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Supplemental Approvals
Generic Name (Trade Accompany)Uses/Notes August 30, 2017Amantadine
(GocovriAdamas)
New indication, dosage form approved for treatment
of dyskinetic in Parkinson diseaseAdamas
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How to fill out new indication dosage form
01
To fill out a new indication dosage form, follow these steps:
02
Start by obtaining the necessary information about the patient, such as their age, weight, and medical history.
03
Determine the specific indication for which the dosage form is being prescribed. This could be for a particular disease, condition, or symptom.
04
Consult the relevant guidelines and protocols to ensure the dosage form aligns with the recommended treatment approach.
05
Calculate the appropriate dosage based on the patient's characteristics and the indication. This may involve converting between units or adjusting for factors like renal or hepatic impairment.
06
Select the appropriate form of medication, such as tablets, capsules, liquid, or injectables, based on the patient's age, condition, and preferences.
07
Determine the frequency and duration of the dosage based on the indication and the specific medication being used.
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Document all the relevant information accurately, including the patient's details, indication, dosage, and any relevant instructions.
09
Review and double-check the filled-out indication dosage form for any errors or omissions before submitting it for further processing or dispensing.
Who needs new indication dosage form?
01
The new indication dosage form may be needed by:
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Physicians or healthcare providers who are prescribing medications for patients with a specific indication.
03
Pharmacists who are responsible for dispensing the medications and need to ensure the dosage form is appropriate for the indication.
04
Patients who require a specific dosage form due to their medical condition or treatment regimen.
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Researchers or pharmaceutical companies developing new medications and dosage forms for specific indications.
06
Regulatory agencies or authorities responsible for evaluating and approving new indication dosage forms for therapeutic use.
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What is new indication dosage form?
New indication dosage form is a form that must be submitted by pharmaceutical companies to obtain approval for a new use or indication for a drug product.
Who is required to file new indication dosage form?
Pharmaceutical companies are required to file new indication dosage form.
How to fill out new indication dosage form?
New indication dosage form must be filled out completely and accurately, following the guidelines provided by regulatory authorities.
What is the purpose of new indication dosage form?
The purpose of new indication dosage form is to provide regulatory authorities with information about the new use or indication for the drug product.
What information must be reported on new indication dosage form?
New indication dosage form must include information about the drug product, the new indication or use, and any relevant clinical data.
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