NUROFEN FOR CHILDREN

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • NUROFEN FOR CHILDREN
  • Φαρμακολογική κατηγορία (ATC):
  • M01AE01
  • Δοσολογία:
  • 100MG/5ML
  • Φαρμακοτεχνική μορφή:
  • ΠΟΣΙΜΟ ΕΝΑΙΩΡΗΜΑ
  • Σύνθεση:
  • 0015687271 - IBUPROFEN - 20.000000 MG
  • Οδός χορήγησης:
  • ΑΠΟ ΤΟΥ ΣΤΟΜΑΤΟΣ
  • Τρόπος διάθεσης:
  • ΜΕ ΙΑΤΡΙΚΗ ΣΥΝΤΑΓΗ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

  • για το ευρύ κοινό:
  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.


    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

Εντοπισμός

  • Διατίθεται σε:
  • NUROFEN FOR CHILDREN
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • IBUPROFEN
  • Περίληψη προϊόντος:
  • 2802075004017 - 01 - FLx50 ML - 50.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802075004024 - 02 - FLx100 ML - 100.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802075004031 - 03 - FLx150 ML - 150.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802075004048 - 04 - FLx50 ML +δοσιμετρική σύριγγα - 50.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802075004055 - 05 - FLx100 ML + δοσιμετρική σύριγγα - 100.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY; 2802075004062 - 06 - FLx150 ML + δοσιμετρική σύριγγα - 150.00 - ΧΙΛΙΟΣΤΟΛΙΤΡΟ - Εγκεκριμένο (ΕΟΦ) - ΦΑΡΜΑΚΕIOY

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • Καθεστώς αδειοδότησης:
  • Εγκεκριμένο (ΕΟΦ)
  • τελευταία ενημέρωση:
  • 15-02-2018

Περίληψη των χαρακτηριστικών του προϊόντος

ΕΛΛΗΝΙΚΗ ΔΗΜΟΚΡΑΤΙΑ

ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ

Μεσογείων 284, 155 62 Χολαργός

ΑΘΗΝΑ, 12-5-2000

ΑΡ. ΠΡΩΤ.: 17870

Δ/νση Διοικητικών Υπηρεσιών Ελέγχου Προϊόντων

Πληροφορίες: Ε. ΧΑΝΤΖΗ

Τηλέφωνο: 6507200

ΕΓΚΥΚΛΙΟΣ - ΑΠΟΦΑΣΗ

ΘΕΜΑ: Καθορισμός Περίληψης Χαρακτηριστικών του Προϊόντος φαρμακευτικών

ιδιοσκευασμάτων

που

περιέχουν

δραστικό

συστατικό

IBUPROFEN για

μορφές από του στόματος και το ορθό.

΄Έχοντες υπόψη:

Τις διατάξεις του άρθρου 8 της κοινής Υπουργικής Απόφασης Α6/9392/91 “Περι

εναρμόνισης της Ελληνικής Νομοθεσίας με την αντίστοιχη Κοινοτική στον τομέα

της κυκλοφορίας ……….. των φαρμακευτικών ιδιοσκευασμάτων”,

Τη Γνωμάτευση του Επιστημονικού Συμβουλίου Εγκρίσεων αρ.Φ-409/13-10-99

Α Π Ο Φ Α Σ Ι Ζ Ο Υ Μ Ε

1.

Η Περίληψη Χαρακτηριστικών του Προϊόντος φαρμακευτικών ιδιοσκευασμάτων

που περιέχουν δραστικό συστατικό ΙBUPROFEN ορίζεται ως εξής:

ΕΝΔΕΙΞΕΙΣ

Φλεγμονώδεις και εκφυλιστικές παθήσεις των αρθρώσεων.

Χρόνια νεανική αρθρίτιδα.

Σαν αναλγητικό - αντιπυρετικό σε περιπτώσεις που δεν έχει αποδώσει η χρήση των

απλών αναλγητικών - αντιπυρετικών φαρμάκων.

