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De H 3937 001 Par
De H 3937 001 Par
Ziloxicum 60 mg Hartkapseln
Acemetacin
DE/H/3936-3937/001/DC
Acemetacin is well known product containing a widely used, well-known active substance. No
further clinical trials are provided by the applicant.
Drossapharm AG has developed a new Acemetacin forte 60 mg capsule in order to provide more
predictable absorption. The new (Drossapharm) formulation has a slightly different composition
which serves to reduce variability. Therefore, due to formulation changes, differences between Test
and Reference product were expected regarding pharmacokinetic values.
Drug Product
The development of the product Ziloxicum 60 mg Hartkapseln has been described, the choice of
excipients is justified and their functions explained. The active ingredient and excipients used are
well known and of pharmacopoeial quality. The product specifications cover appropriate parameters
for this dosage form. Validations of the analytical methods have been presented. Batch analysis has
been performed on four production batches. The batch analysis results show that the finished
products meet the specifications proposed. The conditions used in the stability studies are according
to the ICH stability guideline. The control tests and specifications for drug product are adequately
drawn up. A shelf-life of 60 months with a storage restriction of Do not store above 30C. for the
drug product is accepted.
User Testing
Overall, the test methodology follows the guidelines of the European Commission (Guideline on the
readability of the label and package leaflet of medicinal products for human use, Revision January
2009; Update of Directive 2001/83/EC as amended by Directive 2004/27/EC / Guidance concerning
consultations with target patient groups for the packet leaflet, May 2006).
Both the first and the second test round met the success criteria of 90% of the subjects being able to
locate the requested information, and of those, 90% being able to give the correct answer, to indicate
that they understood the information presented. The general impression of the PL (Content, language
and layout) was mostly positive. In conclusion, the user test is considered acceptable.
With regard to PSUR submission, the MAH should take the following into account:
PSURs shall be submitted in accordance with the requirements set out in the list of Union
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and
published on the European medicines web-portal. Marketing authorisation holders shall
continuously check the European medicines web-portal for the DLP and frequency of
submission of the next PSUR.
For medicinal products authorized under the legal basis of Article 10(1) or Article 10a of
Directive 2001/83/EC, no routine PSURs need to be submitted, unless otherwise specified in
the EURD list.
For medicinal products that do not fall within the categories waived of the obligation to
submit routine PSURs by the revised pharmacovigilance legislation, the MAH should follow
the DLP according to the EURD list.