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

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·† ‰˜·‡‰† ˙ÒӉφ ÒÓÓ† „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Ùφ ÔÈÙ¯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¯·† ıÚÂÂȉφ ÈÏ·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‡† Â‰˘ÏΆ ÔÂÊÓφ ‰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‰‰† ÔÓÊφ ÌÈ˘† 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·† ¨˙ÂÏډφ ÏÂÏÚ† ‰ÏÈ„‚† ÔÂӯ‰

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

ÛË¢† ·˜ÚÓ† Æ˙¯ȉʆ ÈÚˆÓ‡† ˙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‰

·ÎÚφ ÏÂÏÚ† ˙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Óφ È„Ά ÏÙËÓ‰† ‡Ù¯φ Á„φ ÍÈÏÚ† ¨‰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·˜ÈȆ ÔÂ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‡

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

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

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 reconstitution injection 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 a Genotropin Pen only.

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

by non-secretion or inadequate secretion of pituitary growth

hormone.

• Growth problems in girls with Turner’s syndrome.

• Delayed growth in children with renal insufficiency.

• Prader-Willi's syndrome.

• Children born small for gestational age (SGA).

Adults: For adults who have suffered from growth hormone

deficiency since childhood, and for adults who have acquired

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 of Genotropin.

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 kidney disease, treatment with

Genotropin  should be discontinued prior to kidney

transplantation. Do not use if you have had a kidney

transplant.

Do not use this preparation in patients with Prader-Willi

syndrome who are severely obese or have severe

respiratory impairment.

Do not use this preparation without consulting a

doctor before starting treatment:

If you are pregnant or breastfeeding.

If you suffer, or have suffered 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 heart surgery, 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 airway obstruction or sleep

apnea before initiation of treatment with Genotropin; 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, Genotropin should 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 on prolonged treatment in 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 above a certain dosage may

inhibit growth. Patients suffering from co-existing ACTH

deficiency should have their corticosteroid replacement

dose carefully adjusted to avoid its inhibitory effect on growth.

Make sure that thyroid function is balanced before starting

treatment with Genotropin. 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 airway obstruction 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 by the doctor only! This should

be done after 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

by the doctor. Even if there is an improvement in your

health, do not discontinue use of this medicine before

consulting your doctor.

Avoid poisoning!

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 have taken 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. Do not induce vomiting

unless explicitly instructed to do so by a 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.  Do not take medicines in the dark! Check

the label and the dose each time you take your medicine.

Wear glasses if you need them.

Storage:

Storage before reconstitution:

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

Do not freeze!

Storage after reconstitution:

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

for no more than 28 days . 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

To inject Genotropin use only the Genotropin Pen

device which is intended for mixing and injecting

Genotropin  doses according to the dosage

determined by the doctor.

What will you need?

• Genotropin Pen that is suitable for the cartridge

that has been prescribed for you.

• A cartridge of Genotropin 5.3 mg or 12 mg

(according to the doctor's instructions).

• Alcohol swab.

• An 8 mm needle (30G).

• A disposal container for used needles.

Components of the Genotropin Pen

Before you start

In order to prevent infection always wash your

hands with soap and water before preparing and

using the Genotropin Pen.

1. Attach the needle

• Remove the front cap of the Genotropin Pen.

• Unscrew the filling cartridge chamber.

• Take a new needle and remove the paper

covering.

• Screw the needle gently onto the filling cartridge

chamber by gently 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.

• Turn the black injection knob

counterclockwise as far as it will go.

• 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 move the Genotropin Pen 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 inject it. Instead contact the

Pfizer representative.

• Remove the outer needle cap and save it for

later.

• Remove and discard the inner needle cap.

Be careful not to touch the exposed needle.

• Remove any trapped air from the solution as

detailed below:

a. Turn the 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 the Genotropin Pen 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 grey mark 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.

• The Genotropin Pen contains a battery for the

dose display. To save the 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

by your healthcare provider.

• Pinch a fold of skin at the injection site firmly,

and push the Genotropin Pen 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

the Genotropin Pen.

8. Discard the needle and store the Genotropin

Pen

• Remove and store the needle guard, if you

used one.

• Carefully replace the outer protective needle

cap on the needle, as instructed by your

healthcare provider.

• Unscrew the needle and discard it in a proper

disposal container. Never reuse a needle.

• Replace the front cap, then put the Genotropin

Pen back in its protective case. Store it in the

refrigerator until your next injection.

Your next injection

If you already have a drug cartridge in your

Genotropin  Pen, prepare the pen and your dose

as follows:

• Remove the front cap of the Genotropin Pen.

• Remove the paper covering from the back of a

new needle.

• Screw the needle onto the filling cartridge chamber

by turning it clockwise.

• Remove the outer and inner protective needle caps.

• Follow the instructions above, starting with  step 6.

To replace the filling cartridge

• Press the white release button to reset the

Genotropin  Pen.

• Turn the black injection knob counterclockwise

as far as it will go.

• Unscrew the filling cartridge chamber and remove

the empty cartridge.

• Discard the empty cartridge as instructed by your

healthcare provider.

• To insert a new cartridge and prepare the

Genotropin  Pen for use, follow the instructions

detailed above.

Storage

Between uses, store your Genotropin Pen  in the

refrigerator in its protective case. Always remove

the needle  before storing.

Discard the cartridge in your Genotropin Pen 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 away from

home, keep your Genotropin Pen 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. To clean 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. To clean 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 the Genotropin Pen 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 very low 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

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ÈˆÈÁ ÈÓ„˜†‰ÒÎÓ ÔÂÈÓ‰†‚ˆ

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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

15-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency

Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency

Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.

FDA - U.S. Food and Drug Administration

10-5-2018

Meubles Adams et fils Inc. recalls Adams Model Ride Strollers

Meubles Adams et fils Inc. recalls Adams Model Ride Strollers

Health Canada's sampling and evaluation program has determined that these strollers do not meet the requirements of the Carriages and Strollers Regulations. Specifically, the maximum recommended weight and height of the occupant is not indicated on the label which could lead to structural failure when the stroller is in use. The Adams-Ride Stroller is designed for maximum weight of 15 kilos and for children from 0 to 36 months.

Health Canada

28-3-2018

Orphan designation:  Recombinant fusion protein linking coagulation factor VIIa with albumin,  for the: Treatment of congenital factor VII deficiency

Orphan designation: Recombinant fusion protein linking coagulation factor VIIa with albumin, for the: Treatment of congenital factor VII deficiency

On 7 October 2013, orphan designation (EU/3/13/1188) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking coagulation factor VIIa with albumin for the treatment of congenital factor VII deficiency.

Europe - EMA - European Medicines Agency

28-3-2018

Orphan designation:  Recombinant fusion protein linking human coagulation factor VIIa with human albumin,  for the: Treatment of haemophilia B

Orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin, for the: Treatment of haemophilia B

On 13 May 2011, orphan designation (EU/3/11/863) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia B.

Europe - EMA - European Medicines Agency

7-3-2018

National Research Programme for Environmental and Occupational Health: 36 projects selected and €6.3 million mobilised for the 2017 calls for projects

National Research Programme for Environmental and Occupational Health: 36 projects selected and €6.3 million mobilised for the 2017 calls for projects

Today, ANSES is publishing the list of projects selected as part of its three 2017 calls for research projects for the National Research Programme for Environmental and Occupational Health: the first for projects on a general theme, the second on the theme of "Radiofrequencies and health" and the third on the theme of "Antimicrobial resistance and the environment". Following the selection process, 36 projects are being supported with funding amounting to a total of 6.3 million euros. Language English

France - Agence Nationale du Médicament Vétérinaire

16-5-2018

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Active substance: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class) - Transfer of orphan designation - Commission Decision (2018)3035 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/08/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

30-4-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2709 of Mon, 30 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3729/T/36

Europe -DG Health and Food Safety

25-4-2018

TOBI Podhaler (Novartis Europharm Limited)

TOBI Podhaler (Novartis Europharm Limited)

TOBI Podhaler (Active substance: Tobramycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2592 of Wed, 25 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2155/T/36

Europe -DG Health and Food Safety

25-4-2018

Nevanac (Novartis Europharm Limited)

Nevanac (Novartis Europharm Limited)

Nevanac (Active substance: nepafenac) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2582 of Wed, 25 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/818/T/36

Europe -DG Health and Food Safety

23-4-2018

Opatanol (Novartis Europharm Limited)

Opatanol (Novartis Europharm Limited)

Opatanol (Active substance: Olopatadine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2511 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/407/T/36

Europe -DG Health and Food Safety

17-4-2018

Equip WNV (Zoetis Belgium S.A.)

Equip WNV (Zoetis Belgium S.A.)

Equip WNV (Active substance: West Nile fever vaccine (inactivated recombinant)) - Centralised - Yearly update - Commission Decision (2018)2339 of Tue, 17 Apr 2018

Europe -DG Health and Food Safety

10-4-2018

England's Scarlet Fever Cases Highest in 36 Years

England's Scarlet Fever Cases Highest in 36 Years

An outbreak of scarlet fever in England and Wales has seen the highest number of cases reported in the first quarter of a year since Public Health England (PHE) began collecting data in 1982.

US - RxList

10-4-2018

T-36 (Bromus Ramosus Whole) Solution [DNA Labs, Inc.]

T-36 (Bromus Ramosus Whole) Solution [DNA Labs, Inc.]

Updated Date: Apr 10, 2018 EST

US - DailyMed

27-3-2018

Perjeta (Roche Registration GmbH)

Perjeta (Roche Registration GmbH)

Perjeta (Active substance: pertuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)1961 of Tue, 27 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2547/T/36

Europe -DG Health and Food Safety

26-3-2018

Suvaxyn PCV (Zoetis Belgium S.A.)

Suvaxyn PCV (Zoetis Belgium S.A.)

Suvaxyn PCV (Active substance: Porcine circovirus recombinant virus (cpcv) 1-2, inactivated) - Centralised - Yearly update - Commission Decision (2018)1927 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

26-3-2018

Suvaxyn CSF Marker (Zoetis Belgium S.A.)

Suvaxyn CSF Marker (Zoetis Belgium S.A.)

Suvaxyn CSF Marker (Active substance: Live Recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 (CP7_E2alf)) - Centralised - Yearly update - Commission Decision (2018)1928 of Mon, 26 Mar 2018

Europe -DG Health and Food Safety

23-3-2018

Shingrix (GlaxoSmithKline Biologicals S.A.)

Shingrix (GlaxoSmithKline Biologicals S.A.)

Shingrix (Active substance: herpes zoster vaccine (recombinant, adjuvanted)) - Centralised - Authorisation - Commission Decision (2018)1896 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4336

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Amicus Therapeutics UK Ltd)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Orphan designation - Commission Decision (2018)1877 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/230/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (uniQure Biopharma B.V.)

EU/3/18/1999 (Active substance: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA) - Orphan designation - Commission Decision (2018)1888 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/232/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

22-3-2018

Oncept IL-2 (Merial)

Oncept IL-2 (Merial)

Oncept IL-2 (Active substance: Feline interleukin-2 recombinant canarypox virus (vCP1338)) - Centralised - Renewal - Commission Decision (2018)1848 of Thu, 22 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2562/R/6

Europe -DG Health and Food Safety

22-3-2018

ECOPORC SHIGA (IDT Biologika GmbH)

ECOPORC SHIGA (IDT Biologika GmbH)

ECOPORC SHIGA (Active substance: Genetically modified recombinant Stx2e antigen) - Centralised - Renewal - Commission Decision (2018)1847 of Thu, 22 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2588/R/6

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Quintiles Ireland Limited)

EU/3/16/1727 (Active substance: Recombinant human interleukin-12) - Transfer of orphan designation - Commission Decision (2018)1824 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/116/16/T/01

Europe -DG Health and Food Safety

21-3-2018

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Yearly update - Commission Decision (2018)1745 of Wed, 21 Mar 2018

Europe -DG Health and Food Safety

6-3-2018

Somatropin

Somatropin

Somatropin (Active substance: somatropin) - Centralised - Art 28 - (PSUR - Commission Decision (2018) 1479 of Tue, 06 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2772/201703

Europe -DG Health and Food Safety