Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)

1

Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for nadifloxacin, the scientific conclusions are as follows: Based on data from a post-marketing surveillance study carried out during the reporting period, the frequency categories for the adverse reactions erythema, application site burning, rash and urticaria have been estimated as uncommon for erythema, application site burning and rash (47, 36 and 27 cases respectively) and rare for urticaria (20 cases). The study included a total of 19.918 patients. Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing nadifloxacin, 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 nadifloxacin the CMDh is of the opinion that the benefitrisk balance of the medicinal product(s) containing nadifloxacin is unchanged subject to the proposed changes to the product information. The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied. To the extent that additional medicinal products containing nadifloxacin are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that such marketing authorisations are varied accordingly.

2

Annex II Amendments to the product information of the nationally authorised medicinal product(s)

3

Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)

Summary of Product Characteristics •

Section 4.8

[The adverse reactions application site burning and rash should be added with uncommon frequency. The frequency of the adverse reaction erythema should be changed to uncommon. The frequency of the adverse reaction urticaria should be changed to rare.] […] System Organ Class

Frequency

Adverse reactions

Skin and subcutaneous tissue

Common



Uncommon

Papules, dry skin, contact

disorders

dermatitis, skin irritation, skin warm, erythema, rash

General disorders and

Rare

Urticaria

Uncommon

Application site burning

application site conditions ….

Post-Marketing Data: Isolated reports: erythema, urticaria and hypopigmentation of the skin. […]

Package Leaflet 4. Possible side effect [The adverse reactions burning at application site and skin rash should be added with uncommon frequency. The frequency of the adverse reaction redness should be changed to uncommon. The frequency of the adverse reaction urticaria should be changed to rare.]

[…] Uncommon side effects (may affect up to 1 in 100 people): […] - Redness - Skin rash - Burning at application site

4

Rare side effects (may affect up to 1 in 1,000 people): - Urticaria

Post-Marketing Data: Isolated reports: erythema, urticaria and hypopigmentation of the skin. […]

5

Annex III Timetable for the implementation of this position

6

Timetable for the implementation of this position

Adoption of CMDh position:

January 2017 CMDh meeting

Transmission to National Competent Authorities

11 March 2017

of the translations of the annexes to the position: Implementation of the position by the Member

10 May 2017

States (submission of the variation by the Marketing Authorisation Holder):

7

CMDh Scientific conclusions and grounds for variation, amendments to

Mar 11, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for ... 3. Annex II. Amendments to the product information of the nationally ...

39KB Sizes 27 Downloads 314 Views

Recommend Documents

CMDh scientific conclusions and grounds for variation, amendments to ...
29 Oct 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for dexlansoprazole, lansoprazole, the scientific conclusions are as follows: During the ... Based on the above information, the PRAC considers that an update of the product

granisetron: CMDh scientific conclusions and grounds for the variation ...
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 ...

fluvastatin: CMDh scientific conclusions and grounds for the variation ...
The following adverse reaction(s) should be added under the SOC gastrointestinal disorders with a frequency 'not known': Diarrhoea. Package Leaflet.

Permethrin: CMDh scientific conclusions and grounds for the variation ...
Jun 9, 2018 - Based on a comprehensive review of “paraesthesia”, including ... of hypersensitivity reactions to chrysanthemums including literature ...

Felbamate: CMDh scientific conclusions and grounds for the variation ...
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 ...

Quetiapine: CMDh scientific conclusions and grounds for the variation ...
Jun 9, 2018 - peak toxicity and prolonged recovery when compared to immediate-release (IR) quetiapine overdose: a retrospective cohort study. Clinical ...

Finasteride: CMDh scientific conclusions and grounds for the variation ...
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 ...

alteplase: CMDh scientific conclusions and grounds for the variation ...
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

Rabeprazole: CMDh scientific conclusions and grounds for variation ...
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 ...

Bilastine: CMDh scientific conclusions and grounds for the variation ...
Nov 25, 2017 - Allergic reactions the signs of which may include difficulty in breathing, dizziness, collapsing or losing consciousness, swelling of your face, lips ...

gabapentin: CMDh scientific conclusions and grounds for the variation ...
Nov 26, 2016 - Taking into account the PRAC Assessment Report on the PSUR(s) for gabapentin, ... Annex III. Timetable for the implementation of this position ...

Thiopental: CMDh scientific conclusions and grounds for the variation ...
Jan 28, 2017 - Therefore, in view of the data presented in the reviewed PSUR(s), the ... The CMDh reaches the position that the marketing authorisation(s) of ...

Oxytocin: CMDh scientific conclusions and grounds for the variation ...
Due to the existing structural homology between oxytocin and latex, latex allergy/intolerance may be an important predisposing risk factor for anaphylaxis.

diacerein: CMDh scientific conclusions and grounds for the variation ...
28 Oct 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for diacerein, the scientific ... Based on the information presented in this PSUR, PRAC considered that section 4.8 of the Summary of. Product ... Amendments to be included i

Quinine - CMDh scientific conclusions and grounds for the variation ...
Oct 28, 2017 - Scientific conclusions. Taking into account the PRAC Assessment Report on the PSUR(s) for quinine, the scientific conclusions are as follows: Atrioventricular block ... The PRAC considers that the above information is relevant and ther

ivermectin: CMDh scientific conclusions and grounds for the variation ...
Taking into account the PRAC Assessment Report on the PSUR(s) for ivermectin (topical use), the scientific conclusions are as follows: During the reporting period, ... Amendments to be included in the relevant sections of the Product Information (new

Bilastine: CMDh scientific conclusions and grounds for the variation ...
Nov 25, 2017 - Taking into account the PRAC Assessment Report on the PSUR(s) for bilastine, the scientific conclusions are as follows: During the reporting interval a ... hypersensitivity reactions should be included in the product information for bi

Naproxen: CMDh scientific conclusions and grounds for the variation ...
Jun 9, 2018 - Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through).

Nicardipine: CMDh scientific conclusions and grounds for the variation ...
Mar 11, 2017 - monitoring of immunosuppressant tacrolimus (sirolimus and cyclosporine) in presence of the concomitant administration of nicardipine to ...

Tramadol: CMDh scientific conclusions and grounds for the variation ...
Mar 12, 2018 - If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect may not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an u

Saccharomyces boulardii: CMDh scientific conclusions and grounds ...
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

chlormadinone: CMDh scientific conclusions and grounds for the ...
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

diclofenac/misoprostol: CMDh scientific conclusions and grounds for ...
possible risks with exposure to non-steroidal anti-inflammatory drugs like diclofenac in pregnant women, in ... drugs with regard to use during pregnancy and risk of miscarriage and congenital malformations as agreed ... Women of childbearing potenti

Lanthanum - CMDh scientific conclusions and grounds for the ...
27 Jan 2018 - Taking into account the PRAC Assessment Report on the PSUR(s) for lanthanum, the scientific ... this PSUR, the PRAC considers that the product information of lanthanum containing medicinal products should be ... Amendments to the produc