ATROPINE INJECTION

Main information

  • Trade name:
  • ATROPINE INJECTION
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 50mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • APEX LABORATORIES

Documents

Localization

  • Available in:
  • ATROPINE INJECTION
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
  • Therapeutic area:
  • anticholinergic,spasmoly
  • Therapeutic indications:
  • ORGANOPHOSPHATE POISONING | PRE-ANAESTHETIC | ANAESTHETIC PREMEDICANT
  • Product summary:
  • Pre-anaesthetic medication in horses, dogs and cats and treatment of organophosphate poisoning. Atropine is a parasympatholytic, mydriatic and partial antidote in organophosphate poisoning.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35677/0309
  • Authorization date:
  • 20-04-2009
  • Last update:
  • 15-06-2017

Summary of Product characteristics: dosage,interactions,side effects

Material Safety Data Sheet

Atropine Injection

Classified as hazardous according to the criteria of NOHSC

Product Name Atropine Injection

Recommended Use Pre-anaesthetic medication and treatment of organophosphate poisonings

in all species.

Supplier Details Apex Laboratories Pty. Ltd.

ACN Number 000 397 240

Street 61 Chivers Road

Suburb Somersby

State NSW

Country Australia

Post Code 2250

Phone +61 2 4372 1661 (Business hours – 8.30am – 5.00pm)

+61 2 4372 1668 (fax)

Website http://www.apexlabs.com.au

Emergency contact As above or Poisons Information Centre 131126 (Australia)

Classification Classified as hazardous according to the criteria of NOHSC

Risk Phrases R40/22 Harmful: possible risk of irreversible effects if swallowed.

Safety Phrases None allocated

ADG Class None allocated

Hazchem Code None allocated

Poisons Schedule S4

Ingredients CAS No Proportion TWA mg/m3 STEL mg/m3

Atropine sulphate 55-48-1 <10% not set not set

Other non hazardous ingredients NA to 100% not set not set

The TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a 5 day

working week over an entire working lifetime. The TWA exposure standard set by Worksafe Australia for dusts not otherwise specified is 10mg/m3. The

STEL (Short Term Exposure Limit) is an exposure value that should not be exceeded for more than 15 minutes and should not be repeated for more than 4

times per day. There should be at least 60 minutes between successive exposures at the STEL.

Ingestion Rinse mouth with water, give water to drink and seek medical advice.

Irrigate with copious quantities of lukewarm water for 10 minutes and seek

medical advice.

Skin Wash well with soap and water and if concerned seek medical advice.

Inhalation Generally not required. If concerned move to fresh air and seek medical

advice.

Extinguishing Media Dry agent, water fog, mist or spray, carbon dioxide. As appropriate for

surrounding material.

Combustion Hazards No known toxic hazards.

MSDS|Atropine Injection

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/56/Atropine+Injection/pdf

SECTION I Identification of the Material and Supplier

SECTION II Hazard Identification

SECTION III Composition

SECTION IV First Aid Measures

SECTION V Fire Fighting Measures

Precautions for Firefighters Wear self contained breathing apparatus and protective clothing.

Hazchem Code None allocated

Emergency Procedures Spillage of formulated product is unlikely to ever be serious, however, in

the event of a major spill, protect drains and water courses from

contamination.

Materials and Methods Wear protective clothing (overalls, gloves, goggles and boots). Shovel

spillage into clean, dry, labelled containers and dispose after consulting

appropriate authorities.

Precautions Always use good occupational work practices and observe

recommendations on the label. Keep exposure to this product to a

minimum. Prohibit eating, drinking and smoking in storage and handling

areas. Wash hands after handling and remove contaminated clothing and

any protective equipment before entering eating areas.

Conditions Store product in original containers as per label instruction (below 25oC,

air conditioning).

National Exposure Standards No exposure standard has been allocated for this mixture or any

significant ingredient within this mixture.

Biological Limit Values No biological limit has been allocated for this mixture.

Engineering Controls No specific engineering controls are required for this mixture.

Personal Protective Equipment

Eye protection is not normally necessary. If concerned wear protective

goggles or glasses. Wash hands after handling and prior to touching eye

and in particular handling contact lenses.

Skin Skin protection is not normally necessary, however it is good practice to

avoid contact with chemicals by wearing suitable gloves when handling.

Respiratory Protection from inhalation is not normally necessary. If ventilation is

inadequate or dust is likely to build up then use of a suitable dust mask

would be appropriate.

Appearance Clear solution.

Odour Non specific odour.

No data available.

Vapour pressure No data available.

Boiling point/range No data available.

Freezing/Melting point No data available.

Solubility No data available.

Specific gravity/density No data available.

Flash Points No data available.

Flammable limits (in air) No data available.

Ignition temperature No data available.

MSDS|Atropine Injection

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/56/Atropine+Injection/pdf

SECTION VI Accidental Release Measures

SECTION VII Handling and Storage

SECTION VIII Exposure Controls and Personal Protection

SECTION IX Physical and Chemical Properties

SECTION IX Physical and Chemical Properties

Chemical stability This mixture is stable under normal ambient and anticipated storage and

handling conditions of temperature and pressure.

Conditions to avoid No specific conditions to avoid other than extreme heat.

Incompatible materials No data available.

Decomposition products No known decomposition products.

Hazardous reactions No data available.

Handling of the formulated product is not expected to cause any adverse affects. The following data pertains

particularly to the active and any hazardous ingredients in the formulation, rather than this specific formulation.

Acute Health Effects

Ingestion

Eye contact may result systemic signs of overdose as described above.

Dilation of pupils and photophobia can also be expected.

Skin Skin contact may result in mild discomfort in sensitive individuals. Skin

signs may also be seen following ocular contact or ingestion.

Inhalation Respiratory signs may be seen following ingestion or ocular administration.

Chronic Health Effects

Ingestion Chronic ingestion is unlikely however the data available suggests that

signs as described above could be anticipated.

Repeated or prolonged exposure may lead to conjunctivitis, local irritation,

hyperaemia and oedema. There may be an increase in intraocular

pressure especially in patients with angle closure glaucoma.

Skin Chronic skin contact is unlikely.

Inhalation Chronic inhalation is unlikely.

Advice to Doctor There is individual variation in the susceptibility to atropine and children,

people with Downs Syndrome and the elderly may be more susceptible.

The adverse reactions and signs of toxicity seen following overdose

accidental ingestion or administration of atropine are related to its actions

at muscarinic and at high doses nicotinic receptors. The effects are dose

dependant and are usually reversible when administration is discontinued.

Carcinogenicity No ingredient in this formulation is known to be carcinogenic.

Compounding effects Atropine may cross the placenta and be excreted in breast milk.

Ecotoxicity No data available.

Persistence and Degradability No data available.

Mobility No data available.

Disposal Methods Empty containers may be recycled or sent to a commercial waste disposal

site. Unused product should be suitable for landfill however contact the

relevant local Waste Disposal Authority.

Special Precautions Do not dispose into sewers or waterways.

UN Number None allocated.

UN Shipping Name None allocated.

ADG Class None allocated

MSDS|Atropine Injection

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/56/Atropine+Injection/pdf

SECTION XI Toxicological Information

SECTION XII Ecological Information

SECTION XIIIDisposal Considerations

SECTION XIV Transport Information

Packing Group None allocated.

Special Precautions None allocated.

Hazchem Code None allocated

Poisons Schedule S4

Date This MSDS has been reviewed and updated as required in May 2009.

NOHSC: National Occupational Health and Safety Commission

ADG Class: Australian Dangerous Goods Class

CAS Number: Chemical Abstracts Service Number

TWA: Time Weighted Average

STEL: Short Term Exposure Limit

UN: United Nations

Disclaimer

This Material Safety Data Sheet has been developed according to WORKSAFE Australia, NOHSC Guidelines.

Hazard Classifications have been determined in consultation with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)].

However, to the best of our knowledge, the finished product is unlikely to cause harm to humans handling, administering and dispensing as per label

instructions.

The data, information and recommendations herein are represented in good faith and are believed to be correct as of the date hereof.

The purpose of this Material Safety Data Sheet is to describe products in terms of their safety requirements.

Apex Laboratories Pty Ltd make no representation of merchantability, fitness for a particular purpose or application, or of any other nature with respect to the

information or the product to which the information refers ("the product").

The information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability prior to use of the product.

The physical data shown herein are typical values based on material tested. These values should not be construed as guaranteed analysis of any specific lot

or as guaranteed specification for the product or specific lots hereof.

Due care should be taken to make sure that the use or disposal of this product and/or its packaging is in compliance with relevant Federal, State and Local

Government Regulations.

MSDS|Atropine Injection

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/56/Atropine+Injection/pdf

SECTION XV Regulatory Information

SECTION XVI Other Information

Key to Abbreviations

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

21-12-2018

FDA approves new treatment for adult patients with rare, life-threatening blood disease

FDA approves new treatment for adult patients with rare, life-threatening blood disease

The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.

FDA - U.S. Food and Drug Administration

20-12-2018

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

FDA - U.S. Food and Drug Administration

18-12-2018

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

[07-26-2016] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection).

FDA - U.S. Food and Drug Administration

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

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

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

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

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

30-7-2018

July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections

July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections

July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

8-5-2018

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.

FDA - U.S. Food and Drug Administration

8-5-2018

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall: Exposure to particulate matter may result in local irritation/swelling or more serious outcomes.

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

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Europe - EMA - European Medicines Agency

11-12-2018

Ziagen (ViiV Healthcare BV)

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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

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

19-11-2018


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

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Europe - EMA - European Medicines Agency

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

14-5-2018

Girolan and its associated name Apralan

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Girolan and its associated name Apralan (Active substance: Apramycin sulfate) - Community Referrals - Art 34 - Commission Decision (2018)2989 of Mon, 14 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/122

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety