چينوتروپين ١٢

المعلومات الرئيسية

  • اسم تجاري:
  • چينوتروپين ١٢
  • الشكل الصيدلاني:
  • LYOPHILIZED POWDER FOR INJECTION
  • طريقة التعاطي:
  • S.C
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • PFIZER MANUFACTURING BELGIUM NV/SA

المستندات

الأقلمة

  • متاح في:
  • چينوتروپين ١٢
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • SOMATROPIN
  • الخصائص العلاجية:
  • Children: Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner`s syndrome. Short stature in children with renal insufficiency. Growth disturbance (height SDS<2.5 and parenteral adjusted height SDS < -1) in short children born SGA (SGA - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth witght and/or length < 2 SD who failed to show catch up growth (HV SDS < 0 during the last year) by 4 years of age or later. Prader willi syndrome for improvement of growth and body composition. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have aquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 121352754022
  • تاريخ الترخيص:
  • 01-02-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ

±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©

‡Ù¯†Ì˘¯Ó·†·ÈÈÁ†‰Ê†¯È˘Î˙

¯È˘Î˙·†ÈØ˘Ó˙˘˙†Ì¯Ë·†ÂÙÂÒ†„Ú†ÔÂÏÚ‰†˙‡†ÔÂÈÚ·†È؇¯˜

˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ

¯˘Â‡Â†˜„·†ÂÎÂ˙Â

ÔÈÙ¯ËÂ‚ ÔÈÙ¯ËÂ‚

‚¢Ó †μÆ≥ ‚¢Ó †±≤

˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†‰˜·‡ ˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†‰˜·‡

‰ÒÓ‰†È¯Á‡ ‰ÒÓ‰†È¯Á‡

∫·Î¯‰

∫‰ÏÈÎÓ†‰˜·‡†˙ÈÒÁÓ†ÏÎ ∫‰ÏÈÎÓ†‰˜·‡†˙ÈÒÁÓ†ÏÎ

Somatropin 5.3 mg Somatropin 12 mg

Glycine, Sodium dihydrogen ††††††††††∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ

phosphate anhydrous, Disodium phosphate anhydrous,

Water for injections, m-Cresol, Mannitol.

∫‰Êȯ‡

¯Â„Ó·†‰˜¯Ê‰Ï†‰˜·‡†ÌÚ†˙ȯ„Ó≠„†˙ÈÒÁÓ†‰ÏÈÎÓ†‰Êȯ‡†ÏÎ

„ÚÂÈÓ†¯È˘Î˙‰†ÆÈ˘‰†¯Â„Ó·†‰˜·‡‰†˙ÒӉφÒÓÓ†„Á‡

Æ„·Ï·†ÔÈÙ¯ËÂ‚†ËÚ·†˘ÂÓÈ˘†˙ÂÚˆÓ‡·†˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï

ËÚ·†˙ȯ„Ó≠„‰†˙ÈÒÁÓ·†ÈÓÚÙ≠·¯†˘ÂÓÈ˘†˘Ó˙˘‰Ï†Ô˙È

Ɖ˜¯Ê‰‰

ƉÏÈ„‚†ÔÂӯ‰ ∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜

∫˙ȇÂÙ¯†˙ÂÏÈÚÙ

‰˘¯Ù‰≠ȇ†È„È≠ÏÚ†˙ÂÓ¯‚‰†ÌÈ„ÏÈ·†‰ÏÈ„‚†˙ÂÈÚ··†ÏÂÙȈ∫ÌÈ„ÏÈ·

˙¯˙ÂȆ˙ËÂÏ·Ó†‰ÏÈ„‚‰†ÔÂӯ‰†Ï˘†˙˜ÙÒÓ†‡Ï†‰˘¯Ù‰†Â‡

ÆÁÂÓ‰

Ư¯Ë†Ì¯„ÈÒ†ÌÚ†˙Â··†‰ÏÈ„‚†˙ÂÈÚ·

Æ˙È˙ÈÈÏΆ‰˜ÈÙ҆ȇ†·˜Ú†ÌÈ„ÏÈ·†‰ÏÈ„‚†·ÂÎÈÚ

Æ® Prader-Willi's syndrome ©†ÈÏÈÂÂ≠¯„‡¯Ù†˘¢Ú†Ì¯„ÈÒ

Æ® SGA ©†ÔÂȯ‰‰†ÔÓÊφÌÈ˘†Â„ÏÂ˘†ÌÈ„ÏÈ

ʇӆ‰ÏÈ„‚†ÔÂӯ‰·†¯ÂÒÁÓÓ†ÂÏ·Ò˘†Ìȯ‚·Óφ∫Ìȯ‚·ӷ

·˜Ú†‰ÏÈ„‚†ÔÂӯ‰·†¯ÒÂÁÓ†ÌÈÏ·ÂÒ‰†Ìȯ‚·Óφ¨˙„Ïȉ

ÆÁÂÓ‰†˙¯˙ÂȆ˙ËÂÏ··†‰ÈÚ·

ø¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó

È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†‰Ú„Ȇ̇†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ¯È˘Î˙‰

Æ®ÔÏ‰Ï†È /‰‡¯©†Ï„Ȃφ˙„چÌÚ†ÌÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

ÆÏÈÚÙ†È˙Ï‚Ï‚†ÍÂ˙†Ï„Ȃ†ÌÚ†ÌÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

˙ÏÁ˙‰†Ì¯Ë†Â·†ÏÂÙÈˉ†˙‡†ÌÈÏ˘‰Ï†˘È†Ï„Ȃ†ÔÁ·Â‡†Ì‡

ÆÔÈÙ¯ËÂ‚·†˘ÂÓÈ˘‰

¯Á‡Ï†ÌÈÈËȯ˜†ÌÈηÈÒÓ†ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†˘Ó˙˘‰Ï†Ôȇ

‰˜ÈÙÒ≠ȇ†¨˙È˙ίÚÓ≠·¯†‰Ó‡¯Ë†¨ÔË·†ÈÁÂ˙È†¨ÁÂ˙Ù†·Ï†ÁÂ˙È

ÆÌÈÓ„†ÌÈ·ˆÓ†‰ÓÈ˘‰†˙ίÚÓ†Ï˘

˙ÂÈÁÂφÌÚ†ÌÈ„ÏÈ·†‰ÏÈ„‚†„„ÈÚ†¯Â·Ú†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ˙¯‚҆®˙ÂÊÈÙÈÙ‡©†‰ÏÈ„‚

ÏÂÙÈˉ†˙‡†˜ÈÒىφ˘È†¨˙È¯Ά˙ÂÈÏΆ˙ÏÁÓ†ÌÚ†ÌÈ„ÏÈ·

Íȉ†Ì‡†˘Ó˙˘‰Ï†Ôȇ†Æ‰ÈÏΆ˙Ï˙˘‰†ÈÙφÔÈÙ¯ËÂ‚·

ƉÈÏΆ˙ØÏ˙˘ÂÓ

ÌÈÏ·ÂÒ‰†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙†ÈÏÂÁ·†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

Æ˙¯ÂÓÁ†‰ÓÈ˘†˙Âگى†¨‰¯ÂÓÁ†‰Ó˘‰Ó

ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ

∫ÏÂÙÈˉ†˙ÏÁ˙‰

Ɖ˜ÈÈӆ‡†ÔÂȯ‰·†Íȉ†Ì‡

¨‰ÈÏΉ†„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íȉ†Ì‡

∫˙¯‰Ê‡

ÍÈÏÚ†¨È‰˘ÏΆ‰Ù¯˙φ‡†Â‰˘ÏΆÔÂÊÓφ‰Ø˘È‚¯†Íȉ†Ì‡

Æ¯È˘Î˙·†˘ÂÓÈ˘‰†ÈÙφ‡Ù¯φÍÎ≠ÏÚ†ÚȄ‰Ï

·Ï†ÈÁÂ˙È†Ô‚Ω†˙ÎÂÒÓ†‰ÏÁÓ·†ÌÈÏÂÁ†ÏÂÙÈˉ†Íωӷ†Ì‡

˘È†®ßÂΆ˙È˙ίÚÓ†·¯†‰Ó‡¯Ë†¨˙È˙ÓÈ˘†‰˜ÈÙ҆ȇ†¨ÔË·Â

ƇÙ¯φÍÎ≠ÏÚ†ÚȄ‰Ï

˙¯Á‡†˙ÂȇÂÙ¯†˙·ÈÒ†ÏÂÏ˘Ï†˘È†ÌÈÎÂÓ†Â„ÏÂ˘†ÌÈ„ÏÈ·

Æ¯È˘Î˙·†ÏÂÙÈˉ†˙ÏÈÁ˙†ÈÙφ‰ÏÈ„‚†˙ÂÚ¯Ù‰Ï

Úˆ·Ï†˘È†®ÔÂȯ‰‰†ÔÓÊφÌÈ˘†Â„ÏÂ˘†ÌÈ„ÏÈ©† SGA †ÈÏÂÁ·

ÏÂÙÈˉ†˙ÏÈÁ˙†ÈÙφ̈·†Ì„·†ÔÈÏÂÒȇ†Ê˜ÂÏ‚†˙Âӯφ˙˜Ȅ·

ÈÂÓ„†‰ÏÈ„‚†¯Â˘ن˙˜È„·†ÔΆ¨ÔÎÓ†¯Á‡Ï†‰˘†ÏΆ¯È˘Î˙·

ÆÏÂÙÈˉ†Íωӷ†‰˘·†ÌÈÈÓÚÙ†ÏÂÙÈˉ†ÈÙφ ( IGF-I )†±†ÔÈÏÂÒȇ

‰ÓÈÒÁ†˙ÂÁÎÂφ¯Â¯È·†Úˆ·Ï†˘È†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙·†ÌÈÏÂÁ·

̯ˆ‰È˘·†‰ÓÈ˘†˙˜Òىφ˙ÂÂÈÏÚ‰†‰ÓÈ˘‰†Èί„·

¯È˘Î˙·†ÏÂÙÈˉ†Âχ†ÌÈÏÂÁ·†ªÔÈÙ¯ËÂ‚·†ÏÂÙȈ˙ÏÁ˙‰

ƉÓȇ˙Ó†‰Ë‡È„†ÌÚ†·Ï¢ӆ˙ÂȉφÍȯˆ

ÌÈÓÈÒ†¯Á‡†·˜ÚÓ†Úˆ·Ï†˘È†ÈÏÈÂÂ≠¯„‡¯Ù†˙ÂÓÒ˙·†ÌÈÏÂÁ·

¨˙¯ÈÁ·†‰¯ÓÁ‰†Â‡†‰ÏÁ˙‰†Ô‚Ά¨‰ÓÈ˘‰†Èί„·†Ì‰ÈÊÏ

ÆÌÈ„ÏÈ·†˙Ó˜ÚÂ

˙È˙ÁÙ˘Ó†‰È¯ÂËÒȉ†∫‡Ó‚„ϩ†˙¯ÎÂÒφÔÂÎÈÒ†ÌÚ†ÌÈÏÂÁ·

‰Ș˙†‡Ï†‰ÈˆËÓ‚ÈÙ†¨ÔÈÏÂÒȇφ˙„‚˙†¨‰Ó˘‰†¨˙¯ÎÂÒ†Ï˘

ÆʘÂςφ˙ÂÏÈ·Ò†˙˜È„·†Úˆ·Ï†˘È†®¯ÂÚ‰†Ï˘

˙Ó¯†˙‡†¨ÌÈÓÈÂÒÓ†ÌÈ·ˆÓ·†¨˙ÂÏډφÏÂÏÚ†‰ÏÈ„‚†ÔÂӯ‰

ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†ÔÈÙ¯ËÂ‚·†˘ÂÓÈ˘‰†ÔÎφ¨Ì„·†¯ÎÂÒ‰

ÛË¢†·˜ÚÓ†Æ˙¯ȉʆÈÚˆÓ‡†˙ËȘ†ÍÂ˙†‰˘ÚÈȆ˙¯ÎÂÒÓ

ƉχΆÌȯ˜Ó·†ÌÈÈÁ¯Î‰†‰„ÂÓˆ†‰Á‚˘‰Â†¯ÎÂÒ‰†˙Ó¯†¯Á‡

ÏÂÙÈ˷†∂∞†ÏÈ‚†ÏÚÓ†ÌÈÏÂÁ·†ÏÂÙÈˉ†˙„‡†Ï·‚ÂÓ†Ú„ÈÓ†ÌÈȘ

ÆÈÏÈÂÂ≠¯„‡¯Ù†˘¢Ú†Ì¯„ÈÒ†ÈÏÂÁ·Â†Ìȯ‚·ӷ†Í˘ÂÓÓ

ÈÂÏȂφ˙ÂÙÂÎ˙†˙˜Ȅ·†¯Â·Úφ˘È†¨Ï„Ȃ†ÌÚ†¯·Ú·†˙Á·Â‡†Ì‡

ÆÏ„Ȃ‰†˙Â˘È‰

·ÎÚφÏÂÏÚ†˙ÓÈÂÒÓ†‰Ó†ÏÚÓ†ÌȄȇ¯ËÒ˜È˯˜·†ÏÂÙÈË

Ìȇ˙‰Ï†˘È†¨ ACTH †¯ÒÂÁÓ†ÏÈ·˜Ó·†ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·†Æ‰ÏÈ„‚

ÚÂÓφȄΆȄȇ¯ËÒ˜È˯˜‰†ÛÈÏÁ˙‰†Ï˘†ÔÂÈÓ‰†˙‡†‰„ÈÙ˜·

ƉÏÈ„‚‰†ÏÚ†ÂÏ˘†˙·ÎÚÓ‰†‰ÚÙ˘‰‰†˙‡

ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφÔʇӆÒȯ˙‰†˙ËÂÏ·†„˜Ù˙˘†‡„ÂÂφ˘È

„˜Ù˙†¯Á‡†È˙Ù˜˙†·˜ÚÓ†Úˆ·Ï†˘È†¨ÔΆÂÓΆÆÔÈÙ¯ËÂ‚·

ÆÏÂÙÈˉ†ÔÓÊ·†¨‰ËÂÏ·‰

ÏΆ‡†‰ÚÈψ†˙ÂÁ˙Ù˙‰Ï†Ìȯچ˙ÂȉφÌȯ‰‰Â†‡Ù¯‰†ÏÚ

Æͯ··†Â‡†Í¯È·†·‡Î†ÏÚ†‰ÂÏ˙

¨ÌÈ˘†˘‡¯†È·‡Î†Ï˘†‰¯˜Ó·†ÌÈÈÈÚ†˙˜Ȅ·†Í¯ÚφıÏÓÂÓ

ƉÈȇ¯·†˙ÂÚ¯Ù‰†Â‡†˙‡˜‰†¨‰ÏÈÁ·

∫˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙

ÏÂÙȈ‰˙Ú†‰Ê†˙¯Ó‚†Ì‡†Â‡†¨˙ÙÒÂ†‰Ù¯˙†˙ØÏËÂ†Íȉ†Ì‡

ÈÙÒÂ˙Â†Ì˘¯Ó†‡Ïφ˙¯ÎÓ‰†˙ÂÙ¯˙†ÏÏÂΆ¨˙¯Á‡†‰Ù¯˙·

‡†ÌÈÂÎÈÒ†ÚÂÓφȄΆÏÙËÓ‰†‡Ù¯φÁ„φÍÈÏÚ†¨‰ÂÊ˙

È·‚φ„ÁÂÈÓ·†¨˙ÂÈ˙Ù¯˙≠ÔÈ·†˙·‚˙Ó†ÌÈÚ·Â‰†˙ÂÏÈÚÈ≠ȇ

¨ÌȄȇ¯ËÒ˜È˯˜†¨ÔÈÓ†ÈÂӯ‰†∫˙‡·‰†˙ˆ·˜‰Ó†˙ÂÙ¯˙

˙¯ÎÂÒ·†ÏÂÙÈËφ˙ÂÙ¯˙†¨ÔȯÂÙÒÂϘȈ†¨‰ÈÒÙÏÈهφ˙ÂÙ¯˙

ÆÒȯ˙‰†˙ËÂÏ·†„˜Ù˙·†‰Ú¯Ù‰·†ÏÂÙÈËφ˙ÂÙ¯˙Â

∫ȇÂÂφ˙ÂÚÙÂ˙

˙ÂÏÂÏچ·†˘ÂÓÈ˘‰†ÔÓÊ·†¨¯È˘Î˙‰†Ï˘†‰Èˆ¯‰†˙ÂÏÈÚÙφÛÒÂ·

¨ËÁÓ‰†˙¯È˜„†¯Âʇ·†˙·‚˙†∫Ô‚Ά¨È‡ÂÂφ˙ÂÚÙÂ˙†ÚÈÙ‰Ï

˙˘ÂÁ˙†¨ÌȘ¯Ù†·‡Î†¨„Ï˘‰†È¯È¯˘·†ÔÂÈ˘È˜†¨˙ȯÙȯن˙ÂÁÈÙ

Carpal tunnel syndrome ©†„ȉ†˘¯Â˘†˙ÏÚ˙†˙ÂÓÒ˙†¨ÏÂÓÈ

¨®¯È„©†¯·‚ÂÓ†È˙Ï‚Ï‚≠ÍÂ˙†ıÁφ¨®¯È„©†≤†‚ÂÒ†˙¯ÎÂÒ†¨®¯È„©

Ô‚Ω†Ì„·†ÌÈÂӯ‰‰†˙Ó¯·†ÌÈÈÂÈ˘†¨®„‡ӆ¯È„©†‰ÈÓ˜ÂÏ

Æ®¯È„©†·Ï·Ï·†˙˜Ï„†¨®ÏÂÊÈ˯˜†¨ÔÈÏÂÒȇ

∫˙„ÁÂÈÓ†˙ÂÒÁÈÈ˙‰†˙·ÈÈÁÓ‰†È‡ÂÂφ˙ÂÚÙÂ˙

˙‡†ÈؘÒÙ‰†≠†‰˜¯Ê‰‰†¯Âʇ·†‚ȯÁ†·‡Î†Â‡Ø†Ìȯȯ˘†·‡Î

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ

ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†ÌÈÈÏ‚¯‰†˙Á‡·†‰ÚÈψ†‰ÚÈÙÂӆ̇

¨‰Èȇ¯·†˙ÂÚ¯Ù‰†¨ÌȯÊÂÁ†Â‡†ÌȯÂÓÁ†˘‡¯†È·‡Î†ÌÈÚÈÙÂӆ̇

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†‰‡˜‰†Â‡Ø†‰ÏÈÁ·

ÌÈÂÈÏÚ†‰ÓÈ˘†Èί„†˙ÓÈÒÁ†Ï˘†ÌÈÓÂËÙÓÈÒ†ÌÈÚÈÙÂӆ̇

È؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†®˙¯ÈÁ·†‰¯ÓÁ‰†Â‡†‰ÏÁ˙‰©

ƇÙ¯Ï

ƇÙ¯φÈ؉Ù†ÏÂÙÈˉ†˙‡†ÈؘÒÙ‰†≠†‰˘˜†‰ÏÁÓ·†˙ÈÏÁ†Ì‡

ÌÈÏÂÏÚ‰†ÌÈÓÈÒ©†˙ÂÙÈÈÚ†¨Ô˙˘‰†˙ÂÓ熉ÈÈÏÚ†¨¯·‚ÂÓ†‡Óˆ

ÏÂÙÈË·†ÈØ͢Ӊ†≠†ÌÈÊÚ†ÔË·†È·‡Î†¨®≤†‚ÂÒÓ†˙¯ÎÂÒ†ÏÚ†„ÈÚ‰Ï

ƇÙ¯φÈ؉ÙÂ

ÂÈȈ†‡Ï˘†È‡ÂÂφ˙ÂÚÙÂ˙†‰Ø˘È‚¯Ó†Íȉ†Â·˘†‰¯˜Ó†Ïη

ıÚÈÈ˙‰Ï†ÍÈÏÚ†¨˙ÈÏÏΉ†Í˙˘‚¯‰·†ÈÂÈ˘†ÏÁ†Ì‡†Â‡†¨‰Ê†ÔÂÏÚ·

Æ„ÈÓ†‡Ù¯‰†ÌÚ

∫ÔÂÈÓ

˙˜¯Ê‰†¯Á‡Ï†¨˙‡Ê†°„·Ï·†‡Ù¯‰†È„È≠ÏÚ†Ú·˜ÈȆÔÂÈÓ‰

˙Ó‡˙‰Â†¨ÂÁ˜Èٷ†‡Ù¯‰†˙‡Ù¯Ó·†‰¢‡¯Ï†‰Ù¯˙‰

ÆÏÙÂËÓ†ÏÙÂËÓ†ÏÎφÈχ„ȷȄȇ†ÔÙ‡·†ÔÂÈÓ‰

Æ˙ˆÏÓÂÓ‰†‰Ó‰†ÏÚ†¯Â·ÚφÔȇ

∫˘ÂÓÈ˘‰†ÔÙ‡

Æ„·Ï·†‡Ù¯‰†˙‡¯Â‰†ÈÙÏ

Æ˙ȯÂÚ≠˙˙†‰˜¯Ê‰Ï†˙„ÚÂÈÓ†‰Ù¯˙‰

Ɖ˜È¯Êφ‰˜È¯ÊÓ†ÌÈ¢†‰˜¯Ê‰†È¯˙‡·†¯È˘Î˙‰†˙‡†˜È¯Ê‰Ï†˘È

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Æ¥∂∑≤μ†ÁÂ˙ÈÙ†‰Èψ¯‰†¨π†¯˜˘†ßÁ¯ GENO POWD PL SH 060912

PATIENT PACKAGE INSERT IN ACCORDANCEWITH

THE PHARMACISTS' REGULATIONS

(PREPARATIONS)-1986

The dispensing of this medicine

requires a doctor's prescription

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by

the Ministry of Health and

its content was checked and approved

GENOTROPIN GENOTROPIN

5.3 mg 12 mg

Powder for subcutaneous Powder for subcutaneous

injection after reconstitutioninjection after reconstitution

Composition:

Each powder cartridge Each powder cartridge

contains: contains:

Somatropin 5.3 mg Somatropin12 mg

Inactive ingredients: Glycine, Sodium dihydrogen

phosphate anhydrous, Disodium phosphate anhydrous,

Water for injections, m-Cresol, Mannitol.

Package:

Each package contains a two-chamber cartridge with

powder for injection in one chamber and a solvent for

reconstitution of the powder in the second chamber.

The preparation is intended for subcutaneous injection by

means of aGenotropinPenonly.

The two-chamber cartridge in the injector pen is suitable

for multiple use.

Therapeutic group:Growth hormone.

Therapeutic activity:

Children:Treatment of growth problems in children caused

bynon-secretion or inadequate secretion of pituitarygrowth

hormone.

Growth problems in girls withTurner’s syndrome.

Delayed growth in children with renal insufficiency.

Prader-Willi's syndrome.

Children born small for gestational age (SGA).

Adults:For adults who havesuffered from growth hormone

deficiency since childhood, and for adults who haveacquired

