Public Assessment Report for paediatric studies submitted in ...

E) Summary of clinical program sponsored by InfectoPharm Arzneimittel GmbH,
Germania
InfectoPharm Arzneimittel GmbH has confirmed that dispose only bibliographic data,
concerning the active substance salbutamol, which has not yet been submitted. This data is based on freely
accessible literature. It has been assumed that all kind of literature open to the public was already
submitted and it was not submitted the same documents once again.
Assessor’s comments
Publications only. Its can not be considered a relevant clinical change.
F) Summary of clinical program sponsored by Warsaw Pharmaceutical Works Polfa SA,
Poland
Oral administration: tablets and syrup
Warsaw Pharmaceutical Works Polfa SA has submitted a copy of the study “Clinical
Evaluation of the Preparation Salbutamol Tablets and Syrup" with the participation of the paediatric
population, carried out in 1973, in Department of Internal Disease, Medical Academy, Warszawa.
The patients included were 30 women and 26 men aged 16 to 72 years.
Assessor’s comments
It is noted that the study is performed in 1973 and according to the current guidelines it suffered from
some deficiencies. As only a summary of this study was submitted, no appropriate information could be
identified on inclusion and exclusion criteria as well as on the primary clinical endpoint. Therefore
clinical relevance of the outcomes of this study is questionable.
The analysis of the PSUR(s) submitted by the concerned Marketing Authorisation Holders
revealed no new safety information requiring the amendements to the SPC.
IV. RAPPORTEUR’S OVERALL CONCLUSION
AND RECOMMENDATION ON DAY 89
� Overall conclusion
In general, it is agreed with the MAH (s) that the data from the submitted studies do not
specifically indicate any need of major change of the current paediatric information in the SmPCs.
However, the precise wording of all European national SmPCs was not provided by the MAH (s), and in
the review provided by the MAH (s), it is unclear whether all European countries where salbutamol is
approved do have similar recommendations for dosage in paediatric patients. Furthermore, according to
the CMD(h) best practice guide on article 45-Paediatric regulation (September 2008), “the aim of Article
45 procedure is to make the information on the use of medicines in the paediatric population available for
all healthcare professionals and patients (or parents). After finalisation of the assessment of the data
recommendations for the text to be included in the SmPC and PL will be published on the CMD(h)
website. This information should be included in all SmPCs/PLs of products with the same active substance
and pharmaceutical form within 90 days of publication of Public assessment report.”
The Applicants should review the national SmPC and previously submitted studies and all other
available data which should form a basis for a proposed harmonised SmPC text regarding paediatric
indications and dosage recommendation.
� Recommendation
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
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