Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Scientific conclusions Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the scientific conclusions are as follows: The joint database drug utilisation final study report submitted by the MAHs, together with the joint survey drug utilisation final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0005), complies with their obligation to conduct a database drug utilisation study to characterise prescribing practices for the medicinal product during typical and clinical use in representative groups of prescribers and to assess the main reason for prescription as imposed during the Article 107i procedure EMA/H/A-107i/1357 for cyproterone/ethinylestradiol containing products. Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint database drug utilisation final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0005), the PRAC considered that changes to the conditions of the marketing authorisation were warranted. The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance cyproterone/ethinylestradiol and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information. The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Annex II Conditions to the Marketing Authorisation(s)
Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance cyproterone/ethinylestradiol concerned by the non-interventional imposed PASS final report The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription. Final study report by:
31 July 2015
Annex III Timetable for the implementation of this position
Timetable for the implementation of the position
Adoption of CMDh position:
December 2016 CMDh meeting
Transmission to National Competent Authorities
28 January 2017
of the translations of the annexes to the position: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
cyproterone acetate /ethinylestradiol: CMDh scientific conclusions and ...
The joint database drug utilisation final study report submitted by the MAHs, together with the ... The MAH(s) should provide within the risk management plan.
PASS to evaluate the effectiveness of the risk minimisation activities as imposed during ... Grounds for the variation to the terms of the Marketing Authorisation(s).
Procedure Management and Committees Support. List of nationally authorised medicinal .... PL 00289/1604. Teva UK Limited, United Kingdom. United Kingdom.
Oct 28, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for levobunolol (ophthalmic indication), the scientific conclusions are as ...
Sep 2, 2017 - Summary of Product Characteristics. â¢. Section 4.8. The following adverse reactions should be added under the SOC âReproductive system and ...
Oct 28, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for levobunolol (ophthalmic indication), the ... reactions should be included in the product information for levobunolol-containing products authorised ... indication) is un
Dec 23, 2017 - 2. Scientific conclusions. Taking into account the PRAC Assessment Report on the PSUR(s) for mefloquine, the scientific conclusions are as follows: ... Amendments to be included in the relevant sections of the Product Information (new
5 days ago - with the frequency not known. The Package Leaflet should be updated accordingly. The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s). On the basis of
Mar 10, 2018 - Scientific conclusions. Taking into account the PRAC Assessment Report on the PSUR(s) for azithromycin (systemic use formulations), the scientific conclusions are as follows: In view of the increasing understanding on drug-drug interac
Oct 29, 2016 - PRAC reviewed the available post marketing safety data, published ... The CMDh reaches the position that the marketing authorisation(s) of ...
Nov 25, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for saccharomyces boulardii, the scientific ... patients is considered changed and an update of the product information is warranted. ... relevant sections of the SmPC (sect
Jul 1, 2017 - ... Report on the PSUR(s) for cetirizine / pseudoephedrine e, ... Grounds for the variation to the terms of the Marketing ... [The following adverse reaction should be added under the SOC Reproductive system and breast.
Apr 7, 2018 - **Uterine rupture has been uncommonly reported after prostaglandin intake during the second or third trimester of pregnancy. Uterine ruptures occurred particularly in multiparous women or in women with a caesarean section scar. Package
Dec 22, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for granisetron ... Annex III. Timetable for the implementation of this position ...
Jun 9, 2018 - Based on a comprehensive review of âparaesthesiaâ, including ... of hypersensitivity reactions to chrysanthemums including literature ...
Aug 5, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... for the variation to the terms of the Marketing Authorisation(s) ... Page 3 ...
Jun 9, 2018 - peak toxicity and prolonged recovery when compared to immediate-release (IR) quetiapine overdose: a retrospective cohort study. Clinical ...
Jun 4, 2017 - Grounds for the variation to the terms of the Marketing Authorisation(s). On the basis of the scientific conclusions for finasteride the CMDh is of ...
Mar 10, 2018 - trace residue from the manufacturing process), or to any of the excipients., or The the stopper of the glass vial with Actilyse powder which contains natural rubber (a derivative of latex). which may cause allergic reactions. No sustai
Dec 27, 2017 - for anxiety in one case and taking into account the listedness of these adverse reactions in the product information of other progestin only medicinal products, the lead member state considers that anxiety and depression should be incl
Aug 5, 2017 - colitis for proton pump inhibitors is relatively small and the number of ... Given the cases with positive de-challenge which clearly support the ...
Nov 25, 2017 - Allergic reactions the signs of which may include difficulty in breathing, dizziness, collapsing or losing consciousness, swelling of your face, lips ...