growth hormone deficiency due to a pituitary pathology.

When should the preparation not be used?

Do not use this preparation if there is a known sensitivity

to any of its ingredients.

Do not use this preparation in patients with evidence of

a tumor (see below).

Do not use the preparation in patients with an active

intracranial tumor.

If a tumor has been diagnosed anti-tumor therapy must

be completed before initiating use ofGenotropin.

Do not use in patients with critical complications following

open heart surgery,abdominal surgery,multi-system

trauma, respiratory failure or similar conditions.

Do not use the preparation for growth promotion in

children with closed epiphyses.

In children with chronic kidneydisease,treatment with

Genotropin should be discontinued prior to kidney

transplantation.Do not use if you havehad a kidney

transplant.

Do not use this preparation in patients with Prader-Willi

syndrome who are severely obese or havesevere

respiratory impairment.

Do not use this preparation without consulting a

doctor before starting treatment:

If you are pregnant or breastfeeding.

If you suffer, or havesuffered in the past, from impaired

Warnings:

If you are sensitive to any type of food or medicine, notify

your doctor before using this preparation.

Patients suffering from critical illness in the course of

treatment (such as heartsurgery,abdominal surgery,

respiratory failure, multiple organ trauma, etc.) should

inform the doctor about that.

In children who were born short, other medical reasons

for growth disturbances should be ruled out before

commencing treatment with this preparation.

In SGA patients (children born small for gestational age)

the following tests should be performed:measurement of

blood glucose and fasting insulin levels before starting

treatment with the preparation and every year after,as

well as insulin-like growth factor 1 (IGF-I) levels before

start of treatment and twice a year during treatment.

Patients with Prader-Willi syndrome should be evaluated

for the presence of upper airwayobstruction or sleep

apnea before initiation of treatment withGenotropin; in

these patients, treatment should always be in combination

with an appropriate diet.

Patients with Prader-Willi syndrome should be monitored

for signs of respiratory infection, such as onset of or

increased snoring, and signs of scoliosis in children.

In patients at risk for diabetes mellitus (for example, familial

history of diabetes, obesity, insulin resistance, abnormal

skin pigmentation) glucose tolerance testing should be

performed.

In certain cases, growth hormone may elevate the blood

sugar level;therefore,Genotropinshould be used with

caution in patients with diabetes mellitus.Regular monitoring

of blood sugar levels and close supervision are imperative

in such cases.

There is limited information on treatment of patients over

60 years of age and onprolonged treatmentin adults

and in patients with Prader-Willi syndrome.

If you were diagnosed with a tumor in the past, you must

undergo frequent tests to check for a recurrence of the

tumor.

Treatment with corticosteroids abovea certain dosage may

inhibit growth.Patients suffering from co-existing ACTH

deficiency should havetheir corticosteroid replacement

dose carefully adjusted to avoid its inhibitoryeffect on growth.

Make sure that thyroid function is balanced before starting

treatment withGenotropin.Thyroid function should also

be monitored periodically during treatment.