Οξεία ουρική αρθρίτιδα.

Επώδυνα εξωαρθρικά μυοσκελετικά σύνδρομα.

Πρωτοπαθής δυσμηνόρροια.

ΔΟΣΟΛΟΓΙΑ

Μορφές άμεσης αποδέσμευσης

Χορηγούνται κατά προτίμηση μετά το γεύματα.

Ενήλικές:

Φλεγμονώδεις

και

εκφυλιστικές

παθήσεις

των

αρθρώσεων,

επώδυνα

εξωαρθρικά μυοσκελετικά σύνδρομα:

1,2g - 1,8g ημερησίως σε 3-4 διηρημένες δόσεις. Εάν κριθεί απαραίτητο η δόση

μπορεί να αυξηθεί μέχρι το ανώτερο 2,4g ημερησίως. Δόση συντήρησης

0,6-1,2g ημερησίως.

Πρωτοπαθής δυσμηνόρροια:

400mg κάθε 4 ώρες.

Ουρική αρθρίτιδα:

Η μέγιστη επιτρεπόμενη ημερήσια δόση για βραχύ χρονικό διάστημα (2 ημέρες).

Στη συνέχεια μείωση της δόσης στο ήμισυ.

Σαν αναλγητικό - αντιπυρετικό σε ενήλικές και παιδιά άνω των 12 ετών:

200mg κάθε 4-6 ώρες ή 300-400mg, 3-4 φορές ημερησίως.

Να λαμβάνεται η μικρότερη δυνατή δόση, που είναι αποτελεσματική.

Αν ο πόνος ή ο πυρετός δεν υποχωρήσουν η δόση μπορεί να ανέλθει στα

400mg χωρίς όμως να υπερβαίνει τα 1,2g/24ωρο, εκτός αν το συστήσει ο ιατρός.

Να μη χρησιμοποιείται σε εμπύρετες καταστάσεις για διάστημα μεγαλύτερο των

3 ημερών και σε επώδυνες καταστάσεις για διάστημα μεγαλύτερο των 6 ημερών,

εκτός αν το συστήσει ο ιατρός.

Μορφές βραδείας αποδέσμευσης, μόνο για ενήλικες (δεν ενδείκνυνται στην

Ένδειξη Αναλγητικό - Αντιπυρετικό):

- των 300mg:

600mg δύο φορές ημερησίως, που μπορεί να αυξηθεί σε 900mg δύο φορές

ημερησίως μέχρι να τεθεί υπό έλεγχο η οξεία φάση. Η τροφή καθυστερεί την

έναρξη της απορρόφησης.

Συνήθης δόση συντήρησης 300-600mg δύο φορές ημερησίως.

- των 800mg 800-1600mg ως εφάπαξ ημερήσια δόση ανάλογα με τη βαρύτητα

της νόσου, κατά προτίμηση νωρίς το βράδυ, αρκετό χρόνο πριν από την

κατάκλιση. Σε βαρείες ή οξείες καταστάσεις η ολική ημερήσια δόση μπορεί να

αυξηθεί σε 2,4g διηρημένα σε δύο δόσεις.

Παιδία.

- Χρόνια νεανική αρθρίτιδα.

Συνήθης δόση 30-70mg/kg/ημέρα σε 3 ή 4 διηρημένες δόσεις. Για ήπιες

καταστάσεις 20mg/kg/ημέρα μπορεί να επαρκούν.

- Σαν αναλγητικό-αντιπυρετικό (σε παιδιά μεγαλύτερα των 3 ετών και βάρους

άνω των 15kg) 20mg/kg/ημέρα σε 3 ή 4 διηρημένες δόσεις.

Μέγιστη δόση 500mg ημερησίως σε διηρημένες δόσεις.

Να λαμβάνεται η μικρότερη δυνατή δόση που είναι αποτελεσματική.

Να μη χρησιμοποιείται σε εμπύρετες καταστάσεις για διάστημα μεγαλύτερο των

3 ημερών και σε επώδυνες καταστάσεις για διάστημα μεγαλύτερο των 6 ημερών,

εκτός αν το συστήσει ο ιατρός.

ΑΝΤΕΝΔΕΙΞΕΙΣ

Σε ασθενείς με ενεργό πεπτικό έλκος ή ιστορικό πεπτικού έλκους ή άλλες οργανικές

παθήσεις του πεπτικού ή με ιστορικό υποτροπιαζουσών αιμορραγιών.

Σε ασθενείς με ιστορικό βρογχόσπασμου, ρινίτιδος ή κνίδωσης που σχετίζονται με

χρήση ασπιρίνης ή άλλων αντιφλεγμονωδών μη στεροειδών φαρμάκων.

Σε ασθενείς αλλεργικούς στο φάρμακο.

Στην εγκυμοσύνη και γαλουχία ( η ασφάλεια του για τέτοια χρήση δεν έχει ακόμη

διαπιστωθεί).

Σε ασθενείς που λαμβάνουν ταυτόχρονα άλλα μη στεροειδή αντιφλεγμονώδη

φάρμακα ή ασπιρίνη.

Σε ασθενείς με αιματολογική νόσο.

Σε ασθενείς με βαρεία ηπατική ή νεφρική ανεπάρκεια.

Σε παιδιά ηλικίας μικρότερης των 3 ετών και βάρους μικρότερου των 15kg.

ΙΔΙΑΙΤΕΡΕΣ ΠΡΟΦΥΛΑΞΕΙΣ & ΠΡΟΕΙΔΟΠΟΙΗΣΕΙΣ ΚΑΤΑ ΤΗ ΧΡΗΣΗ

Το φάρμακο πρέπει να χορηγείται σε μειωμένη δόση και με προσοχή:

Σε ασθενείς με χρόνια νεφρική ανεπάρκεια.

Σε υπερήλικες και εξασθενημένα άτομα.

Σε ασθενείς με σημαντική έκπτωση της καρδιακής λειτουργίας.

Σε ασθενείς με υπέρταση που λαμβάνουν διουρητικά.

Σε ασθενείς με ηπατική ανεπάρκεια.

Σε ασθενείς με συστηματικό ερυθηματώδη λύκο.

Σε μακροχρόνια χορήγηση χρειάζεται κατά διαστήματα αιματολογικός έλεγχος του

ασθενούς.

ΑΛΛΗΛΕΠΙΔΡΑΣΕΙΣ ΜΕ ΑΛΛΑ ΦΑΡΜΑΚΑ

Το φάρμακο, όπως και τα υπόλοιπα μη στεροειδή αντιφλεγμονώδη, συνδέεται σε

μεγάλο ποσοστό με τις λευκωματίνες του ορού και υπάρχει η πιθανότης να εκτοπίσει

από αυτές άλλα φάρμακα που έχουν την ίδια ή μικρότερη ικανότητα σύνδεσης

αυξάνοντας έτσι την δραστικότητά τους. Γι' αυτό χρειάζεται προσοχή όταν χορηγείται

ταυτόχρονα, ιδιαίτερα σε μεγάλες δόσεις, με κουμαρινικού τύπου αντιπηκτικά

(βαρφαρίνη), σουλφονυλουρίες, υδαντοϊνες ή σουλφοναμίδες.

Η συγχορήγησή του με λίθιο αυξάνει τα επίπεδα του λιθίου στο πλάσμα, με

μεθοτρεξάτη αυξάνεται η τοξικότητα της, με κινολόνες αυξάνεται ο κίνδυνος

εμφάνισης σπασμών, με κορτικοειδή αυξάνεται ο κίνδυνος αιμορραγίας από το

γαστρεντερικό και με διουρητικά προκαλείται μείωση της δράσης τους, αφετέρου δε

τα διουρητικά μπορεί να ενισχύσουν τον κίνδυνο νεφροτοξικότητας από τα μη

στεροειδή αντιφλεγμονώδη φάρμακα.

Συνιστάται να αποφεύγεται η συγχορήγηση του φαρμάκου με άλλα μη στεροειδή

αντιφλεγμονώδη

φάρμακα,

αμεθοπτερίνη,

κυκλοσπορίνη

και

αντιυπερτασικά

φάρμακα, για τα οποία απαιτείται προσαρμογή της δοσολογίας.

ΧΟΡΗΓΗΣΗ ΚΑΤΑ ΤΗΝ ΚΥΗΣΗ ΚΑΙ ΓΑΛΟΥΧΙΑ

Η ασφάλεια κατά τη χρήση της IBUPROFEN, όπως και των άλλων ΜΣΑΦ κατά την

κύηση δεν έχει τεκμηριωθεί, δια τούτο δεν συνιστάται η χρήση της. Ιδιαίτερα κατά το

τρίτο τρίμηνο της κύησης μπορεί να προκαλέσει πρώιμη σύγκλειση του βοτάλειου

πόρου παράταση της κύησης και αύξηση της τοξικότητας στο γαστρεντερικό

σύστημα της εγκύου, διά τούτο αντενδείκνυται η χορήγησή της αυτήν την χρονική

περίοδο.

Παρόλο που η ποσότητα του φαρμάκου που εκκρίνεται στο μητρικό γάλα είναι πολύ

μικρή, συνιστάται να αποφεύγεται η χρήση του κατά τη γαλουχία.

ΕΠΙΔΡΑΣΗ ΣΤΗΝ ΙΚΑΝΟΤΗΤΑ ΟΔΗΓΗΣΗΣ ΚΑΙ ΧΕΙΡΙΣΜΟΥ ΜΗΧΑΝΗΜΑΤΩΝ

Δεν έχει αναφερθεί τέτοια επίδραση.

ΑΝΕΠΙΘΥΜΗΤΕΣ ΕΝΕΡΓΕΙΕΣ

Οι συχνότερες ανεπιθύμητες ενέργειες είναι:

Από το γαστρεντερικό σύστημα: Επιγαστρικό άλγος, καύσος, ναυτία, διάρροια,

δυσπεψία, αίσθημα πληρότητας, ελαφρά κοιλιακά άλγη, δυσκοιλιότητα, τυμπανισμός.

Από το Κεντρικό Νευρικό σύστημα: Κεφαλαλγία, καρηβαρία, νευρικότητα. Άσηπτη

μηνιγγίτιδα σε μερικές περιπτώσεις. Στη χρόνια χρήση μείωση της μνήμης.

Από το δέρμα: Εξάνθημα κνησμός, κνίδωση.

Από τα αισθητήρια όργανα: Εμβοές των ώτων, τοξική αμβλυωπία.

Γενικά: Ανορεξία, κατακράτηση υγρών και ελαφρό οίδημα.

Σπάνια έχει αναφερθεί πνευμονική ίνωση.

Σπανιώτατα έχουν αναφερθεί πεπτικό έλκος, γαστρορραγία, έμετος, μέλαινα,

διάτρηση στομάχου, αλωπεκία, πολύμορφο ερύθημα, παγκρεατίτιδα, διαταραχές

νεφρικής λειτουργίας, διαταραχές της ηπατικής λειτουργίας, καρδιακό οίδημα,

αρρυθμία, διαταραχές της όρασης, επιπεφυκίτις, κατάθλιψη, αϋπνία, αναιμία,

λευκοπενία, θρομβοπενία.

ΥΠΕΡΔΟΣΟΛΟΓΙΑ

Δεν υπάρχει ειδικό αντίδοτο. Σε περίπτωση υπερδοσολογίας πρέπει να εφαρμόζεται

η κλασσική υποστηρικτική θεραπεία δηλ. πρόκληση εμέτου, πλύση στομάχου,

διατήρηση της νεφρικής λειτουργίας.

ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ

To IBUPROFEN είναι ένα μη στεροειδές αντιφλεγμονώδες φάρμακο, παράγωγο του

προπιονικού οξέος. Έχει σημαντική αντιφλεγμονώδη, αναλγητική και αντιπυρετική

δράση που οφείλεται κύρια στην αναστολή της σύνθεσης των προσταγλανδινών που

προκαλεί.

Όταν χορηγηθεί από το στόμα απορροφάται ταχέως και η μέγιστη στάθμη του στο

αίμα επιτυγχάνεται μετά από 1 έως 2 ώρες για τις μορφές άμεσης και πολύ

περισσότερο για τις μορφές βραδείας αποδέσμευσης.

Ο χρόνος ημίσειας ζωής του στο πλάσμα είναι περίπου 2 ώρες.

Επίσης ταχέως απορροφάται μετά την χορήγηση του από το ορθό. Συνδέεται σε

μεγάλο βαθμό (90-99%) με τις πρωτεΐνες του πλάσματος. Μεταβολίζεται στο ήπαρ

σε δύο αδρανείς μεταβολίτες και αποβάλλεται από τους νεφρούς, κύρια και αδρανείς

μεταβολίτες και ολιγώτερο σαν αμετάβλητη IBUPROFEN. Η απέκκριση από τους

νεφρούς είναι ταχεία και πλήρης.

2.

Οι δικαιούχοι και αντιπρόσωποι υποχρεούνται για την εφαρμογή της ανωτέρω

εγκυκλίου.

3.

Κατόπιν των ανωτέρω παύει να ισχύει η εγκύκλιος μας αρ. 33128/25-10-94.

ΑΠΟΔΕΚΤΕΣ ΓΙΑ ΕΝΕΡΓΕΙΑ:

Ετ.: WYETH ΕΛΛΑΣ ΑΕΒΕ

Ο ΠΡΟΕΔΡΟΣ ΔΣ/ΕΟΦ

Κύπρου 126 & 25ης Μαρτίου

164 52 Αργυρούπολη

Υπουργείο Υγείας & Πρόνοιας

ΚΑΘ. ΧΑΡ.

ΜΟΥΤΣΟΠΟΥΛΟΣ

Δ/νση Φαρμάκων & Φαρμακείων

Αριστοτέλους 17, 101 87 Αθήνα

Υπ. Εργασίας & Κοιν. Ασφαλίσεων

Γενική Γραμματεία Κοινωνικών Ασφαλίσεων

Δ/νση Ασφάλισης Ασθένειας & Μητρότητας

Σταδίου 29, 101 10 Αθήνα

Πανελλήνιο Ιατρικό Σύλλογο

Πλουτάρχου 3, 106 75 Αθήνα

(με την παράκληση ενημέρωση

των τοπικών Ιατρικών Συλλόγων της χώρας)

Πανελλήνια Ένωση Φαρμακοποιών

Κορύζη 6, 117 43 Αθήνα

Πανελλήνιο Φαρμακευτικό Σύλλογο

Πειραιώς 134 & Αγαθημέρου

118 54 Αθήνα

(με την παράκληση ενημέρωση των

τοπικών Συλλόγων

Πανελλήνια Ένωση Φαρμακοποιών

Νοσηλευτικών Ιδρυμάτων

Μιχαλακοπούλου 99, 115 27 Αθήνα

ΙΚΑ-Φαρμ/κή Υπηρεσία

Αγ.Κων/νου 8, 102 41 Αθήνα

ΟΓΑ Κλάδος Φαρμακευτικής Περίθαλψης

Πατησίων 30, 106 77 Αθήνα

Οίκος Ναύτου Πειραιώς

Κ.Παλαιολόγου 15

185 35 Πειραιάς

Οίκος Ναύτου Αθήνας

Σατωβριάνδου 20

104 31 Αθήνα

Κέντρο Δηλητηριάσεων

Νοσοκομείο Παίδων “Π.& Α.Κυριακού”

115 27 Γουδί

ΣΦΕΕ

Λ. Βασ. Γεωργίου 50 & Μ.Ασίας

152 33 Χαλάνδρι

Πανελλήνια ‘Ενωση Φαρμακοβιομηχανίας

Δεληγιώργη 12, 104 37 Αθήνα

Σύλλογο Αντ/πων Φαρμακευτικών Ειδών & Ειδικοτήτων

Οδός Τατοϊου

18ο χλμ. εθνικής Οδού Αθηνών-Λαμίας

146 10 ΝΕΑ ΕΡΥΘΡΑΙΑ

Δελτίο Αγορανομίας

Πανεπιστημίου 42, 106 79 Αθήνα

17 . Μη μέλη Συλλόγων

(όπως ο πίνακας)

ΕΣΩΤΕΡΙΚΗ ΔΙΑΝΟΜΗ:

Δ/νση Αξιολόγησης Προϊόντων

Δ/νση Πληροφόρησης & Δημ. Σχέσεων

Δ/νση Φαρ/κών Μελετών & ‘Έρευνας

Δ/νση Εργαστηρίων

Δ/νση Ελέγχου Παραγωγής & Κυκλοφορίας Προϊόντων

Δ/νση Δ/κών Υπηρεσιών Ελέγχου Προϊόντων

α) Τμήμα Γενικού Αρχείου

β) Τμήμα Μηχ. Ενημέρωσης

γ) Τμήμα Έκδοσης & Κωδ. Αποφάσεων

Γραμματεία Δευτεροβάθμιου Επιστημονικού Συμβουλίου

εγκ.1

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  • Έγγραφα σε άλλες γλώσσες διατίθενται εδώ

14-11-2018

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

Laboratoire RivaInc. and Laboratoires Trianon Inc. are voluntarily recalling several over-the-counter children’s strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option, or Laboratoires Trianon Inc. The products, which are used for pain and fever relief, are being recalled because the child-resistant safety cap may be defective.

Health Canada

7-11-2018

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

2-11-2018

Brin de Folie recalls Wind-up Racoon Toys

Brin de Folie recalls Wind-up Racoon Toys

Health Canada's sampling and evaluation program has determined that the affected products do not meet the Canadian safety requirements for toys. The tail can detach from the toy, posing a choking hazard to young children.

Health Canada

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

18-10-2018

CTG recalls Friction Powered School Bus

CTG recalls Friction Powered School Bus

Health Canada's sampling and evaluation program has determined that the school bus toy does not meet Canadian safety requirements for toys. Specifically, the school bus released small parts during testing, which are a choking hazard for young children.

Health Canada

10-10-2018

BSN SPORTS recalls Rubber Critter Toys

BSN SPORTS recalls Rubber Critter Toys

The paint on the toys contained levels of lead in excess of the allowable limit. Lead is toxic to children even at low exposure levels. Children can ingest harmful amounts of lead when they chew or suck items containing lead.

Health Canada

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

28-9-2018

Button batteries: ingestion by young children can have serious consequences

Button batteries: ingestion by young children can have serious consequences

France - Agence Nationale du Médicament Vétérinaire

26-9-2018

Boy Story LLC recalls Action Dolls

Boy Story LLC recalls Action Dolls

The joints on the vinyl dolls can break, creating broken pieces that pose a choking hazard to young children.

Health Canada

20-9-2018

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Health Canada's sampling and evaluation program has determined that the rubber animals do not meet the Canadian safety requirements for toys. The squeakers inside the rubber animals can be easily removed; these small parts pose a choking hazard to young children.

Health Canada

19-9-2018

Exclusive Brands and iSweet recall Kidsmania Bubble Dozer

Exclusive Brands and iSweet recall Kidsmania Bubble Dozer

Health Canada's sampling and evaluation program has determined that these products do not meet the Canadian safety requirements for toys.Small parts can break off the toys, posing a choking hazard to young children.

Health Canada

19-9-2018

Imagine recalls Minyore Aircraft

Imagine recalls Minyore Aircraft

Plastic parts can separate from the airplane posing a small parts choking hazard for small children.

Health Canada

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

FDA awards five grants to advance the development of pediatric medical devices

FDA awards five grants to advance the development of pediatric medical devices

FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices

FDA - U.S. Food and Drug Administration

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

30-8-2018

Great Canadian Dollar Store recalls Lobster Plush Toys

Great Canadian Dollar Store recalls Lobster Plush Toys

Health Canada's sampling and evaluation program has determined that these plush toys do not meet the Canadian safety requirements for toys. The hard plastic eyes on these plush toys can detach, posing a choking hazard to young children.

Health Canada

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

27-8-2018

ELEMENT recalls boys' jackets with waist drawstrings

ELEMENT recalls boys' jackets with waist drawstrings

Drawstrings on children's outerwear can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant entanglement hazard to children.

Health Canada

24-8-2018

Imagine recalls Buckyballs magnet sets

Imagine recalls Buckyballs magnet sets

Health Canada has determined that these magnet sets are a danger to human health and safety because they contain small powerful magnets which can be easily swallowed or inhaled by children. Unlike other small objects that would be more likely to pass normally through the digestive system if swallowed, when more than one small powerful magnet is swallowed, the magnets can attract one another while travelling through the digestive system. The magnets can then pinch together and create a blockage and slowly...

Health Canada

23-8-2018

The Manhattan Toy Company recalls Pull-Back Speedy Jets

The Manhattan Toy Company recalls Pull-Back Speedy Jets

The rubber tires can separate from the wheels posing a small parts choking hazard for small children.

Health Canada

21-8-2018

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...

FDA - U.S. Food and Drug Administration

21-8-2018

Confer Plastics, Inc. recalls Curve Pool Step Systems

Confer Plastics, Inc. recalls Curve Pool Step Systems

Children’s limbs can be entrapped in the side openings, posing a drowning hazard.

Health Canada

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

14-8-2018

Calikids Inc. recalls children's jackets with waist drawstrings

Calikids Inc. recalls children's jackets with waist drawstrings

Drawstrings on children’s outerwear can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant entanglement hazard to children.

Health Canada

7-8-2018

Dollarama recalls the Skip Ball toy

Dollarama recalls the Skip Ball toy

The Skip Ball toy may contain levels of phthalates that exceed the allowable limit. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

4-6-2018

Reward Connections Inc. Recalls Ottawa Senators Onesies with Metal Snaps

Reward Connections Inc. Recalls Ottawa Senators Onesies with Metal Snaps

The metal snaps on the recalled Ottawa Senators onesies may detach resulting in a choking hazard to young children.

Health Canada

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhe...

FDA - U.S. Food and Drug Administration

25-5-2018

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

These toys do not meet the Canadian safety requirements for toys. Some of the soft, stretchy parts of the toys can stretch to extreme lengths, posing a strangulation hazard to children.

Health Canada

23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

OTC oral health products containing benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed. FDA is asking companies to stop selling these products for such use and requesting that companies add new warnings to all other benzocaine oral health products to describe certain serious risks.

FDA - U.S. Food and Drug Administration

23-5-2018

Do Teething Babies Need Medicine on Their Gums? No

Do Teething Babies Need Medicine on Their Gums? No

Teething is a normal part of childhood that doesn’t need a 'cure' with prescription or over-the-counter (OTC) medications. FDA warns parents that benzocaine products are not safe for treating teething in children. There are safer, non-toxic alternatives.

FDA - U.S. Food and Drug Administration

23-5-2018

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication  - Risk of Serious and Potentially Fatal Blood Disorder

Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder

Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.

FDA - U.S. Food and Drug Administration

23-5-2018

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Health Canada's sampling and evaluation program has determined that the recalled toy does not meet the Canadian safety requirements for toys. The numbered blocks are small parts and the toy may further break apart exposing more small parts, posing a choking hazard for young children.

Health Canada

23-5-2018

Golden International Corporation  Issues Public Safety Warning For Stolen Tilapia Because  of Possible Health Risk

Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection wi...

FDA - U.S. Food and Drug Administration

22-5-2018

Porsche Cars Canada, Ltd. recalls My First Porsche - Wooden Car (in blue/black)

Porsche Cars Canada, Ltd. recalls My First Porsche - Wooden Car (in blue/black)

The wheels and axles of the toy car may come loose and detach, posing a choking hazard to young children.

Health Canada

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

19-5-2018

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarr...

FDA - U.S. Food and Drug Administration

17-5-2018

Dollarama L.P. recalls Oball Rollin' Rainstick and Oball 2-IN-1 Roller

Dollarama L.P. recalls Oball Rollin' Rainstick and Oball 2-IN-1 Roller

If the ball structure were to be damaged, pieces of the ball could be pulled off therefore posing a choking hazard to young children. As of May 14, 2018, the company has received two incidents with no injuries in Canada.

Health Canada

11-5-2018

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

FDA - U.S. Food and Drug Administration

4-5-2018

 Slime: a very popular toy putty that is not without risk

Slime: a very popular toy putty that is not without risk

ANSES and the DGCCRF are alerting consumers to the risks associated with making and handling "slime". Slime, a sticky and elastic putty for kneading, is currently very popular with children and adolescents. It is commercially available in ready-to-use form or in kits. It can also be made at home, in order to vary its appearance and texture (by adding colour, glitter, etc.). Tutorials on how to make slime have proliferated on the Internet and offer many recipes, based on ingredients such as paper glue and...

France - Agence Nationale du Médicament Vétérinaire

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

1-5-2018

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies

FDA - U.S. Food and Drug Administration

1-5-2018

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

FDA - U.S. Food and Drug Administration

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.

Health Canada

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

14-8-2018

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting.  We look forward to continuing discussions around increasing medical device options for children today.  #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevice pic.twitter.com/7cXPFfvfif

FDA - U.S. Food and Drug Administration

31-7-2018

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more.  https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/UzKDyAyER5

FDA - U.S. Food and Drug Administration

31-7-2018

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children.  https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/ZP3ImzNw2T

FDA - U.S. Food and Drug Administration

31-7-2018

The #FDA promotes timely access to safe and effective medical devices for all patients, and supports pathways for children to share equally in medical device innovation.

The #FDA promotes timely access to safe and effective medical devices for all patients, and supports pathways for children to share equally in medical device innovation.

The #FDA promotes timely access to safe and effective medical devices for all patients, and supports pathways for children to share equally in medical device innovation.

FDA - U.S. Food and Drug Administration

31-7-2018

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date.  Learn more about the PDC here:  https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #Med

FDA’s Pediatric Device Consortia Grant Program (PDC) facilitates the development, of medical devices for children. 18 pediatric medical devices have been approved/cleared to date. Learn more about the PDC here: https://go.usa.gov/xUvBC  #Pediatrics #MedicalDevice #FDA pic.twitter.com/HgMSCIbmra

FDA - U.S. Food and Drug Administration

31-7-2018

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market.  http://go.usa.gov/xUvZ7 

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7 

Many medical devices for children may be approved by the Humanitarian Device Exemption pathway. Learn how the Humanitarian Device Exemption pathway program & other pathways can bring more devices intended for children to market. http://go.usa.gov/xUvZ7  #Pediatrics #medicaldevice pic.twitter.com/LEaSk1efJ5

FDA - U.S. Food and Drug Administration

31-7-2018

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here:  https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm  #Pediatrics #medicaldevice pic.twitter.com/c0cuVYtTLK

FDA - U.S. Food and Drug Administration

17-7-2018

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register.  #Pediatrics  https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevice pic.twitter.com/hL7vawmOgR

FDA - U.S. Food and Drug Administration

24-5-2018

Pedea (Orphan Europe S.A.R.L.)

Pedea (Orphan Europe S.A.R.L.)

Pedea (Active substance: Ibuprofen) - PSUSA - Modification - Commission Decision (2018)3257 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1712/201707

Europe -DG Health and Food Safety