Public Assessment Report for paediatric studies submitted in ...

It is acknowledge that the paediatric indication for salbutamol in the treatment of asthma is
confirmed, but it is the Rapporteur’s opinion that some changes to the SmPC might be advisable in section
4.1 and 4.2 in order to specify the age range limits of paediatric population for different formulations of
salbutamol.
The Rapporteur acknowledges that the aim of the paediatric worksharing is not to harmonise the
SmPC and PIL as a whole but a harmonisation of the paediatric data throughout Europe taking into
account the national Marketing authorisations should be possible and should be achieved.
However a harmonisation procedure across the European Union, under Article 30 of Directive
2001/83/EC, as amended would be recommended.
I.1 Scope of the variation
None proposed by the MAH(s).
III. INTRODUCTION
Ten MAH(s) submitted completed paediatric studies for salbutamol in accordance with Article
45 of Regulation (EC) No 1901/2006, as amended, conducted on medicinal products for paediatric use.
This is in response to the CMD(h) and the EMEA requirement that paediatric studies of authorised
medicinal products not previously submitted should be submitted for assessment to European Health
Agencies.
In accordance with Article 45 of Regulation (EC) No. 1901/2006, studies assessed in this
procedure are paediatric studies completed before 26 January 2008, which have not been submitted yet to
the National Competent Authorities. It is intended to describe and summarise the outcome of the presented
studies and to draw conclusions and suggestions with regards to the impact on the marketing
authorisations.
Ten MAH(s) are involved in this European Work-sharing of paediatric data on salbutamol. Only
GlaxoSmithKline submitted a dossier including 18 clinical studies conducted in children, which have been
performed by the MAH and an extensive review of the literature clinical overview. MEDA and
MENARINI submitted a list of published clinical studies and ORION submitted a list of the same
references. Ivax, Lannacher and McDermott did not submit any data.
Generics [UK] Ltd. submitted one clinical study conducted on children, which has been carried
out by Generics [UK] Ltd., with the product Respigen.
Orion Pharm has carried out 4 clinical trials with the product Buventol Easyhaler DPI, which
included children. To date, no other clinical trials with Buventol Easyhaler in children have been carried
out by Orion Pharma or independent investigator.
The first 3 studies have been included and evaluated for marketing authorisation applications (MAA) in
EU countries. The most recent study has not been included in previous MAAs and a brief synopsis of all
these studies is given in the submitted documentation.
A short critical expert overview has also been provided.
The aim of this EU Work-sharing project is the proper assessment of paediatric data on
salbutamol and the update the summary of product characteristics accordingly.
The MAHs stated that the submitted paediatric studies do not influence the benefit risk balance
for medicinal products which contain salbutamol as active substance and that there is no consequential
regulatory action.
No additional documentation has been included.
A line listing and annex II, including SmPC wording of sections 4.1 and 4.2 related to the
paediatric use of the medicinal products have to be submitted for all concerned MAH (s).
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
Page 6/76