Vydate 24 L

Primær information

  • Handelsnavn:
  • Vydate 24 L Flydende middel
  • Lægemiddelform:
  • Flydende middel
  • Sammensætning:
  • 240 g/l oxamyl
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Vydate 24 L Flydende middel
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Sidste ændring:
  • 08-02-2018

Produktresumé: dosering, interaktioner, bivirkninger

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

This SDS adheres to the standards and regulatory requirements of the European Community and may not meet the

regulatory requirements of other countries.

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

Product information

Product name

Vydate

L (blue)

Synonyms

B10067501

Use of the

Substance/Preparation

insecticide

Company

Du Pont de Nemours (France) S.A.S.

Rue de L'Université 137

75334 Paris

Telephone

+330145506550

Telefax

Emergency telephone

number

+44-(0)2871-861.313

2. COMPOSITION/INFORMATION ON INGREDIENTS

Chemical nature of the

preparation

Carbamate in aqueous methanol solution

Chemical Name

CAS-No.

EC-No.

Classification

Concentration [%]

Methanol

67-56-1

200-659-6

F; R11

T; R23/24/25

R39/23/24/25

30 - 50

Oxamyl

23135-22-0

T+; R26/28

Xn; R21

N; R51

For the full text of the R phrases mentioned in this Section, see Section 16.

3. HAZARDS IDENTIFICATION

Flammable.

Toxic by inhalation and if swallowed.

Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

4. FIRST AID MEASURES

General advice

Call a physician or Poison Control Centre immediately. This product contains an

anticholinesterase compound. Do not use if under medical advice not to work

with such compounds. Never give anything by mouth to an unconscious person.

If breathing is irregular or stopped, administer artificial respiration.

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Inhalation

Move to fresh air. If victim is unconscious but breathing: Give oxygen.

Skin contact

Wash off immediately with soap and plenty of water. Take off contaminated

clothing and shoes immediately.

Eye contact

Rinse thoroughly with plenty of water, also under the eyelids. Keep eye wide

open while rinsing. If eye irritation persists, consult a specialist.

Ingestion

Drink 1 or 2 glasses of water. Do not induce vomiting without medical advice.

Notes to physician

Symptoms

constriction of pupils, blurred vision, weakness, headache, Daze, sweating,

muscle twitching, Breathing difficulties

Risks

This product is a cholinesterase inhibitor carbamate.

Treatment

Administer atropine sulphate as antidote. bis zur völligen Atropisierung

Morphine, 2-PAM and oxime therapy are contra-indicated.

5. FIRE-FIGHTING MEASURES

Suitable extinguishing

media

water spray, dry chemical, foam, carbon dioxide (CO2),

Extinguishing media which

must not be used for safety

reasons

high volume water jet, (contamination risk),

Special protective

equipment for fire-fighters

In the event of fire, wear self-contained breathing apparatus.

Further information

In the event of fire and/or explosion do not breathe fumes. (on small fires) If area

is heavily exposed to fire and if conditions permit, let fire burn itself out since

water may increase the area contaminated. Cool containers / tanks with water

spray.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions

Wear personal protective equipment. Evacuate personnel to safe areas.

Environmental precautions

Do not flush into surface water or sanitary sewer system. Do not contaminate

surface water. Do not allow material to contaminate ground water system.

Methods for cleaning up

Neutralise with sodium hydroxide and allow to stand for 4 hours. Soak up with

inert absorbent material. If liquid has been spilt in large quantities clean up

promptly by scoop or vacuum. Use approved industrial vacuum cleaner for

removal. Shovel into suitable container for disposal.

7. HANDLING AND STORAGE

Handling

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Advice on safe handling

Provide adequate ventilation. Wear personal protective equipment.

Advice on protection

against fire and explosion

Keep away from heat and sources of ignition.

Storage

Requirements for storage

areas and containers

Keep containers tightly closed in a dry, cool and well-ventilated place. Store in a

place accessible by authorized persons only. Keep out of the reach of children.

Advice on common storage

No materials to be especially mentioned.

Storage temperature

> 0 °C

Other data

: Do not freeze.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Engineering measures

Ensure adequate ventilation, especially in confined areas.

Personal protective equipment

Respiratory protection

Respirator with combination filter for vapour/particulate. respirator with A2B2-P3

filter

Hand protection

Material: solvent-resistant gloves (butyl-rubber)

Glove thickness: 0,4 - 0,7 mm

Wearing time: 480 min

Please observe the instructions regarding permeability and breakthrough time

which are provided by the supplier of the gloves. Also take into consideration the

specific local conditions under which the product is used, such as the danger of

cuts, abrasion, and the contact time.

Eye protection

face-shield tightly fitting safety goggles

Skin and body protection

protective suit

Hygiene measures

Wash hands before breaks and immediately after handling the product. Keep

away from food, drink and animal feeding stuffs. When using, do not eat, drink

or smoke. Remove and wash contaminated clothing and gloves, including the

inside, before re-use.

Protective measures

All chemical protective clothing should be visually inspected prior to use.

Clothing and gloves should be replaced in case of chemical or physical damage

or if contaminated.

9. PHYSICAL AND CHEMICAL PROPERTIES

Form

liquid,

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Colour

blue,

Odour

slight, sulphurous,

2,8 - 3,2 at 10 g/l ( 20 °C)

Solidification point

-5 °C

Flash point

23 °C , Method: closed cup

Flash point

30 °C , Method: open cup

Density

0,98 g/cm3 at 25 °C

Solubility/qualitative

completely miscible

Partition coefficient (n-

octanol/water)

POW: 0,33 log Pow: -0,48

Viscosity, dynamic

1 - 5 mPa/s at 20 °C, see user defined free text

10. STABILITY AND REACTIVITY

Conditions to avoid

: Processing temperature : > 130 °C

Hazardous decomposition

products

: Carbon oxides, nitrogen oxides (NOx), Heating can release vapours which can

be ignited.

Hazardous reactions

: Vapours may form explosive mixture with air. No decomposition if stored and

applied as directed.

11. TOXICOLOGICAL INFORMATION

Acute oral toxicity

LD50/rat male: 37 mg/kg

Acute oral toxicity

Methanol

LD50/rat : 5 628 mg/kg

Acute inhalation toxicity

LC50/1 h/rat : 0,3009 mg/l

Acute inhalation toxicity

Methanol

LC50/4 h/rat : 50 mg/l

Acute dermal toxicity

LD50/rat : > 5 000 mg/kg

Acute dermal toxicity

Methanol

LD50/rat : 15 800 mg/kg

Skin irritation

No skin irritation

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Eye irritation

No eye irritation

Sensitization

Did not cause sensitization on laboratory animals.

Repeated dose toxicity

Methanol

Inhalation rat, Exposure time: 90 d, NOEL: 13,3 mg/l

12. ECOLOGICAL INFORMATION

Elimination information (persistence and degradability)

Biodegradability

According to the results of tests of biodegradability this product is considered as

being readily biodegradable.

Ecotoxicity effects

Toxicity to fish

LC50/96 h/Oncorhynchus mykiss (rainbow trout): 12,4 mg/l

Toxicity to fish

Methanol

LC50/96 h/Fathead minnow: 28 100 mg/l

Aquatic toxicity

EC50/48 h/Daphnia: 1,95 mg/l

13. DISPOSAL CONSIDERATIONS

Product

In accordance with local and national regulations. Must be incinerated in a

suitable incineration plant holding a permit delivered by the competent

authorities. The product should not be allowed to enter drains, water courses or

the soil.

14. TRANSPORT INFORMATION

ADR

Class:

Packaging group:

Classification Code:

HI No::

UN-No:

2991

Labelling No.:

6.1, 3

Proper shipping name:

Carbamate pesticide, liquid, toxic, flammable (Oxamyl, Methanol)

IATA_C

Class:

Packaging group:

UN-No:

2991

Labelling No.:

6.1, 3

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Proper shipping name:

Carbamate pesticide, liquid, toxic, flammable (Oxamyl, Methanol)

IMDG

Class:

Packaging group:

UN-No:

2991

Labelling No.:

6.1, 3

Proper shipping name:

Carbamate pesticide, liquid, toxic, flammable (Oxamyl, Methanol)

15. REGULATORY INFORMATION

Labelling according to EC Directives

Symbol(s)

Toxic

Dangerous for the environment

Hazardous components:

Methanol

Oxamyl

R-phrase(s)

Flammable.

R23/25

Toxic by inhalation and if swallowed.

R39/23/24/25

Toxic: danger of very serious irreversible effects through

inhalation, in contact with skin and if swallowed.

R51/53

Toxic to aquatic organisms, may cause long-term adverse

effects in the aquatic environment.

S-phrase(s)

Keep out of reach of children.

Keep away from food, drink and animal feeding stuffs.

S20/21

When using do not eat, drink or smoke.

This material and its container must be disposed of in a safe

way.

S36/37

Wear suitable protective clothing and gloves.

In case of accident or if you feel unwell, seek medical advice

immediately (show the label where possible).

Use appropriate container to avoid environmental

contamination.

Exceptional labelling of

special preparations

To avoid risks to man and the environment, comply with the instructions for use.

16. OTHER INFORMATION

Text of R phrases mentioned in Section 2

Print Date: 2006 - 5 - 16

SAFETY DATA SHEET

according to EC directive 2001/58/EC

Vydate

®

L (blue)

Version 2.0

Revision Date 11.01.2005

Ref. 130000013373

Highly flammable.

Harmful in contact with skin.

R23/24/25

Toxic by inhalation, in contact with skin and if swallowed.

R26/28

Also very toxic by inhalation and if swallowed.

R39/23/24/25

Toxic: danger of very serious irreversible effects through inhalation, in contact with skin

and if swallowed.

Toxic to aquatic organisms.

May cause long-term adverse effects in the aquatic environment.

The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at

the date of its publication. The information given is designed only as a guidance for safe handling, use, processing,

storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The

information relates only to the specific material designated and may not be valid for such material used in

combination with any other materials or in any process, unless specified in the text.

Print Date: 2006 - 5 - 16

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


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

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

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

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Orphan designation: Somapacitan, Treatment of growth hormone deficiency, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: tilorone, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: tilorone, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Orphan designation: tilorone, Treatment of idiopathic pulmonary fibrosis, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: pemigatinib, Treatment of biliary tract cancer, 24/08/2018, Positive

Orphan designation: pemigatinib, Treatment of biliary tract cancer, 24/08/2018, Positive

Orphan designation: pemigatinib, Treatment of biliary tract cancer, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018

TGA operations over the holiday period 2018-19

TGA operations over the holiday period 2018-19

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018

Therapeutic Goods Administration - Australia

30-11-2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on the delegate's interim decision for alkyl nitrites

Therapeutic Goods Administration - Australia

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Renvela (Genzyme Europe B.V.)

Renvela (Genzyme Europe B.V.)

Renvela (Active substance: sevelamer (carbonate)) - Centralised - Variation - Commission Decision (2018)6225 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/993/X/39

Europe -DG Health and Food Safety

24-9-2018

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Lipomed GmbH)

Deferiprone Lipomed (Active substance: Deferiprone) - Centralised - Authorisation - Commission Decision (2018)6233 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4710

Europe -DG Health and Food Safety

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

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

24-9-2018

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

Sevelamer carbonate Zentiva (Active substance: Sevelamer carbonate) - Centralised - Variation - Commission Decision (2018)6214 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3971/X/11

Europe -DG Health and Food Safety

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

Mektovi (Pierre Fabre MEdicament)

Mektovi (Pierre Fabre MEdicament)

Mektovi (Active substance: binimetinib) - Centralised - Authorisation - Commission Decision (2018)6217 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004579/0000

Europe -DG Health and Food Safety

24-9-2018

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Eli Lilly Nederland B.V.)

Cyramza (Active substance: ramucirumab) - Centralised - Yearly update - Commission Decision (2018)6246 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Braftovi (Pierre Fabre MEdicament)

Braftovi (Pierre Fabre MEdicament)

Braftovi (Active substance: encorafenib) - Centralised - Authorisation - Commission Decision (2018)6216 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004580/0000

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Diacomit (Biocodex)

Diacomit (Biocodex)

Diacomit (Active substance: Stiripentol) - Centralised - Renewal - Commission Decision (2018)6254 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/664/R/21

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Novo Nordisk A/S)

Ryzodeg (Active substance: Insulin degludec/insulin aspart) - Centralised - Yearly update - Commission Decision (2018)6242 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Tresiba (Novo Nordisk A/S)

Tresiba (Novo Nordisk A/S)

Tresiba (Active substance: Insulin degludec) - Centralised - Yearly update - Commission Decision (2018)6244 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Neofordex (Laboratoires CTRS)

Neofordex (Laboratoires CTRS)

Neofordex (Active substance: dexamethasone) - Centralised - Yearly update - Commission Decision (2018)6239 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Lumark (IDB Holland B.V.)

Lumark (IDB Holland B.V.)

Lumark (Active substance: lutetium, isotope of mass 177) - PSUSA - Modification - Commission Decision (2018)6212 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010391/201712

Europe -DG Health and Food Safety