Arixtra

Maklumat utama

  • Nama dagangan:
  • Arixtra® 2.5 mg/0.5 ml Solution For Injection
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Arixtra® 2.5 mg/0.5 ml Solution For Injection
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL20034441
  • Kemaskini terakhir:
  • 29-05-2018

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

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ARIXTRA

®

2.5 MG/0.5 ML SOLUTION

FOR INJECTION

Fondaparinux sodium (2.5 mg/0.5 ml)

Apakah yang ada pada risalah

ini

Apakah kegunaan ARIXTRA

Bagaimana ARIXTRA

berfungsi

Sebelum mengambil

ARIXTRA

Cara menggunakan

ARIXTRA

Semasa menggunakan

ARIXTRA

Kesan-kesan sampingan

Cara penyimpanan dan

pelupusan ARIXTRA

Maklumat Lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan ARIXTRA

Arixtra digunakan untuk:

mencegah pembentukan

bekuan darah dalam saluran

darah kaki atau peparu selepas

pembedahan ortopedik

(seperti pembedahan pinggul

atau lutut) atau pembedahan

abdomen

mencegah pembentukan

bekuan darah semasa, dan

tidak lama selepas satu

tempoh pergerakan terhad

kerana penyakit

merawat sesetengah jenis

serangan jantung atau angina

yang tenat (kesakitan yang

disebabkan oleh penyempitan

arteri di dalam jantung)

Bagaimana ARIXTRA

berfungsi

Arixtra merupakan sejenis ubat

yang membantu mencegah

pembentukan bekuan darah

dalam saluran darah (trombosis),

atau merawat bekuan darah jika

mereka sudah terbentuk (sejenis

agen antitrombotik). Ia berfungsi

dengan menghentikan satu

faktor pembekuan yang dikenali

sebagai Xa (“ten-A”) daripada

berfungsi di dalam darah.

Sebelum mengambil

ARIXTRA

Bila tidak boleh mengambil

Jangan gunakan Arixtra:

jika anda alah/hipersensitif

terhadap fondaparinux sodium

atau mana-mana bahan

kandungan Arixtra

jika anda sedang berdarah

dengan banyaknya

jika anda mempunyai

jangkitan jantung berbakteria

jika anda mempunyai

kerosakan buah pinggang

yang teruk

Berjumpa dengan doktor anda

jika anda rasa anda mengalami

mana-mana yang tersebut.

Arixtra tidak harus

dipreskripsikan untuk wanita

hamil kecuali betul-betul

diperlukan. Jika anda hamil, atau

rasa anda mungkin hamil,

beritahu doktor anda.

Penyusuan anak tidak disyorkan

semasa dirawat dengan Arixtra.

Sebelum mula mengambil

Sebelum anda diberi Arixtra,

doktor anda perlu tahu:

jika anda berisiko perdarahan

yang tidak terkawal

(hemoragi) termasuk:

- ulser perut

- gangguan perdarahan

- perdarahan dalam otak baru-

baru ini (perdarahan

intrakranium)

- pembedahan pada otak,

tulang belakang atau mata

baru-baru ini

jika anda pernah mempunyai

masalah pembekuan darah,

atau sejarah pengurangan

bilangan sel yang diperlukan

untuk pembekuan selepas

rawatan dengan heparin

(Heparin Induced

Thrombocytopenia)

jika anda mempunyai penyakit

hati

jika anda mempunyai penyakit

buah pinggang

jika anda berumur 75 tahun

dan ke atas

jika berat badan anda kurang

daripada 50 kg.

Berjumpa dengan doktor anda

jika anda rasa anda mengalami

mana-mana yang tersebut.

Jika mengambil ubat-ubat lain

Beritahu doktor atau ahli farmasi

anda jika anda sedang

mengambil sebarang ubat lain,

jika anda telah mengambil

sebarang ubat baru-baru ini, atau

jika anda mula mengambil ubat

baru. Ini termasuk ubat-ubat

yang anda membeli tanpa

preskripsi. Sesetengah ubat lain

mungkin menjejaskan cara

Arixtra berfungsi atau

meningkatkan kemungkinan

anda mengalami kesan-kesan

sampingan seperti pendarahan.

Cara menggunakan

ARIXTRA

Berapa banyak harus

digunakan

Dos biasa Arixtra ialah 2.5 mg

sekali sehari, disuntik pada masa

yang sama setiap hari.

Arixtra diberi melalui suntikan

di bawah kulit (subkutaneus) ke

dalam lipatan kulit bahagian

bawah abdomen. Untuk merawat

sesetengah jenis serangan

jantung, pengamal perubatan

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

mungkin memberi dos pertama

ke dalam vena (intravena).

Picagari ini telah diisi dengan

dos tepat yang anda perlukan.

Langkah-langkah penggunaan

Bahagian-bahagian picagari:

Penutup jarum

Pelocok

Pemegang

Penutup keselamatan

Arahan penggunaan

Cuci tangan anda dengan teliti

dengan sabun dan air dan

keringkan mereka dengan tuala.

2. Keluarkan picagari dari karton

dan memastikan:

tarikh luput masih belum

berlalu

larutan adalah jernih dan tidak

berwarna dan tidak

mengandungi partikel

picagari tidak dibuka atau

dirosakkan

3. Duduk atau baring dalam

posisi yang selesa.

Pilih satu tempat di bahagian

bawah abdomen (perut),

sekurang-kurangnya 5 cm di

bawah pusat perut anda (gambar

Gambar A

Gilir-gilirkan sebelah kiri dan

kanan bahagian bawah abdomen

untuk setiap suntikan. Ini akan

membantu mengurangkan

ketidakselesaan di tempat

penyuntikan.

Jika tidak dapat menyuntik di

bahagian bawah abdomen, tanya

jururawat atau doktor anda untuk

nasihat.

4. Bersihkan bahagian suntikan

dengan sapuan alkohol.

5. Keluarkan penutup jarum,

dengan pusingkannya terlebih

dahulu (gambar B1) dan

kemudian tariknya dengan lurus

daripada badan picagari (gambar

B2).

Gambar B1

Gambar B2

Buang penutup jarum itu.

Nota penting:

Jangan sentuh jarum itu atau

biarnya sentuh sebarang

permukaan sebelum suntikan.

Satu gelembung udara kecil

biasanya wujud di dalam

picagari ini. Jangan cuba

mengeluarkan gelembung udara

ini sebelum menyuntik – anda

mungkin mengurangkan kuantiti

ubat anda jika anda berbuat

demikian.

6. Picit kulit yang telah

dibersihkan dengan lembut

untuk membuat satu lipatan.

Pegang lipatan itu di antara ibu

jari dan jari telunjuk semasa

proses penyuntikan (gambar C).

Gambar C

7. Pegang picagari dengan kuat

di tempat pemegang. Masukkan

keseluruhan panjang jarum pada

sudut tegak ke dalam lipatan

kulit (gambar D).

Gambar D

8. Suntikkan semua kandungan

picagari dengan menekan

pelocok sejauh yang mungkin

(gambar E).

Gambar E

9. Lepaskan pelocok dan jarum

itu akan undur daripada kulit

secara automatik dan kembali ke

dalam sarung keselamatan di

mana ia akan dikunci untuk

selamanya (gambar F).

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Gambar F

Jangan lupuskan picagari yang

telah digunakan dalam sisa

buangan isi rumah. Lupuskannya

sebagaimana yang diarahkan

oleh doktor atau ahli farmasi

anda.

Bila perlu digunakan

Sentiasa gunakan Arixtra

sebagaimana yang diarahkan

oleh doktor anda. Berjumpa

dengan doktor atau ahli farmasi

anda jika anda tidak pasti.

Berapa lama perlu digunakan

Tempoh rawatan anda akan

bergantung kepada keadaan

anda. Doktor anda akan

menasihatkan anda.

Jangan berhenti menggunakan

Arixtra tanpa nasihat. Jika anda

menghentikan rawatan sebelum

diarahkan oleh doktor anda,

anda berkemungkinan tinggi

mengalami bekuan darah dalam

vena kaki atau peparu anda.

Hubungi doktor atau ahli farmasi

anda sebelum berhenti.

Jika terlupa menggunakan

Jika anda terlupa menggunakan

satu dos, suntikkannya sebaik

sahaja anda teringat. Jangan

suntikkan dos berganda untuk

menggantikan dos yang terlupa.

Jika anda tidak pasti tentang

langkah yang harus diambil,

tanya doktor atau ahli farmasi

anda.

Jika mengambil berlebihan

(terlebih dos)

Jika anda menggunakan terlalu

banyak Arixtra dengan tidak

sengaja, hubungi doktor atau

ahli farmasi anda untuk nasihat

secepat mungkin, kerana anda

mungkin mempunyai risiko

tinggi untuk mendapat

pendarahan.

Semasa menggunakan

ARIXTRA

Perkara yang perlu dilakukan

Berjumpa dengan doktor atau

ahli farmasi anda sebelum

menggunakan ubat anda dan

menggunakannya seperti yang

dipreskripsikan oleh doktor

anda.

Perkara yang tidak boleh

dilakukan

Ubat ini hanya dipreskripsikan

untuk anda sahaja. Jangan

berikannya kepada orang lain. Ia

mungkin memudaratkan mereka,

walaupun tanda-tanda mereka

sama dengan anda.

Jangan suntikkan Arixtra ke

dalam otot.

Perkara yang perlu diberi

perhatian

Arixtra belum diuji dengan

secukupnya di kalangan kanak-

kanak dan remaja di bawah

umur 17 tahun.

Penutup jarum picagari mungkin

mengandungi lateks. Beritahu

doktor anda jika anda alah

terhadap lateks.

Kesan-kesan sampingan

Seperti semua ubat, Arixtra

boleh menyebabkan kesan-kesan

sampingan, tetapi bukan setiap

orang mengalaminya.

Kesan-kesan sampingan biasa

Ini mungkin menjejaskan

sehingga 1 dalam 10 orang:

perdarahan (contohnya, dari

tempat pembedahan, lebam

berlebihan, darah di dalam

kencing dan najis, hidung

berdarah, jarang sekali,

perdarahan boleh berlaku

dalam dan di sekeliling otak

atau organ dalaman)

bengkak (edema).

Kesan-kesan sampingan biasa

yang mungkin muncul dalam

ujian darah anda:

anemia (penurunan bilangan

sel darah merah).

Kesan-kesan sampingan tidak

biasa

Ini mungkin menjejaskan

sehingga 1 dalam 100 orang:

sakit kepala

rasa sakit (loya), muntah

ruam, kulit gatal

lelehan dari tempat luka

pembedahan

demam

pembekuan darah tidak

normal

Kesan-kesan sampingan tidak

biasa yang mungkin muncul

dalam ujian darah anda:

penurunan atau peningkatan

bilangan platelet (sel darah

yang diperlukan untuk

pembekuan darah)

peningkatan sesetengah bahan

kimia (enzim) yang dihasilkan

oleh hati.

Kesan-kesan sampingan jarang

Ini mungkin menjejaskan

sehingga 1 dalam 1,000 orang:

reaksi alahan

keresahan, kekeliruan

pengsan, pening, tekanan

darah rendah, sensasi berputar

(vertigo)

mengantuk, keletihan

kemerahan kulit

batuk, kesesakan nafas

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

sakit dada, sakit kaki

cirit-birit, sembelit

sakit perut, ketakcernaan

jangkitan luka

iritasi pada tempat

penyuntikan.

Kesan-kesan sampingan jarang

yang mungkin muncul dalam

ujian darah anda:

peningkatan bilirubin (sejenis

bahan yang dihasilkan oleh

hati)

kalium rendah.

Beritahu doktor atau ahli farmasi

anda jika mana-mana kesan

sampingan tersenarai bertambah

buruk atau menyusahkan, atau

jika anda mendapati sebarang

kesan sampingan yang tidak

tersenarai dalam risalah ini.

Anda boleh melaporkan

sebarang kesan sampingan atau

kesan advers ubat kepada Pusat

Pemantauan Kesan Advers Ubat

Kebangsaan melalui No. Tel:

03-78835550, atau laman web

portal.bpfk.gov.my (Consumers

Reporting)

Cara penyimpanan dan

pelupusan ARIXTRA

Penyimpanan

Jauhkan daripada capaian dan

penglihatan kanak-kanak.

Jangan bekukannya.

Jangan gunakan Arixtra:

selepas tarikh luput yang

tertera atas label dan karton

jika anda mendapati sebarang

partikel di dalam larutan, atau

jika larutan itu bertukar warna

jika anda mendapati picagari

telah rosak

jika anda telah membuka

picagari dan anda tidak

menggunakannya dengan segera.

Pelupusan

Jika anda mempunyai sebarang

picagari yang tidak diperlukan

lagi, jangan buang mereka ke

dalam sisa buangan isi rumah.

Tanya doktor atau ahli farmasi

anda untuk nasihat tentang cara

pelupusan picagari yang anda

tidak perlukan. Ini akan

membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Larutan ini merupakan cecair

yang jernih dan tidak berwarna.

Ia dibekalkan dalam picagari

yang sudah diisi dengan dos

tepat dan untuk penggunaan

sekali sahaja. Arixtra juga

dipasang dengan sistem

keselamatan automatik untuk

membantu mencegah kecederaan

cuckan jarum selepas

penggunaan.

Bahan-bahan kandungan

Bahan aktif

Setiap picagari mengandungi

2.5 mg fondaparinux sodium di

dalam 0.5 ml larutan untuk

suntikan

Bahan tidak aktif

Sodium chloride, hydrochloric

acid or sodium hydroxide for pH

adjustment as necessary, water

for injection.

Nombor MAL

MAL20034441A

Pengilang

Aspen Notre Dame De

Bondeville

1, Rue De L’Abbaye

76960

Notre Dame De Bondeville

France

Pemegang Pendaftaran

Produk

Aspen Medical Products

Malaysia Sdb Bhd

Unit 1302A, Level 13A, Uptown

1, 1 Jalan SS21/58, Damansara

Uptown, 47400 Petaling Jaya,

Selangor, Malaysia

Tarikh kemaskini RiMUP

24/07/2015

Nombor Siri

BPFK(R4/1)220715/00218

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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

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

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency