Alendronate

Maklumat utama

  • Nama dagangan:
  • Alendronate Sandoz Tablets
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Alendronate Sandoz Tablets
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL10080040
  • Kemaskini terakhir:
  • 31-08-2017

Risalah Maklumat Pesakit: ciri produk - komposisi, petunjuk, kesan sampingan, dos, interaksi, tindak balas buruk, kehamilan, penyusuan

ALENDRONATE SANDOZ TABLET

Alendronic acid (70mg)

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini:

Apakah

kegunaan

Alendronate

Sandoz

Bagaimana

Alendronate

Sandoz

berfungsi

Sebelum menggunakan Alendronate

Sandoz

Cara

menggunakan

Alendronate

Sandoz

Semasa

menggunakan

Alendronate

Sandoz

Kesan-kesan sampingan

Cara

penyimpanan

pelupusan

Alendronate Sandoz

Maklumat lanjut

Pengilang

Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah

kegunaan

Alendronate

Sandoz

Doktor

anda

telah

mengesyorkan

Alendronate

Sandoz

untuk

merawat

osteoporosis anda.

Osteoporosis ialah satu keadaan di mana

terjadinya

penipisan

pelemahan

tulang. Ia adalah biasa dalam kalangan

wanita

selepas

putus

haid

atau

menopaus.

Apabila

putus

haid,

ovari

berhenti mengeluarkan hormon wanita,

estrogen,

yang

membantu

menjaga

kesihatan

tulang

wanita.

Akibatnya,

tulang menjadi nipis dan lebih lemah.

Lebih awalnya wanita putus haid, lebih

tingginya risiko osteoporosis.

Pada

peringkat

awal,

osteoporosis

biasanya

tidak

menunjukkan

sebarang

gejala.

Bagaimanapun,

jika

dibiarkan

tanpa

rawatan,

boleh

menyebabkan

kepatahan

tulang.

Sungguhpun

biasanya menyakitkan, kepatahan tulang

belakang

boleh

berlaku

tanpa

disedari

hingga

mengurangkan

ketinggian.

Kepatahan tulang boleh berlaku semasa

melakukan aktiviti harian biasa, seperti

mengangkat

barang,

atau

berpunca

daripada

kecederaan

kecil

yang

umumnya

tidak

mematahkan

tulang

normal.

Kepatahan

tulang

biasanya

berlaku ke atas tulang pinggul, tulang

belakang, atau pergelangan tangan, dan

bukan

sahaja

boleh

mendatangkan

kesakitan tetapi juga boleh menimbulkan

masalah

seperti

bongkok

(‘bongkok

udang’)

kehilangan

upaya

untuk

bergerak.

Bagaimana

Alendoronate

Sandoz

berfungsi

Alendronate tergolong dalam kumpulan

ubat

bukan

hormon

yang

dinamakan

bisphosphonate. Alendronate mencegah

penipisan

tulang

yang

berlaku

dalam

kalangan wanita selepas putus haid, dan

membantu

membina semula tulang. Ia

mengurangkan

risiko

keretakan

tulang

belakang dan pinggul.

Sebelum menggunakan Alendronate

Sandoz

- Bila tidak boleh menggunakan

Jangan ambil Alendronate Sandoz:

jika anda hipersensitif

(alah)

kepada

alendronate

sodium

trihydrate,

bisphosphonate

lain

atau

mana-mana

bahan

lain

dalam

Alendronate

Sandoz

(lihat

pada

bahagian

Maklumat lanjut

Jika anda mengalami masalah

tertentu

dalam

gulet

atau

kerongkong anda (esofagus –

tiub

yang

menyambungkan

mulut nada dengan perut anda)

seperti

penyempitan

atau

kesukaran untuk menelan

Jika anda tidak boleh berdiri

atau

duduk

tegak

untuk

sekurang-kurangya 30 minit

Jika

doktor

anda

telah

memberitahu

anda

bahawa

paras

kalsium

darah

anda

rendah.

Jika anda fikir anda mengalami mana-

mana

keadaan

tersebut,

jangan

ambil

pil ini. Bincangkan dengan doktor anda

terlebih dahulu dan ikut nasihat yang

diberikan.

Kanak-kanak dan remaja

Alendronate Sandoz tidak sewajarnya

diberikan

kepada

kanak-kanak

remaja.

Mengandung dan menyusukan anak

Mengandung

Anda

tidak

sewajarnya

mengambil

Alendronate Sandoz jika anda sedang

mengandung

atau

anda

fikir

anda

mungkin

mengandung.

Alendronate

Sandoz

hanya

disyorkan

untuk

penggunaan

dalam

kalangan

wanita

putus haid.

Menyusukan anak

Anda

tidak

sewajarnya

mengambil

Alendronate

Sandoz

jika

anda

menyusukan anak. Alendronate Sandoz

hanya

disyorkan

untuk

penggunaan

dalam kalangan wanita putus haid.

Sebelum

menggunakan

Alendronate

Sandoz

Beritahu

doktor

anda

jika

anda

mengalami

atau

pernah

mengalami

sebarang

masalah

perubatan

terutamanya masalah berikut:

Jika

anda

mengalami

masalah

buah pinggang

Jika

anda

mengalami

masalah

untuk

menelan

atau

masalah

penghadaman

Jika paras kalsium darah anda

rendah

Anda

dinasihatkan

untuk

menjalani

pemerikasaan

gigi

sebelum

memula

rawatan

dengan

Alendronate

Sandoz.

Beritahu

doktor

anda

jika

anda

mempunyai masalah berikut yang boleh

meningkatkan

risiko

untuk

mendapat

masalah tulang rahang:

Masalah

dengan

gigi,

mulut

atau

gusi,

seperti

sakit

atau

bengkak pada gusi dan rahang,

kekebasan pada rahang, rahang

berasa

berat

atau

jika

anda

kehilangan satu gigi

Kanser,

rawatan

radioterapi

atau kemoterapi

Jangkitan

Anda

sedang

mengambil

steroid

Anda

merancang

untuk

menjalani

prosedur

dental

seperti

mencabut

gigi

atau

pembedahan oral yang lain

Anda tidak kerap menjaga gigi

anda atau melawat doktor gigi.

- Jika mengambil ubat-ubat lain

Sila beritahu doktor atau ahli farmasi

anda jika anda sedang mengambil atau

telah

mengambil

ubat

lain

baru-baru

ini,

termasuk

ubat

yang

dibeli

tanpa

preskripsi,

terutamanya

jika

anda

mengambil :

Apa-apa

hormon

atau

ubat

glukokortikoid

Ubat anti radang tanpa steroid

(NSAID)

ALENDRONATE SANDOZ TABLET

Alendronic acid (70mg)

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Makanan

tambahan

kalsium,

antasid

sesetengah

ubat

makan

mungkin

akan

mengganggu

penyerapan

Alendronate Sandoz jika diambil pada

masa

yang

sama.

Oleh

itu,

anda

hendaklah

mengikut

nasihat

yang

diberikan

bahagian

Cara

menggunakan Alendronate Sandoz’

Mengambil Alendronate Sandoz dengan

makanan dan minuman

Terdapatnya kemungkinan makanan dan

minuman (termasuk air mineral) akan

menjadian Alendronate Sandoz kurang

berkesan jika diambil pada masa yang

sama. Justeru, anda hendaklah mengikut

nasihat

yang

diberikan

bahagian

“Cara

Menggunakan

Alendronate

Sandoz”.

Cara

menggunakan

Alendronate

Sandoz

- Berapa banyak harus digunakan

Sentiasa mengambil Alendronate Sandoz

secara tepat seperti yang diarahkan oleh

doktor anda. Dapatkan kepastian daripada

doktor atau ahli farmasi anda jika anda

tidak pasti.

Ambil

satu

bersalut

70mg

sekali

seminggu.

Ikut

arahan

dengan

teliti

untuk

memastikan anda akan mendapat manfaat

daripada Alendronate Sandoz:

Pilih satu hari dalam seminggu yang

paling

sesuai

dengan

jadual

anda.

Setiap

minggu,

ambil

satu

bersalut

selaput

Alendronate

70mg

pada hari yang anda pilih.

Anda mesti mengikut arahan 2), 3),

4)

dan

5)

untuk

membolehkan

Alendronate

Sandoz

sampai

ke

dalam perut anda dengan cepat dan

membantu

mengurangkan

kemungkinan

merengsakan

gulet

(esophagus

tiub

yang

menghubungkan mulut anda dengan

perut anda) anda.

Selepas bangun daripada tidur pada

hari

yang

anda

pilih

sebelum

mengambil

apa-apa

makanan,

minuman

atau

ubat

lain,

telan

bersalut

Alendronate

Sandoz 70mg

anda

dengan

satu

gelas

penuh

biasa

sahaja

(bukan

mineral)

(tidak kurang daripada 200ml atau 7

anus bendalir).

Jangan

ambil

dengan

mineral (biasa atau bergas).

Jangan

ambil

dengan

kopi

atau teh.

Jangan ambil pil dengan jus atau

susu.

Jangan kunyah pil atau biarkan pil

larut dalam mulut anda.

Jangan

baring

tegakkan

badan

(duduk, berdiri atau berjalan) – untuk

sekurang-kurangnya 30 minit selepas

menelan

pil.

Jangan

baring

hingga

selepas

anda

mengambil

makanan

pertama pada hari anda mengambil

pil.

Jangan

ambil

Alendronate

Sandoz

pada waktu tidur malam atau sebelah

bangun pagi.

Jika anda mengalami kesulitan atau

kesakitan

apabila

menelan,

merasa

sakit

dada,

atau

baru

mengalami

pedih hulu hati atau pedih hulu hati

yang

sudah

anda

alami

bertambah

teruk,

berhenti

mengalami

Alendronate

Sandoz

hubungi

doktor anda.

Selepas

menelan

Alendronate

Sandoz

anda,

tunggu

sekurang-

kurangnya

minit

sebelum

mengambil makanan atau minuman

pertama

anda

atau

ubat

lain

yang

perlu diambil pada hari itu, termasuk

antasid, makanan tambahan kalsium

vitamin.

Alendronate

Sandoz

hanya berkesan jika diambil apabila

perut anda kosong.

Anda

hendaklah

terus

mengambil

Alendronate

Sandoz

selama

yang

ditetapkan

oleh

doktor

andadalam

prekskripsi.

Alendronate

Sandoz

boleh

merawat

osteoporosis

anda

hanya jika anda terus mengambil pil

ini.

- Bila perlu digunakan

Ambil ubat ini betul-betul seperti yang

diarahkan oleh doktor anda. Sila tanya

doktor atau ahli farmasi anda jika anda

tidak pasti (lihat pada bahagian Berapa

banyak harus digunakan).

- Berapa lama perlu digunakan

Anda hendaklah mengambil ubat anda

setiap

hari.

Minta

nasihat

doktor

jika

anda ingin berhenti mengambil ubat ini,

Sungguhpun jika anda rasa sihat, anda

mungkin perlu terus mengambil ubat ini.

Jika

anda

mempunyai

sebarang

soalan

lanjut

tentang

penggunaan

produk

ini,

tanyalah doktor atau ahli farmasi anda.

- Jika terlupa menggunakan

Jika anda tertinggal satu dos, anda hanya

perlu mengambil satu pil pada pagi hari

anda teringat. Jangan ambil dua pil pada

hari yang sama. Kembali kepada jadual

asal

pengambilan

satu

sekali

seminggu pada hari yang anda pilih.

- Jika mengambil berlebihan (terlebih dos)

Jika anda mengambil terlalu banyak pil

secara tidak sengaja, minum satu gelas

penuh susu dan segera hubungi doktor

anda. Jangan paksa muntah, dan jangan

baring..

Jika

anda

mengambil

terlalu

banyak

Alendronate

Sandoz,

anda

mungkin

berasa sakit perut, pedih hulu hati atau

ulser.

Jika anda mempunyai sebarang soalan

lanjut

tentang

penggunaan

produk

ini,

tanyalah doktor atau ahli farmasi anda.

Semasa

menggunakan

Alendronate

Sandoz

- Perkara yang perlu dilakukan

Ambil ubat anda betul-betul seperti yang

diarahkan oleh doktor anda.

Makumkan

semua

doktor,

doktor

gigi

ahli

farmasi

yang

merawat

anda

bahawa

anda

sedang

menggunakan

Alendronate Sandoz.

Beritahu doktor anda dengan segera jika

anda

hamil

semasa

menggunakan

ubat

ini.

ALENDRONATE SANDOZ TABLET

Alendronic acid (70mg)

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

- Perkara yang tidak boleh dilakukan

Jangan

mula

mengambil

sebarang

ubat

baru

tanpa

berbincang dengan doktor atau

ahli farmasi anda,

Jangan

memberi

Alendronate

Sandoz

kepada

sesiapa,

walaupun

mereka

mempunyai

simptom

atau

keadaan

yang

sama dengan anda dengan anda.

Jangan berhenti menggunakan

ubat ini kecuali diarahkan

oleh doktor anda.

- Perkara yang perlu diberi perhatian

Memandu dan menggunakan mesin

Alendronate

Sandoz

boleh

menjejaskan

aktiviti

yang

memerlukan

kecerdasan

mental. Anda tidak sepatutnya memandu,

menggunakan

mesin

atau

melakukan

aktiviti

lain

yang

boleh

mendatangkan

bahaya sehingga anda tahu sama ada ubat

menjejaskan

keupayaan

anda

untuk

melakukan aktiviti ini.

Risiko kerengsaan esofagus

Kerengsaan, keradangan atau ulser gulet

(esofagus

tiub

yang

menghubungkan

mulut anda dengan perut anda) biasanya

berwujud dengan gejala sakit dada, pedih

hulu hati, kesakitan atau kesukaran untuk

menelan

mungkin berlaku, terutamanya

sekali jika pesakit tidak minum satu gelas

penuh

dan/atau

jika

pesakit

baring

kurang

daripada

minit

selepas

mengambil

Alendronate Sandoz. Kesan

sampingan

boleh

bertambah

buruk

jika pesakit terus mengambil Alendronate

Sandoz selepas mengalami gejala ini.

Diet

Pastikan

anda

mengambil

kalsium

vitamin D yang cukup dalam diet anda.

Doktor, ahli farmasi atau pakar diet anda

akan memberitahu jenis makanan yang

anda

patut

ambil

jika

anda

perlu

makanan tambahan.

Kebersihan mulut yang baik

Pastikan

anda

terus

mengamal

amalan

kebersihan

mulut.

Bersihkan

gigi

anda

dengan kerap dan melawat doktor gigi

anda secara rutin. Beritahu doktor gigi

bahawa

anda

sedang

menggunakan

Alendronate

Sandoz

sebab

beberapa

rawatan

pergigian

adalah

tidak

digalakkan.

Kesan-kesan sampingan

Seperti semua ubat, Alendronate Sandoz

boleh

menyebabkan

kesan

sampingan,

walaupun

bukan

semua

orang

mengalaminya.

Beritahu

doktor

anda

jika

anda

notis

kesan-kesan berikut dan apa-apa

yang

merisaukan anda:

Kesan-kesan sampingan yang umum:

Sakit kepala

Sakit abdomen

Sembelit

Cirit-birit

Kelebihan gas di dalam perut

atau usus (kembung perut)

Asid regurgitasi di mana asid

dari

perut

terlepas

dalam

gulet

(tiub

yang

menghubungkan tekak dengam

perut anda)

Sakit otot rangka (tulang, otot

atau sendi)

Kesan-kesan

sampingan

yang

tidak

umum:

Loya

Muntah

Keradangan

pada

perut

(gastritis)

Keradangan

pada

esofagus

(oesophagitis)

Tahi hitam (melaena)

Ruam

Gatal pada kulit (pruritus)

Kemerahan

pada

kulit

(erythema)

Kesan-kesan sampingan yang jarang:

Keradangan

pada

bahagian

dalam

mata

seperti

uvea

(uveítis),

sklera

(scleritis),

episklera (episcleritis)

Tindak

balas

alahan

seperti

geligata

(urticaria),

kebengkakan pada muka, bibir,

tangan

atau

tapak

kaki

(angioedema)

Kesan-kesan

sampingan

yang

sangat

jarang:

Masalah

kulit

termasuk

sindrom

Stevens-Johnson.

Beritahu

doktor

anda

dengan

segera

jika

kulit

anda

mula

menjadi merah dan kemudian

lepuh atau mengelupas.

Penembusan pada esofagus

Kesan-kesan

sampingan

yang

kekerapan tidak diketahui:

Osteonekrosis

(kematian

tisu

tulang). Beritahu doktor anda

dengan

segera

jika

anda

mendapati

apa-apa

masalah

pada tulang rahang (lihat pada

bahagian

Sebelum

menggunakan

Alendronate

Sandoz).

Sebaik-baiknya,

catatkan

yang

anda

alami,

bila

gejala

bermula

berapa

lama

anda

mengalaminya.

Kesan-kesan

sampingan

lain

yang

tidak disenaraikan boleh berlaku pada

pesakit yang lain. Beritahu doktor anda

jika

anda

mendapati

apa-apa

kesan

sampingan

yang

tidak

disenaraikan

dalam

risalah

menyebabkan

anda

rasa tidak sihat.

Anda boleh melaporkan sebarang kesan

sampingan atau kesan advers ubat kepada

Pusat

Pemantauan

Kesan

Advers

Ubat

Kebangsaan

melalui

Tel:

78835550,

atau

laman

portal.bpfk.gov.my

(Consumers

Reporting)

Cara

penyimpanan

dan

pelupusan

Alendronate Sandoz

- Penyimpanan

Simpan

tempat

yang

tidak

boleh

dicapai dan dilihat oleh kanak-kanak.

Jangan ambil pil selepas tarikh luput

yang dinyatakan pada pek gelembung

dan kotak.

Simpan pada suhu bawah 30°C dalam

pembungkusan asal.

- Pelupusan

Ubat

tidak

sepatutnya

dilupuskan

dalam

buangan

atau

bersama

sampah-sarap

rumah

anda.

Tanya

ahli

farmasi

anda

cara

untuk

melupuskan

ubat

yang

tidak

lagi

diperlukan.

Langkah

akan

membantu melindungi alam sekitar.

Maklumat lanjut

- Rupa dan warna produk

bersalut

selaput

putih,

bulat,

dwicembung,

dicetak

gores

dengan

“ALN 70” pada satu permukaan.

ALENDRONATE SANDOZ TABLET

Alendronic acid (70mg)

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

- Bahan-bahan kandungan

- Bahan aktif

Bahan aktif ialah sodium alendronate.

Setiap pil bersalut mengandungi 70mg

alendronic

acid

(sebagai

sodium

alendronate trihydrate).

- Bahan-bahan tidak aktif

Teras pil: Microcrystalline cellulose,

Colloidal anhydrous silica,

Croscarmellose sodium, Magnesium

stearate.

Salutan pil: Microcrystalline cellulose,

Carrageenan, Macrogol.

- No. MAL

MAL10080040A

Pengilang

Lek

Pharmaceuticals

d.d

Verovockova 57, S1-1526

Ljubjana, Slovenia

Pemegang pendaftaran produk

Novartis Corporation (M) Sdn Bhd

Level 22, Tower B, Plaza 33,

No.1, Jalan Kemajuan, Seksyen 13,

46200 Petaling Jaya,

Selangor, Malaysia.

Tarikh kemaskini RiMUP

18/11/2015

Nombor Siri

BPFK(R4/1)061115/00411

23-3-2019

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16-3-2019

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Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

14-3-2019


Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (Active substance: Beraprost sodium (modified release tablet)) - Transfer of orphan designation - Commission Decision (2019)1354 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003232

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, 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

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety