Etravirine 100mg Tablets(Janssen-Cilag International N.V.),
HA532

WHOPAR part 1May 2023

WHO Prequalification Programme
WHO PUBLIC ASSESSMENT REPORT (WHOPAR)INTELENCE 100 mg tablets 1
Etravirine 100 mg tablets
The innovator product INTELENCE 100 mg tablets was submitted by Janssen Cilag International N.V in2012 to be considered for prequalification and subsequently accepted for the WHO list of prequalified
medicinal products for the treatment of HIV/AIDS on 11 September 2012.
Information on the site(s) involved in the manufacture of the product and the API is available at the products
listing information ( https://extranet.who.int/pqweb/medicine/2573 )The “Procedure for prequalification of pharmaceutical products2”defines specific evaluation mechanisms for
products approved by regulatory authorities, which apply similar stringent standards for quality, safety andefficacy as those required by WHO.
The prequalification of this product by the WHO Prequalification Team: Medicines (PQTm) is based on theapproval by the European Medicines Agency (EMA: http://www.ema.europa.eu/ema/), in line with the“Guidelines on submission of documentation for prequalification of finished pharmaceutical productsapproved by stringent regulatory authorities”3.
Hence, no assessment of the data underlying this approval has been undertaken within the WHO
Prequalification Team: Medicines (PQTm).
However, according to the SRA guideline WHO may request additional data when considered necessary forthe safe use of the product in regions relevant for prequalified products and such information may be includedin the WHOPAR as a separate piece of information. In order to safeguard product quality throughout its entire
intended shelf‐life in hot and very humid areas, stability studies under the conditions defined for Climatic
Zones IVb have been requested from the Applicant4
WHO PQTm considers the following storage condition appropriate for the product when distributed in regionswith zone III, IVa and IVb climatic conditions, based on available stability information:•Do not store above 30°C. Store in the original bottle and keep the bottle tightly closed inorder to protect from moisture. Do not remove the desiccant pouches.

•The shelf-life at this storage condition is 24 months.

Based on the above, the WHOPAR for INTELENCE refers for parts 3, 4, 5, 6 and 8 to the previously issued
public assessment report as follows:1

Trade names are not prequalified by WHO. This is the National Medicines Regulatory Authority’s responsibility
Throughout this WHOPAR the proprietary name is given as an example only.
2
https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/prequalification/trs961annex10-who-procedure-prequalification.pdf?sfvrsn=85029f47_2
3
https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/prequalification/trs986annex5.pdf?sfvrsn=8aae767d_2
4
https://extranet.who.int/pqweb/sites/default/files/documents/48 Stability data SRA FPPs_March2016_newtempl.pdf

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Etravirine 100mg Tablets(Janssen-Cilag International N.V.),
HA532

WHOPAR part 1

May 2023

WHOPAR part

Reference5

Part 1

Summary for
the Public

https://www.ema.europa.eu/documents/overview/intelence-epar-summary-public_en.pdf

Part 3

Package
Leaflets

https://www.ema.europa.eu/documents/product-information/intelence-epar-productinformation_en.pdf

Part 4https://www.ema.europa.eu/documents/product-information/intelence-epar-productinformation_en.pdf

Part 5Summaries ofProductCharacteristics
Labelling

Part 6Discussion

https://www.ema.europa.eu/documents/smop-initial/committee-medicinal-products-humanuse-summary-positive-opinion-intelence_en.pdf

Part 8

Steps taken
following
Authorization

https://www.ema.europa.eu/documents/procedural-steps-after/intelence-epar-procedural-stepstaken-scientific-information-after-authorisation_en.pdf

https://www.ema.europa.eu/documents/product-information/intelence-epar-productinformation_en.pdf

Parts 2 and 7 of the WHOPAR for INTELENCE are included here.
Summary of Prequalification Status for INTELENCE
Initial AcceptanceRequalification

Status on PQ list

Date
11 September 2012

OutcomelistedDate
24 April 2023

OutcomelistedDossier Evaluation

July 2012

MRApril 2023

requalified

PQ: prequalification
MR: meets requirements

The table represents the status of relevant completed activities only.

5Intelence | European Medicines Agency (europa.eu)

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