Get the free International nonproprietary name: - ema europa

20 October 2011 EMA/916997/2011Assessment report TevaInternational nonproprietary name: efavirenzProcedure No. EMEA/H/C/002352Assessment Report as adopted by the CHMP with all information of a commercially

How to fill out international nonproprietary name

How to fill out international nonproprietary name:

1. Start by researching and understanding the guidelines and regulations set forth by the World Health Organization (WHO) for naming pharmaceutical substances. Familiarize yourself with the requirements and restrictions for creating an international nonproprietary name (INN).
2. Begin the process by determining the pharmacological classification and function of the substance for which you need an INN. This will help in choosing appropriate stems and prefixes.
3. Select a suitable stem for the nonproprietary name. The stem should reflect the pharmacological class or specific function of the substance. It should be unique and adhere to the guidelines provided by the WHO.
4. Consider adding a prefix to the stem, if necessary, to further describe the substance. The prefix should be relevant and meaningful in relation to the pharmacological class or therapeutic indication of the substance.
5. Avoid using proprietary/trademarked names or terms that may cause confusion with existing drug names. The purpose of an INN is to provide a universally recognized and non-proprietary name for a pharmaceutical substance.
6. Ensure that the chosen INN is easily pronounceable and doesn't violate any cultural or linguistic sensitivities. It should be readily understood and communicated across different languages and regions.
7. Review and cross-reference the proposed INN against existing INNs and trademarks to ensure its uniqueness and avoid any potential conflicts or confusion.
8. Prepare a formal submission of the proposed INN along with supporting documentation, such as pharmacological data and justification for the name selection, as per the guidelines provided by the WHO.

Who needs international nonproprietary name:

1. Pharmaceutical companies and manufacturers: INNs are commonly used in pharmaceutical labeling, packaging, and regulatory processes to provide a standardized and globally recognized name for a substance.
2. Regulatory authorities and government bodies: INNs aid in the regulation, approval, and monitoring of pharmaceutical substances, allowing for easier identification and classification.
3. Healthcare professionals and researchers: INNs help facilitate communication and understanding among healthcare professionals, researchers, and scientists globally. Having a standardized name for a substance makes it easier to discuss, research, and prescribe medications.
4. Patients and consumers: INNs can be found on medication labels and information leaflets, providing patients with clear and consistent information about the substances they are taking. This helps in avoiding confusion and promotes patient safety.

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What is international nonproprietary name?

The International Nonproprietary Name (INN) is the official generic and scientific name given to a pharmaceutical drug or active ingredient.

Who is required to file international nonproprietary name?

Pharmaceutical companies or manufacturers are required to file international nonproprietary names for their products.

How to fill out international nonproprietary name?

International nonproprietary names can be filled out by submitting an application to the relevant regulatory authority or organization.

What is the purpose of international nonproprietary name?

The purpose of international nonproprietary names is to provide a standardized and globally recognized name for pharmaceutical substances, facilitating communication and ensuring patient safety.

What information must be reported on international nonproprietary name?

The information reported on international nonproprietary names typically includes the active ingredient or chemical name of the drug, dosage form, and strength.