mg n
NDC 0002-7636-11n
Medication Guide is to be dispensed to patients.n
VL7636/VL7622n
ZYPREXA Relprevvn
(olanzapine)n
For Extended Release Injectable Suspensionn
300 mg/vial Convenience kitn
Convenience kit includes:n
One vial of Zyprexa Relprevv 300 mg/vialn
One 3-mL vial of diluentn
One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro needle with needle protection devicen
Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection devicen
Hypodermic Needle-Pro is a registered trademark of Smiths Medical.n
Reconstitute each vial with 1.8 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.n
Rx onlyn
tttttttFOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.ttttttn
tttttttDosing Frequency: Once every two or four weeksttttttn
www.zyprexarelprevv.comn
Lillyn

PACKAGE LABEL - ZYPREXA Relprevv 405 mg n
NDC 0002-7637-11n
Medication Guide is to be dispensed to patients.n
VL7637/VL7622n
ZYPREXA Relprevvn
(olanzapine)n
For Extended Release Injectable Suspensionn
405 mg/vial Convenience kitn
Convenience kit includes:n
One vial of Zyprexa Relprevv 405 mg/vialn
One 3-mL vial of diluentn
One 3-mL syringe with pre-attached 19-gauge, 1.5-inch Hypodermic Needle-Pro needle with needle protection devicen
Two 19-gauge, 1.5-inch Hypodermic Needle-Pro needles with needle protection devicen
Hypodermic Needle-Pro is a registered trademark of Smiths Medical.n
Reconstitute each vial with 2.3 mL of enclosed diluent. The resultant solution will contain 150 mg/mL.n
Rx onlyn
tttttttFOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.ttttttn
tttttttDosing Frequency: Once every four weeksttttttn
www.zyprexarelprevv.comn
Lillyn

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Olanzapine Pamoate - Relprevv (Zyprexa)

Trade Name : ZYPREXA

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Olanzapine Pamoate - Relprevv (Zyprexa)

Trade Name : ZYPREXA

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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