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Certain Procedural steps taken and scientific information after the authorisationApplicationScopenumberOpinion/CommissionProductNotificationDecisionInformationissued issued 2 /affected 31Summaryamended
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The package insert prescribing is a document that provides important information about the drug, including its uses, dosages, side effects, and possible interactions with other drugs.
The pharmaceutical company that manufactures the drug is typically responsible for filing the package insert prescribing.
The package insert prescribing is usually filled out by medical professionals, such as doctors or pharmacists, based on the guidelines provided by the pharmaceutical company.
The purpose of the package insert prescribing is to ensure that healthcare providers and patients have access to accurate and up-to-date information about the drug.
The package insert prescribing must include information on indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, and use in specific populations.
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