The doctor and parents should be alert to the development

of a limp or any complaint of pain in the hip or knee.

Eye examinations should be carried out in the event of

recurrent headaches, nausea, vomiting or vision

disturbances.

Drug interactions:

If you are taking another drug concomitantly or if you have

just finished treatment with another medicine, including

non-prescription medicines and food supplements, inform

the attending doctor, in order to prevent hazards or lack

of efficacy arising from drug interactions.This is especially

important for medicines belonging to the following groups:

sex hormones, corticosteroids, antiepileptics, cyclosporin,

medicines for treatment of diabetes, and medicines for

thyroid function disorders.

Side effects:

In addition to the desired effect of the medicine, adverse

reactions may occur during the course of taking this

medicine, such as:reactions in the area of injection,

peripheral edema, skeletal muscle stiffness, joint pain,

tingling sensation, carpal tunnel syndrome (rare), diabetes

mellitus type 2 (rare), intracranial hypertension (rare),

leukemia (very rare), changes in blood hormone levels

(such as insulin, cortisol), pancreatitis (rare).

Side effects requiring special attention:

Muscle pain and/or unusual pain in the area of injection -

If limping appears in one of the legs - stop treatment and

consult your doctor.

In case of severe or recurrent headaches, vision

disturbances,nausea and/or vomiting - stop treatment and

consult your doctor.

If symptoms of upper airwayobstruction appear (onset of

or increased snoring) - stop treatment and consult your

doctor.

If you become seriously ill - stop treatment and consult

your doctor.

Increased thirst, increased urine output, tiredness (signs

that may indicate diabetes mellitus type 2), intense

abdominal pain - continue treatment and consult your doctor.

In the event that you experience side effects not mentioned

in this leaflet, or if there is a change in your general health,

consult your doctor immediately.

Dosage:

Dosage will be determined bythe doctor only!This should

be doneafter the first injection of the medicine in the

doctor's clinic and with his supervision, and the dosage

should be adjusted individually for each patient .

Do not exceed the recommended dosage.

Directions for use:

According to the doctor's instructions only.

The medicine is intended for subcutaneous injection.Inject

the preparation at different injection sites for each injection.

You must be instructed by an authorized healthcare provider

on the method of preparing and injecting the medicine.

Instructions for use:

See detailed instructions for use below.

How can you contribute to the success of the

treatment?

Complete the full course of treatment as recommended

bythe doctor.Even if there is an improvement in your

health, do not discontinue use of this medicine before

consulting your doctor.

Avoidpoisoning!

This preparation, and all other medicines, must be stored

in a safe place out of the reach of children and/or infants,

to avoid poisoning.If you havetaken an overdose, or if a

child has accidentally swallowed the medicine, proceed

immediately to a hospital emergency room and bring the

package of the medicine with you.Donotinducevomiting

unless explicitly instructed to do so bya doctor!This

preparation has been prescribed for the treatment of your

ailment;in another patient it may cause harm.Do not give

this preparation to your relatives, neighbours or

acquaintances. Donottakemedicinesinthedark! Check

the label and the doseeachtime you take your medicine.

Wear glasses if you need them.

Storage:

Storagebeforereconstitution:

Store in the refrigerator (2°C-8°C) and protect from light.

Do not freeze!

Storageafterreconstitution:

Store in the refrigerator (2°C-8°C) and protect from light

fornomorethan28days .Do not freeze!

Even if kept in their original container and stored as

recommended, medicines may be kept for a limited period

only.Please note the expiry date of the preparation! In

case of doubt, consult the pharmacist who dispensed the

preparation to you.Do not store different medications in

the same package.

License numbers:

Genotropin 5.3 mg: 111.08.26780.00, 111.08.26780.22

Genotropin 12 mg: 121.35.27540.22

Manufacturer:Pfizer, Manufacturing Belgium NV/SA.

License holder:Pfizer Pharmaceuticals Israel,

9 Shenkar St., Herzliya Pituach 46725.

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INSTRUCTIONS FOR USE

ToinjectGenotropinuse only theGenotropinPen

device which is intended for mixing and injecting

Genotropin doses according to the dosage

determined bythe doctor.

What will you need?

GenotropinPen that is suitable for the cartridge

that has been prescribed for you.

Acartridge ofGenotropin5.3 mg or 12 mg

(according to the doctor's instructions).

Alcohol swab.

An 8 mm needle (30G).

Adisposal container for used needles.

Components of the Genotropin Pen

Before you start

In order to prevent infectionalwayswash your

hands with soap and water before preparing and

using theGenotropinPen.

1.Attach the needle

Removethe front cap of theGenotropinPen.

Unscrew the filling cartridge chamber.

Take a new needle and removethe paper

covering.

Screw the needle gently onto the filling cartridge

chamber bygently turning it clockwise.

2.Insert the filling cartridge into the Genotropin Pen

Use only the 5.3 mg cartridge for the 5.3 mg

Pen or the 12 mg cartridge for the 12 mg Pen

(according to the doctor's instructions).

Wipe the metal/rubber tip of the cartridge with

an alcohol swab.

Insert the cartridge into the filling cartridge

chamber with the metal/rubber tip (the powder

side) facing inwards.

Push the cartridge firmly into place.

3.Prepare the body of the Pen

Press the release button (with the red end) to

release the black injection knob.

Turnthe black injection knob

counterclockwiseasfarasitwillgo.

Check that the plunger rod is not visible through

the window at the top of the plastic body of the

pen.After the rod is no longer visible through

the window,proceed to the next step.

4.Screw the Genotropin Pen parts together

Hold the filling cartridge chamber upright (facing

upward).

Gently screw the filling cartridge chamber and

plastic body back together.This action mixes

the diluent in the rear chamber of the cartridge

with the growth hormone powder in the front

chamber.

Gently movetheGenotropinPen from side to

side to help dissolve the powder completely.

Do not shake it as that might inactivate the

growth hormone.

5.Examine the solution and release trapped air

Look through the cartridge window in the filling

cartridge chamber and make sure the solution

is clear.If you see particles or if the solution is

discolored,do not injectit.Instead contact the

Pfizer representative.

Removethe outer needle cap and saveit for

later.

Removeand discard the inner needle cap.

Be careful not to touch the exposed needle.

Removeany trapped air from the solution as

detailed below:

a.Turnthe black injection knob clockwise.

This will line up the white mark on the black

injection knob with the gray mark on the

body of the pen.

b.Hold theGenotropinPen with the needle

pointing upward and gently tap the filling

cartridge chamber with your finger to move

any air bubbles to the top.

c.Push the black injection knob all the way in.

You will see a drop of liquid appear at the

needle point.

This action will release any trapped air.

d.If no liquid squirts out, press the white release

button and turn the black injection knob

clockwise (to the right) until the white mark

lines up with the greymark again.Repeat

the detailed instructions in steps b and c.

If necessary,reattach the needle guard - push

it back to its place until a click is heard.Again,

be careful not to touch the exposed needle.To

avoid an accidental needle prick, grip the sides

of the needle guard;never push on the end.

6.Dial your prescribed dose

Press the red release button to reset the device.

The black injection knob will pop out and

the dose display window will read 0.0.

With the dose display activated, turn the black

injection knob clockwise until your prescribed

dose is displayed.

If you go too far,just turn the knob back the

other way until the correct dose is displayed.

NOTE: If you turn the black injection knob backwards

beyond 0.0 after a cartridge has been inserted, the

dose display will show (--).Just turn the injection

knob clockwise until numbers reappear on the dose

display.

TheGenotropinPen contains a battery for the

dose display.Tosavethe battery’s energy, the

dose display is activated for two minutes and

then automatically disappears.

Although the display is no longer visible, the

dose remains available for delivery.

NOTE:

5.3 mg Pen - Each click of the black injection

knob equals a one-tenth-of-a milligram dose

(0.1 mg).One click - or 0.1 mg - is the minimum

possible dose per injection;20 clicks - or 2.0

mg - is the maximum possible dose per injection.

If you accidentally dial more than the maximum

2 mg dose, some liquid may emerge from the

tip.This is normal and will not affect your injection

- simply dial back to the correct dose.

12 mg Pen - Each click of the black injection

knob equals a two-tenths-of-a milligram dose

(0.2 mg).One click - or 0.2 mg - is the minimum

possible dose per injection;20 clicks - or 4.0

mg - is the maximum possible dose per injection.

If you accidentally dial more than the maximum

4 mg dose, some liquid may emerge from the

tip.This is normal and will not affect your injection

- simply dial back to the correct dose.

7.Inject your Genotropin dose

Select and prepare an injection site (such as

thigh, buttocks, arm or abdomen), as directed

byyour healthcare provider.

Pinch a fold of skin at the injection site firmly,

and push theGenotropinPen into the skin fold

at a 90°angle.

Push the pen down as far as possible.

Push the black injection knob until it clicks.

Wait at least 10 seconds and then withdraw

theGenotropinPen.

8.Discard the needle and store the Genotropin

Pen

Removeand store the needle guard, if you

used one.

Carefullyreplace the outer protective needle

cap on the needle, as instructed byyour

healthcare provider.

Unscrew the needle and discard it in a proper

disposal container.Never reuse a needle.

Replace the front cap, then put theGenotropin

Pen back in its protective case.Store it in the

refrigerator until your next injection.

Your next injection

If you already havea drug cartridge in your

Genotropin Pen, prepare the pen and your dose

as follows:

Removethe front cap of theGenotropinPen.

Removethe paper covering from the back of a

new needle.

Screw the needle onto the filling cartridge chamber

byturning it clockwise.

Removethe outer and inner protective needle caps.

Follow the instructions above, starting with step 6.

Toreplace the filling cartridge

Press the white release button to reset the

Genotropin Pen.

Turnthe black injection knob counterclockwise

asfarasitwillgo.

Unscrew the filling cartridge chamber and remove

the empty cartridge.

Discard the empty cartridge as instructed byyour

healthcare provider.

To insert a new cartridge and prepare the

Genotropin Pen for use, follow the instructions

detailed above.

Storage

Between uses, store yourGenotropinPen in the

refrigerator in its protective case.Always remove

the needle before storing.

Discard the cartridge in yourGenotropinPen within

28 days from reconstitution (from the moment the

growth hormone and the liquid were mixed) even if

the cartridge is not empty.When you are awayfrom

home, keep yourGenotropinPen in its protective

case and carry it in an insulated bag with an ice

pack to protect it from heat.Place a barrier between

the ice pack and the pen to prevent freezing.

Put it back in a refrigerator as soon as possible.

Caring for your Genotropin Pen

No special maintenance is required.Toclean the

Genotropin Pen, wipe the outside surface with a

damp cloth.Do not immerse in liquid.Do not use

alcohol or any other cleaning agents, as they may

damage the plastic body.Toclean the reusable needle

guard, wipe it with a damp cloth or alcohol swab.

COMMON QUESTIONS

How do I tell how much Genotropin is left in

the Genotropin Pen?

Look at the dose scale located along the side of

the window of the filling cartridge chamber.The

front edge of the gray rubber plunger lines up with

the number of milligrams remaining in the cartridge.

What happens when the battery runs low?

The battery in theGenotropinPen should run for

two years.When it begins to run low due to the end

of the battery’s life,you will see a flashing symbol

( ) in the dose display.This means the battery will

last about another month.When the battery is dead,

the dose display will show the symbol ( ) steadily.

A flashing "bt" in the dose display means the battery

is running verylow for some other reason and will

last for about another month.When the battery is

dead, the display will show a steady "bt".

Call the Pfizer representative for help.

If the battery suddenly dies, can the Genotropin

Pen still be used?

Yes.Call the Pfizer representative for instructions

on how to determine the dose without the electronic

Inner protective

needle cap ÔÂÈÓ†ÌÏÂÒ

ÔÂÏÁ

˙ÈÒÁÓ‰ ËÁÓ†Ô‚Ó

ÈÓÈÙ ËÁÓ†Ô‚Ó

ÈˆÈÁ ÈÓ„˜†‰ÒÎÓ ÔÂÈÓ‰†‚ˆ

ÔÂÏÁ ËÁÓ†Ô‚Ó

¯ÂÁ˘†‚¯Â·

¯Â¯Á˘†¯Â˙ÙÎ ËÚ ˙ÈÒÁÓ†˙È·

ÈÂÏÈÓ‰

ËÁÓ Needle guard

Outer protective

needle cap Needle Front cap Filling cartridge

chamber

Cartridge window Window

Dose scale

Release button Black injection

knob Dose display

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Minister Bruno Bruins verwelkomt EMA in Nederland

Minister Bruno Bruins verwelkomt EMA in Nederland

De tijdelijke huisvesting voor het Europees Geneesmiddelen Agentschap (EMA) is klaar voor gebruik. Dit is een belangrijke stap in de verhuizing van het EMA naar Nederland. Het EMA brengt jaarlijks 36.000 bezoekers naar Nederland en zorgt voor de komst van vele bedrijven. Vandaag heeft minister Bruins de sleutel van het Spark-gebouw overgedragen aan EMA.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

FDA - U.S. Food and Drug Administration

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018

Vijf jaar NIX brengt normverandering roken en drinken op gang

Vijf jaar NIX brengt normverandering roken en drinken op gang

Op 1 januari is het precies vijf jaar geleden dat de leeftijdsgrens voor roken en drinken werd verhoogd naar 18 jaar. In deze periode is er veel veranderd, blijkt uit een recente peiling in opdracht van het ministerie van VWS. Zo vindt ongeveer driekwart van de ouders en tieners het ‘normaal’ dat je pas mag roken en drinken vanaf 18 jaar. 78,2% van de ouders vindt dit tegenover 75,4% van de jongeren. De afgelopen jaren is het gebruik van alcohol onder tieners teruggelopen. Sinds 2011 gaat het in de total...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018

Teva Canada Product Recall (2018-12-17)

Teva Canada Product Recall (2018-12-17)

Health Canada

14-12-2018


Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

Europe - EMA - European Medicines Agency

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Enforcement Report for the Week of December 12, 2018

Enforcement Report for the Week of December 12, 2018

Recently Updated Records for the Week of December 12, 2018 Last Modified Date: Wednesday, December 12, 2018

FDA - U.S. Food and Drug Administration

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

19-12-2018


Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Dengvaxia, dengue tetravalent vaccine (live, attenuated), Dengue, Date of authorisation: 12/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia

17-12-2018


Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Orphan designation: Nanoliposomal irinotecan, Treatment of pancreatic cancer, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Adcetris,brentuximab vedotin,  13/12/2018,  Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Besremi,ropeginterferon alfa-2b,  13/12/2018,  Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Lusutrombopag Shionogi,lusutrombopag,  13/12/2018,  Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rapiscan,regadenoson,  13/12/2018,  Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Miglustat Dipharma,miglustat,  13/12/2018,  Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Tobramycin PARI,tobramycin,  13/12/2018,  Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Simponi,golimumab,  13/12/2018,  Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Summary of opinion: Simponi,golimumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Sprycel,dasatinib,  13/12/2018,  Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Summary of opinion: Sprycel,dasatinib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rizmoic,naldemedine,  13/12/2018,  Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Summary of opinion: Rizmoic,naldemedine, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rubraca,rucaparib,  13/12/2018,  Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Summary of opinion: Rubraca,rucaparib, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Zirabev,bevacizumab,  13/12/2018,  Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Summary of opinion: Zirabev,bevacizumab, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein

Europe - EMA - European Medicines Agency

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Scientific recommendation on classification of advanced therapy medicinal products: Four independent DNA plasmid vectors encoding HBV antigens and human interleukin-12

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety