Opinion of the Paediatric Committee on the granting of...

Opinion of the Paediatric Committee on the granting of a
product-specific waiver
EMEA-002698-PIP03-22

Opinion
1. The Paediatric Committee, having assessed the waiver application in accordance with Article 13 of
Regulation (EC) No 1901/2006 as amended, recommends as set out in the appended summary
report:
• to grant a product-specific waiver for all subsets of the paediatric population and the above
mentioned condition(s) in accordance with Article 11(1)(b) of said Regulation, on the grounds
that the disease or condition for which the specific medicinal product is intended occurs only in
adult populations.
The Paediatric Committee members of Liechtenstein and Norway agree with the above-mentioned
recommendation of the Paediatric Committee.
2. The grounds for the granting of the waiver are set out in Annex I.
This opinion is forwarded to the applicant and the Executive Director of the European Medicines
Agency, together with its annexes and appendix.


Annex I
Grounds for the granting of the waiver

1. Waiver
1.1. Condition:
Treatment of non-small cell lung cancer
The waiver applies to:
• all subsets of the paediatric population from birth to less than 18 years of age;
• all pharmaceutical forms, all routes of administration;
• on the grounds that the disease or condition for which the specific medicinal product is intended
does not occur in the specified paediatric subset(s).